Histogen's Composition for Oncology Treatments Receives US Patent

SAN DIEGO, October 8, 2014 - Histogen Oncology, a company developing innovative cancer therapies based on Histogen's regenerative medicine technology, today announced that the United States Patent & Trademark Office has issued patent 12/363,479 entitled "Extracellular matrix compositions for the treatment of cancer" to Histogen.

The patent, which is the fifth U.S. patent issued to Histogen, covers the soluble and insoluble compositions of proteins and cofactors that are secreted by multipotent stem cells through Histogen's technology process for use in the treatment of cancer. The patent claims support of the use of the compositions alone or as a delivery system for traditional chemotherapeutic agents.

Through the recent formation and funding of the Histogen Oncology joint venture, research and development of the unique, naturally secreted compositions is progressing toward a Phase I clinical trial for end stage pancreatic cancer.

"We are pleased about the timely issuance of our U.S. patent for the treatment of cancer," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "Our collaborations with top institutions continue to produce mounting evidence supporting the unique mechanism of action of our secreted material in preventing metastasis and reducing tumor load while having no toxic affect on normal cells."

Histogen's composition has shown effectiveness in inhibiting over 21 human cancer cell lines both in vitro as well as in animal models. The mechanism of action of the secreted material is through the induction of apoptosis (controlled cell death) primarily in malignant cells, so there is little to no toxicity to normal cells. Histogen Oncology is studying the efficacy of a small molecular weight fraction of the cell secreted composition as a stand alone treatment as well as in combination therapy to evaluate whether effectiveness can be demonstrated with less toxic drug doses.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.

Contacts
Eileen Brandt, (858) 200-9520
ebrandt@histogeninc.com


Histogen Oncology Created to Develop Novel Biologic Cancer Treatments
Histogen, Inc. and Wylde, LLC Form Joint Venture

SAN DIEGO, July 8, 2014 - Histogen Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, has partnered with Southern California medical device group Wylde, LLC to create Histogen Oncology. This joint venture will focus on the development of unique cell-derived materials for cancer applications.

Under this joint venture, Histogen Oncology has acquired exclusive rights to Histogen's human multipotent cell conditioned media (CCM) and extracellular matrix (ECM) materials, as well as their derivatives, for oncology applications throughout North America. Histogen Oncology's initial clinical focus is pancreatic cancer, a highly treatment-resistant cancer in which a sub-fraction of the CCM has shown substantial preclinical promise.

"We have been very impressed with the results of Histogen's preliminary oncology work, not only because of the significant survival benefit but also because it is a naturally-derived material that is showing no toxicity," said Christopher Wiggins of Wylde, LLC. "There are so many patients out there who are not candidates for existing therapies due to the toxic nature of available drugs. This is particularly true in pancreatic cancer, where 80% of people diagnosed already have stage four disease."

In post-resection nude mouse models, intravenous treatment with the CCM sub-fraction resulted in prolonged survival by more than three fold in a majority of treated animals. In non-resection models, more than 50% of treated mice lived twice as long as the control. These results point to a potentially significant outcome for pancreatic cancer patients, and Histogen Oncology intends to progress the material toward a Phase I clinical trial for no-option pancreatic cancer patients in the coming 18 months.

Research on the mechanism responsible for cancer cell inhibition by the CCM shows the upregulation of Caspase 9 and cleaved Caspase 3, which causes cancer cells to enter apoptosis, or programmed cell death.

"The activity of the CCM sub-fraction is unique in a number of ways. Whereas most cancer therapies target rapidly dividing cells but not cancer stem cells, the inhibitory effect of this material is seen in malignant cells and circulating tumor cells as well," said Dr. Gail Naughton, CEO and Chairman of the Board of Histogen, Inc. "In addition, the activity is selective for malignant cells, supporting the proliferation of human dermal fibroblasts, embryonic stem cells and mesenchymal stem cells, while inhibiting tumor growth."

Histogen Oncology will be supported by Histogen's research group and funded by Wylde, LLC., made up of experts from the surgery and medical device industries. The creation of this joint venture allows for dedicated development of the CCM sub-fraction as a cancer treatment, as Histogen continues to allocate resources to the Company's revenue-generating aesthetic and promising therapeutic programs.

"We are extremely excited to fuel and push the next stage of development for this innovative and potentially life-saving therapy," said Wiggins. "The next generation of cancer treatment will have cell-signaling at its core, be beneficial in combination with existing therapies as well as stand alone, and provide an option to patients who currently have none. We believe Histogen's material has all of those characteristics and more."

About Histogen Aesthetics
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.

Contacts
Eileen Brandt, (858) 200-9520
ebrandt@histogeninc.com


Histogen Aesthetics Acquires CellCeuticals Biomedical Skin Treatments

SAN DIEGO, March 10, 2014 - Histogen Aesthetics, a subsidiary of regenerative medicine company Histogen, Inc. focused on skin care and cosmeceuticals, announced today that the Company has acquired the CellCeuticals Biomedical Skin Treatments line of skincare products.

Histogen Aesthetics will continue sales of the eleven existing CellCeuticals Biomedical Skin Treatments skincare products, while bringing new innovation to the line through the addition of a unique regenerative medicine technology, working to improve skin aging at a cellular level.

"We have long admired the science, clinical data and elegant formulas behind the CellCeuticals line, and see it as an ideal fit for our recently revitalized aesthetics subsidiary," said Dr. Gail K. Naughton, CEO and Chairman of Histogen, Inc. "We are very excited to begin infusing unique cell-signaling factors into the CellCeuticals regimen, to truly transform skin one cell at a time."

Dr. Naughton has spent more than 30 years in tissue engineering and regenerative medicine, and holds over 100 patents in the field. She founded Histogen in 2007, focused on developing therapies that work to stimulate the stem cells in the body to regenerate tissues and organs. Through this work, she has also seen how different compositions of human proteins can have cosmetic benefits, particularly in anti-aging and rejuvenation.

"I am pleased that the CellCeuticals Biomedical Skin Treatments will evolve, and see Histogen Aesthetics as an excellent home for this innovative product line," said Paul Scott Premo, co-founder of CellCeuticals Skin Care, Inc. "I believe the addition of this regenerative medicine technology will be the opportunity to introduce a new generation of products that are the vanguard of regenerative skin care."

The CellCeuticals system is made up of eleven distinctive products including the Extremely Gentle Skin Cleanser, CellGenesis Regenerative Skin Treatment, and PhotoDefense Color Radiance SPF55+ with proprietary and patented PhotoPlex technology. The line is currently available at retailers including QVC.com, Dermstore.com, and Nordstrom.com, as well as www.cellceuticalskincare.com.

About Histogen Aesthetics
Histogen Aesthetics LLC, formed in 2008 as a subsidiary of Histogen, Inc., focuses on the development of innovative skin care products utilizing regenerative medicine technology. Histogen Aesthetics' technology is based on the expertise of founder Dr. Gail K. Naughton, in which fibroblasts are grown under unique conditions, producing a complex of naturally-secreted proteins and synergistic bio-products known to stimulate skin cells to regenerate and rejuvenate tissues. In 2014, Histogen Aesthetics acquired CellCeuticals Biomedical Skin Treatments, a line of scientifically-proven products that reactivate cells to help aging skin perform and look healthier and younger. For more information, visit www.cellceuticalskincare.com.

About Suneva Medical, Inc.
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process is also being researched for oncology applications, and in orthopedics through joint venture PUR Biologics, LLC. For more information, please visit www.histogen.com.

Contacts
Eileen Brandt, (858) 200-9520
ebrandt@histogeninc.com


Histogen and Suneva Medical Expand License for Cell Conditioned Media-based Aesthetic Products Internationally

SAN DIEGO, CA, January 14, 2014 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, today announced that they have entered into an international license agreement with Suneva Medical, Inc. for physician-dispensed aesthetic products containing Histogen's proprietary multipotent cell conditioned media (CCM).

This agreement is an amendment to the existing license between Histogen and Suneva Medical, through which Suneva has exclusively licensed the Regenica® skincare line within the United States since February 2012. Under the terms of the international agreement, Suneva Medical is now the exclusive licensee for the distribution of Regenica through the physician-dispensed channel in Europe, most of Asia, South America, Canada, Australia, and the Middle East.

"Not only has Suneva had sales success, but they have generated enthusiasm around the Regenica product line and our technology here in the US," said Gail K. Naughton, Ph.D., CEO and Chairman of the Board of Histogen. "We are excited about expanding our skincare partnership internationally, and look forward to an exciting year for Regenica."

Regenica contains Histogen's proprietary Multipotent Cell Conditioned Media, made up of soluble cell-signaing proteins and growth factors which support the body's epidermal stem cells and renew skin throughout life. Through Histogen's technology process, which mimics the embryonic environment including conditions of low oxygen and suspension, cells are triggered to become multipotent, and naturally produce these proteins associated with skin renewal and scarless healing.

"We believe that Regenica truly is the next generation in growth factor technology, and we are extremely pleased that the products will now have a presence around the world," said Nicholas L. Teti, Jr., Chairman and Chief Executive Officer of Suneva Medical. "Our relationship with Histogen in the US physician market has been a valuable asset to Suneva, and has laid the groundwork for international success."

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit www.histogen.com.

About Suneva Medical, Inc.
Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the general dermatology and aesthetic markets. The company currently markets Artefill® in the US, Korea, Singapore and Vietnam; Refissa® and Regenica® Skincare in the U.S.; and Bellafill® in Canada. For more information, visit www.sunevamedical.com.

Regenica® is a trademark of Suneva Medical, Inc. The Multipotent Cell Conditioned Media Complex is covered by U.S. patents #8,257,947 and #8,524,494.


Multipotent Stem Cell Proteins Support Soft Tissue Regeneration
Histogen to present data at TERMIS AM Annual Conference in Atlanta

ATLANTA, November 13, 2013 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, announced that Dr. Michael Zimber will give a podium presentation entitled "Human Multipotent Stem Cell Proteins Support Soft Tissue Regeneration" today at the Tissue Engineering and Regenerative Medicine International Society (TERMIS) Americas Annual Meeting in Atlanta, GA.

Through its proprietary technology process that simulates the conditions of the embryonic environment, Histogen has developed a human extracellular matrix (hECM) material composed of stem cell-associated proteins including SPARC, decorin, collagens I,III,IV, V, fibronectin, fibrillin, laminins, and hyaluronic acid. The hECM's distinctive composition of growth factors and other proteins are known to stimulate stem cells in the body, regenerate tissues, and promote scarless healing.

Histogen sought to examine whether the hECM may promote scarless healing in full thickness wounds, similar to that seen in fetal healing, using a variety of forms of the material, including hollow spheres to maximize void fill volume. In preclinical studies, all hECM-treated wounds healed rapidly with minimum contractions, and the hECM microspheres had a statistically significant improvement in healing as compared to the controls (p<0.05) and produced a 25% thicker dermis. In addition, hECM applied topically after microneedling resulted in up to a 3X dermal thickening.

"We are very pleased that our propriety materials produced by hypoxia-induced human multipotent stem cells have shown significant healing results in both soft and hard tissues," said Dr. Gail Naughton, CEO and Chairman of the Board of Histogen. "These results open new therapeutic markets, show tremendous potential for our material in cutaneous wound care and orthopedics, as well as support the expansion of our aesthetic pipeline to include soft tissue fillers."

In addition to "Human Multipotent Stem Cell Proteins Support Soft Tissue Regeneration", Dr. Zimber will also be presenting "Human Multipotent Stem Cell Proteins Support Osteogenesis In Vitro" during the TERMIS AM Annual Meeting taking place November 10-13, 2013 in Atlanta. Following the event, these presentations will be available upon request.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit www.histogen.com.


Multipotent Stem Cell Proteins Support Rejuvenation while Inhibiting Skin Cancer
Histogen to present data at TERMIS AP Annual Conference in Shanghai

San Diego, October 24, 2013 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, announced that the Company's Chairman and CEO, Dr. Gail Naughton, will present today at the Tissue Engineering and Regenerative Medicine International Society (TERMIS) Asia Pacific Annual Meeting in Shanghai, China.

Through its proprietary technology process that simulates the conditions of the embryonic environment, Histogen is uniquely able to trigger the de-differentiation of skin cells into multipotent stem cells without genetic manipulation. The cells express key stem cell markers including Oct4, Sox2 and Nanog, and secrete a distinctive composition of growth factors and other proteins known to stimulate stem cells in the body, regenerate tissues, and promote scarless healing.

It is the soluble and insoluble compositions of multipotent proteins and growth factors resulting from this process that have been shown to both promote skin regeneration and induce controlled cell death in multiple skin cancers.

"The anti-aging and rejuvenation benefits of human multipotent stem cell proteins have been shown in several clinical studies, and have resulted in the material's use as a thriving next-generation ingredient for skin care," said Dr. Naughton. "In parallel, we have also been studying the anti-cancer activity of these proteins, and have shown that, just as in the embryonic environment, they support normal tissue growth while resulting in the controlled death of cancer cells".

In vitro studies performed with Histogen's material have shown reduction in Squamous Cell Carcinoma (SCC), Basal Cell Carcinoma, and Melanoma cell number through the mechanism of apoptosis, or controlled cell death, induced by the upregulation of Caspase in these cancer cells. In one in vivo model, melanoma load was reduced by up to 80% versus the control (p<0.05) by the addition of the insoluble multipotent stem cell proteins, and a dose response curve was seen. Similar inhibition was seen with SCC. In subcutaneous mouse experiments, tumor growth was inhibited by 70-90%.

"Human Multipotent Stem Cell Proteins Stimulate Skin Regeneration While Inducing Skin Cancer Cell Apotosis" will be presented by Dr. Naughton during the TERMIS AP Annual Meeting taking place October 23-26, 2013 in Shanghai. Further information and data on the ability of multipotent stem cell proteins to induce apoptosis in skin cancers can be found in the publication Journal of Cancer Therapy at file.scirp.org/Html/1-8901700_33923.htm.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit www.histogen.com.


Histogen to present at 2013 STEM CELL MEETING ON THE MESA

San Diego, October 11, 2013 - Histogen, Inc., a regenerative medicine company developing therapies for conditions including hair loss and cancer, announced today that Histogen CEO Gail K. Naughton, Ph.D. will give a company presentation at the 3rd Annual Regen Med Partnering Forum, part of the Stem Cell Meeting on the Mesa to be held October 14-16 in La Jolla, CA.

Histogen's solutions are based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. The technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of proteins that have been shown to support stem cell growth and differentiation.

"It is an exciting time for Histogen, as we continue to move the technology forward with expanded partnerships in skincare, compelling clinical data in both male and female hair loss, and early but exciting results in orthopedics," said Dr. Naughton. "We look forward to sharing our story during the Stem Cell Meeting on the Mesa, and to progressing our products even further through growing relationships with industry leaders and through our potential merger with Stratus Media to form publicly-traded Restorgenex."

Organized by the Alliance for Regenerative Medicine (ARM), the California Institute for Regenerative Medicine (CIRM) and the Sanford Consortium for Regenerative Medicine, the 2013 Stem Cell Meeting on the Mesa is a three-day conference aimed at bringing together senior members of the regenerative medicine industry with the scientific research community to advance stem cell science into cures. The Regen Med Partnering Forum, held October 14 &15 at the Estancia La Jolla Hotel, is the only partnering meeting organized specifically for the regenerative medicine and advanced therapies industry.

The following are specific details regarding Histogen's presentation at the conference:

Event: Regen Med Partnering Forum - 2013 Stem Cell Meeting on the Mesa
Date: October 14, 2013
Time: 3:15pm
Location: Estancia La Jolla Hotel & Spa, 9700 North Torrey Pines Road, La Jolla

A live video webcast of all company presentations will be available at: stemcellmeetingonthemesa.com/webcast and will also be published on ARM's website shortly after the event. Histogen will also make a copy of Dr. Naughton's presentation available at www.histogen.com.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products. For more information, please visit www.histogen.com.


Stratus Media Group and Histogen Execute Letter of Intent for Biotechnology Merger

LOS ANGELES, October 07, 2013 - Stratus Media Group, Inc. (OTCQB:SMDI) announced today that it was planning to expand its entrance into the biotechnology industry with the execution of a letter of intent between the Company and Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer.

The non-binding letter of intent outlines the primary terms of a merger of San Diego-based Histogen into Stratus, to be renamed Restorgenex Corporation. The letter of intent has been approved by the board of directors of both companies, and the parties are engaged in completing a formal merger agreement.

Histogen's solutions are based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. The technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of proteins that have been shown to support stem cell growth and differentiation. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in skincare products including ReGenica, which is distributed by Suneva Medical in partnership with Obagi Medical Products.

"Histogen's technology platform opens a spectrum of potential product opportunities in both aesthetics and therapeutics, an ideal fit with our vision for Restorgenex," said Sol J. Barer, Ph.D., who will assume the position of Chairman of the Board of Restorgenex effective November 1, 2013. "The expertise of the Histogen team in developing regenerative products from concept to market, along with the success Histogen has already found in skincare partnering, will add significant value to our Company."

Following successful completion of this proposed merger, the company's goal is to build Restorgenex into a world-class cosmeceutical and pharmaceutical company in the large and expanding fields of dermatology and hair restoration. The parties intend to move toward a formal merger agreement in which Histogen would become a wholly-owned subsidiary, Histogen founder Gail K. Naughton, Ph.D. would assume the position of Chief Executive Officer of Restorgenex, and the corporate headquarters of Restorgenex would be located in San Diego. The merger will require, among other things, the satisfaction of customary closing conditions including the approval of Histogen's shareholders.

"I am very excited about the potential of a merger between Histogen and Restorgenex, and look forward to moving into the next stage," said Dr. Naughton. "It is an honor to be working with biotechnology visionaries Dr. Sol Barer and Isaac Blech, and to have them recognize the promise of Histogen's products is a true testament to the unique and exciting nature of our technology."

Dr. Naughton has spent more than 25 years extensively researching the tissue engineering process, holds more than 95 U.S. and foreign patents, and has been honored for her pioneering work in the field by prestigious organizations including receiving the Intellectual Property Owners Association Inventor of the Year Award.

Prior to founding Histogen in 2007, Dr. Naughton oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four human cell-based products from concept through FDA approval and market launch as President of Advanced Tissue Sciences.

"I believe the potential acquisition of Histogen, and the expertise and vision Dr. Naughton will bring as Chief Executive Officer will be a tremendous asset in ushering the Company into the biotechnology industry," said Jerold Rubinstein, current Chairman and Chief Executive Officer of Stratus.

www.histogen.com
www.stratusmediagroup.com

Forward-Looking Statements
Statements in this press release relating to plans, strategies, projections of results, and other statements that are not descriptions of historical facts may be forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the Securities Acts of 1933 and 1934. Forward-looking information is inherently subject to risks and uncertainties, and actual results could differ materially from those currently anticipated due to a number of factors. Although the company's management believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, performance or achievements. The company has no obligation to update these forward-looking statements.

Contacts
Histogen, Inc.
Eileen Brandt, (858) 200-9520
ebrandt@histogeninc.com

Stratus Media Group, Inc.
Tim Boris, 310-526-8700
timb@stratusmediagroup.com


Histogen's Composition for Hair Growth Receives US Patent

SAN DIEGO, September 17, 2013 - Histogen, Inc., a regenerative medicine company developing innovative therapies based on the products of cells grown under simulated embryonic conditions, today announced that the United States Patent & Trademark Office has issued patent 8,535,913, entitled "Soluble Composition for Promoting Hair Growth Produced by Hypoxic Culture of Fibroblast Cells".

The patent, which is the fourth US patent issued to the Company, covers the liquid composition of proteins and cofactors that is secreted by multipotent stem cells through Histogen's technology process, and the method of administering that composition to stimulate hair growth. Histogen's Hair Stimulating Complex (HSC), covered by this new patent, is in clinical development as an injectable treatment for male pattern and female diffuse hair loss.

"We are extremely pleased that HSC, and future hair restoration treatments using this technology, are now bolstered by a US patent," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "At a time when the industry continues to uncover information about how cell-signaling results in hair growth and maintenance, patent protection for our unique composition of proteins and growth factors is of great benefit to Histogen and its future partners."

Several factors critical to hair growth such as follistatin, VEGF and KGF, are present in HSC, and their secretion by the cells is stimulated by low oxygen and special culture conditions utilized by Histogen. The conditions under which the cells are manufactured not only upregulates genes associated with hair growth, but induces significantly increased production of these critical factors than seen with traditional culture conditions.

In two Company-sponsored clinical trials, HSC has resulted in statistically significant increases across hair growth parameters, including hair count, density and thickness. In addition, the treatment has shown efficacy in difficult-to-treat patient groups, including women, older subjects and those with temporal recession region hair loss. Histogen looks forward to progressing HSC to the next clinical stage, and to further analyzing its newly-patented composition.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.


Histogen's Method of Generating Multipotent Stem Cells Receives US Patent

SAN DIEGO, September 3, 2013 - Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer, today announced that the United States Patent & Trademark Office has issued patent 8,524,494, entitled "Low Oxygen Tension and bFGF Generates a Multipotent Stem Cell from a Fibroblast In Vitro" to the Company.

The issued patent covers Histogen's method of triggering the de-differentiation of fibroblast cells into multipotent stem cells through low oxygen and special culture conditions. The resulting multipotent cells naturally secrete a variety of soluble and insoluble molecules that are the basis for Histogen's products.

"Histogen's process is uniquely capable of harnessing all of the benefits and excitement of stem cell therapies without any of the ethical, safety or sourcing concerns," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "Issuance of this patent adds great strength to our technology, and value to our partners and products."

Current stem cell-derived therapies utilize embryonic stem cells or genetically-manipulated induced pluripotent stem cells, both of which have an inherent ethical and scientific risk, and raise a number of regulatory issues. Still, enthusiasm continues to build around stem cells, both for their potential to address serious medical conditions as well as their aesthetic benefits for beauty and rejuvenation.

Through Histogen's technology process, the Company is uniquely able to begin with newborn fibroblasts cells, a safe, well-established and non-controversial cell source, and convert the cells into multipotent stem cells without genetic manipulation. The cells express key stem cell markers including Oct4, Sox2 and Nanog, and secrete a distinctive composition of growth factors and other proteins known to stimulate stem cells in the body, regenerate tissues, and promote scarless healing.

It is the soluble and insoluble compositions of multipotent proteins and growth factors which make up Histogen's products, with numerous applications. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in two Company-sponsored clinical trials as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's process can be found in the ReGenica line of skincare products, currently being distributed by Suneva Medical in partnership with Obagi Medical Products. Further indications of the materials currently being developed include oncology and orthopedics.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.


Histogen Wins Appellate Court Hearing in SkinMedica Patent Case

SAN DIEGO, August 26, 2013 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, today announced that the United States Court of Appeals for the Federal Circuit has affirmed a lower court decision that the Company does not infringe patents in the lawsuit that SkinMedica, Inc. filed against Histogen in 2009.

SkinMedica had previously sued the Company for infringement of United States Patent Nos. 6,372,494 (titled "Methods of making conditioned cell culture medium compositions") and 7,118,746 (titled "Conditioned cell culture medium compositions and methods of use"). In 2011, the United States District Court for the Southern District of California granted the Company's Motion for Summary Judgment, confirming a finding of noninfringement. SkinMedica appealed the Summary Judgment Order, and on August 23, 2013 was rebuffed again by the Federal Circuit.

"We are excited to have confirmation from the Federal Circuit Court of Appeals that Histogen's technology is unique, and outside of SkinMedica's patent rights," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "We look forward to continuing the rapid revenue growth we're seeing in our skincare business through our current partners, bringing on new partners in the near future, and expanding the skin care line to other aesthetic applications."

Histogen's proprietary human multipotent cell conditioned media is the key ingredient in the ReGenica line of skincare products within the United States, and will be incorporated into additional cosmetic products in various countries through promising partnerships.

The Federal Circuit Court of Appeals affirmed the grant of Motion for Summary Judgment in case 2012-1560 following a hearing on May 9, 2013. A copy of the appellate court opinion is available upon request.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.


Histogen Creates PUR Biologics, a Joint Venture Developing Next-Generation, Biologic Solutions in Orthopedic Applications

ALISO VIEJO, March 11, 2013 - Histogen Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, has partnered with a Southern California medical device executive management and investment group to establish PUR Biologics, LLC. PUR is a joint venture focused on the emerging field of biologics for musculoskeletal conditions, including spine, dental and medical device applications.

Under this joint venture, PUR Biologics has acquired exclusive worldwide rights to Histogen's human multipotent cell conditioned media (CCM) and extracellular matrix (ECM) materials for use in the orthopedic areas of bone, cartilage, spinal disc and ligament regeneration, as well as device coatings. A soluble composition of naturally-secreted proteins, the CCM contains growth factors such as follistatin and stem cell factor which are known to stimulate stem cell growth, differentiation, and tissue regeneration. The insoluble ECM, made up of a variety of collagens and other matrix proteins, holds promise as an excellent biologically-active filler, attracting fibroblasts and stem cells as well as supporting new tissue growth.

"Regenerative technologies are paramount in advancing the current state of orthopedics and neurosurgery," said Dr. Chad Prusmack Chief of Neurosurgery at Rocky Mountain Spine Clinic and consultant to the Denver Broncos. "The use of naturally-secreted human growth factors and matrix proteins, known to stimulate and support stem cell growth in the body, can prove to be transformational in the regeneration of multiple musculoskeletal and neuronal tissues .These unique preparations may be the universal 'transducer' needed for optimizing directed stem cell differentiation and healthy proliferation."

PUR Biologics will build upon early proof-of-concept data to bring orthopedic products based on the CCM and ECM through all stages of development and commercialization. The Company's first research and development efforts will be in the area of bone regeneration, which has potential benefit in a number of orthopedic applications.

The joint venture will be managed and funded by Histogen's partner group, made up of experts from the surgery and medical device industries. Ryan Fernan, CEO of the newly-created PUR Biologics, has spent more than a decade in medical sales and management, including bringing OC Surgical from a fledgling medical device distributorship to a multi-million dollar orthopedic business during his time as President of the Company. PUR Biologics' management and investment group has a proven track record synergistically packaging technologies and advancements in surgery to serve unmet medical needs.

"We are extremely excited to have access to Histogen's groundbreaking scientific platform," said Ryan Fernan. "Coupled with our extensive experience in product development, sales, and distribution, this will be a powerful relationship that will fuel development of much needed innovation in this space."

The creation of PUR Biologics allows Histogen to support the research required to bring its biologic products toward commercialization in the rapidly growing multi-billion dollar orthopedic market, while continuing to dedicate resources to the Company's other promising aesthetic and therapeutic programs.

"Histogen's preliminary studies have shown that our human CCM and ECM materials support stem cell growth and differentiation into bone and other structural tissues, making orthopedics a promising and exciting area of research for our products," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "This joint venture provides Histogen the opportunity to see its innovative cell-derived products make strides in the large and important orthopedic market, while continuing to focus on development of its hair growth, skincare and oncology applications."

About PUR Biologics
PUR Biologics is dedicated to providing regenerative biologic solutions to address musculoskeletal surgical needs, including spine, dental, ligament and medical device coating applications. In addition to distribution of approved allograft and biologic products, PUR is focused on development of next-generation orthopedic products based upon human protein and growth factor materials for bone and tissue regeneration. For more information visit www.purbiologics.com.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation. For more information, please visit www.histogen.com.

Contacts:

Eileen Brandt
Phone: (858) 200-9520
ebrandt@histogeninc.com


Histogen Announces Initial Results from Phase I/II Clinical Trial of HSC

Data shows significant efficacy at all time points and all treated hair loss regions

SAN DIEGO, October 19, 2012 - Histogen, Inc., a regenerative medicine company developing innovative therapies based on the products of cells grown under simulated embryonic conditions, will present preliminary data from the ongoing clinical trial of its Hair Stimulating Complex (HSC) today at the International Society of Hair Restoration Surgery (ISHRS) Annual Meeting. Statistically significant improvement was seen across all targeted hair growth parameters in this Phase I/II clinical trial, with an 86% responder rate.

The double-blind Phase I/II clinical trial was undertaken to further examine the safety and efficacy of intradermal injections of HSC in 56 men with androgenetic alopecia. In addition to other safety outcome measures, clinical evaluation of blood serum chemistry, hematology and urinalysis showed no indication of toxicity over 12 weeks. The treatment was well-tolerated and no study-related adverse events have been reported.

In this second clinical trial of HSC, which was designed with an additional treatment timepoint, the increase in total hair count was 46.5% above that seen in the pilot HSC trial at 12 weeks. Statistical significance was noted in all efficacy endpoints, which include increases in total hair count (p=0.0013), terminal hairs (p=0.0135), and hair thickness (p=0.026). A significant increase in vellus hair count (p=0.033) was seen for the first time, supporting the hypothesis that the HSC treatment rescues dying follicles, in addition to converting vellus to terminal hairs and increasing the number of hairs per follicle. Statistical significance continued to be seen at the 24 week time point.

"We are excited that HSC has not only continued to show unprecedented results, but that the addition of a second treatment time point in the Phase I/II clinical trial has resulted in even greater hair growth than the pilot study," said Gail K. Naughton, Ph.D., Histogen CEO and Chairman of the Board. "Particularly compelling is the growth seen in more difficult types and stages of hair loss. Without limitations to treatment area, age or stage of balding, HSC has the potential to expand the hair restoration market by offering a successful option to those that currently have none."

Available non-surgical treatment options for alopecia focus on younger patients in the earlier stages of hair loss, with a primary purpose of retaining existing hair and supporting limited hair regrowth. This is not the trend seen in the clinical trials of HSC. In both the pilot and Phase I/II clinical trial, HSC treatment has shown efficacy across age groups, with subjects age 40-59 seeing cosmetically significant results beginning at 12 weeks, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in this age group in the current trial.

Importantly, the efficacy of HSC is not limited by hair loss region. The Phase I/II clinical trial has shown noted new hair growth in subjects treated in all regions of the scalp, including temporal recession, mid-scalp and vertex. Subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase of 22.6% at 12 weeks and 25.2% at the 24 week time point.

In addition to the Phase I/II data, Dr. Naughton will present results from a Physician-sponsored IND of HSC conducted by Dr. Craig Ziering, an ISHRS member and leading hair restoration surgeon. Five men and five women received up to four treatments of HSC, with all subjects showing positive hair growth. Increased hair growth was seen as early as 6 weeks, with clinically and cosmetically relevant results seen as early as 18 weeks.

"The clinical data seen to date with HSC is very compelling," said Dr. Craig Ziering, Founder and CEO of Ziering Medical. "Not only is the strong safety profile clinically important, but we have seen cosmetically significant results, with coverage of thinning areas, in a clinical setting. In addition, the response seen in women treated with HSC is unprecedented."

HSC is a complex of proteins and growth factors naturally secreted by multipotent cells under Histogen's proprietary growth conditions. The proteins within HSC, such as KGF, VEGF, and follistatin, are involved in signaling stem cells in the body, and have been shown to be key in hair formation and the stimulation of resting hair follicles.

"Scalp Injection of Active Embryonic-like Cell-secreted Proteins and Growth Factors" will be presented by Dr. Naughton at the ISHRS Annual Meeting, taking place October 17-20, 2012, in the Bahamas.


U.S. Patent issued for Histogen's Novel Cell Growth Process

SAN DIEGO, September 5, 2012 - Histogen, Inc., a regenerative medicine company developing innovative therapies for conditions including hair loss and cancer, today announced that the United States Patent & Trademark Office has issued patent 8,257,947, entitled "Extracellular Matrix Compositions Produced Under Hypoxic Culture Conditions" to the Company.

The patent, which is the Company's first patent issued in the United States, covers Histogen's method of growing cells under low oxygen and suspension conditions, and the process through which the naturally-secreted protein compositions are produced . The issuance of the `947 patent is an important milestone for Histogen, as all of its products, each with a range of therapeutic applications, are derived from this core manufacturing process.

"Acceptance of this core patent gives tremendous strength to Histogen's technology and products, and establishes them as unique from any other cell-derived therapies in development today," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "By altering the conditions under which cells are grown, we can actually trigger the cells to revert back to an earlier, multipotent state. This creates products with virtually limitless applications for unmet medical needs."

By growing cells under proprietary conditions that simulate the embryonic environment, particularly hypoxia, it has been shown that normal human fibroblast cells become multipotent, and express key stem cell markers including Oct4, Sox2 and Nanog. The multipotent cells secrete a variety of soluble and insoluble molecules associated with stem cell niches in the body, as well as rapid tissue regeneration and scarless healing.

It is the soluble and insoluble compositions of multipotent proteins and growth factors which make up Histogen's products. Applications for these compositions are numerous. Histogen's lead product, Hair Stimulating Complex (HSC) has shown success in early clinical trials, and is currently in a Phase I/II stage trial as an injectable treatment for alopecia. In addition, the human multipotent cell conditioned media produced through Histogen's technology process can be found in the ReGenica line of skincare products by Suneva Medical. Histogen is also evaluating a subfraction of its material as an oncology therapy with the first application in clinical trials expected to be pancreatic cancer.

About Histogen
Histogen is a regenerative medicine company developing solutions based upon the products of cells grown under proprietary conditions that mimic the embryonic environment, including low oxygen and suspension. Through this unique technology process, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen's technology focuses on stimulating a patient's own stem cells by delivering a proprietary complex of multipotent human proteins that have been shown to support stem cell growth and differentiation.


Histogen Signs License Agreement with Suneva Medical for Cell Conditioned Media-based Aesthetic Products

SAN DIEGO, CA - March 5, 2012 - Histogen Inc., a regenerative medicine company, and Suneva Medical, a privately-held aesthetics company, today announced that they have entered into a license agreement for physician-dispensed aesthetic products containing Histogen's proprietary multipotent cell conditioned media (CCM).

Under the terms of this license agreement, Suneva Medical has acquired exclusive U.S. licensing rights to Histogen's multipotent CCM and the ReGenica™ branded line of products for topical applications in the licensed market. Suneva Medical will manufacture the ReGenica product line and market it to aesthetic practitioners throughout the U.S. Histogen will receive a transfer price on the CCM, as well as royalties on future sales of ReGenica and product line extensions.

"First, let me say that, as the first step in expanding our business, we are very excited about this particular opportunity as the advent of regenerative medicine is upon us. One of our key business objectives is to find novel products that complement our rapidly growing dermal filler business. We believe Histogen's innovative technology coupled with our proven experience of developing and marketing aesthetic products is a winning combination as it enables us to offer our customers a differentiated product line," stated Nicholas Teti, Chairman and Chief Executive Officer of Suneva Medical.

Through Histogen's technology process, which mimics the embryonic environment including conditions of low oxygen and suspension, cells are triggered to become multipotent, and naturally produce proteins associated with skin renewal and scarless healing. The result is a soluble cell conditioned media containing cell-signaling proteins such as KGF, follistatin, stem cell factor, collagens and laminins, which support the epidermal stem cells that renew skin throughout life. In addition, factors associated with scarring, such as TGF-beta, are decreased or nonexistent.

"The applications for this proprietary multipotent CCM within the field of medical aesthetics are numerous and, based upon the way the proteins within the complex signal the body's own stem cells to rejuvenate and regenerate skin, potentially groundbreaking," said Dr. Gail K. Naughton, CEO and Chairman of the Board at Histogen. "This recognition from Suneva's expert team, with a rich background in developing and marketing aesthetics, validates Histogen's technology and supports the fact that it is different from anything currently in the market."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, including low oxygen and suspension, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary cell conditioned media, and a human Extracellular Matrix (ECM) material.

About Suneva Medical
Suneva Medical, Inc. is a privately-held aesthetics company focused on developing, manufacturing and commercializing novel, differentiated products for the dermatology, plastic and cosmetic surgery markets. The Company's long-lasting injectable product is marketed as Artefill® in the U.S. and BellafillTM in Canada to correct facial wrinkles. For more information visit www.sunevamedical.com.

Contacts:

For Histogen Inc.:
Eileen Brandt
Phone: (858) 200-9520
ebrandt@histogeninc.com

For Suneva Medical:
Kate Gilbert
Vice President, Marketing
Phone: (858) 550-9999 x7844
or
Kellie Walsh
Phone: (914) 830-4973
kwalsh@kwmcommunications.com


Histogen Wins Motion for Summary Judgment in Patent Case, Defeating SkinMedica's Claims

SAN DIEGO, November 28, 2011 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, today announced that the United States District Court for the Southern District of California has granted the Company's motion for summary judgment of non-infringement of patents in the lawsuit that SkinMedica, Inc. filed against Histogen in 2009.

In the ruling issued on November 21, 2011, the court addressed the patents in suit, United States Patent Nos. 6,372,494 (titled "Methods of making conditioned cell culture medium compositions") and 7,118,746 (titled "Conditioned cell culture medium compositions and methods of use"). The court found that Histogen's products do not infringe, and dismissed all of the patent infringement allegations against Histogen.

"After nearly three years of patent litigation, we are excited to have confirmation that Histogen's technology is unique, and free from any patent rights that SkinMedica has," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "This outcome was signaled by the court in its claim construction order earlier this year, and we are happy to now have this matter officially behind us."

Commenting on the Company's business strategy going forward, Histogen President David Nassif stated, "The pathway is now clear for us to re-start our skin care business, using our proprietary conditioned medium in an array of cosmetic products. We are already talking with potential partners and distributors in a number of countries. Any residual litigation matters with SkinMedica will not prevent or delay us."

The federal court in San Diego granted the motion following a hearing on November 4, 2011. A copy of the Order is available upon request.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, including low oxygen and suspension, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Histogen Wins Patent Ruling

SAN DIEGO, June 2, 2011 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, today announced that it won a key ruling from the United States District Court for the Southern District of California in the patent lawsuit that SkinMedica, Inc. filed against Histogen in 2009. In this hearing, known as a "Markman hearing", both sides presented evidence and arguments to the court on how they requested that the disputed terms be interpreted.

In the ruling issued on May 24, 2011, the court addressed the meaning of disputed terms in United States Patent Nos. 6,372,494 (titled "Method of making conditioned cell culture medium compositions") and 7,118,746 (titled "Conditioned cell culture medium compositions and methods of use"). The court interpreted the terms in both of the patents-in-suit as excluding cells grown on microcarrier beads. Histogen grows cells in suspension on microcarrier beads to produce its products, which the federal court has confirmed is outside the scope of the claims of the patents in the lawsuit.

With this result, Histogen has prevailed on the key claim interpretation relevant to the lawsuit filed by SkinMedica. This important ruling should lead to the trial court's dismissal of the patent infringement allegations against Histogen.

"The Order supports what we have believed since Histogen's inception, which is that Histogen's methods and products are unique, and that our technology for culturing cells on microcarrier beads is free from any patent rights that SkinMedica may have," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "It will allow us to raise the additional capital to continue the development of our lead therapeutic products, and will re-start partnership discussions, all of which have been slowed by this litigation since January 2009."

The federal court in San Diego issued the order following a two day evidentiary hearing on February 15-16, 2011, where the court determined the meaning of disputed claim terms in the patents being asserted in the case. A copy of the Markman Order is available upon request.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, including low oxygen and suspension, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


David Nassif Joins Histogen as President and CFO

Company Poised to Reach Clinical and Business Development Milestones

SAN DIEGO, May 26, 2011 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of cells grown under simulated embryonic conditions, announced today that David Nassif, J.D. has joined the Company as President and Chief Financial Officer. Histogen welcomes Mr. Nassif as the Company prepares for the start of its Phase I/ II clinical trial of HSC for hair growth, raises additional capital and directs new focus on achieving business development goals. In this capacity, Mr. Nassif will oversee the business development, finance, accounting, legal, manufacturing, process development and quality functions.

"With our second clinical trial of HSC about to begin, exciting proof of concept data in the oncology area, and plans to expand beyond pilot scale manufacturing, Histogen has entered an exciting new phase," said Dr. Gail K. Naughton, Histogen CEO and Chairman of the Board. "I am pleased to welcome David Nassif to Histogen, and believe his business acumen and background in life sciences management and partnership building will be a great asset to Histogen as we move forward. David has worked closely with me, the Histogen team, and our Board for the past 6 months on a variety of projects, and is the right person to continue our growth on these fronts."

David Nassif brings nearly 18 years of experience in life sciences management, capital raising, mergers and acquisitions, licensing and investor relations to Histogen. Most recently, he served as principal at Strategic Consulting Services, providing high-level management consulting to various public and private life science and technology companies. He also served as the Executive Vice President, Chief Financial Officer, Secretary and Treasurer of Zogenix, Inc., a pharmaceutical company developing products for central nervous system disorders.

Previously, Mr. Nassif was Chief Financial Officer and Senior Vice President of Global Licensing at Amphastar Pharmaceuticals, Inc., a privately-held, generic and specialty pharmaceutical company. He also held the position of Senior Vice President and Chief Financial Officer of RealAge, Inc., a privately-held health care database information marketing company. Over his six years with Cypros Pharmaceutical Corporation, an American Stock Exchange listed specialty pharmaceutical company, Mr. Nassif held various titles culminating in the position of Senior Vice President and Chief Financial Officer. In 1999, he led the merger of Cypros and Ribogene, resulting in the creation of Questcor Pharmaceuticals. Mr. Nassif received a B.Sc. in Finance and Management Information Systems with honors from the University of Virginia and a J.D. from the University of Virginia School of Law.

"From a single manufacturing process, Histogen is uniquely capable of producing cell-derived products with a range of opportunities in various therapeutic and aesthetic areas," said Nassif. "I am excited to join Histogen as President and CFO, and look forward to helping to grow the Company and its value for employees, investors and partners."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Hypoxia Induces Multipotency in Skin Cells, Proteins Produced Trigger Cancer Stem Cell Death

Histogen to present data at Stem Cells and Regenerative Medicine World Congress

SAN DIEGO, January 24, 2011 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present new findings today at the 5th Annual Stem Cells and Regenerative Medicine World Congress.

Histogen scientists have demonstrated that, in both monolayer and suspension cultures under hypoxic conditions, normal human newborn fibroblasts become multipotent cells and express key pluripotent stem cell markers including Oct4, Sox2 and Nanog as well as a number of tissue and germ layer-specific stem cell markers, such as Brachyury, Gata4, alpha-fetoprotein, and Pax6. The stem-like cells induced in monolayer are seeded onto dextran beads and grown in a hypoxic suspension where they secrete a variety of soluble and insoluble molecules associated with stem cell niches in the body, as well as rapid tissue growth with scarless healing.

Unlike traditional fibroblast conditioned media, the media from hypoxia-induced multipotent cells contains no TGF beta, a protein associated with scar formation, no Wnt 5a and 5b that have been associated with cancer formation, and significantly increased levels of Wnt 7a and follistatin, both of which have been shown in a variety of studies to stimulate native stem cells to generate new tissue. In addition, various embryonic matrix proteins have been associated with the reversion of cancer cell phenotype, and follistatin is known to induce apoptosis in cancer cells.

"Embryonic development is characterized by stem cell activation, rapid cell growth, and a highly controlled micro environment to prevent the induction of malignancy," said Dr. Jonathan Mansbridge, Chief Scientific Officer at Histogen. "We are pleased our research has revealed that mimicking the hypoxic fetal environment induces cells to become multipotent and secrete proteins that have been shown to stimulate stem cell growth and inhibit both cancer stem cells and rapidly dividing cancer cell growth."

In a study by Pinney et al, cancer cell lines exposed to the matrix produced by the hypoxia-induced multipotent cells upregulated Caspase 9 and went into a controlled cell death, known as apoptosis. To date, the cancer lines that have been positively affected in vitro and in two animal models include breast cancer, glioma, melanoma, colon cancer, and mesothelioma. The inhibitory effect is selective for malignant cells only, with cell death induced in both rapidly dividing cancer cells and non-dividing cancer stem cells.

"It is exciting to see that this matrix produces controlled cell death in multiple human cancer cell lines, and that it also targets cancer stem cells," said Dr. David Easter, Professor of Clinical Surgery at UCSD Medical Center. "Plus, areas filled with this matrix after breast cancer resection have shown no tumor recurrence in the animal model, but untreated animals nearly always regrow tumors. These results point towards a significant new strategy in the post-surgical treatment of solid tumors."

"Hypoxic Culture Conditions Induce a Stem Cell-Like Phenotype in Human Dermal Fibroblasts" and "Human Embryonic-like ECM (hECM) Stimulates Proliferation and Differentiation in Stem Cells While Killing Cancer Cells" will be presented by Dr. Michael Zimber, and Emmett Pinney respectively, during the Stem Cell Congress taking place January 24-25, 2011 in San Diego. Extracellular matrix compositions produced under the hypoxic conditions discussed here are covered by pending US patents 2010/ 0047305 and 2010/ 0124573.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Histogen Announces Completion of Series A Financing

SAN DIEGO, December 1, 2010 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, today announced the successful completion of its Series A financing at $10 million. Among other private investors, Secure Medical, Leonard Lavin, Lordship Ventures and Angus Mitchell brought the round to a close.

With its pilot clinical trial for hair regrowth completed, a skincare line launched, and exciting preclinical data in applications including oncology, Histogen has added significant value which was recognized by the Company's new and existing shareholders. In addition, Histogen has recently moved into a new facility that will allow for up-scaled manufacturing for its upcoming clinical trials, and later commercial production.

"With the Series A completed, we are excited to build on the momentum Histogen has created over the past two years, and further advance the Company's rich product portfolio," said Gail K. Naughton, Ph.D., CEO and Chairman of the Board for Histogen. "We have made significant strides in several important research areas, advanced partnership discussions, and are on track to reach key value inflection points in 2011."

This successful completion follows the announcement of initial Series A financing in May 2008. Simultaneously, Histogen opens its Series B financing, which has been approved up to $23 million. The Series B was opened by Angus Mitchell, and Histogen has already received further commitments toward that round.

The Company is scheduled to begin a Phase I/II clinical trial of its Hair Stimulating Complex (HSC) in Singapore in Spring 2011, and hopes to also begin a clinical study of its soluble human extracellular matrix (hECM) for the treatment of carcinomatosis, a rapidly progressing and debilitating cancer, mid-year.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Dr. David Easter Joins Histogen Scientific Advisory Board

SAN DIEGO, November 18, 2010 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, today announced the addition of respected surgeon and oncology specialist Dr. David Easter to the Company's Scientific Advisory Board.

Currently a Professor of Clinical Surgery at University of California, San Diego, Dr. Easter is focused on surgical care and education, with special interests in surgical oncology, diseases of the gastrointestinal tract, and laparoscopic surgery. Most recently, Dr. Easter served as Director of the Clinical Oncology Programs for the Rebecca and John Moores Cancer Center, where he organized the Center's clinical and research efforts to provide the finest possible care for cancer patients.

"Dr. Easter's research background and surgical expertise, particularly in the cancer field, will be a tremendous asset as Histogen progresses through preclinical, and later clinical, oncology work," said Emmett Pinney, Histogen's Director of Oncology and Special Projects. "Dr. Easter's guidance will be critical to a shortened path to the clinic, and we are excited to welcome him to our Scientific Advisory Board."

In addition to his work as a professor, researcher and surgeon, Dr. Easter participates in the Graduate Medical Education Committee as the Program Director for General Surgery, the Patient Care Committee, and a number of other groups that influence patient care at UCSD. Dr. Easter was also honored as the first UCSD recipient of the Vice Chancellor's Excellence in Clinical Care award. At UCSD and in national surgical organizations, Dr. Easter is a leader in developing new ways to ensure that medical students and surgical residents receive excellent training in the increasingly complex world of surgery.

In his research at UCSD, Dr. Easter conducts clinical and basic science studies in many areas, including surgery techniques and training, and empathy in doctor-patient communication. One of his recent studies addressed ways for physicians to improve their ability to help cancer patients understand and discuss their fears during a clinic visit.

"Histogen's extracellular matrix has shown compelling results which have not been seen with any other single treatment to date. Not only does it have a positive effect on inducing a controlled cell death in multiple human cancer cell lines, it also targets cancer stem cells," said Dr. Easter. "As a member of Histogen's Scientific Advisory Board, I look forward to contributing to accelerating this unique and exciting potential treatment to the clinic."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Renowned Dermatologist Dr. Neil Sadick Joins Histogen Scientific Advisory Board

SAN DIEGO, July 22, 2010 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, today announced that Dr. Neil Sadick has joined the Company's Scientific Advisory Board.

A prominent dermatologist and researcher, Dr. Sadick holds positions as Clinical Professor of Dermatology at Weill Cornell Medical College and President of the Cosmetic Surgery Foundation, in addition to being the founder of Sadick Dermatology, a leading aesthetic medicine practice in New York. He is board certified in Dermatology, Cosmetic Surgery, Internal Medicine, and Hair Transplantation.

"We are excited to welcome Dr. Sadick to Histogen's Scientific Advisory Board," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "His clinical and research background and expertise will be invaluable as development and clinical studies of Histogen's dermal filler and hair regrowth applications progress."

Dr. Sadick is the recipient of the Jobst Award for Research in Vascular Diseases, American Cancer Society Research Award, American Medical Association's Continuing Medical Education Award, and is a lead research physician for Merck Pharmaceutical, ESC Medical, Jobst Biersdorf, and Aesclepion. He has authored more than 500 peer-reviewed articles, written/ edited more than 10 books on cosmetic surgery, hair and vein treatment, and contributed more than 75 medical book chapters.

"Histogen's technology, and its numerous applications in aesthetic medicine, are truly unique and exciting," said Dr. Sadick. "As a member of the Company's SAB, I look forward to contributing to the development of Histogen's near-term applications, particularly in the areas of cosmetic surgery and hair restoration where these next-generation products can have a large impact."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Human Embryonic-Like Extracellular Matrix Significantly Inhibits Tumor Growth and Cancer Cell Proliferation

Histogen to present new data at ISSCR Annual Conference

SAN DIEGO, June 17, 2010 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present findings tomorrow at the International Society for Stem Cell Research (ISSCR) Annual Meeting. Studies of the human extracellular matrix (hECM) produced under proprietary conditions of hypoxia and suspension have demonstrated its ability to diminish or eliminate tumor load in melanoma, breast cancer, colon cancer and glioma, both in vitro and in vivo.

Tumor growth was significantly inhibited across these cancer cell lines, with a 50-80% reduction in tumor weight seen in the tumor chorioallantoic membrane (tumcam) model (p<0.05) and a 70-90% reduction seen in subcutaneous mouse xenograft experiments (p<0.02). In studies of a carcinomatosis model established with a human colon carcinoma line, treatment with the hECM resulted in reduced tumor number and size, reduction of ascites, and, to date, a doubling in lifespan, as compared to untreated and cisplatin-treated mice.

"To see significant inhibition of multiple neoplastic cell lines, in multiple models, is a powerful indication of the future clinical potential of our embryonic-like extracellular matrix," said Dr. Mark Hubka, Histogen's Director of Clinical Affairs. "We are particularly excited about the potential utility of the hECM in rapidly progressing and debilitating cancers, such as carcinomatosis, where there are limited treatments that can offer an improvement in the quality and length of life."

Further studies of human colon adenocarcinoma have shown the ability of the hECM, when used to coat biopsy needles, to significantly reduce tumor seeding along the needle track (p=0.002) and prevent the development of secondary subcutaneous tumors. This represents a potential nearer-term application of the hECM in oncology.

"Our studies with hECM substantiate various reports which have shown that embryonic matrix proteins can selectively target the growth of cancer cells in vivo," said Emmett Pinney, Histogen's Director of Oncology. "We are excited about demonstrating the efficacy of our embryonic-like ECM proteins in vivo and about the range of potential applications of the hECM, such as a biopsy needle coating, and as a post-resection tissue filler to improve healing and to prevent possible recurrence or metastasis."

The inhibitory affect of the hECM is selective for malignant cells, supporting fibroblast expansion while concurrently inhibiting mesothelioma cells in vitro. Preliminary indications point to the activation of apoptotic enzymes, as seen through caspase upregulation, leading to apoptosis, or programmed cancer cell death.

"Human embryonic-like ECM stimulates proliferation and differentiation in stem cells while killing cancer cells" will be presented by Histogen CEO Dr. Gail Naughton at the ISSCR Annual Meeting, taking place June 16-19, 2010 in San Francisco.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Human Extracellular Matrix Significantly Improves Device Biocompatibility

Histogen to present data at ASAIO Annual Conference

SAN DIEGO, May 28, 2010 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present findings today at the American Society for Artificial Internal Organs (ASAIO) Annual Conference. Assessment of bioengineered, human extracellular matrix (hECM)-coated polymers showed a statistically significant reduction in immune cell infiltration, foreign body giant cell formation (p<0.05) and fibrous capsule formation (p<0.001), in addition to improved cell binding and proliferation, representing the potential for this hECM to significantly enhance the biocompatibility of various medical devices.

A large number of biomechanically suitable polymers, such as those devices utilized for cardiovascular, urological and hernia repair, fail due to the inflammatory and thrombogenic response by the body. Pre-clinical research on the insoluble, embryonic-like hECM produced through Histogen's unique manufacturing process has shown the capability of the material to significantly reduce these negative responses, and improve the performance of medical devices.

"Device implants represent an important and expanding multi-billion dollar market and have had a major impact on patient care," said Dr. Gail Naughton, CEO and Chairman of the Board at Histogen. "Problems such as fibrous capsule formation, poor tissue ingrowth, and neointimal hyperplasia resulting from suboptimal biocompatibility must be addressed to offer improved patient benefits. We are encouraged by the results with our embryonic-like matrix, which demonstrate its potential for reducing the foreign body reaction, as well as improving and prolonging the life and function of implantable devices."

Testing, which was performed as part of a partnership with the National Research Council's Advanced Materials Division, involved coating of several commonly utilized device materials, including nylon, polypropylene (PPE), and polyethylene terephthalate (PET) nonwoven scaffolds with hECM using several common coating methods. The hECM-coated and uncoated scaffolds were then surgically implanted in the subcutaneous space of SCID mice and histological samples of excised implants were assessed for inflammatory response, cellular infiltration, foreign body giant cells and capsule formation.

"Coating polymers with a naturally-produced, all-human ECM masks the foreign device material and offers a physiological surface which supports healthy tissue infiltration and interaction," said Dr. Michael Zimber, Director of Applied Research at Histogen. "The hECM-coated polymers promoted a two-fold increase in normal cell proliferation as compared to uncoated polymers, as well as causing a significant reduction in the host inflammatory and fibrotic response to surgically implanted polymers."

"Coating Polymers with a Human Extracellular Matrix Significantly Improves Implant Biocompatibility" will be presented by Dr. Zimber at the ASAIO Annual Conference, taking place May 27-29, 2010 in Baltimore.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Hypoxia Induces Stem Cell Gene Expression, Protein Production and Cell Surface Markers

Histogen to present data at International Conference on Stem Cell Engineering

SAN DIEGO, May 3, 2010 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, will present new findings today at the International Conference on Stem Cell Engineering (ICSCE). Analysis of the cells grown under Histogen's proprietary conditions of hypoxia and low gravity show the expression of specific markers associated with embryonic stem cells.

Different cell types can be identified by unique profiles based on the genes they express, the proteins they produce, and markers that they have on their cell surface. Histogen has discovered that, under growth conditions of 2-5% oxygen (hypoxia) and low gravity, safe and non-controversial newborn skin cells (fibroblasts) acquire the profile of pluripotent stem cells.

"Over 5,000 genes are differentially expressed by these cells, as compared to fibroblasts grown under traditional conditions," said Dr. Gail K. Naughton, CEO and Chairman of the Board at Histogen. "What we are seeing is a shift in the profile of these cells to one that is more embryonic-like, more similar to stem cells than fibroblasts."

DNA microarray analysis revealed that, under hypoxic culture conditions, fibroblasts upregulate the expression of key embryonic stem cell markers including Oct4, Nanog, and Sox2. These specific genes are known to be critical in the generation of induced pluripotent stem cells. A number of other stem cell-associated markers, such as Brachyury, Gata4, CCR4, LIN28 and Nodal FGF5 were also expressed at higher levels in the hypoxic cultures as compared to fibroblasts grown under normal oxygen levels.

These studies suggest hypoxic culture of somatic cells in large-scale bioreactor systems is a potentially feasible and efficient method for obtaining and producing adequate amounts of pluripotent stem cells and associated factors for clinical regenerative medicine applications.

"Reprogramming adult, differentiated somatic cell types through chemical manipulation or genetic transfection to transform the cells into a dedifferentiated, pluripotent stem cell phenotype has been the focus of many recent studies," said Dr. Jonathan Mansbridge, Chief Scientific Officer at Histogen. "Although these experiments have demonstrated the ability to induce cells back to a pluripotent state, the methods used have raised considerable issues regarding mutagenicity and clinical safety. We now have preliminary evidence that, by altering the oxygen levels under which neonatal fibroblasts are cultured, there is potential for a viable pluripotent stem cell source that would be free of these issues."

Human extracellular matrix (hECM) compositions produced under the hypoxia/ microgravity conditions discussed here are covered by pending US patent #2010/0047305. "Induction of Stem Cell Marker Expression in Human Dermal Fibroblasts in Hypoxic Culture Conditions" will be presented by Dr. Mansbridge at the ICSCE event, taking place May 2-5, 2010 in Boston, Mass.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


HSC Trial Shows Continued Significant Hair Growth at One Year Follow-up

Histogen to present one year clinical trial data at Society for Investigative Dermatology Annual Meeting

SAN DIEGO, April 13, 2010 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn cells grown under embryonic conditions, today announced the one year data findings of its Hair Stimulating Complex (HSC) pilot clinical trial. Statistically significant new hair growth was seen in HSC-treated subjects at this follow-up timepoint, one year after their single treatment with HSC.

In addition to the number of new hairs, a statistically significant (p<0.05) increase in hair density, which is directly related to hair count over the treatment areas, was also seen at the one-year timepoint. Other efficacy factors, such as hair thickness and terminal hair density, showed an upward trend at this timepoint as well. The pilot trial tested two formulations of HSC and, although one formulation was determined to be superior, significant new hair growth was seen in both groups. (p=0.032)

This new data indicates that a single HSC treatment not only results in rapid hair growth (statistically significant increases in the number of terminal hairs, hair thickness density and hair shaft diameter was seen at three months), but that these results persist over time.

"Seeing continued hair growth at this one year follow-up is truly groundbreaking," said Dr. Craig Ziering, Founder of Ziering Medical and Principal Investigator on the HSC clinical trial. "Not only do currently available non-surgical treatments show limited hair regrowth, but any new hair is lost shortly after discontinued use. We now have preliminary evidence that HSC significantly increases hair counts, and that the effects of a single treatment are lasting."

The pilot 24 subject clinical trial of HSC was a double-blind, placebo-controlled evaluation of safety in the clinical application of the product as an injectable for hair growth. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy. No adverse events were seen at any timepoint, including the one year follow-up.

HSC is a proprietary formulation of naturally secreted embryonic-like proteins and growth factors. In addition to Wnt 7a, which is recognized to be critical in the induction and maintenance of hair follicle growth, the complex contains a wide variety of factors typically produced by embryonic cells and which are important to the hair cycle, such as follistatin. While these embryonic-like materials are amplified under Histogen's unique manufacturing conditions, undesirable proteins and growth factors, including Wnt 5a, which has been shown to be associated with cancer, are eliminated.

"The development of hair follicles is the consequence of a complex interplay of factors that is still being unraveled," said Dr. Jonathan Mansbridge, Histogen's Chief Scientific Officer. "However, several factors critical to hair growth, such as Wnt 7a, follistatin, VEGF and KGF, are present in HSC, and their secretion by the cells is stimulated by the culture conditions we use. The embryonic conditions under which our cells are manufactured not only upregulates genes associated with hair growth, but induces significantly more production of these critical factors than seen with other culture conditions."

HSC is a unique composition resulting from growing newborn cells under embryonic conditions. The hypoxia/microgravity results in large amounts of follistatin (41.6 ng/ml in HSC versus 6.75 ng/ml in normal culture conditioned media), VEGF (9.1 ng/ml versus 2 ng/ml), KGF (5.4 ng/ml versus 2.1 ng/ml), and a lack of the scar-related TGF beta (0 ng/ml versus 1.7 ng/ml in normal cultures). This composition is covered by pending US patent #2010/0047305.

The full results of the HSC clinical trial will be presented at the Society for Investigative Dermatology (SID) Annual Meeting, taking place in Atlanta, May 5-8, 2010. Presentation abstracts have been published by SID are now available for review at sid.abstractcentral.com/login.

Histogen is currently in planning stages for the next clinical trial of HSC, which is scheduled to begin in late 2010. This next trial will further examine the safety and efficacy of the HSC product as an injectable for hair growth, and will also evaluate optimum treatment dosing and delivery. Histogen is currently seeking a Series B investment round, which will be utilized to finance these next stages of HSC development and trials.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn cells are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Histogen CEO Speaks to the Science of HSC in an Interview with ISHRS

SAN DIEGO, August 13, 2009 - Histogen CEO Dr. Gail Naughton addressed the technology behind the Company's Hair Stimulating Complex (HSC), as well as the results of the product's preliminary clinical trial, in an interview with the International Society of Hair Restoration Surgery's Hair Transplant Forum International.

The interview has been published in the July/ August issue of the publication, and is available for view at www.ishrs.org/PDF/F4-2009.pdf.


Histogen Hair Regrowth Clinical Trial Presented at ISHRS Annual Meeting

Data shows statistical significance at three key efficacy endpoints

SAN DIEGO, July 27, 2009 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, shared the results of the Company's preliminary clinical trial of Histogen's HSC human hair regrowth product for the first time at the International Society of Hair Restoration Surgeons (ISHRS) Annual Scientific Meeting. Dr. Craig Ziering, founder of Ziering Medical and principal investigator on the clinical trial, addressed attendees on July 25th, 2009 during the conference, taking place in Amsterdam July 22-26, 2009.

Patients treated with Histogen's Hair Stimulating Complex (HSC)

3 months

Hair count + 22.4%
Terminal hair + 27.8%
Thickness + 23.9%

Baseline results
Hair Regrowth results after 3 months

3 months

Hair count + 23.7%
Terminal hair + 24.2%
Thickness + 22.2%

Baseline results
Hair Regrowth results after 3 months

HSC is a proprietary formulation of naturally secreted embryonic proteins, growth factors and contains the first naturally stabilized, bioactive solution of Wnt proteins and their cofactors, which have been implicated in the induction of new hair follicle formation and growth.

The five-month double-blind, placebo-controlled clinical trial was focused on evaluation of safety in the clinical application of Histogen's Hair Stimulating Complex (HSC), formerly known as ReGenica. The 24 subject clinical trial was designed to examine the safety and efficacy of a single injection of HSC alone, as well as in combination with three different perturbation methods. Quantitative analysis of clinical macrophotography and subject biopsies were utilized to evaluate treatment safety and efficacy.

Efficacy at 12 weeks with one Application of HSC

  • cumulative thickness density (mm/cm2) p=0.0249
  • thickness mean (um) p=0.0402
  • terminal hair density (n/cm2) p=0.0029

84.6% of the patients receiving one injection of Histogen's serum-free HSC showed an increase in terminal hair 12 weeks post-injection, with a statistically significant (p<0.05) increase in the number of terminal hairs, cumulative hair thickness density and hair thickness mean. Perturbation did not enhance the results seen with HSC. There were no adverse reactions seen in any of the treated 24 patients at baseline, 12 weeks, or the 22 week endpoint.

"We are excited that our trial demonstrated safety and efficacy of our HSC product, which contains Wnt proteins and other growth factors important to hair follicle maintenance and growth," said Dr. Gail K. Naughton, CEO of Histogen. "Wnt signaling has been shown by a number of experts in the field to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and to be important in maintaining the hair inducing activity from existing follicles. Histogen's trial is the first demonstration that compounds containing bioactive Wnt increase hair growth in humans."

While additional clinical evaluation is needed to further examine product safety, efficacy and treatment specifications, the preliminary clinical trial of HSC represents a potentially significant new treatment option for the millions suffering from hair loss. Of the 87 million people in the United States that suffer from hair loss, it is estimated that only 2-7% seek surgical or pharmacological treatment. The same is true internationally due to the general lack of effective medical options for this widespread condition.

"Hair restoration treatments range in effectiveness and invasiveness. All of the current treatment options share the common goal of saving and redistributing existing hairs," said Dr. Craig Ziering. "For the millions of men and women who grapple every day with their hair loss, the results of our HSC trial indicate the potential for a phenomenal treatment option that stimulates growth of new hairs along with increasing the thickness of existing hairs. Histogen's HSC represents a potentially major paradigm shift from conventional treatment options to one that can promote the growth of new or dormant hairs using principles of the body's own regenerative mechanisms."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - a proprietary liquid complex of embryonic-like proteins and growth factors, and a human Extracellular Matrix (ECM) material, ExCeltrix.


Histogen Aesthetics Launches ReGenica Rejuvenation System

Natural embryonic-like human proteins stimulate skin cells to combat aging and help support healing

SAN DIEGO, April 27, 2009 - Histogen Aesthetics, a division of Histogen focused on providing unique, clinically proven, human skin cell-derived products for aesthetics medicine, today announced the launch of the ReGenicaTM Rejuvenation System for anti-aging and post-resurfacing.

Histogen Aesthetics utilizes a proprietary manufacturing process in which newborn dermal fibroblast cells are grown on beads in controlled bioreactors that maintain an embryonic-like environment, including low oxygen and low gravity conditions. During this process, the cells secrete growth factors such as Keratinocyte Growth Factor and Vascular Endothelial Growth Factor, and soluble extracellular matrix proteins such as collagens, laminin and decorin, which are associated with skin renewal and scarless healing. In addition, factors associated with scarring, such as TGFbeta, are decreased or nonexistent.

The resulting product is ReGenica, a complex made up of the naturally produced cell signaling materials and embryonic-like proteins which support the epidermal stem cells that renew skin throughout life.

Through Histogen's unique and proprietary technology process, Histogen Aesthetics is able to produce a skincare system that differentiates itself from other growth factor-containing skin products on the market. ReGenica:

  • does not contain any plant-derived growth factors or phytoestrogens which can be subject to seasonal variability and pesticide contamination
  • does not contain genetically-engineered growth factors (recombinant proteins)
  • does not contain fetal bovine or other animal serum, so no animal hormones are present

"Our patients undergoing cosmetics procedures are very interested in minimizing their downtime as well as minimizing their risk, and I believe the Histogen formulations do both," said Dr. Garth Fisher, renowned plastic surgeon and primary investigator on the first ReGenica post-resurfacing clinical study. "In addition, they have the added benefit of minimizing the risks associated with allergic responses from using animal products."

The ReGenica products are formulated based upon the results of randomized double-blind, placebo-controlled clinical studies, in which independent dermatologists both collected and blind-reviewed the data. In addition to before and after photographs, assessment of product efficacy was determined by instrumental assessment of transepidermal water loss (TEWL), viscoelasticity measurements and three dimensional image analysis of silicon replicas.

"As a participant in a ReGenica clinical study, I was impressed to see the rigorous and controlled trial process Histogen Aesthetics' products undergo," said Stephanie Parker, a patient in the ReGenica post-resurfacing clinical study. "I feel comfortable in knowing that any products released by the Company have been tested and proven safe and effective, and am excited that the anti-aging and post-resurfacing products will now be available. ReGenica products aren't just making claims - I saw real results."

Initial product launches in the ReGenica rejuvenation system include the ReGenica Facial Rejuvenation Complex for post-resurfacing, ReGenica Advanced Rejuvenation Day Repair with sunscreen and ReGenica Advanced Rejuvenation Overnight Repair. The system is now available at special introductory pricing through dermatologists, plastic surgeons and other aesthetic medicine professionals, and can also be purchased online through www.histogenaesthetics.com.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - ExceltrixTM, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.


Histogen Hair Regrowth Clinical Trial Results to be Presented at AAD Annual Meeting

SAN FRANCISCO, March 7, 2009 - Attendees of the American Academy of Dermatology Annual Meeting, taking place March 6-10, 2009 in San Francisco, will receive a peek of Histogen's preliminary hair regrowth clinical trial results in two presentations during the event. Data will be shared within an electronic poster from Histogen throughout the event, as well as within a podium presentation being given by Dr. Kenneth Washenik on advances in the treatment of hair loss on Sunday, March 8th.

Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, has recently released data from the 12 week timepoint of the Company's first human clinical evaluation of ReGenicaTM for hair regrowth. This clinical trial is the first time that a single application of a treatment has shown an increase in new follicles, thickness of existing hairs, and number of hairs in pre-existing follicles, in a human study.

ReGenica, a proprietary liquid containing naturally secreted embryonic proteins and growth factors, is the first naturally stabilized and bioactive formulation of Wnt proteins and natural cofactors, which have been implicated in the formation of new hair follicles.

"It is definitely exciting to see the laboratory promise of Wnt's effect on hair growth successfully translated into a clinical study," said Dr. Washenik, who is the Medical Director of Bosley, the nation's largest hair restoration group, and a faculty member in the Department of Dermatology at NYU's School of Medicine.

Histogen scientists reported on the upregulation of several Wnt genes in response to the embryonic conditions in the Company's proprietary bioreactors. In addition, the data has confirmed the activity of these Wnt proteins, through the nuclear translocation of beta catenin in human keratinocytes, the downstream signaling of Wnt-responsive TCF/ Lef promoter, and the presence of secreted Wnt 7a through western blot analysis.

Histogen began its outside-U.S. clinical trial of ReGenica for hair regrowth in November, with the goal of more rapidly obtaining human safety data which will allow the Company to progress with product development. Dr. Craig Ziering, the principal investigator on the trial, is a leading hair transplant specialist and the founder of Ziering Medical.

"For the millions of men and women who grapple every day with their hair loss, the results of our early testing indicate the potential for a phenomenal treatment option, particularly for women and men presenting with diffuse hair loss who are not good candidates for hair transplant surgery," said Dr. Ziering. "In addition to growing new hair, it increases the diameter of existing hair, creating more volume and coverage, which are the primary goals of those seeking help for their thinning or balding hair."

The trial is currently in progress, with the final scheduled 5 month timepoint upcoming. The Company expects to release full results from this first clinical trial in the first half of 2009.

Histogens' electronic poster presentation, entitled Tissue-engineered human embryonic-like conditioned media for therapeutic applications, will be available for viewing throughout the American Academy of Dermatology Annual Meeting.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - ExceltrixTM, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.


Histogen to Present Preliminary Hair Regrowth Clinical Results at Stem Cell Summit

Company will Share Sneak Peek at Safety and Efficacy Results from In Progress Clinical Trial

NEW YORK, February 16, 2009 - Dr. Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, will address attendees tomorrow at the 4th Annual Stem Cell Summit in New York. Dr. Naughton will be presenting preliminary mid-trial results from Histogen's first human clinical evaluation of ReGenicaTM for hair regrowth.

Baseline results
Hair Regrowth results after 12 weeks

The primary objective of this double-blind, placebo-controlled, randomized study is to evaluate safety in the clinical application of the ReGenica product for hair regrowth. Histogen is also examining product efficacy as a secondary objective, specifically looking at the same end-points the Company has seen in the animal model - new hair growth, and the thickness of new and existing hair. The study is in progress, but the Company has reviewed data from the scheduled 12 week time point and is pleased with the results to date.

"Histogen's clinical trial was designed to assess the safety of its product over a five month period," commented Dr. Craig Ziering, principal investigator of the study and founder of Ziering Medical. "In addition to seeing no adverse reactions, we were delighted to see more hair, thicker hair shafts, and what appears to be the growth of completely new hair follicles in the areas that received the ReGenica treatment."

ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted embryonic wnt proteins, growth factors, and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles.

"Wnt signaling has been shown to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and is also important in maintaining the hair inducing activity from existing follicles," said Frank Zeigler, General Manager at Histogen. "We are excited to be the first group to show these effects in a clinical setting using human WNT proteins."

Histogen began this outside-U.S. study of ReGenica for hair regrowth in November, with the goal of more rapidly obtaining human safety data which will allow the Company to progress with product development. The trial is currently ongoing, and Histogen expects to release full results from this first clinical study in the first half of 2009.

Dr. Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. Dr. Naughton founded Histogen in 2007, and currently serves as Chief Executive Officer and Chairman of the Board for the Company, in addition to her position as Dean of the College of Business at San Diego State University.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - ExceltrixTM, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.


Histogen Welcomes Dr. Hyma Gollamudi as Chief Business Officer

Regenerative Medicine Company Poised for Business Growth

SAN DIEGO, December 03, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, announced today that Dr. Hyma Gollamudi has joined the Company as Chief Business Officer. Gollamudi's business and product development expertise will be invaluable as Histogen begins seeking strategic alliances nationally and internationally.

"With our early-stage product launches underway, and exciting projects coming quickly down the pipeline, Histogen is increasingly examining relationships with companies, physicians and investors," said Dr. Gail Naughton, Histogen CEO and Chairman of the Board. "I am excited to welcome Hyma Gollamudi to Histogen, and look forward to seeing the Company's business development and strategic planning efforts flourish through her oversight and experience."

Dr. Gollamudi brings more than 10 years of experience from the healthcare and financial industries to Histogen. Most recently, she served as a Product Director in the healthcare division of Fair Isaac Corporation, a leading provider of analytics and decision management technology. In this position, Dr. Gollamudi oversaw alliances and partnerships and grew the Company's government (Medicare and Medicaid) and commercial business through dedicated attention to client relationships and client managements.

Dr. Gollamudi has authored a number of papers, presented at various healthcare conferences and working groups, and is the co-inventor on two patents. She holds a doctorate in Agricultural Economics from the Ohio State University.

"Histogen's broad range of product applications from a single technology platform is intriguing, and offers almost limitless opportunities in markets from research tools to cosmetics," said Gollamudi. "I am excited to work toward forming alliances, navigating products through reimbursement hurdles, and contributing to the Company's success in various markets."

Through the Company's proprietary bioreactor technology, Histogen is uniquely capable of simulating the embryonic environment, creating products that are embryonic in nature without containing embryonic stem cells or animal components. From two product families - ExCeltrixTM, Histogen's insoluble human Extracellular Matrix (ECM), and ReGenicaTM, Histogen's proprietary liquid complex - the Company has created a product portfolio which includes applications from stem cell culturing to skin care, tissue regeneration to hair regrowth.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high-value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen recently launched its first product - BioNuesisTM Human Stem Cell Culturing Kits - and announced the creation of its cosmeceutical venture - Histogen Aesthetics.


Histogen Announces Start of Hair Regrowth Clinical Evaluation

SAN DIEGO, November 20, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the start of the Company's first human clinical evaluation of ReGenica for hair regrowth. The primary objective of the study is to evaluate safety in the clinical application of the ReGenica product.

ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted growth factors, anitoxidants and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles.

Histogen's in-vitro and preclinical research to date has shown ReGenica to be safe, and has indicated the complex's ability to increase hair growth and new follicle formation. Based on the results of preliminary research, and the potential of ReGenica as a hair regrowth treatment, Histogen has moved forward with this outside-U.S. study to more rapidly obtain human safety data which will allow the Company to progress with product development.

We are excited to be on schedule with the initiation of our first human clinical evaluation of ReGenica for hair growth," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "We look forward to the results of this preliminary safety evaluation, which we can parlay into further studies."

The ReGenica study, which began today, will be a double-blind, placebo-controlled, randomized single site study. Dr. Craig Ziering, renowned hair transplant surgeon and founder of Ziering Medical, is serving as Principal Investigator on the study with Dr. David Perez-Meza as Sub-Investigator. Results of this first human hair regrowth product clinical evaluation will be released by Histogen in the first half of 2009.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.


Dr. Gail Naughton Speaks on Histogen's Business Plan and the Rise of Bioaesthetic Medicine during Commercial Translation of Regenerative Medicine

ExCeltrix Preliminary Oncology Data Presented for the First Time

SAN DIEGO, November 17, 2008 - Dr. Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today addressed attendees at the 6th Annual Commercial Translation of Regenerative Medicine conference, taking place November 17-18, 2008 in London. Dr. Naughton examined the growing bioaesthetic medicine industry, as well as shared Histogen's business plan for near-term regenerative medicine products focused on anti-aging and post-resurfacing treatments, at the event.

"Due to long timelines in the development of medical devices and pharmaceuticals, Histogen is taking advantage of the unique opportunity to enter the growing $4.5 billion global aesthetic medicine market, to help generate early revenues and allow the Company to continue to fund the development and clinical evaluation of future products," said Dr. Lawrence Rheins, President of Histogen Aesthetics LLC. "The newly formed Histogen Aesthetics division addresses this market, offering scientific and clinically-proven products based on Histogen's proprietary technology, for skin hair and nail products dispensed by physicians."

Histogen Aesthetics' initial product line will be focused on ReGenica, the Company's unique complex made up of the naturally secreted growth factors, antioxidants and other synergistic bio-products that are produced by newborn fibroblasts. Product launches in the areas of anti-aging and post-resurfacing are scheduled for early 2009.

In addition to ReGenica, Dr. Naughton spoke to Histogen's plan to bring their human embryonic-like extracellular matrix product, ExCeltrix, into clinical trials as an injectable for wrinkles and deep furrows.

"ExCeltrix, Histogen's unique human extracellular matrix which is grown in a simulated embryonic environment, is currently being evaluated for a variety of applications, from dermal fillers to implant coatings," said Dr. Robert Kellar, VP of Research and Development at Histogen. "Intriguing preliminary results from ongoing ExCeltrix research shows promise of in the field of oncology."

Dr. Naughton presented data for the first time supporting the ability of ExCeltrix to diminish or eliminate tumor load in preclinical trials. Studies were performed with three rapidly growing human tumor cell lines: melanoma, adenocarcinoma, and glioma. Cancer cells were either mixed with ExCeltrix or delivered alone in two preclinical models. In the CAM model (chollioallantoic membrane) tumor mass was significantly reduced by the presence of ExCeltrix. In the nude mouse model, cells with ExCeltrix showed little to no tumor growth, in comparison to the control which did form palpable tumors.

Dr. Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. Dr. Naughton founded Histogen in 2007, and currently serves as Chief Executive Officer and Chairman of the Board for the Company, in addition to her position as Dean of the College of Business at San Diego State University.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.


Recognized Dermatology Expert Dr. Zoe Draelos Joins Histogen Scientific Advisory Board

SAN DIEGO, November 13, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Zoe Diane Draelos, M.D., clinical and research dermatologist and President of Dermatology Consulting Services, has joined the Company's Scientific Advisory Board.

Dr. Draelos is a board certified dermatologist in private practice, and a recognized expert in cosmetic and biologically active skin medication research. As President and Primary Investigator for Dermatology Consulting Services, a company she founded in 1988, Dr. Draelos is focused on providing education, developing formulation technology, and conducting clinical studies in association with the pharmaceutical and cosmetics industry.

Histogen recently announced the creation of Histogen Aesthetics LLC, a venture developing products for the growing medical aesthetic industries based on the Company's core technology. Dr. Draelos' addition to the Scientific Advisory Board will be invaluable as Histogen Aesthetics moves forward with product launches and further clinical evaluations in this area.

"To have Dr. Draelos, a renowned dermatologist, and skin biologist with focused expertise in cosmetic dermatology, join Histogen's SAB validates our technology and potential for treatments in the growing specialty of aesthetic medicine," stated Lawrence A. Rheins, Ph.D., President of Histogen Aesthetics LLC. "We are excited to have the opportunity to utilize her insight and clinical expertise as we prepare for product launches in post-resurfacing and anti-aging in early 2009, and continue development of additional skin, hair, and nail care products in the aesthetic medicine arena."

Dr. Draelos has served as Principal Investigator on more than 200 clinical trials, is a national and international speaker, and has been the recipient of numerous research grants. She is also a significant contributor to medical literature, with more than 200 articles and 25 book chapters to her credit. She is the author of the text Cosmetics in Dermatology, now in its third edition, and Hair Care, as well as serving as the editor for the textbook Cosmeceuticals, which has been translated into 5 languages.

Complementing her writing endeavors, Dr. Draelos serves on 8 editorial boards, including Cosmetic Dermatology, The International Journal of Cosmetic Science, Dermatologic Surgery, and Dermatology Times. She also serves as editor-in-chief of the Journal of Cosmetic Dermatology.

Dr. Draelos is a fellow and past board member of the American Academy of Dermatology and a member of the American Dermatological Association, the Society for Investigative Dermatology, the American Society of Mechanical Engineers, among others. A former Rhodes Scholar, Dr. Draelos has been the recipient of many awards and honors in recognition of her professional and academic accomplishments. She was recently given a Lifetime Achievement Award for her research from Health Beauty America, a professional skin care and cosmetics industry organization.

"The rapid development of the sub-specialty of cosmetic dermatology, with a growing focus on basic and clinical research into all aspects of cosmetic medicine, requires new technological advances to address the complexities for this growing area of medicine," commented Draelos. "Histogen scientists have developed a technology that may address many future clinical challenges of aesthetic medicine."

Histogen Aesthetics LLC, established in 2008 as a subsidiary of Histogen, Inc., focuses on the development of skin and hair care products for the plastics surgery, dermatology and cosmetic industries. Histogen Aesthetics products are based on Histogen's core technology, in which newborn fibroblasts are grown in a proprietary simulated embryonic-like environment. From this process, Histogen Aesthetics extracts ReGenica, a unique complex containing naturally secreted growth factors, antioxidants and other synergistic bio-products. ReGenica is currently undergoing clinical studies as a treatment in the areas of post-resurfacing and anti-aging, with a planned product portfolio addressing a range of skin and hair care needs.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Histogen Aesthetics is Created to Address Growing Medical Aesthetics Market

Dr. Lawrence A. Rheins Joins Histogen Aesthetics as President

SAN DIEGO/ PHOENIX, October 20, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn dermal fibroblasts, today announced the creation of Histogen Aesthetics LLC, a venture developing products for the growing medical aesthetic industries based on Histogen's core technology.

From a proprietary bioreactor process in which newborn fibroblasts are grown under proprietary embryonic-like conditions, Histogen Aesthetics extracts a unique
complex - ReGenica - made up of the naturally secreted growth factors, antioxidants and other synergistic bio - products that are produced. This complex will become the active ingredient in the Histogen Aesthetics line of products for skin, hair and nail care.

A recent clinical study of 49 patients, in which ReGenica was used as a treatment following an ablative cosmetic laser procedure, revealed improvement of overall skin condition in comparison to the vehicle control. Histogen Aesthetics is beginning follow - up studies of ReGenica for post - laser resurfacing, as well as topical skin and hair
anti - aging applications.

Dermatology, cosmetics and biotechnology industry veteran Lawrence A. Rheins, Ph.D. has joined Histogen Aesthetics, LLC as President.

"The market for next generation, novel cosmeceuticals is rapidly evolving, including the movement of physician - dispensed, non - prescription products beyond the traditional medical specialties of plastic surgery and cosmetic dermatology, and into other medical specialties," said Rheins. "There is a continuing need for adjunct palliative skin conditioning products for use following all sorts of minimally and more invasive cosmetic procedures - laser, dermabrasion - by physicians engaged in aesthetic medicine."

Based on Histogen Aesthetics' initial studies, the Company believes that the proteins and growth factors within ReGenica work synergistically with the skin and hair's own physiology to combat the effects of the normal aging process, making the complex ideal for a breadth of advanced aesthetic products.

"Of the numerous products on the market, few have robust controlled scientific data to support claims of clinical improvement," continued Rheins. "Our goal is to create a line of skin, hair and nail care products that are not only sensorially appealing to consumers, but are based on the proven results of controlled clinical studies. I am excited to announce the creation of Histogen Aesthetics, and look forward to the launch of our first skin care products for the physician - dispensed medical aesthetics arena."

Dr. Rheins joins Histogen Aesthetics from the cosmetic/ personal care industry, and brings a rich, varied background in research dermatology, tissue engineering and contract research clinical services. Most recently, he served as Vice President of Science and Technology at Floratech International, a raw material supplier of botanical - derived ingredients for the cosmetic and personal care industries. Prior to this, Dr. Rheins founded DermTech International; a biotechnology company focused on dermatologic, "point of care" diagnostics, and was co-inventor of the Company's proprietary Epidermal Genetic Information Retrieval (EGIR) technology.

Dr. Rheins was also previously Executive Director at Advanced Tissue Sciences, a tissue engineering company focused on the growth of human skin and other tissues. He served as Director of pre - clinical/ clinical CRO services at Hill Top Research, and Divisional Toxicologist and Skin Laboratory Manager with Procter & Gamble. Prior to his industry career, Dr. Rheins served as Assistant Professor of Dermatology, at the University of Cincinnati, College of Medicine. Dr. Rheins holds several patents, and has authored more than 50 articles and book chapters on immunology, toxicology, dermatology and in vitro alternatives.

Histogen Aesthetics is currently focusing on the development of the ReGenica line of products, with launches beginning in the first quarter of 2009. These products will be distributed through Secure Medical, a technology and health care solutions provider based in Tempe, Arizona. Secure Medical already partners with Histogen to distribute its first product, the BioNuesis Human Stem Cell Culturing Kit.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high - value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula. Histogen Aesthetics can be found online at www.histogenaesthetics.com.

About Secure Medical
Secure Medical is a privately held company based in Tempe, Arizona. The company possesses ownership and interests in a variety of business models, all related to the medical industry. The following solutions are among those provided by Secure Medical: medical processing and fulfillment services/ call center capabilities;
telemedicine/ telehealth services in conjunction with the American Telemedicine Association; and patented medical kiosk manufacturing/ creation of associated software and hardware. Secure Medical is a biotech industry partner with Histogen, Inc. of San Diego, and its newest venture, Histogen Aesthetics. Histogen provides products that are naturally produced, for regenerative medicine and stem cell research.


Histogen Launches BioNuesis, the Only All-Human Stem Cell Culturing Kit

SAN DIEGO, September 22, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today launched BioNuesis, the only soluble human extracellular matrix (ECM) developed as a culturing kit for stem cell growth. The kit was launched and is being exhibited at the 2008 World Stem Cell Summit taking place in Madison, Wisconsin.

Through its proprietary bioreactors, Histogen is uniquely capable of simulating the embryonic environment, creating products that are embryonic-like in nature without the utilization of embryonic stem cells. Products are developed by extracting the proteins and growth factors produced by these fibroblasts. In working with the unique liquid formulation, Histogen researchers identified the potential for the human soluble ECM in the field of stem cell research, as compared to currently available products.

"There is a significant need for an all-human ECM product that can support pluripotent huES cell expansion in culture, without the complications inherent with mouse tumor-derived ECM extracts that are still the best replacement for feeder-layer cells," Dr. Jeanne Loring, Director of the Center for Regenerative Medicine at Scripps Research Institute. "Histogen's technology may provide the solution and help accelerate both basic science and translational research using huES cells."

BioNuesis is the first product that provides a limitless source of the natural human ECM proteins, such as laminin, collagen type 4 and fibronectin, which are required to expand human ES cells to commercial-scale.

Because current products utilize non-human sources, and can even contain mouse viruses, stem cell therapies developed using these animal products are not likely to be approved by the FDA. The technology behind the BioNuesis research kit, soluble natural human ECM, offers a solution which will eventually facilitate translation of stem cell cures to the public.

The launch of BioNuesis marks the entrance of Histogen into the marketplace as a number of products based on Histogen's proprietary technology continue down the pipeline.

"Histogen is uniquely capable of utilizing every aspect of the liquid and solid created by the Company's proprietary technology process, and developing high-value, all-human products at a commercial scale," said Dr. Gail Naughton, CEO of Histogen. "We are excited to bring our first product to the stem cell research market, and look forward to launching products in the cosmeceutical and medical fields in the near future."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.

About the World Stem Cell Summit
The World Stem Cell Summit, to be held Sept. 22-23, 2008 at Madison's Alliant Center, is a gathering of scientists, company leaders, ethicists, investors and others. The Summit will provide an opportunity for the exchange of important stem cell information among key players from throughout the globe. The event will coincide with the 10-year anniversary of UW-Madison scientist James Thomson becoming the first to successfully isolate and culture human embryonic stem cells. For more information about the Summit, visit www.worldstemcellsummit.com.


Stem Cell Research Expert Dr. Jeanne Loring Joins Histogen Scientific Advisory Board

SAN DIEGO, July 17, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Dr. Jeanne Loring, internationally recognized authority in the field of stem cell research, has joined Histogen's Scientific Advisory Board.

As founding Director of the Center for Regenerative Medicine at Scripps Research Institute in La Jolla, Calif., Dr. Loring focuses on supporting collaboration and strategic partnerships in human stem cell research, as well as training the next generation of stem cell scientists. She also currently serves as Professor of Developmental Neurobiology with the Institute.

"Dr. Loring's knowledge and background in the growing field of stem cell research will be an invaluable addition to Histogen's Scientific Advisory Board," said Dr. Robert Kellar, Vice President of Research & Development for Histogen. "We are excited to utilize her expertise as we move forward with research, and prepare to launch our first product, a research kit for stem cell growth."

Dr. Loring's extensive experience in the field includes research and management positions at biotechnology companies such as Hana Biologics, GenPharm International, Molecular Dynamics, and Incyte Genomics, as well as founding and serving as chief scientific officer of Arcos BioScience (now part of Novocell). Most recently, Dr. Loring acted as Co-director of the Stem Cell Center at Burnham Institute for Medical Research.

"Histogen's unique technology shows significant promise for the fields of regenerative medicine and stem cell research," said Dr. Loring. "I look forward to contributing to the Company's research initiatives and product development."

Histogen's proprietary bioreactor technology enables the Company to simulate the embryonic environment, creating products that are embryonic-like in nature with a variety of product applications from research kits to hair growth.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


CSUPERB Executive Director Dr. Susan Baxter Joins Histogen Board of Directors

SAN DIEGO, July 09, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Dr. Susan M. Baxter, Executive Director of the California State University Program for Education and Research in Biotechnology (CSUPERB), has joined Histogen's Board of Directors.

As Executive Director of CSUPERB, Dr. Baxter works with California State University (CSU) students, faculty and administrators system-wide to provide top-tier biotechnology education, capabilities and real-world research experience. CSUPERB serves as a liaison between the CSU and industry, academia, government, and the public in biotechnology matters.

"We are excited to welcome Dr. Susan Baxter to Histogen's Board," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "As someone with her finger on the pulse of the industry, Dr. Baxter will be an invaluable asset to Histogen as we grow the company and our presence in the regional biotechnology sector."

Previously, Dr. Baxter served as Chief Operating Officer at the National Center for Genome Resources in Santa Fe, New Mexico, where she managed a portfolio of state - and federal-funded projects providing information technology for collaborative, interdisciplinary biotechnology research and education. Prior to this, Dr. Baxter served as Vice President of Research and Genome Analysis for GeneFormatics, later Cengent Therapeutics, a drug discovery company in San Diego. In this position, she managed programs in both target and lead discovery.

"I think Histogen's unique business model and rich product portfolio poise the Company to become a leader in the regenerative medicine field, and offer compelling opportunities for collaborations with other industry innovators" said Dr. Baxter. "I look forward to contributing to Histogen's success, and continuing to develop the region's life sciences community in this exciting, fast growing field."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Histogen Presents at ASAIO Annual Conference

WHO: Gail Naughton, Ph.D, Histogen CEO and Chairman of the Board
Robert Kellar, Ph.D., Histogen Vice President of Research & Development
WHAT: Dr. Kellar to present "Tissue-Engineered Human Embryonic Extracellular Matrix for Therapeutic Device Applications"
Dr. Naughton to present "A Unique Business Model - Regenerative Medicine Redefined"
WHEN: June 19-21, 2008
WHERE: American Society for Artificial Internal Organs Annual Conference
Hilton San Francisco
333 O'Farrell Street
San Francisco, CA 94102
TOPIC: "Tissue Engineered Human Embryonic Extracellular Matrix for Therapeutic Device Applications"
Thursday, June 19, 2008 at 1:30pm
 
  • Histogen has developed methods for production of an embryonic human extracellular matrix that is similar to fetal mesenchymal tissue (rich in collagens, glycoproteins such as fibronectin, SPARC, thrombospondin, and hyaluronic acid)
  • Histogen's hECM creates an environment conducive to rapid cell proliferation and healing without the formation of scars or adhesions
  • Results support the use of this hECM as a biological surface coating and tissue filler treatment for various therapeutic applications
  "A Unique Business Model - Regenerative Medicine Redefined"
Friday, June 20, 2008 at 11:00am
 
  • Regenerative medicine company utilizing the products of newborn fibroblasts to develop solutions that do not contain embryonic stem cells or animal components
  • Proprietary bioreactor technology simulates the embryonic environment, creating products that are embryonic-like in nature
  • Unique business model based on short, mid and long term products that address markets from stem cell research to cosmeceuticals and hair growth

About Gail Naughton, Ph.D.
In addition to serving as CEO of Histogen, Dr. Gail Naughton has been the Dean of the College of Business Administration at San Diego State University since August 2002. Prior to that, she spent more than 15 years at Advanced Tissue Sciences, where she was the company's co-founder and co-inventor of its core technology. During her tenure there, Dr. Naughton held a variety of key management positions, including president. While serving as an officer and director of the Company, Dr. Naughton oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, established corporate development and marketing partnerships with companies including Smith & Nephew, Ltd., Medtronic and Inamed Corporation, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four fibroblast-based products from concept through FDA approval and market launch.

Dr. Naughton holds over 90 U.S. and foreign patents and has been extensively published in the field of tissue engineering. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering. Dr. Naughton has continued her research in cell based products for the last 5 years and in June of 2007 founded Histogen, which is focused on insoluble human extracellular matrix proteins and soluble protein products manufactured by human neonatal fibroblasts under embryonic (hypoxic) conditions.

About Robert Kellar, Ph.D.
Dr. Kellar has more than 11 years of experience in research and product development. Dr. Kellar has joined Histogen from his positions as co-owner and President of Development Engineering Sciences, a firm based in Flagstaff, Arizona. Kellar's experience in the biomedical industry includes prior positions with W.L. Gore & Associates and Advanced Tissue Sciences, where he was involved with commercial worldwide management of research, product development, business, marketing, and sales.

Kellar has authored over 7 papers and is the inventor on 5 patents and patent applications. Kellar serves on the Scientific Advisory Board for Theregen, a cell therapy company investigating the cardiovascular applications of the cell-based human tissue patch, AngineraTM. Dr. Kellar also holds an Adjunct Professor Faculty position in Mechanical Engineering at Northern Arizona University.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Dr. Gail Naughton to Present Histogen as Part of the BIO Biotechnology Entrepreneurship Bootcamp

WHO: Gail Naughton, Ph.D, Histogen CEO and Chairman of the Board
WHAT: Local Company Pitch Presentation: Histogen, Inc.
WHEN: June 17, 2008 at 1:45pm
WHERE: Biotechnology Entrepreneurship Bootcamp (BIO 2008)
San Diego Convention Center
Room 32AB
111 West Harbor Drive
San Diego, CA 92101
TOPIC: Local Company Pitch to VCs: Histogen, Inc.
 
  • Regenerative medicine company utilizing the products of newborn fibroblasts to develop solutions that do not contain embryonic stem cells or animal components
  • Proprietary bioreactor technology simulates the embryonic environment, creating products that are embryonic-like in nature
  • Unique business model based on short, mid and long term products that address markets from stem cell research to cosmeceuticals and hair growth
  • Initial clinical evaluations support the potential for post-laser treatment and hair growth products

About Gail Naughton, Ph.D.
In addition to serving as CEO of Histogen, Dr. Gail Naughton has been the Dean of the College of Business Administration at San Diego State University since August 2002. Prior to that, she spent more than 15 years at Advanced Tissue Sciences, where she was the company's co-founder and co-inventor of its core technology. During her tenure there, Dr. Naughton held a variety of key management positions, including president. While serving as an officer and director of the Company, Dr. Naughton oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, established corporate development and marketing partnerships with companies including Smith & Nephew, Ltd., Medtronic and Inamed Corporation, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four fibroblast-based products from concept through FDA approval and market launch.

Dr. Naughton holds over 90 U.S. and foreign patents and has been extensively published in the field of tissue engineering. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering. Dr. Naughton has continued her research in cell based products for the last 5 years and in June of 2007 founded Histogen, which is focused on insoluble human extracellular matrix proteins and soluble protein products manufactured by human neonatal fibroblasts under embryonic (hypoxic) conditions.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Histogen to Present Human ECM for Stem Cell Culture Applications at ISSCR Annual Meeting

WHO: Frank Zeigler, General Manager of In Vitro Products for Histogen, Inc.
WHAT: Poster Presentation: "Production of Human Extracellular Matrix (ECM) for Stem Cell Culture Applications"
WHEN: June 11 - 14, 2008
WHERE: International Society for Stem Cell Research (ISSCR) Annual Meeting
Pennsylvania Convention Center
1101 Arch Street
Philadelphia, PA 19107
TOPIC: "Production of Human Extracellular Matrix (ECM) for Stem Cell Culture Applications"
 
  • Technology uses hypoxia to upregulate ECM protein production during tissue formation
  • Key components of a fetal-like, undifferentiated mesenchymal tissue have been produced, including collagens and key glycoproteins such as fibronectin, tenascin, and laminins
  • Product technology offers a commercially-viable source of human ECM for a wide variety of in vitro applications including pluripotent stem cell culture
 Attendees are invited to visit Histogen's poster presentation in the exhibit area from 5:30 - 7:00pm, June 11, 12 and 13, 2008.

About Frank Zeigler
Frank Zeigler serves as General Manager of In Vitro Products for Histogen. He has more than 18 years of experience in research and product development, previously serving as senior scientist and project manager with biotechnology companies including Genentech, Advanced Tissue Sciences, and Stem Cells Inc. Recently, Zeigler was founder and CSO of Orion Biosolutions, a start-up biotech company, where he developed and brought research kit products to market. He has 8 peer-reviewed research publications and holds 3 issued US patents in the field of cell biology and cell analysis.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Histogen Presents Feasibility Data on Hair Growth and Laser Resurfacing

Evaluations of HGEN-001 formulation indicate capabilities for new hair follicle creation and more rapid healing post-laser resurfacing

SAN DIEGO, CA May 16, 2008 - Histogen Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today presented findings from preliminary evaluations of the Company's HGEN-001 formulation, during International Investigative Dermatology 2008, taking place May 14-17, 2008 in Kyoto, Japan.

Histogen's HGEN-001 liquid formulation is produced through a proprietary bioreactor system which simulates the embryonic environment, including hypoxic conditions of 3-5% oxygen. Under these conditions, a number of growth factors key to tissue development and regeneration are significantly elevated, specifically WNT proteins 5A, 6, 7A, 10A and 11. HGEN-001 is the first evidence of naturally-secreted, native human WNT proteins in a commercially scalable growth system.

The HGEN-001 formula was evaluated as a post-laser resurfacing treatment in 49 patients, with 26 receiving a placebo gel and 23 receiving a gel with HGEN-001. The products were applied several times per day for 8 days, after a micro-fractional ablative and non-ablative laser treatment to the face. Patients were monitored for 14 days with mexameter readings, survey data, as well as independent clinical assessment of re-epithelialization.

The preliminary results indicate that patients receiving the active HGEN-001 product experienced less dramatic post-laser symptoms, such as erythema, edema, and flaking, with a more rapid recovery when compared to the placebo group. The data suggests that topical application of a skin gel supplemented with HGEN-001 can provide overall improved visible re-epithelialization of post ablative laser facial skin, and thereby accelerate patient recovery, while keeping superficial cutaneous side effects to a minimum.

"The ability to provide a treatment that results in better patient comfort and overall healing outcomes is key to many plastic surgery treatments," said Dr. Mark Hubka, Histogen's Director of Clinical Affairs. "Histogen is dedicated to developing a product pipeline to provide multiple patient benefits post dermatological and plastic surgery procedures."

Because of the native soluble WNT proteins and growth factors contained in the formula, HGEN-001 was also evaluated as a stimulus for new hair follicle creation. In the C57 Bl mouse model, an animal model widely used for hair growth, HGEN-001 was shown to significantly increase hair growth and new follicle formation.

"HGEN-001 induced a significant increase in hair follicle growth, as compared to the control, in our preclinical model," Said Frank Zeigler, General Manager of In Vitro Products for Histogen. "Researchers have reported the importance of wnt proteins and wound healing growth factors in the induction of new hair follicles for over a decade. Our research helps to substantiate the importance of these active agents in follicular neogenesis, all of which are components in HGEN-001."

Clinical trials for HGEN-001 as an application for hair growth are planned for late 2008.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Secure Medical CEO John Rao Joins Histogen Board of Directors

SAN DIEGO, May 9, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that John Rao, founder and CEO of Secure Medical Inc., a medical technology company, has joined Histogen's Board of Directors.

Within the medical field, Mr. Rao is an accomplished entrepreneur, innovator, and strong patient rights advocate, including his involvement with the American Telemedicine Association and his current patents relating to remote health kiosks and glyph identification. Mr. Rao founded Tempe-based Secure Medical in 1999 to bring healthcare services closer to patients through telemedicine, telehealth and telecare applications.

"John Rao's background in technology innovation, and success within the medical industry, make him a prime addition to our Board of Directors," said Dr. Gail Naughton, Histogen CEO and Chairman of the Board. "We look forward to tapping into John's expertise as Histogen moves forward with manufacturing, research and development, and product launches."

In addition to Secure Medical, Mr. Rao has owned and operated 14 technology-driven companies spanning a variety of industries including retail, wholesale, manufacturing and product development, as well as computer sciences and security driven methodologies. His passion for technology spans over 40 years, and he holds a number of patents and patent applications for innovative technologies.

"I am pleased to join Histogen's Board of Directors, and excited to contribute to the Company's success at this stage of tremendous growth," said Rao. "Histogen's unique technology platform, which has enabled the development of an extensive product portfolio from a single manufacturing process, gears the Company to become a leader in the industry."

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Histogen Announces Initial Close of Series A Financing Round

SAN DIEGO, May 2, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the initial close of Series A financing at $5.35 million. The round was completed by private and corporate investors, including Secure Medical Inc., CellCeuticals Skin Care Inc., and Leonard H. Lavin, founder and Chairman Emeritus of the Alberto-Culver Company.

Histogen will utilize the round to fund Phase 1 clinical trials for hair growth and complete 510k submissions for wound and hernia repair applications. The round will also enable the Company to upscale manufacturing for Exceltrix, Histogen's human Extracellular Matrix product, and HGEN-001, Histogen's proprietary liquid formulation.

"We are pleased that we have exceeded our original target for the Series A round, and have added highly experienced investors to our list of shareholders," said Gail K. Naughton, Ph.D., CEO of Histogen. "With the close of this financing, we look forward to bringing additional talent to our already seasoned team, and getting our first products to market within the next 12 months."

The initial close of Series A financing will allow Histogen to maintain timelines for product introductions, including the Company's first tissue engineering products, which are slated for launch in late 2008 and early 2009. From two product families, Exceltrix and HGEN-001, which are derived from a single manufacturing process, Histogen forsees a breadth of applications in a variety of markets, from research tools to cosmeceuticals.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.


Hair Restoration Specialist Dr. Craig Ziering Joins Histogen Scientific Advisory Board

SAN DIEGO, April 23, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Dr. Craig Ziering, renowned hair transplant surgeon and founder of Ziering Medical, has joined Histogen's Scientific Advisory Board.

A leading authority in hair transplant surgery, Dr. Ziering has performed over 12,000 procedures in his career, and currently operates hair restoration centers in California, Utah and Nevada. He is certified by both the American Board of Hair Restoration Surgery and the American Osteopathic Board of Dermatology, serves on the advisory board for companies including Merck and Lexington International, and is Surgical Faculty for the Procedural Dermatology Fellowship at the University of California at Irvine.

Dr. Ziering is recognized as an expert in the art and science of hair transplant surgery, including his work as an Extreme Team Surgeon for television's Extreme Makeover and appearances on Dr. 90210 and the Today Show. He also remains an active participant in research, and serves as a strong advocate of hair cloning as a future treatment for hair loss.

"Dr. Ziering's expertise in the areas of hair growth and restoration will be invaluable to Histogen as the Company moves toward clinical trials for our HGEN-001 formula as an injectable for hair growth," said Dr. Robert Kellar, Histogen's Vice President of Research and Development. "His understanding of maintaining and stimulating healthy hair follicles and his clinical background make him an ideal addition to Histogen's Scientific Advisory Board."

Histogen's proprietary HGEN-001 liquid formula has potential in a variety of areas from research to cosmeceutical products, but the Company sees hair regrowth as a homerun application with real potential impact. The formula's unique combination of proteins and growth factors has been shown to both stimulate resting hair follicles and induce new follicle formation.

"I am excited to join Histogen's Scientific Advisory Board, and look forward to bringing this promising product through clinical trials," said Dr. Ziering. "Recent research findings on the capabilities of wnt proteins and growth factors to induce hair follicle formation are compelling, and show great potential for the more than 50 million Americans affected by hair loss."

Histogen's injectable for hair growth will begin clinical trials in late 2008, with product launch planned for 2015. Data will be presented at International Investigative Dermatology 2008, taking place May 14-17, 2008 in Kyoto, Japan.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen has two product families - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.

About Ziering Medical
Ziering Medical was established in April of 2003 as a private practice dedicated exclusively to the specialty of hair restoration. Founder and Medical Director Dr. Craig L. Ziering is an industry pioneer, leader and lecturer who remains in constant pursuit of seeking and developing new technology such as the Ziering Whorl and Sneak Peek Long Hair Transplant. Ziering Medical performs facial hair aesthetics and corrective procedures for scars, as well as laser therapy and medical solutions for men and women. By combining art and science to create exceptional, natural looking results, Dr. Ziering's refined eye for aesthetics perfectly complements his advanced surgical skills. Providing excellence in hair restoration to patients from around the world, Ziering Medical is headquartered in Beverly Hills with offices in Newport Beach, Encino, Rancho Mirage, California, Las Vegas, Nevada and Salt Lake City, Utah. For more information, visit www.zieringmedical.com


Alberto-Culver Founder Leonard Lavin Joins Histogen Board of Directors

SAN DIEGO, February 14, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Leonard Lavin, founder and chairman emeritus of the Alberto-Culver Company, has joined Histogen's Board of Directors.

In addition to his distinguished career with Alberto-Culver, a Fortune 1000 consumer products company, Leonard Lavin's experience and interests cross various industries. In 1946, Lavin joined Halgar, Inc., a company specializing in toiletry products, where he was instrumental in building the company into one of the leaders in its field. Lavin also formed the Excello Sales Agency, where he gained exclusive advertising and sales rights for Stopette spray deodorant, which went on to become the number one product of its kind.

Leonard Lavin and his wife Bernice bought Alberto-Culver Company in 1955 for $400,000, and turned it into a multi-billion dollar company. By positioning his products and making innovative use of television advertisements, Lavin has supplied the world with some of the most well known hair, skin and personal care products.

"Mr. Lavin's extraordinary business acumen will be invaluable as Histogen enters a tremendous stage of growth in 2008," said Gail K. Naughton Ph.D., Histogen founder and Chairman of the Board. "Leonard has proven himself to be a marketing genius, and having someone with his expertise join the board truly validates Histogen's distinctive business model."

Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. The company's business plan benefits from the lessons learned at Advanced Tissue Sciences, and focuses on near, mid and long term products that are either self-pay or reimbursable.

"I am excited to be a new director on Histogen's board, and look forward to contributing to the company's success" said Lavin." The field of regenerative medicine offers many potential therapeutic and cosmetic benefits, and Histogen's unique technology positions the company to be a global leader in the field."

Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio.


Histogen CEO Presents Extracellular Matrix Data for the First Time at MD&M West

Embryonic extracellular matrix contains unique composition of proteins for rapid cell proliferation and healing without scars

SAN DIEGO, January 31, 2008 - Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, will present data on the company's unique embryonic extracellular matrix (ECM) today at the MD&M West Conference in Anaheim, Calif.

Through the company's proprietary bioreactor technology, Histogen is uniquely capable of simulating the embryonic environment, including hypoxic conditions of 1-5% oxygen, creating a human extracellular matrix with a wide distribution of embryonic proteins unmatched by adult ECM.

"Histogen's human extracellular matrix contains a variety of proteins found only in the embryonic environment," said Dr. Robert Kellar, VP of Research and Development at Histogen. "Our human ECM provides the benefits of a natural biologic for surface modification and tissue regeneration, without the problems of allergic responses and possible viral transmission associated with porcine and bovine derived materials."

Under these hypoxic culture conditions, over 5,000 genes are differentially expressed as compared to cells grown under traditional tissue culture conditions. These distinct genes may be responsible for encouraging increased wound healing and regeneration.

"It is well known that operations performed in the prenatal environment will not leave scars present at birth," said Dr. Gail Naughton, CEO of Histogen. "To be able to replicate this rapid, scarless healing in adult patients would mean countless benefits in the areas of plastic and general surgery. The regenerative capabilities of the embryonic-like matrix also support its use as a coating for medical devices and as patches for hernia and soft tissue repair."

Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen's business plan benefits from the lessons learned at Advanced Tissue Sciences, and focuses on near, mid and long term products that are either self-pay or reimbursable.


Histogen Welcomes Robert Kellar as Vice President of Research and Development

New regenerative medicine company armed for growth in 2008

SAN DIEGO, December 20, 2007 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, announced today that Dr. Robert Kellar has joined the company as Vice President of Research and Development. Kellar's knowledge in the field of tissue engineering, and experience in bringing products from concept through to commercial market, will be vital in enabling Histogen to meet the company's product launch goals in the coming year.

"I am excited to welcome Robert Kellar to our new, but rapidly growing, Histogen team," said Dr. Gail Naughton, CEO of Histogen. "With Rob on board, we look forward to reaching great milestones in 2008, including bringing our first tissue engineering products to market. Rob's appointment brings our senior management's total experience in tissue engineering to more than 50 years."

Dr. Kellar joins Histogen from his positions as co-owner and President of Development Engineering Sciences, a firm based in Flagstaff, Arizona. Kellar's prior experience in the biomedical industry includes positions with both W.L. Gore & Associates and Advanced Tissue Sciences, where he was involved with commercial worldwide management of research, product development, business, marketing, and sales. Kellar has authored over 7 papers and is the inventor on 5 patents and patent applications. Kellar also serves on the Scientific Advisory Board for Theregen, a cell therapy company investigating the cardiovascular applications of the cell-based human tissue patch, Anginera.

"Histogen's technology will afford the opportunity for a variety of product possibilities," said Dr. Robert Kellar. "I'm enthusiastic about joining the Histogen team and I look forward to the role we can play in advancing the field of tissue engineering and regenerative medicine."

Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio. Histogen's business plan benefits from the lessons learned at Advanced Tissue Sciences, and focuses on near, mid and long term products that are either self-pay or reimbursable.


Histogen CEO Speaks on Bringing Tissue Engineered Products from Lab to Market at MD&M Conference

November 15, 2007 - Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, addressed attendees at the annual Medical Design & Manufacturing (MD&M) Conference, Minneapolis this October. Naughton utilized past experiences in bringing four cell-based products from concept to market, while at Advanced Tissue Sciences, to present the challenges and best practices for the development and approval of human cell-based regenerative medicine products.

"Cell based regenerative medicine products offer great potential to address countless of patient unmet needs. The high cost of manufacturing these products, long clinical timelines, and challenges with reimbursement have tremendously hurt product development and investment in this important field," said Naughton. "Developing a robust product pipeline based on one cell type and one manufacturing system is key, and can reduce the cost of developing a new product indication by 75%. It is also critical to have products with short and midterm markets and those where reimbursement challenges do not exist. Histogen's business plan and products directly address each of these key issues."

In addition to presenting at MD&M Minneapolis, which took place on October 16-17, 2007, Naughton will revisit the topic at MD&M West in January 2008.

Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. During her time with Advanced Tissue Sciences, Naughton raised $350 million from the public market and corporate partnerships, and oversaw the design and development of the world's first upscale manufacturing facility for tissue engineered products.

Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the company has developed its rich product portfolio.

For more information about the upcoming MD&M West Conference, taking place between January 28-31, 2008 in Anaheim, visit www.devicelink.com/expo/west08


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Histogen's proprietary tissue-engineering process is utilized for manufacturing all of Histogen's products. Newborn cells are placed into a bioreactor and conditioned with a liquid media.
  • HSC's components have recently been shown to be critical for new hair follicle formation
  • The field of stem cell research is rapidly expanding
  • Histogen scientists have developed regenerative medical technologies without the use of stem cells or animal serum
© Histogen Inc., CA 92121