Through the same proprietary manufacturing process that produces CCM and HSC, a novel human extracellular matrix (hECM) is also created and holds potential as a biological matrix to replace or regenerate tissue for therapeutic applications including orthopedics, soft tissue augmentation and wound healing.
In multiple preclinical models Histogen’s hECM has been shown to regenerate mature cartilage and well vascularized bone, indicating therapeutic potential in the sports medicine, spinal disc repair, orthopedic, and dental areas. Studies conducted by outside experts have demonstrated that hECM is anti-inflammatory, angiogenic, and can stimulate the growth of stem cells in damaged areas to induce tissue regeneration. The most extensive in vivo work in animals has focused on the regeneration of new hyaline cartilage and bone in full thickness knee injuries. Histogen’s first clinical candidate in the area of orthopedics, HST 003, has future market potential to address the loss of cartilage in knees and other joints associated with age, osteoarthritis, rheumatoid arthritis, and injury from sports or accidents. IND submission for HST 003 is anticipated in 2020.
Soft Tissue Augmentation
Studies to date have shown that Histogen’s hECM acts as a biological scaffold to attract the patient’s own stem cells and fibroblasts to migrate into it, divide and differentiate, and generate new soft tissue. Unlike temporary fillers, this approach generates new healthy tissue similar to the patient’s own, and offers the possibility of a long-lasting solution in treating deep wrinkles or acne scars, regenerating tissue after a lumpectomy, or augmenting breast tissue. Histogen plans to file an investigational device exemption, or IDE, with the FDA and commence enrollment of a Phase 1 Clinical Trial of HST 002 in 2020. HST 002 is a human-derived collagen and extracellular matrix dermal filler for the treatment of facial folds and wrinkles.