Trends in Biodevices
The major trends in biodevices are in the areas of orthopedics, cardiology, biomaterials, and regenerative medicine.
Organogenesis (www.organogenesis.com) is focused on regenerative medicine products, involving collagen, fibroblasts, and keratinocytes.
Apligraf, a skin replacement product for burns and wound healing, launched in 1998 and is now selling 700 units a week, according to the company.
Sales are increasing, said vp Dario Eklund, but the product is only reaching 2% of the applicable market at present, so there is still a lot of potential growth. Apligraf is bilayered—fibroblasts in a collagen matrix and a keratinocyte-containing top layer.
VCT-01™ , which is in development, is an improved form of Apligraf. It has a human rather than bovine matrix and is stronger.
TestSkin® is being used by cosmetic companies to test products. As animal testing is phased out, the market for this is likely to increase.
Intercytex (www.intercytex.com) is at various stages of clinical trials with its four cell therapy products for wound healing, scars, wrinkles, and hair regeneration. Lead product, ICX-PRO, for chronic venous ulcers and diabetic ulcers, is a clear competitor for Apligraf.
ICX-PRO and the scar and wrinkle products are based on allogeneic fibroblasts. The hair-regeneration product is based on autologous cells that are taken from the base of the hair follicle. “We want to set a new standard in ease of use and storage,” said Nick Higgins, CEO. “We are trying to make cell therapy appropriately priced, which will broaden the market.”
Cartilage and bone repair are other leading areas in regenerative medicine. Scil Technology (www.scil.com) is developing products for orthopedic and dental tissue regeneration with an emphasis on bone and cartilage repair. These products are composed of recombinant growth factors combined with biodegradable materials to stimulate the formation of new tissue.
The company has identified three growth factors; one of these, rhGDF-5, is a bone morphogenic protein that is being applied specifically to dental tissue and is the active pharmaceutical substance in lead product, MD05, a synthetic granulated bone substitute.
This product is intended for bone augmentation prior to dental implant and for treatment of severe periodontal disease, where the bone, as well as the surrounding tissue supporting the teeth has worn away and where there is no effective regenerative treatment currently available.
According to Weishui Weiser, Ph.D., managing director, it has proof-of-concept on the action of rhGDF-5 in animal models, and a Phase II trial of MD05 is currently being conducted in Germany.
The company also has ongoing projects in orthopedics. They have proof-of-concept for bone augmentation in spinal fusion procedure and for cartilage repair following both accidental damage and degeneration due to osteoarthritis.
Cartela(www.cartela.com) is working on an integrin, a type of cell-surface receptor found specifically on chondrocytes. This marker can be used to pick out cells with chondrocyte potential in mesenchymal stem cells.
TiGenix (www.tigenix.com) is focused on understanding the cell biology of stable hyaline cartilage and the pathogenesis of osteoarthritis in the hope of developing the first-ever durable repair for a worn-out or damaged knee joint. The company’s lead product, ChondroSelect™, an autologous cell therapy for cartilage repair, is in Phase III trials. This trial, at 15 centers, compares the therapy with microfracture, a standard surgical procedure for knee repair.