Within the sports medicine market, repair of cartilage injuries represents one of the greatest unmet medical needs. In the U.S., approximately 500,000 cartilage lesions are detected in knee joints each year. Because adult cartilage cells cannot fully regenerate and repair injuries, lesions left untreated cause damage that can progress to post-traumatic osteoarthritis. Arthritis and related diseases are the most common cause of disability in adults. Currently, the only FDA approved biological product for repairing cartilage in the knee uses the patient’s own cartilage cells. This surgery is complicated, expensive, and has yet to be widely adopted.
ISTO Technologies is a clinical-stage company developing products for sports medicine, spinal therapy and trauma. The company’s orthobiologic products are intended to repair and regenerate damaged tissue in knee joints and spinal discs.
Cartilage regeneration is considered the “holy grail” of the orthopedic industry because of its potential to renew cartilage and restore function to damaged joints. Cartilage protects joints, including spinal discs, from the wear and tear encountered during motion; after a surgery, it experiences only limited healing without surgical intervention. Subsequent degeneration of cartilage in joints and spinal discs often leads to irreversible damage, causing pain and disability.
ISTO’s lead cartilage product DeNovo ET, is a cartilage graft grown from juvenile chondrocytes using the company’s cell-based platform technology. DeNovo ET is a scaffold-free living cartilage graft offered as an off-the-shelf product for the repair and regeneration of cartilage in the knee. DeNovo ET is in Phase I/II human clinical trials.
ISTO’s second target market concentrates on the spine. The company is developing products that can regenerate the spinal disc nucleus. Back pain, mostly due to degeneration of the spinal disc, represents one of the most prevalent medical conditions worldwide. To date, no therapy exists that can reverse or heal damaged cartilage in a degenerated disc, leaving surgical intervention as the only option. In the U.S. alone, surgeons perform more than 400,000 lumbar discectomies and 450,000 spinal fusions each year. Neither procedure addresses the underlying conditions that lead to irreversible disc degeneration; both procedures have significant drawbacks, such as restricted mobility and continued degeneration of the affected discs.
NuQu, a cell-based injectable formulation of juvenile chondrocytes for nucleus regeneration of the spinal disc, offers a therapeutic solution for early intervention of disc degeneration. Degeneration of disc cartilage begins in the nucleus, the innermost disc component, and is accompanied by cell death and tissue destruction. Recent pre-clinical data suggests that NuQu injected into the nucleus can regenerate a cartilage in the disc nucleus. NuQu has been developed for use in conjunction with a minimally invasive procedure.