[Video Profile] Interview with Mitchell Seyedin, President & CEO of ISTO Technologies

Within the sports medicine and spinal markets, repair of cartilage injuries in the knee and spinal disc represents one of the greatest unmet medical needs. Each year in the U.S., orthopedic surgeons detect approximately 500,000 cartilage lesions in knee joints alone. Cartilage protects joints, including spinal discs, from the wear and tear encountered during motion. Because adult cartilage cells cannot fully regenerate tissue and repair injuries, lesions left untreated worsen over time and can progress to post-traumatic osteoarthritis. Subsequent degeneration of cartilage in joints and spinal discs often leads to irreversible damage, causing pain and disability. Currently, the only FDA-approved biologic product for repairing knee cartilage uses the patient’s own cartilage cells in a two-step surgical process. Similar strategies are also used in Europe. These products are inherently expensive. Furthermore, cells derived from adult patients have poor regenerative capacity.

ISTO Technologies is developing products for sports medicine, spinal therapy and trauma. The company’s orthobiologic products are intended to repair and regenerate damaged cartilage in knee joints and spinal discs. Cartilage regeneration is often called the “holy grail” of orthopedics because of its potential to renew cartilage and restore function to damaged joints (versus the more invasive option of surgical intervention). ISTO’s patented technology allows expansion of juvenile cartilage cells that can be used to produce a cartilage graft in vitro for transplantation; alternatively, these cells can be implanted directly to generate cartilage in situ.

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 repair and regeneration of knee cartilage.

The company is also developing NuQu, a cell-based injectable formulation of juvenile chondrocytes for nucleus regeneration of the spinal disc. 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 affected discs.

NuQu 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 suggest that NuQu injected into the nucleus can regenerate cartilage in the disc nucleus. NuQu has been developed for use in conjunction with a minimally invasive procedure.

ISTO’s InQu, which is being developed for the trauma and spinal fusion markets, is the company’s first-to-market device product, offering an early revenue opportunity. InQu, which has received 510(k) clearance as a bone graft substitute, is a biomaterial scaffold of synthetic and biologic polymers.

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