Cartiva has won an FDA premarket approval for its cartilage implant to treat osteoarthritis at the base of the big toe. It is the first synthetic cartilage implant approved by the FDA.
The Synthetic Cartilage Implant (SCI) is an alternative to standard of care: fusing the bones in the foot with screws and plates. While this effectively takes care of pain from the arthritic joint, it also permanently stops it from moving.
A biocompatible, biomedical polymer implant designed to mimic the physical characteristics of articular cartilage, the implant replaces damaged cartilage, relieving pain while maintaining joint function. The procedure takes about 35 minutes and, unlike fusion, allows patients to immediately put as much weight as they can tolerate on the foot.
The approval comes on the back of a randomized, multicenter, 236-patient clinical trial. It compared outcomes from patients who received the SCI with patients who underwent fusion. The SCI group posted a 93% reduction in median pain and a 168% improvement in median function in sporting activities and 65% improvement in daily living activities, according to a statement. The SCI patients also had a 26% increased range of movement from their baseline. While the approved indication is for the base of the big toe, Cartiva is also looking into using it to treat osteoarthritis at the base of the thumb.
The SCI has been on the market outside the U.S. since 2002 and is available in Europe, Canada and Brazil. Back in April, the FDA’s Orthopaedic and Rehabilitation Devices Panel voted in support of the device’s safety and efficacy and that its benefits outweigh its risks. At the time, the company was planning a launch date in early 2016.
“Before Cartiva SCI, the options we could provide to patients with osteoarthritis of the great toe were limited, as the fusion procedure often necessitates sacrificing range of motion to get pain relief,” said Dr. Mark Glazebrook of the Queen Elizabeth II Health Sciences Centre in Halifax, Canada, who uses Cartiva SCI in his practice, in the statement.
Spun out from Carticept Medical in 2011, Cartiva’s latest disclosed financing was its $8.5 million Series D in May 2015. Its investors include New Enterprise Associates, Windham Venture Partners and Domain Associates.
- here's the statement
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