FDA granted breakthrough designation to Active Implants’ NUsurface Meniscus Implant, the company said Thursday.
Active Implants is developing NUsurface for use in patients who undergo a meniscectomy to treat a damaged or torn meniscus but continue to experience pain after the procedure.
NUsurface is designed to alleviate that pain by improving the distribution of pressure within the knee joint, freeing patients from the need to take painkillers or undergo knee replacement surgery.
Around 700,000 patients a year undergo arthroscopic meniscectomy in the U.S., making it one of the most widely performed surgical procedures. However, there are doubts about the effectiveness of the intervention. One clinical trial found partial meniscectomy was no better than a sham procedure. Another study showed patients who undergo the procedure may still need full knee replacements.
The limitations of the procedure have created a population of patients who are failed by the current treatment options. These patients have undergone partial meniscectomies without success, leaving long-term painkiller use and full knee replacements as some of their remaining treatment options.
Active Implants is pitching their product as a better option. The polymer implant is not fixed to bone or soft tissue and designed to perform the same role as the natural meniscus, distributing contact pressures within the knee to reduce joint overload and pain.
A clinical trial designed to deliver data to support a FDA submission is underway. Active Implants completed enrollment in the study last year, putting it on track to generate the required data in 2020. The trial is comparing the implant to nonsurgical care, such as corticosteroid injections, in patients who had a partial meniscectomy more than six months ago but still suffer from pain. The primary endpoint is a scale that assesses knee injuries and osteoarthritis outcomes.
The breakthrough designation positions the company to get additional input from FDA as it works to generate the data, as well as to benefit from an accelerated review at the filing stage. Active Implants could also benefit from changes to how CMS approaches the reimbursement of devices with breakthrough designations.
NUsurface is already on the market in Belgium, Germany, Italy, and Israel.