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Active Implants Plans 2019 Commercial Release For NUsurface Meniscus Implant

 
• By Reed Miller

Active Implants announced the completion of patient enrollment in the VENUS randomized trial of the NUsurface meniscus implant for the treatment of persistent knee pain caused by injured or deteriorated meniscus tissue. Results of the VENUS and SUN trial, which has also completed enrollment, will support a de novo clearance from US FDA, which would make it the first artificial meniscus approved in the US. NUsurface already has a CE mark and the company is planning to start a limited commercial release outside the US in 2019.

Active Implants LLC is ramping up for a 2019 commercial launch of its NUsurface polycarbonate-urethane meniscus implant, outside the US, as it continues clinical trials in the US. It hopes to file for US FDA-approval for NUsurface via a de novo application by the end of 2020.

"We've been really focused on collecting data to to get to more global approvals, [and] our focus for the last several years has been on the US trial and all the efforts there," CEO Ted Davis told Medtech Insight. NUsurface has been used at a few centers in Europe under CE mark since 2008 and in Israel since 2011, but the company has yet to invest in commercialization of the device

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