Episurf Medical’s first EPIC-Knee surgery in Canada scheduled
Episurf Medical (NASDAQ: EPIS B) today announces that the first surgery in Canada within the company’s IDE Clinical Trial, EPIC-Knee: Episealer® Knee System IDE Clinical Study, is scheduled. The randomised controlled IDE study is currently ongoing in the USA/Canada and Europe, and surgeries have this far been performed in Tennessee and California in the US, as well as in Germany. The end goal with the study is an FDA PMA application for US market approval the Episealer® Knee implant.
"This is a milestone in this important study. We have had challenges with the speed of recruitment for the study, but lately we have seen increased activity, which pleases us. For example, we also have the first operation in Texas scheduled, and we have new investigators being added in Europe", says Pål Ryfors, CEO Episurf Medical.
Since previously, the Episealer® Patellofemoral System is cleared for sale in the US, and the company is intending to submit an FDA 510(k)-application for its implant for the 1st MTP joint (big toe) in the near future.
For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com
About Episurf Medical
Episurf Medical is endeavoring to bring people with painful joint injuries a more active, healthier life through the availability of minimally invasive and individualised treatment alternatives. Episurf Medical’s Episealer® individualised implants and Epiguide® surgical drill guides are developed for treating localised cartilage injury in joints. Episurf Medical’s μiFidelity® system enables implants to be cost-efficiently tailored to each individual’s unique injury for the optimal fit and minimal intervention. Episurf Medical’s head office is in Stockholm, Sweden. Its share (EPIS B) is listed on Nasdaq Stockholm. For more information, go to the company’s website: www.episurf.com.
The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CEST on 21 June 2023.
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