CE marking for the Episealer ® Talus implant expected for Episurf Medical
Episurf Medical (NASDAQ: EPIS B) announces that today, the company has been informed by its notified body that the review process for obtaining CE mark for the ankle implant Episealer® Talus has been concluded and that the final formal process for issuing the CE-certificate is expected to be completed within 2 weeks.
The implant is intended for osteochondral lesions of the talar dome of the ankle joint. The new ankle implant is supplied together with a kit of surgical tools, and the devices are based on the same technology platform as the company’s Episealer® knee devices, with an individualised design based on medical imaging and 3D modulation.
“We believe this is a world-unique implant solution and we are very happy to add Episealer® Talus to our product portfolio” says Pål Ryfors, CEO Episurf Medical.
“This device is a next step in the treatment of patients with large secondary osteochondral defects both on the medial or lateral side of the talar dome. It offers a tailor-made solution for these otherwise difficult to treat lesions” says Prof. dr. C. Niek van Dijk, member of the Clinical Advisory Board at Episurf Medical.
In connection with this, the company has a parallel process to receive CE mark for an individualised osteotomy guide that is intended to help surgeons to find the correct position and depth of the sawing when performing a medial malleolar osteotomy.
Pål Ryfors continues: “With the addition of the Episealer® Talus to our product portfolio, we are now expanding outside the knee joint and offer treatment options for focal articular defects of the femoral knee joint as well as medial and lateral positions of the ankle joint. We are very excited that our new product line will finally be available on the market. Surgeons have indicated the need and are eager to get started. We will, of course, inform the market once the final certificate is issued, but today’s information was critical to us and to this process”.
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.
This information is information that Episurf Medical AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 22.00 CET on 2 January 2020.
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