Episurf Medical: Update on Episealer® Patellofemoral System for the US market
Episurf Medical (NASDAQ: EPIS B) today announces that the development of the company’s Episealer® Patellofemoral System is progressing according to plan. The previously communicated plan to submit a 510(k) application before the end of the year to the US FDA for US market clearance is still valid. The design for the system is now set and final device testing is presently being conducted. Episealer® Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint.
Simultaneously, the company is preparing for a commercial launch in the US of the Episealer® Patellofemoral System during 2022.
“Our excitement about this project is growing as we are approaching filing of the 510(k) as well as the subsequent commercialisation in the US market. We will then enter the largest orthopaedic market in the world, which will be a tremendous milestone for us”, comments Pål Ryfors, CEO Episurf Medical.
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[HtmlCompanyInformation:protected] => <p style="font-family:arial,helvetica,sans-serif; font-size:10pt"><strong><span style="font-size:10pt">About Episurf Medical</span></strong></p>
<p style="font-family:arial,helvetica,sans-serif; font-size:10pt"><em>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.</em></p>
<p style="font-family:arial,helvetica,sans-serif; font-size:10pt"><span style="font-family:arial,helvetica,sans-serif; font-size:10pt"><em>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 08.00 CEST on 16 July 2021.</em></span></p>
[HtmlContact:protected] => <p style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><strong><span style="font-size: 10pt; font-family: arial,helvetica,sans-serif;">For more information, please contact:</span></strong></p>
<p style="font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="font-size: 10pt;">Pål Ryfors, CEO, Episurf Medical<br /></span><span style="font-size: 10pt; font-family: arial,helvetica,sans-serif;">Tel:</span><span style="font-size: 10pt;">+46 (0) 709 62 36 69<br /></span><span style="font-size: 10pt;">Email: </span><a href="mailto:pal.ryfors@episurf.com">pal.ryfors@episurf.com</a></p>
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[Body:protected] => Episurf Medical (NASDAQ: EPIS B) today announces that the development of the company’s Episealer® Patellofemoral System is progressing according to plan. The previously communicated plan to submit a 510(k) application before the end of the year to the US FDA for US market clearance is still valid. The design for the system is now set and final device testing is presently being conducted. Episealer® Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint.
Simultaneously, the company is preparing for a commercial launch in the US of the Episealer® Patellofemoral System during 2022.
"Our excitement about this project is growing as we are approaching filing of the 510(k) as well as the subsequent commercialisation in the US market. We will then enter the largest orthopaedic market in the world, which will be a tremendous milestone for us”, comments Pål Ryfors, CEO Episurf Medical.
[HtmlBody:protected] => <p style="margin-bottom: 11px; font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span><span>Episurf Medical (NASDAQ: EPIS B) today announces that the development of the company’s Episealer® Patellofemoral System is progressing according to plan. The previously communicated plan to submit a 510(k) application before the end of the year to the US FDA for US market clearance is still valid. The design for the system is now set and final device testing is presently being conducted. Episealer® Patellofemoral System is an implant system with two implants for treatment of chondral and osteochondral lesions in the knee joint. </span></span></p>
<p style="margin-bottom: 11px; font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span><span>Simultaneously, the company is preparing for a commercial launch in the US of the Episealer® Patellofemoral System during 2022. </span></span></p>
<p style="margin-bottom: 11px; font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span><em><span>"Our excitement about this project is growing as we are approaching filing of the 510(k) as well as the subsequent commercialisation in the US market. We will then enter the largest orthopaedic market in the world, which will be a tremendous milestone for us”</span></em><span>, comments Pål Ryfors, CEO Episurf Medical.</span></span></p>
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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 08.00 CEST on 16 July 2021.
[Contact:protected] => For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com
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