Episurf Medical’s Episealer® Patellofemoral System under substantive review at the US FDA
Episurf Medical (NASDAQ: EPIS B) today announces that the company’s 510(k) application to the US FDA for market clearance for the Episealer® Patellofemoral System now is progressing to the substantive review phase.
“This FDA notification is an important step in the process. We will continue our preparations for a US market launch while the application is undergoing the review” says 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 21:00 CEST on 24 April 2022.</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>
[HtmlTitle:protected] => <h1 style="line-height:120%"><span style="font-family:arial,helvetica,sans-serif"><strong>Episurf Medical’s Episealer® Patellofemoral System under substantive review at the US FDA</strong></span></h1>
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[Body:protected] => Episurf Medical (NASDAQ: EPIS B) today announces that the company’s 510(k) application to the US FDA for market clearance for the Episealer® Patellofemoral System now is progressing to the substantive review phase.
“This FDA notification is an important step in the process. We will continue our preparations for a US market launch while the application is undergoing the review” says Pål Ryfors, CEO Episurf Medical
[HtmlBody:protected] => <p style="margin-bottom:11px;margin-top:12px"><span style="font-size:10pt"><span style="font-family:arial,helvetica,sans-serif">Episurf Medical (NASDAQ: EPIS B) today announces that the company’s 510(k) application to the US FDA for market clearance for the Episealer® Patellofemoral System now is progressing to the substantive<strong> </strong>review phase. </span></span></p>
<p style="margin-bottom:11px"><span style="font-size:10pt"><span style="font-family:arial,helvetica,sans-serif">“<em>This FDA notification is an important step in the process. We will continue our preparations for a US market launch while the application is undergoing the review</em>” says 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 21:00 CEST on 24 April 2022.
[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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