Episurf Medical (Nasdaq: EPIS B) today announces that the company intends to submit a 510(k) application to the US FDA regarding a two-component patellofemoral implant system, the Episealer® Patellofemoral System, during 2021. The company’s aim is to launch the product on the US market in 2022.

Patellar cartilage lesions are common and often occur in conjunction with lesions on the femoral knee joint. Episurf Medical has therefore initiated a development project to use the company’s imaging and CAD technology for a two-component system consisting of one implant for the trochlear area in the knee joint and one for patella. Both components will be individualised, cemented and have corresponding toolkits to ensure correct positioning. Whereas the trochlear component will be similar to the present Episealer® knee implant, the patellar component will be a polymer implant. 

“Since an opposing patellar cartilage lesion is a contraindication for using an Episealer® knee implant in the trochlear area, we see this project as a way to expand the market to a larger group of patients. Additionally, we expect that the 510(k) regulatory pathway will enable Episurf to enter the US market significantly earlier than with the ongoing IDE study”, says Pål Ryfors, CEO, Episurf Medical.

The FDA submission is expected to take place in Q4 2021 and feedback from the FDA is expected in Q1 2022.

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<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, 08.00&nbsp;CET on February 19, 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;">P&aring;l 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:&nbsp;</span><a href="mailto:pal.ryfors@episurf.com">pal.ryfors@episurf.com</a></p>
    [HtmlTitle:protected] => <h1 style="line-height:120%;"><strong>Episealer&reg; Patellofemoral System - planned 510(k) submission in Q4 2021 </strong></h1>
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    [Body:protected] => Episurf Medical (Nasdaq: EPIS B) today announces that the company intends to submit a 510(k) application to the US FDA regarding a two-component patellofemoral implant system, the Episealer® Patellofemoral System, during 2021. The company’s aim is to launch the product on the US market in 2022.
Patellar cartilage lesions are common and often occur in conjunction with lesions on the femoral knee joint. Episurf Medical has therefore initiated a development project to use the company’s imaging and CAD technology for a two-component system consisting of one implant for the trochlear area in the knee joint and one for patella. Both components will be individualised, cemented and have corresponding toolkits to ensure correct positioning. Whereas the trochlear component will be similar to the present Episealer® knee implant, the patellar component will be a polymer implant. 
“Since an opposing patellar cartilage lesion is a contraindication for using an Episealer® knee implant in the trochlear area, we see this project as a way to expand the market to a larger group of patients. Additionally, we expect that the 510(k) regulatory pathway will enable Episurf to enter the US market significantly earlier than with the ongoing IDE study”, says Pål Ryfors, CEO, Episurf Medical.
The FDA submission is expected to take place in Q4 2021 and feedback from the FDA is expected in Q1 2022.
    [HtmlBody:protected] => <p style="margin-bottom: 11px; font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="line-height:107%">Episurf Medical (Nasdaq: EPIS B) today announces that the company intends to submit a 510(k) application to the US FDA regarding a two-component patellofemoral implant system, the Episealer® Patellofemoral System, during 2021. The company’s aim is to launch the product on the US market in 2022. </span></p>
<p style="margin-bottom: 11px; font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="line-height:107%">Patellar cartilage lesions are common and often occur in conjunction with lesions on the femoral knee joint. Episurf Medical has therefore initiated a development project to use the company’s imaging and CAD technology for a two-component system consisting of one implant for the trochlear area in the knee joint and one for patella. Both components will be individualised, cemented and have corresponding toolkits to ensure correct positioning. Whereas the trochlear component will be similar to the present Episealer® knee implant, the patellar component will be a polymer implant.&nbsp; </span></p>
<p style="margin-bottom: 11px; font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="line-height:107%">“<em>Since an opposing patellar cartilage lesion is a contraindication for using an Episealer® knee implant in the trochlear area, we see this project as a way to expand the market to a larger group of patients. Additionally, we expect that the 510(k) regulatory pathway will enable Episurf to enter the US market significantly earlier than with the ongoing IDE study</em>”, says Pål Ryfors, CEO, Episurf Medical.</span></p>
<p style="margin-bottom: 11px; font-family: arial, helvetica, sans-serif; font-size: 10pt;"><span style="line-height:107%">The FDA submission is expected to take place in Q4 2021 and feedback from the FDA is expected in Q1 2022.</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, 08.00 CET on February 19, 2021.
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Pål Ryfors, CEO, Episurf Medical
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