Episurf Medical: Update on 510(k) application for big toe implant
Episurf Medical (Nasdaq: EPIS B) today provides an update on the company’s 510(k) application to the US FDA, for market clearance of the company’s implant for treatment of osteoarthritis in the so-called 1st MTP joint in the big toe. During this process, the company has exchanged information with the FDA, and this process will continue shortly.
“We are pleased to have come this far in the process. We have in-depth experience of interacting with the FDA, and we know that it is difficult to forecast these processes accurately, but we certainly feel that we are moving forward. We will not reach our goal of FDA clearance in 2024, but we aim for the first six months of 2025, hoping to achieve our goal as early as possible in 2025. While the timeline has shifted slightly, our confidence in obtaining approval has recently strengthened.
We see a completely different type of commercial opportunity ahead of us in the US than before, which is why we look forward to positively completing this project,” says Pål Ryfors, CEO of 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>The information was submitted for publication, through the agency of the contact person set out above, at 12.00 CEST on 24 September 2024.</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">Episurf Medical: Update on 510(k) application for big toe implant</span></h1>
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[Body:protected] => Episurf Medical (Nasdaq: EPIS B) today provides an update on the company's 510(k) application to the US FDA, for market clearance of the company's implant for treatment of osteoarthritis in the so-called 1st MTP joint in the big toe. During this process, the company has exchanged information with the FDA, and this process will continue shortly.
"We are pleased to have come this far in the process. We have in-depth experience of interacting with the FDA, and we know that it is difficult to forecast these processes accurately, but we certainly feel that we are moving forward. We will not reach our goal of FDA clearance in 2024, but we aim for the first six months of 2025, hoping to achieve our goal as early as possible in 2025. While the timeline has shifted slightly, our confidence in obtaining approval has recently strengthened.
We see a completely different type of commercial opportunity ahead of us in the US than before, which is why we look forward to positively completing this project," says Pål Ryfors, CEO of Episurf Medical.
[HtmlBody:protected] => <p style="margin-bottom:11px;margin-top:12px"><span><span style="font-size:11pt"><span><span style="font-family:arial,helvetica,sans-serif">Episurf Medical (Nasdaq: EPIS B) today provides an update on the company's 510(k) application to the US FDA, for market clearance of the company's implant for treatment of osteoarthritis in the so-called 1st MTP joint in the big toe. During this process, the company has exchanged information with the FDA, and this process will continue shortly. </span></span></span></span></p>
<p style="margin-bottom:11px"><span><span style="font-size:11pt"><span><span style="font-family:arial,helvetica,sans-serif"><em>"We are pleased to have come this far in the process. We have in-depth experience of interacting with the FDA, and we know that it is difficult to forecast these processes accurately, but we certainly feel that we are moving forward. We will not reach our goal of FDA clearance in 2024, but we aim for the first six months of 2025, hoping to achieve our goal as early as possible in 2025. While the timeline has shifted slightly, our confidence in obtaining approval has recently strengthened. </em></span></span></span></span></p>
<p style="margin-bottom:11px"><span><span style="font-size:11pt"><span><span style="font-family:arial,helvetica,sans-serif"><em>We see a completely different type of commercial opportunity ahead of us in the US than before, which is why we look forward to positively completing this project," </em>says Pål Ryfors, CEO of Episurf Medical.</span></span></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.
The information was submitted for publication, through the agency of the contact person set out above, at 12.00 CEST on 24 September 2024.
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Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com
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