Ready for enrolment of Episealer® patients in the US
Episurf Medical (NASDAQ: EPIS B) announces that the EPIC-Knee Episealer® Knee System IDE Clinical Study is ready for enrolment of patients as the first clinical trial agreement is now fully executed with a hospital in Texas, USA. Episurf Medical is in the very final stages of contract negotiations with several other US hospitals and the study will, apart from the US sites, include participants in three European countries. Episurf Medical has identified the desired study sites and have advanced far in the set-up process, yet, the study allows for additional sites should the company want to increase the number in the coming weeks.
The IDE study is the first step for Episurf Medical to reach US market approval through the PMA route for the Episealer® knee implant. It is a randomized controlled study with 180 subjects. Episurf has during the first quarters of 2019 focused on contract negotiations, surgeon training and final preparations for the sites to be ready to enrol.
“We have been meeting US investigators and performed training of the Episealer® surgical technique, and it has been great to receive their positive feedback on our technology. They are as exhilarated as we are to have this study truly up and running”, says Katarina Flodström, COO, Episurf Medical.
“Impressive surgical technique, innovative and highly informative pre-surgical planning tool and quick return to weight-bearing are just some of the aspects that the US surgeons highlight with the Episealer® technology. Of course, we are very excited about the next steps. If we can repeat the results from Europe, which we believe we can, this company has a bright future”, comments Pål Ryfors, CEO, Episurf Medical.
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 08.30 CEST on 26 June 2019.
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