INTERIM REPORT 1 APRIL– 30 JUNE 2018
“Our business in Europe is growing, driven by Germany which now starts to show signs of real commercial progress. In parallel, we have developed a robust clinical strategy targeting a US FDA approval and have taken a significant step in US by the filing of our IDE application”, says Pål Ryfors, CEO Episurf Medical.
Second quarter 2018 compared to 2017, Group
» Gross order intake increased by 104% and amounted to SEK 1.1m (0.6)
» Order backlog amounted to SEK 1.1m (0.5)
» 54% growth in orders for Episealer® knee implants during the quarter with 43 (28) approved orders
» Group net sales increased by 33% to SEK 0.8m (0.6)
» Loss before tax amounted to SEK –16.2m (–13.0)
» Earnings per share (weighted average) amounted to SEK –0.53 (–0.42)
Significant events during the second quarter
» IDE application filed to the US FDA and FDA has indicated quick feedback
» Strategic decision to enter the Indian market and regulatory preparations for India initiated
» Strong commercial development in Germany
» Promising clinical results, including 2-year follow-up data, accepted for presentations at several clinical congresses
» 45 patients have now had their implant for more than 3 years and 15 patients more than 4 years
» Appointment of Dr. Michael A Kelly as special study advisor for the US IDE study
» Episurf Medical’s knee products were approved for marketing and sale in Spain
» Episurf Medical entered into a distribution agreement in Hong Kong and established subsidiary in the US
» Katarina Flodström assumed the position Chief Regulatory Officer with responsibility for regulatory affairs, quality affairs and Intellectual property
For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@episurf.com
Veronica Wallin, CFO, Episurf Medical
Tel:+46 (0) 700 37 48 95
Email: veronica.wallin@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 personalised treatment alternatives. Episurf Medical’s Episealer® personalised implants and Epiguide® surgical drill guides are developed for treating localized 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 and the Securities Markets Act. The information was submitted for publication, through the agency of the contact person set out above, at 08.30 CEST on 19 July 2018.
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