NewsEpisurf Medical: 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

Link to the report

For more  information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69

Veronica Wallin, CFO, Episurf Medical
Tel:+46 (0) 700 37 48 95