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Product / Company Performance

Episurf Reports 4Q18 Revenue of SEK 1.1MM ($0.1MM), +24.3% vs. 4Q17 -


Episurf posted 4Q18 revenue of SEK 1.1MM (USD $0.1MM), +24.3% vs. 4Q17, with 2018 full-year revenue of SEK 4MM ($0.4MM), +59.8% vs. 2017. Fourth quarter growth was driven by the German market (43% of all Episurf business), where sales increased 187% year-over-year. While total implants for the quarter decreased slightly compared to last year (34 vs. 37), approved orders almost doubled from 36 to 60 in the same time frame. As of February 2019, a total of 432 surgeries have been performed with the Episealer knee implant, with 71 patients having the implant for more than three years and 162 patients reaching the two-year mark.

To date, the company has driven sales through anecdotal evidence and one small study involving 10 patients. In 2019, Episurf is poised to establish a larger clinical pipeline. This year, the company expects the results from an ongoing multi-site study involving 100 patients and 11 surgeons across seven European counties. Episealer will also be involved in a recently announced investigator-initiated study at the Julius Wolff Institute at the Charité University Hospital in Berlin. That study will follow up with patients who received their implant between 2015 and 2017, with the results expected in 2019.

The company reached a significant milestone at the end of 2018, receiving FDA Investigational Device Exemption approval to initiate a clinical trial of Episealer in the U.S. The approval represents the culmination of a three-year effort. The study, called EPIC, will be a multi-site, randomized and controlled trial taking place in the U.S. and in Europe. It is aimed at showing non-inferiority in clinical status improvement at 24 months vs. microfracture, the surgical standard of care technology, as well as superiority in return to weight-bearing vs. microfracture.

Segment sales and growth on an as-reported basis is as follows.

  4Q18 4Q17 $ Change % Change
Joint Replacement, Knees $0.1 $0.1 $0.0 24.3%
  FY18 FY17 $ Change % Change
Joint Replacement, Knees $0.4 $0.3 $0.2 59.8%

Net earnings for 4Q18 are as follows.

4Q18 Amount ($MM) % of Sales
Sales $0.1  
   Cost of Sales -$0.1 81.9%
   Other -$0.9 764.4%
   Personnel -$0.8 646.1%
   Net Earnings -$1.7 -1392.4%

Sources: Episurf

Mike Evers is ORTHOWORLD’s Market Analyst. He can be reached by email.

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