DNB Markets - Episurf Medical: Strong long-term data
The company today announced strong long-term follow-up data from the initial Episealer trial done in Sweden. We previously saw 24-month data; the patients have now been followed for 75 months and the data still looks excellent. This is important for Episurf Medical, as many doctors as well as payers request long-term follow-up for the implant system to be included in treatment algorithms and reimbursement systems. We reiterate our fair value of SEK1.3–3.9.
Long-term follow-up from first 10 patients treated. Episurf Medical reported the long-term follow-up for the first 10 patients treated with the Episealer implant system. These patients have now been followed for at least 75 months, and the outcome is just as good as after the last follow-up at 24 months. The basic result is that the positive outcomes seen at the 24-month follow-up remain after 75 months. We believe the lead investigator is set to publish the findings in a journal during the autumn.
Strong 24-month data maintaining efficacy at 75 months. As a reminder, the trial was conducted in 10 Swedish patients at three different clinics between December 2012 and November 2014. At the 24-month follow-up, the authors saw an improvement in all the scales used to assess the procedures. In particular, there was a statistically significant improvement in the VAS scale (p≤0.001), Tegner (p=0.034), KOOS subscale ADL (p=0.0048), sports and recreation (p=0.034), and quality of life (p=0.037). There were no revisions or implant migrations at 24 months. We have not yet had all the details (due to come in connection with publication of the findings), but believe the statement that all the positive findings seen at 24 months remain at 75 months indicates we should expect results at least as good when this trial is published.
These patients lack treatment options. As these patients are too old for biological treatments and too young for full knee replacements (median age at surgery: 42.5 years), there are no real options for this group. However, in order to be included in reimbursement systems and treatment algorithms at different clinics, long-term follow-up of the outcomes is usually very important. Hence we see this announcement as very positive for the ongoing market introduction of the implant system. We reiterate our fair value of SEK1.3–3.9.
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Best regards
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Patrik Ling | DNB Markets | Equity Research | Senior Analyst Healthcare
DNB Bank ASA
Regeringsgatan 59 | Stockholm | Sweden