What are your financial targets?
Episurf Medical’s financial target is to achieve a 30% market share of the total addressable market in all target markets (15% market share achieved within 3 years from US market launch).
What is your addressable market?
The market potential for Episurf Medical’s initial product portfolio Episealer® Knee, in the initially prioritized regions, is estimated to be worth +USD 1bn p.a., in the US and in the key European markets.
What is your current operational focus?
Current focus is on (i) early commercialization in Europe and certain other markets, (ii) generating clinical evidence supporting the Episealer® technology, (iii) run a clinical trial in the US, targeting a USA PMA approval for Episealer® Knee, and (iv) securing regulatory access to several international markets.
What are the most important milestones during 2021?
During 2021, the company expects the publication of several clinical publications. Further, the company expects to file a 510(k) application in the US for an Episealer® Patellofemoral system. As COVID-19 restrictions are removed and societies are going back to more normalized situations, the company expects to deliver significant growth in its current markets. The company also expects to complete several international registrations, leading to access to additional global markets.
What is your strategy for reaching the US market?
Episurf Medical is running an IDE clinical trial for the Episealer® Knee implant family. The IDE study is approved by the FDA and all investigator sites are recruited. Patient recruitment has started. Episurf is also developing a new knee implant system, the Episealer® Patellofemoral System, for which the company will be seeking a 510(k) approval in the US.
Are you considering partnerships?
The company is always open to discuss partnering opportunities.
What is your distribution model?
Currently, Episurf Medical has employed sales representatives in certain European countries. In addition, the company has distributors in certain countries in Europe, Middle East and in Asia. The company is likely to evaluate more comprehensive distribution arrangements in the future.
Has Episurf had any Capital Markets Day?
The company organized a capital markets day on September 15th 2020. The full video is available here: LINK
What is the difference between the Episealer® and a total or partial knee replacement?
The Episealer® Knee implant is suitable for patients with focal cartilage and bone lesions in the knee. A knee replacement is suitable for patients with severe osteoarthritis in the knee. Episurf’s patients are typically in the age bracket of 35 – 65, while knee replacements are recommended to older patients, typically older than 65.
What is the cost of an Episealer® implant
The Episealer® implant costs approx. EUR 3,000. The pre-surgical damage assessment and surgical tools are included in this price.
What is the IP situation?
Episurf Medical has focused on IP since inception, and today, the global portfolio contains over 200 patent and patent applications in more than 30 patent families. In addition, there are several design and trademark registrations (some of them pending).