Episurf Medical investigates the opportunities for launching an implant for the MTP joint in the US market
Episurf Medical (Nasdaq: EPIS B) today announces that the company is investigating the opportunities for launching an implant system for the MTP joint of the foot in the US market. Episurf Medical has identified this market as a one with significant unmet medical needs. The company has begun the product development phase for this product, and targets the filing of a 510(k)-application to the US FDA for the Episealer® MTP system late 2022 or first half of 2023.
Osteoarthritis (hallux rigidus) in the big toe (1st MTP joint) is a common medical condition, affecting around 2-2,5% of all persons above 50 years old, and is the most common arthritic condition of the foot. Patients experience stiffness and pain in the toe, and range of motion is often significantly decreased. Current treatment algorithms contain biological procedures and various implant solutions, however the most common treatment is fusion. Episurf Medical, and many surgeons, are of the opinion that the market lacks adequate treatment alternatives, and the company believes that an individualised implant technology, which enables full consideration of all important anatomical aspects, could constitute a successful alternative for a large patient population.
“We are constantly reviewing the options for expansion of the targeted indications for our technology, and I am pleased that we now are taking the next step with a potential implant system for the MTP joint. We have demonstrated that we are efficient and successful in our product development efforts and we are now allocating resources to this highly interesting market segment. The US market for big toe implants is worth an estimated USD 400 million, and we believe that current options available to patients and surgeons are less than optimal. We are committed to explore this opportunity fully, as we believe we can create a highly competitive product. Further, without a doubt, COVID-19 has made us intensify our product development work and the pandemic has emphasised the need to reach to the US market as fast as possible with superb orthopaedic solutions,” said Pål Ryfors, CEO Episurf Medical.
“As the positive clinical results for the Episealer® knee implants continue to mount, orthopaedic surgeons concentrating across a range of anatomic locations are beginning to see the benefits of Episurf Medical’s technologies. Solutions that avoid fusion in the big toe continue to attract interest, and we believe that by utilising advanced imaging and individualised implants we may be able to play a role in the treatment of a group of patients that often are unsatisfied with currently available options,” said Patrick Jamnik, President of Episurf Medical, Inc.
For more information, please contact:
Pål Ryfors, CEO, Episurf Medical
Tel:+46 (0) 709 62 36 69
Email: pal.ryfors@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 individualised treatment alternatives. Episurf Medical’s Episealer® individualised implants and Epiguide® surgical drill guides are developed for treating localised 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. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CEST on 28 September 2021.
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