Episurf Medical has announced that the company’s first commercial case in the US has been scheduled for surgery.
This is also the first case ever with the newly introduced product Episealer Patellofemoral System, states the company. The product is a fully individualized implant system for patients with isolated osteoarthritis of the patellofemoral joint in the knee. Personalized implants for both sides of the joint, femur and patella, preserving as much bone and cartilage as possible by treating only the damaged areas of the joint, are designed uniquely for each individual patient.
The launch in the US
510(k) clearance for the product for US market access was obtained late December 2022, and during 2023, Episurf Medical has prepared for the launch in the US market. Key activities have included the identification, contracting and training of distributors. Currently, well over 20 distributors are signed across the US and several more are likely to be onboarded in the coming weeks and months, states the company.
While we still have distributors in many markets to add, I am extremely pleased with both the quality of our third-party distribution partners, and the level of surgeon interest they have been able to generate this far.”
“Anytime a company introduces a new product to the market, there will always be an urgency and level of excitement to generate as much interest as quickly as possible. While that has certainly been true with our Patellofemoral System, we first had to go through the necessary steps of building an independent sales force in numerous markets throughout the country. While we still have distributors in many markets to add, I am extremely pleased with both the quality of our third-party distribution partners, and the level of surgeon interest they have been able to generate this far. Surgeons all over the country are making it clear that they are unsatisfied with currently available treatment options for middle-aged patients, and they see Episurf as an innovative and needed option to assist in their care,” says Patrick Jamnik, President of Episurf Medical, Inc.
Since before, the company’s implants Episealer Knee have been used at several US clinics within the EPIC-Knee: Episealer Knee System IDE Clinical Study.