Episurf Medical (NASDAQ: EPIS B) today announces that a response to the US FDA, addressing a request for additional information on the company's Episealer® MTP implant, has been filed. This is a step in the process for the 510(k) submission for market clearance of the Episealer® MTP implant for the big toe. The FDA review has been on hold while waiting for Episurf to submit this additional information.  

"Getting us to this milestone is a great team effort and an important step in our work towards market clearance for Episealer® MTP. We have performed an extensive work together with prominent surgeons, and we are excited about the next steps," says Pål Ryfors, CEO Episurf Medical.  

The company is currently assessing various options for commercialization strategy, including independent distributors and technology licensing. The implant is intended to treat osteoarthritis (hallux rigidus) in the big toe, a disease affecting several million Americans each year. It is based on Episurf Medical's proprietary technology for patient-specific design of implants and surgical instruments. The product is estimated to expand the company's total addressable market by approximately $400 million while adding over 10,000 surgeons to the company's target customer list.