"This is a significant milestone which we have been looking forward to for quite some time. With this product, we are entering into a fast-moving and fast-growing market segment, with a totally unique solution. This is also the last piece of the puzzle of our current strategy, and with the launch of this product, we will have expanded our product offering in line with our plans to accelerate our commercial strategy. We are very pleased to have reached this milestone, and we look forward to a constructive dialogue with the FDA", 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.