Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, has submitted a De Novo request for market authorization in the United States for the RemeOs™ trauma screw based on bioresorbable magnesium alloy. Bioretec estimates the market authorization in the United States to be granted during the second half of 2022. The previously communicated estimate was in the first half of 2022.

The De Novo request provides a registration pathway for novel medical devices for which there is no predicate device available in the U.S. market. In spring 2021, the U.S. Food and Drug Administration (FDA) granted the RemeOs™ trauma screw a Breakthrough Device Designation status, demonstrating that the product represents breakthrough technology and offers significant advantages over existing approved products.  The submission of the De Novo market authorization application has been preceded by interactive discussions under the FDA's Breakthrough Device program.

"Filing for market authorization for our new product in the United States is a strategic step for us, as the United States is the world's largest individual market for orthopedic trauma products. Our goal is to be the first to commercialize bioresorbable metal implants in the U.S. market. I believe there is demand in this growth market for our products that contribute to patient healing, safety, and cost-efficiency in clinical care. Our bioresorbable implants offer the healthcare system the opportunity to treat bone fractures more effectively by reducing the number of surgeries, and our innovative products have the potential to significantly improve the quality of life for patients. I would like to thank our team for their hard work in reaching this milestone," says Timo Lehtonen, CEO of Bioretec.

Further enquiries

Timo Lehtonen, CEO, tel. +358 50 433 8493

Johanna Salko, CFO, tel. +358 40 754 8172

Certified Adviser: Nordic Certified Adviser AB, tel. +46 70 551 67 29

Bioretec in brief

Bioretec is a globally operating Finnish medical device company that continues to pioneer the application of bioresorbable orthopedic implants. The company has built unique competencies in the biological interface of active implants to enhance bone growth and accelerate fracture healing after orthopedic surgery. The products developed and manufactured by Bioretec are used worldwide in approximately 40 countries. 

Bioretec is developing the new RemeOs™ product line based on a magnesium alloy and hybrid composite, introducing a new generation of strong bioresorbable materials for enhanced surgical outcomes. The RemeOs™ implants are resorbed and replaced by bone, which eliminates the need for removal surgery while facilitating fracture healing. The combination has the potential to make titanium implants redundant and help clinics reach their Value-Based Healthcare targets while focusing on value for patients through efficient healthcare. With the U.S. and EU market authorization for the first RemeOs™ product expected in 2022, Bioretec is positioning itself to enter the addressable USD 7 billion global orthopedic trauma market and become a game changer in surgical possibilities. Better Healing - Better Life. www.bioretec.com.