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Bioretec Ltd Inside information 14 October 2022 at 5:45 p.m. EEST
Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, continues to discuss the company's RemeOs™ trauma screw market authorization with the U.S. Food and Drug Administration (FDA). Based on the current information, Bioretec estimates to receive the authorization in April 2023. Previously the authorization was expected to be received in the second half of 2022. The company shall supplement the authorization request in accordance with the De Novo registration process by the end of 2022, after which the FDA has according to its' internal guideline a maximum of 90 days to finalize the decision.
Bioretec submitted the De Novo market authorization request for the RemeOs™ trauma screw to the FDA in May 2022. The De Novo request process is used when similar products do not yet have market authorization in the United States. As the De Novo request is intended for novel products, the registration process includes general controls as well as new, product-specific requirements defined as special controls for this new class of products. The special controls make the process more complicated for new products and also set the standard for future comparable product market authorizations.
"Regulatory approvals are an integral and important part of a commercialization process in our industry. We will continue to work promptly to obtain a market authorization in the U.S. and expect our service providers to strive for this common goal in a timely manner" says Timo Lehtonen, CEO of Bioretec.
Timo Lehtonen, CEO, m. +358 50 433 8493
Johanna Salko, CFO, m. +358 40 754 8172
Certified advisor: Nordic Certified Adviser AB, tel. +46 70 551 67 29
Information about Bioretec
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. market authorization for the first RemeOs™ product expected in the first half of 2023 and the EU one during 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.