(Información remitida por la empresa firmante)
TAMPERE, Finland, Jan. 4, 2023 /PRNewswire/ -- Bioretec Ltd, a pioneer in bioresorbable orthopedic implants, has finalized the supplement for market authorization request in accordance with the De Novo registration process concerning the company's RemeOs trauma screw, and FDA (U.S. Food and Drug Administration) has now confirmed having received the supplement. Bioretec's estimate for receival of the U.S. market authorization remains unchanged in April 2023. After receiving the supplement, FDA has, according to its internal guidelines, a maximum of 90 calendar 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.
"Our work on this approval process is nearing completion, and we await the FDA's decision-making process and obtaining market authorization for the RemeOs trauma screw during April," 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 thebiological interfaceof active implantsto 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 isdevelopingthe new RemeOsproduct linebased 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 onvalue for patients through efficient healthcare. The first RemeOs product market authorizations are expected in the U.S. during April 2023 and in Europe during 2023. 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
View original content: https://www.prnewswire.co.uk/news-releases/bioretec-has-submitted-additional-information-requested-by-the-fda-for-us-registration-of-remeos-trauma-screws-and-the-estimated-approval-timeline-of-april-2023-remains-unchanged-301712901.html