Bioretec Ltd, 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.