Bioretec achieves FDA breakthrough device designation for innovative spinal implant

Bioretec Ltd., a leader in the development of biodegradable orthopedic implants, has achieved a significant milestone by receiving the Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its innovative RemeOs Spinal Interbody Cage implant. This designation underscores the implant’s potential to revolutionize spinal surgery by providing a breakthrough technology for treating spinal conditions.

The RemeOs Spinal Interbody Cage is designed to restore intervertebral height and facilitate intervertebral body fusion in the cervical spine, representing a significant advancement in spinal surgery technology. The FDA’s Breakthrough Device Designation is a testament to the implant’s innovative approach, aiming to improve patient outcomes significantly by offering a new form of treatment or significant advantages over existing solutions. These benefits include the potential to reduce hospital stays, enhance the quality of life for patients, and provide long-term clinical advantages.

Obtaining this prestigious status from the FDA is not only a recognition of Bioretec‘s pioneering work in the field but also an important step towards the commercial availability of the RemeOs Spinal Cage in the U.S. market. Bioretec is now poised to potentially accelerate the product development and review resource allocation requirements, which could influence the company’s future capital needs.

The FDA requires that a technology be considered a breakthrough if it offers more effective treatment for life-threatening or irreversibly debilitating diseases or conditions. The RemeOs Spinal Interbody Cage meets this stringent criterion by either providing a completely new form of treatment or offering significant advantages over existing approved or cleared alternatives. The Breakthrough Devices Program facilitates an ongoing and prioritized dialogue between Bioretec and the FDA, focusing on the commercial access of the implant in the U.S. market.

Timo Lehtonen, CEO of Bioretec, expressed enthusiasm about the designation, stating, “This designation gives us another validation of our expertise in creating innovative products for the unmet clinical needs in the orthopedic field. I am enthusiastic about the future prospects and the market opportunities of this product, which is based on the patented hybrid technology.”