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Bioretec's RemeOs™ Spinal Interbody Cage Receives FDA Breakthrough Device Designation

Friday, March 15, 2024

Bioretec, known for its advancements in biodegradable orthopedic implants, has achieved a significant milestone with the US Food and Drug Administration granting Breakthrough Device Designation for its RemeOs™ Spinal Interbody Cage implant. This recognition underscores the innovative nature of the product in the realm of spinal surgery, particularly for restoring intervertebral height and facilitating intervertebral body fusion in the cervical spine.

The attainment of Breakthrough Device Designation signifies a pivotal step for Bioretec's entry into the US markets. Consequently, the company will evaluate potential avenues for expediting the development of the RemeOs Spinal Cage and allocate necessary resources accordingly, which may influence future capital needs.

Bioretec's biodegradable RemeOs™ Spinal Interbody Cage met the rigorous criteria established by the FDA for inclusion in the Breakthrough Device Designation program. Such designation requires technologies to offer improved treatment for life-threatening or debilitating conditions or present substantial advantages over existing alternatives, thereby enhancing patient outcomes and quality of life.

Through the Breakthrough Devices Program, the FDA will facilitate ongoing discussions between Bioretec and regulatory authorities, prioritizing the commercial accessibility of the RemeOs™ Spinal Interbody Cage in the US market. This acknowledgment further underscores Bioretec's commitment to developing innovative solutions to address unmet clinical needs within the orthopedic field.

Source: prnewswire.com

 

 

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