Bioretec, a leader in the development of biodegradable orthopedic implants, has achieved a significant milestone today with the US Food and Drug Administration granting Breakthrough Device Designation for its innovative RemeOs™ Spinal Interbody Cage implant. This designation highlights the groundbreaking nature of the product within the field of spinal surgery. The RemeOs Spinal Interbody Cages are designed to restore intervertebral height and facilitate intervertebral body fusion specifically in the cervical spine, marking a significant advancement in patient care.
This designation represents an important step towards introducing the product to the US market. Bioretec will now evaluate opportunities to expedite the development of the RemeOs Spinal Cage and allocate necessary resources accordingly. Meeting the stringent criteria set by the FDA for entry into the Breakthrough Device Designation program, Bioretec's biodegradable RemeOs™ Spinal Interbody Cage promises to offer superior treatment outcomes.
The FDA's Breakthrough Device Designation is reserved for technologies addressing life-threatening or irreversibly debilitating conditions, providing either entirely new treatment approaches or significant improvements over existing options. These advancements aim to reduce hospitalization, improve patient quality of life, and deliver long-term clinical benefits, ultimately prioritizing patient well-being.
Through the Breakthrough Devices Program, the FDA will facilitate ongoing and prioritized communication between Bioretec and regulatory authorities, ensuring streamlined access to the US market for the RemeOs™ Spinal Interbody Cage implant.
Source: https://www.prnewswire.com/news-releases/inside-information-bioretec-has-been-granted-fda-breakthrough-device-designation-status-for-its-remeos-spinal-interbody-cage-302089478.html
