Renovos Biologics receives FDA breakthrough device designation for bone fusion gel
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Key takeaways:
- Biocomposites announced Renovos Biologics received FDA breakthrough device designation of its Renovite bone fusion gel.
- The gel is an alternative to bone graft materials for interbody spinal fusion.
Biocomposites has announced its investee company Renovos Biologics has received FDA breakthrough device designation of its Renovite bone morphogenic protein-2 proprietary, synthetic, nanoclay bone fusion gel, according to a press release.
The Renovite BMP-2 is designed to be used as an alternative to bone graft materials for interbody spinal fusion. The gel contains BMP-2, a growth factor that promotes growth of bone-forming cells, according to the release.
“We are pleased with the breakthrough device designation from the FDA, being among just 100 or so companies granted this designation in orthopedics since the program’s launch in 2015,” Agnieszka Janeczek, PhD, MSc, CEO of Renovos Biologics, said in the release. “This designation is a major milestone in our development journey. The accelerated regulatory feedback and prioritized review will shorten the time to market and allow faster access to expanded treatment options for patients suffering from degenerative disc disease,” she said.
“The granting of FDA breakthrough device designation is a transformational step for Renovos, supporting its goal to rapidly develop and bring to market Renovite - a next-generation drug carrier,” Michael Harris, CEO of Biocomposites, said in the release. “At Biocomposites, our expertise in this field ideally positions us to support and enhance Renovite’s progress toward pre-market approval,” Harris added.
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