RevBio Receives FDA Approval to Conduct a First-in-Human Clinical Trial for its Regenerative Bone Adhesive for Cranial Flap Fixation
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Friday, December 8, 2023
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This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.
Key Points:
- This approval was largely predicated on the successful pivotal preclinical and surgeon handling testing conducted by the company.
- As part of the surgical closure process, the cranial flap is secured back into place with plates and screws.
- The kerf line, however, is typically not sealed, which compromises the ability of the flap to integrate with the surrounding bone.
- “We are truly excited to move this project into the clinical phase of testing,” said Brian Hess, CEO and Founder of RevBio.