FDA grants breakthrough device designation to peptide-enhanced bone graft from Cerapedics
Cerapedics Inc. announced it has received FDA breakthrough device designation for its P-15L Bone Graft for the treatment of degenerative disc disease.
The APSIRE prospective, single-blind, multicenter, randomized, non-inferiority pivotal IDE study is evaluating the safety and efficacy of the bone graft compared with an autologous bone graft. Researchers are investigating its use in patients who undergo transforaminal lumbar interbody fusion.
Cerapedics uses proprietary synthetic small peptide technology in the bone graft to assist bone growth through cell attraction, attachment and activation.
“We are pleased the FDA has granted breakthrough device designation for P-15L Bone Graft, our next-generation P-15 technology platform candidate, as it underscores the urgent need for more effective treatments for patients suffering with degenerative disc disease,” Glen Kashuba, CEO of Cerapedics, said in the release.
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