FDA granted Breakthrough Device designation for Cerapedics' investigational P-15L Bone Graft for the treatment of degenerative disc disease (DDD).
P-15L Bone Graft is currently being studied in the U.S. in ASPIRE, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal Investigational Device Exemption study to evaluate the product vs. autologous bone graft in transforaminal lumbar interbody fusion. The study will include at least 270 patients with DDD at up to 36 clinical trial sites across the U.S. Cerapedics plans to file a Premarket Approval submission with FDA with the results from this study.
"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," said Glen Kashuba, Chief Executive Officer. "We look forward to working closely with the FDA through the ongoing clinical trial and review processes for P-15L, with the goal of bringing this important new technology to a patient population with a significant unmet medical need."