The designation expedites the time taken to develop and review products in clinical trials.
“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,” Cerapedics CEO Glen Kashuba said in an April 29 news release.
P-15L is being evaluated for safety and efficacy compared to use of an autologous bone graft in single-level transforaminal lumbar interbody fusion surgery.
At least 270 patients with degenerative disc disease will be included in the study at up to 36 sites across the U.S.
With results from the study, Cerapedics plans to file a premarket approval submission with the FDA.
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