29 Apr Cerapedics Announces FDA Breakthrough Device Designation Granted for P-15L Bone Graft for the Treatment of Degenerative Disc Disease
P-15L Bone Graft is currently being studied in the Company’s ASPIRE IDE clinical trial
WESTMINSTER, CO – April 29, 2021 – Cerapedics Inc., an ortho-biologics company dedicated to enhancing the science of bone repair, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device designation for its investigational P-15L Bone Graft for the treatment of degenerative disc disease (DDD). The FDA’s Breakthrough Device designation is designed to expedite the development and review of medical devices that are intended to treat serious or life-threatening diseases. To qualify for this designation, preliminary evidence must demonstrate a reasonable expectation that the device will provide improved effectiveness compared to the standard of care.
“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 on-going 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.”
P-15L Bone Graft is currently being studied in the U.S. in the ASPIRE study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15L Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The study will include at least 270 patients with degenerative disk disease at up to 36 clinical trial sites across the U.S. Cerapedics plans to file a Premarket Approval (PMA) submission with the FDA with the results from this study.
CAUTION: In the U.S., P-15L Bone Graft is an Investigational Product limited by Federal Law to investigational use only.
Cerapedics is an ortho-biologics company focused on developing and commercializing its proprietary small peptide (P-15) technology platform. i-FACTOR Peptide Enhanced Bone Graft is the only FDA-approved biologic bone graft in orthopedics that incorporates a small peptide as an attachment factor to stimulate the natural bone healing process. This novel mechanism of action is designed to support safe and predictable bone formation. More information can be found here.
CFO, Cerapedics inc.
SOURCE: Cerapedics, 29th April 2021