Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, announced that it has filed the final module in the Pre-Market Approval application with the U.S. Food and Drug Administration for its investigational P-15 Peptide Enhanced Bone Graft.
If approved, the breakthrough product will bring Cerapedics’ P-15 Peptide to lumbar spine fusion with a TLIF indication, making it Cerapedics’ second Class III drug/device combo product
WESTMINSTER, Colo., Jan. 4, 2024 /PRNewswire/ -- Cerapedics Inc., a commercial-stage orthopedics company dedicated to redefining the standard of care for bone repair, today announced that it has filed the final module in the Pre-Market Approval (PMA) application with the U.S. Food and Drug Administration (FDA) for its investigational P-15 Peptide Enhanced Bone Graft. Cerapedics was able to advance to this submission earlier than anticipated due to the use of a rigorous statistical analysis known as the Bayesian Multiple Imputation. If approved, this will be the latest bone graft product in Cerapedics’ portfolio to leverage its powerful, proprietary P-15 Osteogenic Cell Binding Peptide, which has a proven mechanism of action not found in any other category of bone graft materials.
The new P-15 Bone Graft is designed for use in transforaminal lumbar interbody fusion (TLIF) surgery in patients with degenerative disc disease. In April 2021, the FDA granted breakthrough device designation for the new P-15 Bone Graft intended for use in the treatment of a single-level TLIF in patients with degenerative disc disease. The designation offers an opportunity to interact with FDA experts to address regulatory topics efficiently and allows for prioritized review of regulatory submissions.
“We are proud to submit our PMA application, and to be closer to introducing our innovative P-15 Peptide Enhanced Bone Graft to the large population of patients undergoing TLIF procedures in the U.S.,” said Valeska Schroeder, Chief Executive Officer of Cerapedics. “With substantial Level 1 human clinical data supporting the product, we look forward to our continued collaboration with the FDA in the upcoming review process.”
The PMA application is based on data from the ASPIRE study, a prospective, single-blinded, multi-center, randomized, non-inferiority pivotal IDE study to evaluate the safety and efficacy of P-15 Bone Graft compared to use of an autologous bone graft when applied in TLIF surgery. The ASPIRE trial included 33 US centers and 290 patients, many of which were considered high risk for non-union (diabetics, obese patients, and nicotine users). The primary endpoint of the study looked at a 24-month composite clinical success defined as meeting fusion (assessed via thin cut CT at 6, 12 and 24-months), function (ODI), neurological, index level secondary surgery intervention, and serious device-related adverse event endpoints. Based on meeting the requirements of a Bayesian analysis, Cerapedics submitted the final PMA module before all patients reached the month 24 follow-up visit.
CAUTION: The new P-15 Bone Graft is an investigational product, limited by United States law to investigational use.
About P-15 Osteogenic Cell Binding Peptide
Cerapedics innovative P-15 Peptide provides a mechanism of action to Attach, Activate and Accelerate precise* bone formation. P-15 Peptide is a 15 amino acid sequence found naturally in Type 1 collagen. Cerapedics’ pharmaceutically manufactured version of P-15 Peptide is bound onto an osteoconductive scaffold providing an abundance of attachment sites for osteogenic, bone-forming, cells. P-15 Peptide exhibits a high affinity for cellular attachment; once osteogenic cells attach, intracellular processes that build bone are activated, amplifying natural signaling, and accelerating new bone formation.
*Surface-bound mechanism of action
About Cerapedics
Cerapedics is a global, commercial-stage orthopedics company that aspires to redefine the standard of care for bone repair by healing bones faster and at higher rates, without compromising safety, so that patients can live their healthiest lives. Bone grafts, including Cerapedics’ products, are used in over four million annual spine, orthopedics, trauma, and interventional procedures worldwide. i-FACTOR is a Class III FDA-approved product indicated for single-level ACDF. Cerapedics’ new “P-15 Bone Graft” product is currently being evaluated for use in lumbar interbody fusion through ASPIRE, a pivotal clinical study, and has been granted a Breakthrough Device Designation by the FDA. Cerapedics is headquartered in Westminster, CO.
For more information, visit us at www.cerapedics.com.
Media contact: Ten Bridge Communications
TBCCerapedics@tenbridgecommunications.com
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SOURCE Cerapedics Inc.
