Cerapedics, Inc., an orthobiologics company focused on developing and commercializing novel peptide enhanced bone graft products based on its proprietary synthetic small peptide (P-15) technology platform, announced today that preliminary outcomes data from the company's FDA Investigational Device Exemption (IDE) clinical trial for i-FACTOR Peptide Enhanced Bone Graft will be presented at the Canaccord Genuity Musculoskeletal Conference in New Orleans. The data presentation will be held on Tuesday, March 11, 2014beginning at 2:00 p.m. (CST).
Preliminary results from the randomized, controlled, multi-center, prospective study on the use of i-FACTOR bone graft vs. autograft for single-level instrumented anterior cervical discectomy and fusion (ACDF) procedures will be presented by Glen Kashuba, CEO and Jeff Marx, Ph.D., president and COO. The pivotal clinical study enrollment was completed on May 1, 2013. The company is currently preparing the final clinical report for submission to FDA as part of its premarket approval application.
"The completion of this landmark clinical trial represents a major milestone for Cerapedics. We are extremely grateful to all of the investigators and teams who joined in this effort, and we look forward to reviewing the results at the Canaccord Genuity Musculoskeletal Conference on March 11," said Mr. Kashuba.
WESTMINSTER, Colo., March 4, 2014