Cerapedics announces FDA approval of PMA supplement based on two-year clinical data

Tuesday November 19, 2019 0 comments Tags: Westminster, Cerapedics, Jeffrey Marx, Glen Kashuba

WESTMINSTER -- Cerapedics, a private ortho-biologics company, announced the U.S. Food and Drug Administration (FDA) has approved the company's Premarket Approval (PMA) supplement for i-FACTOR Peptide Enhanced Bone Graft in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative cervical disc disease.Cerapedics_logoUSE 

Cerapedics said it requested approval for an updated package insert that incorporates the 24-month follow-up data from subjects enrolled in the original clinical study.

"We are pleased to receive FDA approval of our PMA supplement, which allows i-FACTOR labeling to reflect longer-term clinical data showing that the statistical superiority to autologous bone in overall clinical success that was observed at one year has been maintained at two-year follow up," said Jeffrey Marx, Cerapedics president and COO.

"We believe i-FACTOR Bone Graft represents one of the most important technological breakthroughs in this field and are committed to compiling extensive Level I human clinical data to support its use across the U.S. and around the world."

"Since the commercial release of i-FACTOR Bone Graft in the US market, Cerapedics has been successful in rapidly penetrating the U.S. Ortho-Biologics market by emphasizing the importance of Level I human clinical data,” said Glen Kashuba, Cerapedicas CEO.

“We are very excited about FDA's approval of our label expansion which further validates the long-term safety and efficacy of i-FACTOR."

Cerapedics commercialized i‑FACTOR Bone Graft beginning in 2016. The drug-device combination is based on synthetic small peptide (P-15) technology that accelerates new bone formation in patients with degenerative disc disease.

It is in a new category of bone graft technology and is one of only two drug-device combination products approved by the FDA, the company said.