|Cerapedics i-Factor Biologic Bone Graft|
Colorado's Cerapedics is ticking toward an FDA submission for its novel bone graft, and now the company has a cash infusion to get it there.
With a $9 million term loan from GE Capital, Cerapedics plans to put the finishing touches on data from its U.S. pivotal trial and complete a regulatory filing for i-Factor. The implant is a biologic bone graft that includes a synthetic small peptide, helping it stimulate the body's natural growth mechanism and making for a safer, more predictable procedure, the company said.
Cerapedics' graft, designed for hernia-treating cervical discectomy and fusion procedures, met its primary endpoints in a large-scale trial, the company said, revealing preliminary results in March in which the synthetic implant proved noninferior to a patient's own tissue. Those results will make up the final module in Cerapedics' submission to the FDA, which the company intends to file this quarter.
The new financing comes on the heels of a $19 million C round closed in 2012, and Cerapedics' investors include MedImmune and OrbiMed Advisors.
The i-Factor implant picked up CE mark clearance in 2008 and has been used in more than 10,000 spine, trauma and orthopedic procedures ever since, Cerapedics said.
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