i-Factor – First FDA Bone Graft Approved Since 2004

It’s been a long, long time since the FDA gave their PMA (Premarket Approval) application blessing to bone graft for the spine.

But on November 3, 2015, Cerapedics, Inc. announced the agency approved their i-Factor Peptide Enhance Bone Graft for use in anterior cervical discectomy and fusion (ACDF) procedures in patients with degenerative disc disease. This is the first bone graft to be approved for use in the cervical spine and only the second PMA-approved bone graft in the spine. The first was Medtronic plc’s Infuse, which was approved for use for the lumbar region of the spine back in 2004.

Company President and COO Jeffrey Marx, Ph.D., said this was “an historic milestone” for the surgical treatment of cervical disc degeneration.

He called the process with the FDA “years of seamless cooperation” with the company’s clinical investigators. In fact, the cooperation was so good that the FDA didn’t even require a meeting of its orthopedic panel of experts to weigh in on whether or not the agency should approve the product. The PMA approval came pretty quickly as the company only submitted its PMA application in September 2014.

i-Factor

i-Factor is a bone graft based on synthetic small peptide (P-15) technology developed by the company to support bone growth through cell attachment and activation. It can be used as a substitute for autologous bone in ACDF procedures.

According to the company, i-Factor is the only biologic bone graft that combines the small P-15 peptide with anorganic bone mineral (ABM). “This unique combination replicates the organic (Type I human collagen) and inorganic (calcium phosphate) components of autograft bone and creates the ideal template for new bone formation.”

Pivotal Trial Data

The company provided data to the FDA from a pivotal clinical trial comparing i-Factor to autograft in ACDF procedures. The product “met all four pre-specified primary endpoints (fusion rate, NDI score, neurological outcomes, and safety success), demonstrating non-inferiority to autograft with p-values of < 0.0005 for each. In addition, says the company, a responder analysis for overall success in all four primary outcomes demonstrated 69% success for i-Factor bone graft versus 57% for autograft. The proportion of the bone graft subjects with overall success was significantly higher than that of the autograft subjects (p = 0.0382).”

Alternative to “less studied products”

Glen Kashuba, Cerapedics’ CEO and former head of Biomet, Inc.’s spine and DePuy’s U.S. spine businesses, said that up until now, the cervical spinal fusion market has been lacking “the ultimate product solution.” Spine surgeons will now have access to a biologic bone graft based on the company’s proprietary P-15 technology platform that is a “safe and effective alternative to a patient’s own bone and other less studied products that are being marketed for cervical spine procedures.”

He did not mention Infuse by name which has been used off-label in the cervical spine. There were complications with Infuse, including growing too much bone and causing patients to have trouble breathing.

Engaging Distributors

As a result of the approval, the company says it has begun to engage a number of top-tier distributors, and is preparing to recruit a number of direct sales representatives, to support the U.S. commercial launch of the product. The U.S. surgical market for biologic bone substitutes, according to the company, is estimated to be about $500 million.

So Infuse now has company in the spine. It will be interesting to watch how the company handles off-label uses of i-Factor. With multiple federal courts striking down the FDA’s regulatory authority to prohibit truthful speech about medical products, the temptation to share independent information from surgeons using the bone graft for other purposes, will be great.