Cerapedics' i-FACTOR Flex bone graft product line receives CE Mark

Jun 30 2010

Cerapedics, Inc., a medical device company focused on developing and commercializing novel osteobiologic products, announced today that it received the CE Mark for its i-FACTOR™ Flex bone graft product line. i-FACTOR Flex is the company's second product in the i-FACTOR product platform based on its proprietary small peptide attachment factor technology.

“We are pleased to now offer another dimension of the i-FACTOR bone graft product portfolio to our customers in Europe and Asia Pacific”

i-FACTOR bone graft is the only biologic bone graft that combines a unique anorganic bone mineral (ABM) and small peptide (P-15™) to act as an attachment factor for specific integrins on osteogenic cells. This novel mechanism of action enhances the body's natural bone healing process resulting in safe, predictable bone formation at a lower cost than growth factors. ABM/P-15 has been in human clinical use for more than thirteen years in an estimated 500,000 patients worldwide.

"We are pleased to now offer another dimension of the i-FACTOR bone graft product portfolio to our customers in Europe and Asia Pacific," said Steve McAdoo, director of marketing at Cerapedics. "i-FACTOR Flex is a freeze-dried form of i-FACTOR Putty, providing complementary handling characteristics surgeons may require in addressing spine, trauma and orthopedic indications."

Cerapedics' flagship product i-FACTOR Putty bone graft received CE Mark in late 2008. It has been utilized clinically in more than 2,000 spine and trauma surgeries worldwide. i-FACTOR bone graft is currently being evaluated in the United States (FDA) as part of an Investigational Device Exemption (IDE) Clinical Study in spine.

Paul Mraz, CEO, said, "We continue to be highly encouraged with the long-term clinical results from the initial market release of i-FACTOR Putty that began in Europe in 2008. i-FACTOR's peptide enhanced cellular attachment factor, a unique mechanism of action among bone grafts, is now available in more than 20 countries worldwide and growing. Cerapedics continues to be well-positioned in the increasingly sophisticated osteobiologics marketplace."

SOURCE Cerapedics, Inc.