CERAPEDICS IFACTOR TRIAL
CERAPEDICS IFACTOR SERIES

CERAPEDICS IFACTOR TRIAL

i-FACTOR bone graft is currently being evaluated in the United States (FDA) as part of an Investigational Device Exemption (IDE) clinical trial in the cervical spine.ĬAUTION: i-FACTOR™ bone graft is not commercially available in the USA. Currently, i-FACTOR bone graft is commercially available in both Putty and Flex (flexible strip) forms in over 25 countries outside the United States. i-FACTOR™ bone graft is the only biologic bone graft that utilizes a synthetic small peptide as an attachment factor intended to stimulate the natural bone healing process resulting in safe, predictable bone formation at a fraction of the cost of growth factors.Ĭerapedics’ i-FACTOR bone graft received CE Mark in 2008 and has been utilized clinically in nearly 10,000 spine, trauma, and orthopedic surgeries worldwide.

Food and Drug Administration (FDA) to proceed with a PMA modular submission for its ongoing IDE clinical trial studying i-FACTOR peptide enhanced bone graft in cervical spine fusion and has commenced that process.Ĭerapedics, a 2012 Colorado Companies to Watch (COCTW) winner, is a privately held medical device company focused on developing and commercializing novel osteobiologic products based on its proprietary anorganic bone mineral (ABM) and synthetic small peptide (P-15™) technology platform for use in a wide variety of spine, trauma and orthopedic surgical procedures. Proceeds from this financing will allow Cerapedics to continue to grow sales strategically outside the USA and gather long-term follow-up data from numerous clinical studies for a variety of bone repair indications.”Ĭerapedics also announced that the company earlier received agreement from the U.S. “Cerapedics is well-positioned to become a key player in the nearly $2 billion osteobiologics marketplace across spine, trauma and orthopedic reconstruction worldwide.”Īndy Handwerker, Chief Operating Officer at Cerapedics commented: “This financing is solid validation of our proposition to be the second premarket approval (PMA) designated osteobiologic product to address the spine market in the United States and the first to be indicated for use in the cervical spine. It is a direct reflection of the merits of the clinically tested i-FACTOR product portfolio and the team we have put in place globally,” said Paul Mraz, Cerapedics’ President and Chief Executive Officer. “We are gratified with the response received from the financial community given the challenging economic environment present industry-wide. The proceeds will also allow Cerapedics to accelerate the development of next generation products and continue investments in sales and marketing to meet demand for the company’s i-FACTOR bone graft outside the United States. Proceeds will be used to support the company’s ongoing activities with its current Investigational Device Exemption (IDE) clinical trial in the United States studying its i-FACTOR™ peptide enhanced bone graft for cervical spine applications and prepare for commercialization upon FDA approval. It is a direct reflection of the merits of the clinically tested i-FACTOR product portfolio and the team we have put in place globally” In conjunction with the financing, Sam Wu, M.D., Ph.D., Managing Director of MedImmune Ventures, joined the Board of Directors. Existing investors including OrbiMed Advisors and NGN Capital also participated.

CERAPEDICS IFACTOR SERIES

announced that it recently completed a Series C round of private equity financing totaling $19 million led by new investors MedImmune Ventures and CVF, LLC, an affiliate of Henry Crown and Company.

Cerapedics ifactor