![]() ![]() They’re definitely on their way out,” Kashuba said. “We’ve taken market share from allogeneic stem cell products because they have no data, and the only approval they’ve got is under the minimal manipulation of tissue status. Competitive products like synthetic bone grafts, demineralized bone matrices (DBMs) and stem cell products generally have to be mixed with autograft material and, therefore, can’t support bone generation and spinal fusion by themselves. Marx pointed to three of the company’s prospective human clinical studies where their product was exclusively used to regenerate bone during interbody spinal fusion. To illustrate the differences between autograft replacements like i-FACTOR and autograft extenders such as the vast majority of Cerapedics’ competitors, Dr. Kashuba remarked that Cerapedics’ flagship product has distinct advantages over Medtronic’s Infuse in terms of safety, its ability to grow bone “more uniformly,” and cost effectiveness.Īutografting bone is the process of harvesting bony material from one part of a patient’s body and using it to repair and regenerate bone in another. “Only two have gone through the full IDE PMA process with prospective, randomized human critical trials to show that they’re autograft replacements and not autograft extenders. “There are over 400 approved bone graft material products being promoted for use in the U.S.,” Dr. We’re able to leverage that in the marketplace.” “It means we’ve proven prospectively with level 1 data that our product is safe and effective. From his perspective, Cerapedics’ Class III status delivers the sort of trust and legitimacy that nearly all of their competitors can’t match. “The challenge with a Class III device is that it takes both an IDE and PMA, and that can take companies upwards of $20 million and four to five years to complete,” Kashuba said. (Wright Medical’s AUGMENT® is also a PMA/Class III bone grafting product, though for a different indication: ankle and hindfoot arthrodesis.) Accomplishing this took years of stringent human clinical trials and a significant financial investment. Instead of being one of myriad Class II bone graft devices that pass FDA clearance quickly and easily by making small adjustments to otherwise nearly identical products, Cerapedics is one of only two companies with FDA Class III bone graft technology on the market for use in the spine. Marx now sell as one of its greatest assets. The chief reason i-FACTOR took so long to be commercially available in the U.S. If you want to develop an innovative product, you can’t be worried about putting the time and money behind data and clinical studies.” “With Class II device clearances, there’s an incremental tweaking of many products that flood the market and cause pricing issues and a lack of differentiation. “I’m a firm believer that there are no shortcuts in business or life,” said Kashuba, the former President of Biomet’s Spine & Bone Healing Technologies. Marx joining Cerapedics in 2013, they weren’t with the company during the early days of i-FACTOR’s development, but heading a company whose only product took more than a decade to commercialize seems to have imparted a philosophy focused on waiting to bring something truly new, safe and effective to the bloated orthopedic market to differentiate. Marx’s estimation, it took 12 years between the development of Cerapedic’s i-FACTOR bone graft product and commercialization in the U.S., which came after achieving FDA’s Premarket Approval (PMA) for cervical spine surgery in late 2015. ![]() Marx serves as the President and COO and Kashuba’s role is CEO at Cerapedics, an orthopedic device company that offers the peptide-enhanced bone autograft replacement product i-FACTOR. ![]() Marx, Ph.D., and Glen Kashuba are two orthopedic device executives well-versed in the art of patience. ![]()
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