Monday November 6, 2017 0 comments
Jeffrey (Jeff) G. Marx, Ph.D. is a senior executive with over 20 years of experience in the medical device space. His experience includes successful leadership roles spanning R&D, business development, corporate strategy, marketing, sales, regulatory, quality and operations.
Marx is currently president and COO of Cerapedics, Inc., a privately held company focused on novel bone grafting solutions. In this role, he led the efforts to bring the company’s i-FACTOR product through the clinical study and regulatory process to achieve FDA PMA approval in November 2015. I-FACTOR is only the second orthobiologic product to receive PMA approval for use in the spine.
Prior to joining Cerpedics, Marx held a variety of leadership roles at Orthovita over a 13-year span through the acquisition by and integration into Stryker. During this time, he was a key member of a management team that grew the company from $0-$100M in revenue and an acquisition for $316M.
Marx has a Ph.D. in Ceramic Engineering, is the inventor on numerous patents, and has lectured extensively on biomaterials, bone biology and bone grafting options.
Q: Cerapedics' primary product is the iFACTOR Peptide Enhanced Bone Graft. What are its features that make it unique in bone graft technology?
A: i-FACTOR is the only product on the market utilizing a peptide (small molecule) to drive cellular attachment and facilitate bone healing. It is one of only two class III drug-device combination products PMA approved for use in the spine on the basis of a prospective randomized level I study. Over 99% of competitive products are either 510(k) cleared, or considered unregulated tissue products with little to no human data.
Q: How is this technology superior to using a patient's own stem cells to repair bone?
A: i-FACTOR actually increases the effectiveness of the patient’s stem cells at the local operative site. The mechanism of action amplifies native biology via it’s Attract, Attach, Activate mechanism of action.
Q: Cerapedics recently partnered with DSM Biomedical to develop the next generation of peptide enhanced bone grafts. How do you see this partnership advancing your company's position in the marketplace?
A: Through our partnership with DSM, we were able to develop an advanced next generation material that neither company could have done by ourselves. This product utilizes a DSM collagen carrier for ideal handling characteristics along with an optimized P15/ABM active component. We are really excited about the potential for this product.
Q: When was Cerapedics founded, and how close is the company to full commercialization?
A: Cerapedics was founded in 2001. We are now in full commercialization activities in the United States and numerous OUS markets. We received our FDA approval in November 2015, and effectively began building our distribution network and launching in the US in June of 2016.
Q: You announced last month that more than 150 U.S. hospitals have now adopted the use of iFACTOR Bone Graft, and you expect to add more than 100 more hospitals in 2018. What's behind this growing wave of adoption of your product?
A: One of the biggest challenges in our market is the length and complexity of the value analysis committee for hospital introduction. We have been quite successful in navigating these processes because of the unique value proposition we bring to the hospital which includes exceptional human clinical data and safety as compared to the majority of our competitors.