First and foremost, it is a drug device combination product, so is very active in terms of driving the biological response within the patient post-implantation. JM: i-FACTOR is different in a couple of important ways. How is i-FACTOR different and what are the benefits to patients and surgeons? So, the technology is very much proven to be safe and effective.” – Glen KashubaĪs you know, the US market is very crowded and there are currently over 400 bone graft substitutes in the market. At this point, we have well over 40,000 cases under our belt.
#Ifactor cerapedics trial
“We have successfully completed that IDE trial resulting in a PMA approval at the end of 2015 becoming only the second Class 3, PMA approved drug-device orthobiologic in the market. This is a major accomplishment as the only other orthobiologic approved in spine as a class 3 drug-device orthobiologics was BMP which had achieved sales over $900M before declining to roughly $500M due to its high expense and safety concerns. So, i-FACTOR has been used and had excellent clinical success in the OUS market as early as 2008. So, the technology was very much proven to be safe and effective as the company initiated the Investigational Device Exemption for ACDF. As mentioned, we have successfully completed that IDE trial resulting in a PMA approval at the end of 2015 becoming only the second Class 3, PMA approved drug-device orthobiologic in the market.
GK: As an added comment, regarding the transition from the initial base technology, the company received approval for i-FACTOR in OUS markets in 2008 via CE MARK and TGA approval so i-FACTOR has been available commercially for Spinal fusions as well as other general orthopedic indications. Along those lines we have also developed the next generation version of the product, and that is what we used in the TLIF trial that is about to get underway. Attach, Activate" mechanism of action of the P15 molecule in i-FACTOR, and have been applying that successfully in our commercial efforts, both outside of the United States since 2008, as well as in the United States since late 2015. So, we have learned an awful lot about the "Attract. So, like most bone grafting technologies, there has been an evolution over time, both in terms of the understanding of how the material works, as well as slow improvements to technology for delivery, as well. Please tell me a little more about how the core technology has been enhanced and how this has inspired the launch of Cerapedics? From my understanding, the core technology of i-FACTOR, P-15, has been a proven bone substitute in dentistry since 2000, and has been available for ACDF since 2015. Gentlemen, thank you for your time.įirst, congratulations on your recent MedTech Breakthrough Award and FDA approval to initiate an IDE Clinical Trial to evaluate i-FACTOR in TLIF surgery.
With us today is Glen Kashuba, Chief Executive Officer, and Jeff Marx, Ph.D. This is Kim French with Biomed GPS and we are fortunate to meet with Cerapedics leadership to discuss the company and their peptide enhanced bone graft technology i-FACTOR.
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