ViaTechMD enthusiastically welcomes its newest Member and FDA Advisor, Benjamin (Ben) Fisher, Ph.D. Ben recently retired as Director of the Office of Health Technologies (OHT3) within the Office of Product Evaluation and Quality (OPEQ), Center for Devices and Radiological Health (CDRH). Ben’s background includes: Ph.D. Developmental Genetics, The George Washington University; MS Development Biology, University of Maryland; and BS Microbiology, University of Maryland.
Ben is intimately knowledgeable of the ViaTechMD FDA file and is highly supportive of the company's mission and its management. With this collaboration and Ben’s insight, the company anticipates it will be granted Breakthrough Devices Program designation (a congressionally mandated program that expedites the approval process) and Early Feasibility Study IDE approval. This regulatory pathway will replace the company's previous plan of undertaking the more time-consuming, costly, and complicated OUS gravid patient clinical trials that would otherwise be necessary to develop additional safety and efficacy data required for FDA Premarket Approval and to obtain European CE Marking and Canadian Medical Device Licensing.
Advancing the above objectives is expected to result in accelerating patient access to the company’s breakthrough treatment in the prevention of preterm birth by way of a highly lucrative early exit to one of the large medical device companies with which ViaTechMD has been in discussions.
The award winning and globally patented ViaTechMD Cervical Stabilization Device (CSD) is the first and only non-invasive, medication-free device-based treatment specifically designed to reduce bearing forces acting on the lower uterine segment and cervix, which are now understood to accelerate the birthing process.
ViaTechMD’s Cervical Stabilization Device (CSD) has been awarded 1st Prize in the 2019 Create the Future Design Contest,
under the Medical Category. The award comes from Tech Briefs Media Group (an SAE International Company). More than 700
entries from 60 counties competed for the recognition and widespread media coverage the award brings. Our win will see
professional press releases about our Company and CSD published in a number of medical journals and reports around the world.
That coverage will be very beneficial in ‘getting the word out’ about our Company, its breakthrough device, and our vital mission.
In June of 2018, ViaTechMD engaged DuVal & Associates to assist in FDA negotiations and development of a risk and mitigation analysis and clinical trial design as requested by the FDA. DuVal & Associates was formed in 2004 with a mission to focus on serving companies with unique needs that are regulated by the FDA, leveraging the firm’s exceptional industry experience, practicality, and responsiveness. The firm brings pragmatism and unapologetic advocacy. Its President and CEO, Mark DuVal, spent 17 years in-house between 3M Pharmaceuticals, 3M Medical Devices, and Medtronic. As a general counsel, he used to hire regulatory and compliance counsel from the big law firms in Washington, D.C. and felt they were often impractical, too expensive and less responsive to the exigencies of business, and did not deliver the results he needed. He often felt short-changed by these firms. They were afraid to advocate hard for clients because they are always fearful of not remaining friendly with the Agency. In contrast, DuVal & Associates believes a lawyer can advocate aggressively, yet diplomatically and with respect, and obtain better results for clients while maintaining the firm’s and the client’s positive relationship with the FDA. DuVal & Associates has been doing that for years, and understands that a firm should serve with distinction as a strategic partner and trusted advisor with real world insight gained from industry experience.
ViaTechMD has contracted Freudenberg Medical, to provide polymer engineering, manufacturing, assembly, packaging, testing and quality control services to our venture. With 11 locations worldwide, Freudenberg Medical is part of the Freudenberg Group. Founded over 165 years ago, the company develops innovative products and services for more than 30 market segments worldwide, and serves 43 of the 50 largest medical device companies in the world.
ViaTechMD has contracted and is in collaboration with Emergo’s senior-level experts in regulatory pathway and market entry strategy, risk management, device classification and registration, quality management system compliance, and clinical evaluation reports. Emergo, a UL company, has become a leading consultancy organization with more than 2,800 medical device and IVD clients worldwide. The company maintains offices in 25+ countries.
Along with our initial human fitment Study Team, including Dr. Phyllis D. Marx (Principal Investigator), Dr. William E. Gannon, Jr. (Medical Monitor), and our CRO Teams at Stiris Research and Radiant Research, ViaTechMD has just completed a series of very successful patient fitment, comfort and organ interaction trials.