PRESS RELEASE

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.