Wearable Ultrasound for Imaging and Modulation

The Ultran Group, Inc., will further develop its wearable ultrasound technology and commercialize a Class II medical device for treatment of inflammation caused by rheumatoid arthritis. The developed technology will be a platform for additional therapies including pain treatment, immunotherapy, and cancer treatment. For this SBIR Phase II effort, Ultran will continue to work closely with the University of Minnesota, ST Microelectronics, 3M Company, design firm Procept, and Medtronic, PLC to produce and deliver a novel wearable ultrasonic medical device. Ultran’s combined experience, capability, and motivation are coupled with close partnerships forged with clinical researchers, component suppliers, design firms, regulatory consultants, and leading medical device OEMs. The Phase II effort will begin with the design and fabrication of a prototype (Beta) Wearable system, followed by human clinical trials conducted with this device. This will be followed by design of the commercial device and application for FDA regulatory approval via the De Novo pathway for non-invasive devices with no predicate. Near the end of the Phase II period, Ultran will also initiate investigational device exemption (IDE) clinical trials and proceed with product launch.