Medical device company Sonavex received $3 million in grant funding from the National Institutes of Health that will allow the company to pursue applications of its FDA-approved products in vascular surgery.
The Small Business Innovation Research Phase IIB Award will support clinical studies and R&D efforts, according to the Canton-based company.
A Johns Hopkins spinout, Sonavex created a system, called EchoSure, which combines ultrasound imaging and deep learning algorithms to bring automation to the process of monitoring blood flow after surgery. That system can work along with tiny implants, called EchoMark, which mark the soft tissue site where surgery was completed for monitoring. It’s designed so that specialized ultrasound training isn’t required to measure blood flow.
Now the company will look to apply these devices for care of patients with end-stage renal disease. The company said more two million of these patients worldwide require a form of access to the blood vessels. The preferred method for this, according to Sonavex, is known as the AV Fistula. That’s a surgical connection of a patient’s vein directly to their artery in the arm. However, 30% to 60% of these do not reach “maturation,” where the fistula has expanded enough to allow for the higher blood flow required for dialysis. There is also risk of failure after maturation is reached.
Ultrasound has been used to monitor the AV Fistula for maturation and its long-term viability, but requires highly trained professionals, and is time-consuming, according to Sonavex. The company is working to apply its technology to that process, with its system enabling an assessment during routing clinical visits.
“This Phase IIB grant will allow us to complete the important research and clinical trials necessary to improve the lives of dialysis patients,” said David Narrow, CEO of Sonavex, in a statement. “Support from the NIH has been instrumental to our company’s early success and we are elated to continue our collaborative relationship as we expand the utility of our devices to help more patients.”
The Canton-based company currently has 12 employees. The funding follows a pair of milestones for the company. Both of its devices were approved by the U.S. Food and Drug Administration within the last 18 months, with EchoSure approved in March.
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