Sonavex Inc. has received a $3-million Phase IIB Small Business Innovation Research (SBIR) grant from the National Institutes of Health to use its EchoMark & EchoSure devices to support arteriovenous (AV) fistula maturation and long-term viability. The award provides capital for prospective clinical studies and continued research and development efforts.
There are millions of patients worldwide with End-Stage Renal Disease (ESRD) that require dialysis to sustain life. Though an AV fistula is the preferred and most cost-effective method for vascular access, the procedure is plagued with high short- and long-term failure rates. Up to 50 percent of AV fistulae suffer primary failure and are never used because they do not mature into a suitable dialysis access, often resulting in a delay in starting dialysis, requiring placement of an artificial dialysis catheter. Even after fistulae mature successfully, the primary failure rate is approximately 33 percent at 1-year and 50 percent at 2-years. In addition to the substantial morbidity, healthcare costs associated with ESRD are substantial and represent seven percent of the total CMS budget, over $26 billion per year.
The grant follows Sonavex’s FDA clearance for its EchoSure 3D ultrasound system in March of 2019. EchoSure combines 3D ultrasound imaging with advanced deep learning algorithms to automate visual and quantitative blood flow monitoring after surgery. Coupled with Sonavex’s FDA-cleared EchoMark bioresorbable markers, EchoSure eliminates the need for specialized ultrasound training in order to measure blood flow and greatly shortens the time to collect data. Though ultrasound-based flow measurements have been proven to improve the success of both AV fistula maturation and patency, use of conventional ultrasound has been limited by its time-consuming nature and need for a highly trained and formally certified professional ultrasonographer.
“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.
The new technology will help to provide a better standard of care for hemodialysis patients by providing simple and routine assessment of fistula health during routine clinic visits.