NIH Awards Sonavex $3M Grant for Vascular Surgery Applications

Sonavex Inc. has received a $3-million Phase IIB SmallBusiness Innovation Research (SBIR) grant from the National Institutes ofHealth to use its EchoMark & EchoSure devices to support arteriovenous (AV)fistula maturation and long-term viability. The award provides capital forprospective clinical studies and continued research and development efforts.

There are millions of patients worldwide with End-StageRenal Disease (ESRD) that require dialysis to sustain life. Though an AVfistula 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 50percent of AV fistulae suffer primary failure and are never used because theydo not mature into a suitable dialysis access, often resulting in a delay instarting dialysis, requiring placement of an artificial dialysis catheter. Evenafter fistulae mature successfully, the primary failure rate is approximately33 percent at 1-year and 50 percent at 2-years. In addition to the substantialmorbidity, healthcare costs associated with ESRD are substantial and represent sevenpercent of the total CMS budget, over $26 billion per year.

The grant follows Sonavex’s FDA clearance for its EchoSure3D ultrasound system in March of 2019. EchoSure combines 3D ultrasound imagingwith advanced deep learning algorithms to automate visual and quantitativeblood flow monitoring after surgery. Coupled with Sonavex’s FDA-clearedEchoMark bioresorbable markers, EchoSure eliminates the need for specializedultrasound training in order to measure blood flow and greatly shortens thetime to collect data. Though ultrasound-based flow measurements have beenproven to improve the success of both AV fistula maturation and patency, use ofconventional ultrasound has been limited by its time-consuming nature and needfor a highly trained and formally certified professional ultrasonographer.

“This Phase IIB grant will allow us to complete theimportant research and clinical trials necessary to improve the lives ofdialysis patients,” said David Narrow, CEO of Sonavex.

The new technology will help to provide a better standard ofcare for hemodialysis patients by providing simple and routine assessment offistula health during routine clinic visits.