Last week, Sonavex, a Baltimore-based medical device company, announced receipt of a $3M Phase IIB Small Business Innovation Research (SBIR) grant for prospective clinical studies and ongoing research and development of its EchoMark and EchoSure devices. This grant funding from the National Institutes of Health (NIH) will specifically allow Sonavex to validate its technology’s application to arteriovenous (AV) fistula maturation and viability for patients with end-stage renal disease (ESRD).
Earlier this year, Sonavex received FDA clearance for its EchoSure 3D ultrasound system. EchoSure, in combination with EchoMark bioresorbable markers, automates both visual and quantitative blood flow monitoring following surgery, alleviating the need for specialized ultrasound training and expediting the time required to capture blood flow data.
Evidence shows that ultrasound-based flow measurements improve historically low rates of AV fistula maturation. Today, approximately 50% of AV fistulas fail to reach maturity while 50% of mature AV fistulas fail by the second year. Critical for dialysis access for ESRD patients, AV fistula failure leads to delayed initiation of dialysis and substantial morbidity.
Despite improved outcomes associated with ultrasound-aided procedures, the need for specialized ultrasonographers and time-consuming procedures have limited the use of ultrasound with AV fistulas. Sonavex aims to prove EchoSure’s ability to solve both of these challenges and allow hemodialysis patients to experience a better standard of care through simplified assessment of fistula health during routine clinic 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.
Flashbacks: Sonavex EchoSure Vascular Blood Flow Monitor Cleared in U.S.; Ultrasound Technology Startup Sonavex Raises $3M Series A and Expands Board: Medgadget Interview; Sonavex’s EchoMark Soft Tissue Markers Receive FDA 510(k) Clearance
Link: Sonavex homepage…