FDA IDE approval of Sonavex's randomized trial comes months after meeting the endpoint of its first clinical study
BALTIMORE, Jan. 2, 2024 /PRNewswire-PRWeb/ -- Sonavex, Inc., a privately held medical device company with ultrasound technologies that deliver quantitative blood flow and other critical vascular data at the point of care, announced that it completed its initial clinical study evaluating the ability to use EchoMark & EchoSure to improve the assessment of arteriovenous (AV) fistula maturation for dialysis patients. Following the positive findings from this study, Sonavex was granted approval from the U.S. Food and Drug Administration under an Investigational Device Exemption (IDE) for its randomized controlled trial, MAFASA (Maturation of Arteriovenous Fistula with Automated Sonography Assessments).
EchoMark & EchoSure will allow medical professionals to collect essential vascular parameters in the dialysis clinic to assess AV fistula maturation. In September 2023, Sonavex completed a study which demonstrated the ability of users without ultrasound experience to successfully collect accurate measurements of AV fistula maturation with EchoSure. These data were presented at the 50th annual VEITH symposium in November.
In December 2023, FDA approved Sonavex's randomized controlled trial, MAFASA, which is set to enroll 304 patients. This trial is designed to provide Level 1 data to demonstrate how the use of EchoMark & EchoSure will reduce time to AV fistula maturation and reduce the costs of managing dialysis patients as compared to standard of care by providing more timely measurements. Dr. Stephen Hohmann, a highly respected Dallas-based vascular surgeon with expertise in dialysis access surgery will serve as the National Principal Investigator for the trial.
"Initial clinical results validate the safe and effective use of EchoMark & EchoSure," said Dr. Stephen Hohmann. "I look forward to leading this large, randomized, multicenter trial to demonstrate the impact that the technology has on improving care for dialysis patients."
"The results from Sonavex's first study corroborate our team's vision for how EchoMark & EchoSure can be used for AV fistula patients," said David Narrow, Chief Executive Officer of Sonavex. "We are excited to embark upon the MAFASA trial to better quantify the clinical and economic benefit of the technology and anticipate enrollment to commence in Q1 2024."
About Sonavex, Inc.
Sonavex, Inc. is a Baltimore-based medical device company originally spun out of Johns Hopkins. The company has developed a portfolio of novel ultrasound solutions that empower patient care by delivering critical visual and quantitative data to improve outcomes and reduce costs. For more information, please visit www.sonavex.com.
SOURCE Sonavex, Inc.