Sonavex, Inc. announced today the final closure of its expanded $4.5M Series A and filing of a 510(k) submission to the U.S. Food and Drug Administration (FDA) for its EchoMark device. The proceeds will accelerate Sonavex’s commercial launch later this year and support further product development. Participants in the additional financing included Fusion Fund (aka NewGen Capital), FundRx, and existing investors.
“Sonavex has one of the strongest product-team combinations in the industry for this endeavor,” said Lu Zhang, Founder and Managing Partner of Fusion Fund. “We are excited to help accelerate the company for its next stage of partnership and market expansion.”
“We are delighted with the performance of EchoMark reflected in our regulatory submission,” said Devin O’Brien-Coon, MD, Sonavex President and Study Director for the pivotal preclinical study. “This submission represents the culmination of four years of hard work by our team in completing comprehensive performance, safety and usability studies.” Sonavex submitted a 510(k) premarket notification to the FDA for EchoMark, a highly echogenic, resorbable polymeric implant featuring a novel manufacturing technique used for marking soft tissue sites after surgery. EchoMark exhibited excellent performance during testing, meeting all standard biocompatibility endpoints for similar resorbable devices.
“This is the first of several revolutionary new technologies in our company’s pipeline and we are preparing to both file additional FDA submissions and demonstrate impact on clinical care,” stated David Narrow, Chief Executive Officer of Sonavex, which develops novel surgical ultrasound technologies to improve healthcare. The company intends to roll out EchoMark to hospitals across the United States later this year.
Sonavex, Inc. is a Baltimore-based medical device company originally spun out of Johns Hopkins. The company has developed a pipeline of novel ultrasound solutions to visualize and quantify critical clinical data for improved outcomes and reduced costs in new surgical applications. For more information, please visit www.sonavex.com.
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