In the spirit of building a better mousetrap, medical device startup SonoVascular is developing a new technology to more effectively treat patients who have potentially life-threatening blood clots.

The Chapel Hill-headquartered company has created what it calls a SonoThrombectomy system to address deep vein thrombosis (DVT) and pulmonary embolism (PE). The technology uses a novel intravascular catheter that delivers a combination of ultrasound, microbubbles, and a clot busting drug to break up, or debulk, clots – along with mechanical retrieval or aspiration to remove any remaining clot.

SonoVascular founder and CEO Daniel Estay said this approach can offer better results than medications or medical devices alone.  

While drugs can be effective at dissolving clots and are often the treatment of choice, high doses can increase the risk of bleeding. And they require lengthy patient monitoring in a hospital intensive care unit (ICU).

Given these risks and the added cost of treating patients in the ICU, medical specialists have increasingly turned to mechanical devices to capture and/or suction out clots. But, Estay said, these tools tend to be a larger and more aggressive option that can create its own set of problems.

He believes the market will increasingly move in the direction of SonoVascular’s less aggressive and more balanced combination therapy. “Historically, patients were treated purely with drugs, and then we saw the pendulum swing towards purely mechanical therapies,” Estay pointed out. “We suggest that the pendulum is going to swing back toward the middle because physicians would like to have the benefit of both approaches.”

The SonoVascular therapy – which is in pre-clinical testing – uses a significantly lower dose of a thrombolytic drug in combination with its other technology.  Estay believes this new approach, which eliminates the need for treatment in an ICU, will meaningfully improve the standard of care while reducing costs.  

And that could provide a better solution to a big problem. DVT and PE, caused by potentially life-threatening blood clots in the legs and lungs, affect close to 900,000 people in the U.S. each year at a cost of around $10 billion.

The ultrasound technology used by SonoVascular was spun out of the Joint Department of Biomedical Engineering, a combined program of the University of North Carolina at Chapel Hill and North Carolina State University. Professor Xiaoning Jiang, Ph.D., in the Department of Mechanical and Aerospace Engineering at NC State and Paul Dayton, Ph.D., chair of the Joint Department of Biomedical Engineering, were responsible for developing the core technology. They currently serve as SonoVascular technical advisors.

Estay, who has spent much of his decades-long career in the cardiovascular medical devices industry, initially read about the research in 2017 while reviewing a vascular medicine journal. He licensed the technology and created SonoVascular in 2018 to develop it into a marketable product.

The company has grown to eight employees and has received over $6 million in seed money so far. Estay plans to raise more than $10 million through a Series A round of funding in the fourth quarter of this year, along with the issuance of convertible notes.

 

The North Carolina Biotechnology Center has long supported SonoVascular. It invested $250,000 in the company’s convertible note financing last year and will provide funding for a summer intern this year. It also recently approved a Strategic Research Loan of $350,000. “NCBiotech has been a great partner to SonoVascular since our beginning, and we’re lucky to have its financial backing and collaboration,” Estay said.

Greta Brunet, senior director of investments at NCBiotech, said the company’s technology and management have continued to advance since the company was founded.

“Over the past 5+ years, I’ve watched this technology advance from benchtop studies and a team of two to a stellar management and engineering team with solid vascular industry expertise and a validated device ready to enter a First-in-Human study,” Brunet said. “We look forward to continuing to support SonoVascular as the technology continues to advance.”

The latest fund-raising efforts will support an initial human trial in Latin America this summer, followed by a pivotal study in the U.S. in late 2025 or early 2026. Estay said he hopes to get U.S. Food and Drug Administration approval to launch the technology for the treatment of deep vein thrombosis in 2027, and for pulmonary embolism in 2028.

“Our team has worked hard, and we’re prepared and positioned to do well,” Estay pointed out. “I like what I see so far, and I’m confident we’ll be successful.”

On May 2, SonoVascular announced an exclusive clinical supply agreement with Lantheus Holdings, Inc., to use Lantheus' microbubbles in combination with SonoVascular's SonoThrombectomy System to treat DVT and PE.