First-in-Human Clinical Results for SonoVascular's SonoThrombectomy™ System Presented at the 2025 Annual Meeting of the American Venous Forum

CHAPEL HILL, N.C., March 18, 2025 /PRNewswire/ -- SonoVascular, Inc., a clinical stage medical device company focused on bringing to market its SonoThrombectomy^™ System for venous thromboembolism (VTE), a novel treatment solution intended to provide better outcomes for millions of patients suffering from deep vein thrombosis (DVT) and pulmonary embolism (PE), has successfully completed an initial set of eight cases in patients with DVT in its First-In-Human (FIH) study.

DVT is a condition that occurs when blood clots form in the deep veins of the leg, restricting blood flow back to the heart and causing pain and swelling.  Additionally, if part of the clot breaks off it can travel through the bloodstream to the lungs, causing a PE which can be life threatening. To treat these conditions, the SonoThrombectomy System delivers ultrasound energy and microbubbles directly to the clot through the RESONATOR^™ Catheter, inducing microbubble-mediated cavitation, which mechanically breaks down the clot.  Additionally, a very low dose of tPA is infused in combination with the microbubbles through the catheter to further improve clot breakdown.  The System is designed to treat VTE more safely and effectively, and at a lower cost to the health care system than currently approved therapies.

SonoThrombectomy treatment was highly effective in the first eight cases of the FIH study, as all cases achieved a complete (100%) Marder score reduction as assessed by an independent core laboratory.  Additionally, significant improvements from baseline in Villalta score, revised Venous Clinical Severity Score, and Numeric Pain Rating Scale scores were observed at 30-day follow-up, and there were no device-related adverse events, major bleeding, or deaths.

"We are very encouraged by the initial cases in our FIH clinical study." said Daniel Estay, Founder and Chief Executive Officer of SonoVascular. "Thus far, our investigators have observed complete thrombus resolution, no blood loss, and no evidence of adverse affects on the vein wall or venous valves or other safety concerns.  Enrollment in the FIH study is ongoing and planned to be completed by the end of Q2 2025.  We are honored that Dr. William Marston presented our initial clinical findings at the 2025 annual meeting of the American Venous Forum on February 19th in Atlanta, Georgia."      

William Marston, MD, Professor of Surgery at the University of North Carolina at Chapel Hill School of Medicine and Past President of the American Venous Forum, remarked:

"The results obtained thus far in SonoVascular's FIH study demonstrate the SonoThrombectomy System has the potential to become a disruptive technology that would effectively overcome the shortcomings of available therapies for the treatment of DVT.  As a vascular surgeon and researcher who has treated patients suffering from DVT for over 25 years, I find that despite improvements in our ability to treat these patients, currently available devices still have significant challenges and limitations. In the initial cases, the SonoThrombectomy System has demonstrated its ability to eliminate intravenous clot in a single treatment session with no blood loss and with preservation of venous valves. The System is not limited by the presence of previously implanted filters or stents and is highly steerable for treatment of specific areas of residual thrombus.

These initial cases suggest that the SonoThrombectomy System is able to eliminate clot with a gentler approach that does not cause blood loss and preserves vessel and valve integrity. This System has the potential to be a revolutionary technology and address critical limitations with current interventional devices and techniques for treatment of DVT."

About Venous Thromboembolism

Venous thromboembolism is a condition that occurs when a blood clot forms in a vein. As many as 900,000 VTE events occur each year in the United States.¹  VTE includes DVT and PE.  DVT occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh or pelvis.  The most serious complication of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a blockage called PE.  If the clot is large, it can stop blood from reaching the lungs and can be fatal.  One-third to one-half of people who have a DVT will have long-term complications caused by damage to the valves in the vein called post-thrombotic syndrome (PTS).²  In some cases, PTS symptoms can be so severe that a person becomes disabled. PE can be life-threatening, with 10-30% of individuals dying within one month of diagnosis.³

About SonoVascular, Inc.

SonoVascular is a clinical-stage medical device company that has developed the SonoThrombectomy system. SonoThrombectomy is a novel and highly differentiated ultrasound facilitated, thrombolytic enhanced thrombectomy system for venous and arterial thrombosis that utilizes microbubble-mediated cavitation as a core enabling mechanical mechanism of action to more safely and effectively treat VTE.  It is a cathlab-based solution designed to maximize the reduction of clot burden, eliminate blood loss and vessel trauma, and harness the benefit of low dose/duration thrombolytic without bleeding risks. SonoVascular is headquartered in Chapel Hill, NC.

For more information, visit www.sonovascular.com.

Contact:
SonoVascular, Inc.
Daniel Estay
Founder and Chief Executive Officer
[email protected]

¹ Gregson J, Kaptoge S, Bolton T, et al. Cardiovascular Risk Factors Associated With Venous Thromboembolism. JAMA Cardiol. 2019;4(2):163–173. doi:10.1001/jamacardio.2018.4537.  
² Wendelboe AM, Campbell J, McCumber M; Bratzler D; Ding K, Beckman M, Reyes N; Raskob G. The Design and Implementation of a New Surveillance System for Venous Thromboembolism using Combined Active and Passive Methods. American Heart Journal. 2015.
³ American Lung Association; https://www.lung.org/lung-health-diseases/lung-disease-lookup/pulmonary-embolism/learn-about-pulmonary-embolism#:~:text=Pulmonary%20embolism%20affects%20around%20900%2C000,that%20travel%20to%20the%20lungs

SOURCE SonoVascular, Inc.