#United States #Chapel Hill #SonoVascular #SonoThrombectomy #Robert Ross

SonoVascular Completes Series A Financing to Revolutionize VTE Treatment

SonoVascular, Inc., a medical device company in the clinical stage, has successfully completed its first close of a $6 million Series A preferred stock financing. This funding round is particularly significant as it aims to further develop the SonoThrombectomy™ System, a pioneering approach designed to transform the treatment of venous thromboembolism (VTE). Leading this investment is Harbright Ventures, headquartered in Cary, North Carolina, with Robert Ross, a founding partner at Harbright, joining SonoVascular's Board of Directors.

The SonoThrombectomy System stands out for its innovative methodology that incorporates ultrasound technology and microbubble-mediated cavitation. This system aims to provide a safer and more effective solution for managing blood clots compared to existing thrombectomy methods. It facilitates a standalone procedure in the catheterization lab, maximizing clot reduction without causing blood loss or vascular trauma, a common risk associated with current treatments.

In an exciting development for the company, SonoVascular has treated ten patients in South America during its First-In-Human (FIH) study for deep vein thrombosis (DVT). Impressively, the SonoThrombectomy System achieved a completely successful 100% reduction in Marder scores across all treated cases, as evaluated by an independent core lab, without any related adverse events. Follow-up assessments at both 30-day and 6-month intervals showed significant and sustained improvements in patients’ Post-Thrombotic Syndrome (PTS) severity scores, utilizing various measures such as Villalta, revised Venous Clinical Severity, and Numeric Pain Rating Scale scores. These promising outcomes suggest that the SonoThrombectomy System could redefine the current clinical practices surrounding clot management by offering a transformative alternative.

Dr. Lisandro Carnero-Vidal, the Principal Investigator and Vascular Surgeon at Clínica La Sagrada Familia in Buenos Aires, expressed optimism about the device's potential: "Current treatment options for deep vein thrombosis carry inherent risks such as blood loss and valve or endothelial injury. The SonoThrombectomy System demonstrated a favorable safety profile and consistent performance during our FIH study. All ten patients treated experienced no serious device-related adverse events and exhibited sustained clinical improvements after six months. While these findings are preliminary, they warrant further clinical evaluation of this innovative therapeutic approach."

Robert Ross from Harbright Ventures remarked, "SonoVascular possesses a unique combination of groundbreaking technology and leadership capable of redefining the VTE treatment standard. We are investing in SonoVascular because they are addressing the longstanding challenge of achieving total clot reduction while minimizing blood loss and vessel damage. Given the robust FIH results, we are confident this system has the potential to become the new standard in care that eases ICU burdens, ultimately saving time and costs for hospitals and patients alike."

The Series A funding will enable SonoVascular to accomplish two critical milestones within 2026: securing FDA approval for a pivotal Peripheral Venous study in the U.S. and conducting a FIH study for pulmonary embolism treatment. The SonoThrombectomy System is fundamentally designed to improve outcomes for millions of patients dealing with DVT and pulmonary embolism (PE). DVT arises when blood clots form in deep veins, typically in the legs, leading to restricted blood flow, pain, and swelling. Additionally, if a clot dislodges, it can migrate to the lungs, resulting in a potentially fatal PE.

To address these serious medical conditions, the SonoThrombectomy System delivers ultrasound energy via the RESONATOR® Catheter directly to the clot, simultaneously deploying microbubbles to induce cavitation that mechanically breaks down the clot. Additionally, a low dose of thrombolytic drug (tPA) is introduced through the catheter to enhance clot treatment efficacy. This innovative system aims to treat DVT and PE with higher safety and effectiveness and to reduce associated healthcare costs compared to currently approved therapies.

About Venous Thromboembolism

Approximately 900,000 VTE incidents occur annually in the United States. A significant number of DVT patients—about one-third to one-half—experience long-term complications due to valve damage in the vein, leading to PTS, which can sometimes severely impair a person's ability to function. Furthermore, PE, a critical condition characterized by the displacement of a clot to the lungs, presents a serious risk of mortality, as statistics indicate that 10% to 30% of individuals diagnosed with PE may die within a month.

About Harbright Ventures

Harbright Ventures is an early-stage venture capital and private equity firm dedicated to investing in and supporting innovative growth companies across various sectors like medical technology, clean technology, and B2B SaaS. The firm aims to partner with entrepreneurs to catalyze their growth through both capital investment and strategic guidance.

About SonoVascular, Inc.

SonoVascular focuses on developing the SonoThrombectomy™ System, which represents an innovative and differentiated approach to treating venous and arterial thrombosis. The system incorporates microbubble-mediated cavitation to deliver safer and more effective results in the treatment of VTE. Based in Chapel Hill, NC, SonoVascular's device is currently investigational and not yet FDA-cleared or approved.

For further details, visit SonoVascular's website or follow their updates on LinkedIn.