WAYNE, PA — Cagent Vascular has raised $41 million in Series D financing and reported the first human procedures using its new intravascular lithotripsy platform, providing capital to support clinical development and commercialization efforts in the competitive vascular intervention market.
The financing round was co-led by U.S. Venture Partners and Astoria Health Investors and will fund the company’s global REMODEL II pivotal trial, commercialization of its SONIC intravascular lithotripsy system and continued development of a coronary artery version of the technology.
The fundraising comes as medical device companies seek to expand treatment options for peripheral artery disease and coronary artery disease, markets the company estimates represent a combined opportunity of roughly $17 billion.
Cagent’s SONIC system combines the company’s existing Serranator Serration Remodeling Therapy technology with lithotripsy, a technique that uses acoustic energy to fracture calcified plaque within arteries.
The company reported that the first human-use procedures were performed in Uzbekistan as part of the REMODEL I clinical study, which is evaluating the device in patients with disease affecting femoropopliteal and infrapopliteal arteries.
According to Cagent, the initial procedures demonstrated successful calcium modification and lesion remodeling as assessed through angiographic and intravascular ultrasound imaging.
“Even though the initial cases involved complex calcified chronic total occlusions, we were encouraged by the safety, deliverability, and effectiveness of the platform,” said Dr. Steven Kum, who participated in the procedures.
The SONIC system differs from many existing lithotripsy platforms by combining acoustic energy with serrated balloon-based vessel remodeling technology in a single disposable device that does not require separate capital equipment.
Dr. Peter Schneider, Cagent’s chief medical advisor and co-founder, described the combined approach as creating a synergistic effect beyond what either technology can achieve independently.
The financing builds on an existing commercial business. Cagent said its Serranator product line is already marketed across most major U.S. markets as well as selected international regions, with more than 40,000 procedures performed to date.
Casey Tansey of U.S. Venture Partners said the company’s combination of clinical development progress, commercial growth and plans for coronary applications contributed to the investment decision.
The REMODEL I study is continuing at sites in Uzbekistan, Australia and New Zealand, while proceeds from the financing are expected to support the larger REMODEL II pivotal trial needed for broader commercialization efforts.
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