Cagent Vascular's Sonic IVL Aims to Remodel Arterial Treatment

WAYNE, PA – May 19, 2026 – Cagent Vascular, a company specializing in endovascular technology, has announced two significant milestones that signal a major push into the competitive multi-billion dollar arterial disease market. The company recently completed the first successful human procedures with its next-generation Serranator® SONIC Intravascular Lithotripsy (IVL) System and simultaneously closed an oversubscribed $41 million Series D financing round.

These developments position the Pennsylvania-based firm to accelerate global clinical trials and prepare for the commercial launch of a device that combines two distinct therapeutic mechanisms into a single platform. The move is a direct challenge to existing vessel preparation technologies and could represent a new paradigm for treating patients with severe peripheral and coronary artery disease.

A New Force in Vessel Preparation

Treating peripheral artery disease (PAD), particularly when arteries are hardened by severe calcium deposits, presents a significant clinical challenge. While Intravascular Lithotripsy—a technology pioneered and dominated by Shockwave Medical—revolutionized the field by using sonic waves to fracture calcium, physicians often encounter complex lesions that include both hard calcium and resistant fibrous plaque. Cagent Vascular's strategy is to tackle this complexity head-on.

The company’s new Serranator® SONIC IVL System integrates its established Serration Remodeling Therapy (SRT) with a lithotripsy generator. The SRT platform utilizes a balloon catheter with embedded serrated metal elements designed to create controlled micro-fissures in the arterial plaque. This action is intended to improve vessel compliance and reduce elastic recoil at low inflation pressures.

By combining this with lithotripsy, the SONIC IVL System becomes the first device to transmit ultrasonic acoustic waves directly through these serrated elements into the calcified plaque. The company asserts this creates a synergistic, "force-multiplying" effect that exceeds what either technology can achieve alone.

“What makes the SONIC IVL System compelling is that it is genuinely more than the sum of its parts," said Dr. Peter Schneider, Chief Medical Advisor and Co-Founder of Cagent Vascular. “Combining SRT with lithotripsy ultrasonic energy creates a synergistic effect we do not see with any other technology.”

A key commercial differentiator is the system's design. The entire platform, including the SONIC generator, is fully disposable and requires no capital equipment. This model could lower the barrier to entry for hospitals and clinics, a significant advantage in a market where some competing systems require a substantial upfront investment in reusable consoles.

Fueling Global Ambition with $41 Million

The dual announcement is backed by significant financial confidence. The oversubscribed $41 million Series D round was co-led by U.S. Venture Partners (USVP) and Astoria Health Investors. This latest infusion brings Cagent Vascular's total funding to over $69 million and provides the necessary capital to transition from a promising technology developer to a global commercial contender.

“Cagent has developed a next generation IVL platform with significant clinical and commercial potential, building on over 40,000 safe and effective Serranator procedures,” said Casey Tansey of USVP, who also led the company's previous Series C round. “This successful first human-use experience, rapidly growing commercial business, and future coronary expansion together positions the company to execute in this high-growth segment.”

The funds are earmarked for three critical initiatives: funding the global REMODEL II pivotal trial, financing the commercial launch of the SONIC IVL System, and advancing the development of a coronary artery platform. This strategic allocation of capital underscores a clear roadmap for capturing a larger share of the estimated $17 billion peripheral and coronary arterial markets.

From Clinical Trials to Patient Care

The technology's first test in human patients occurred within the REMODEL I Study, a prospective, multicenter trial evaluating the system's safety and performance in leg arteries. The initial procedures were performed successfully in Uzbekistan by a team that included Drs. S. Iskhakov, N. Madrakhimov, and Steven Kum of Singapore. The study, which is also enrolling patients in New Zealand and Australia, aims to gather data from 30 participants across both above-the-knee and below-the-knee arteries.

Early observations from the first cases, which involved complex calcified blockages, were encouraging. Physicians reported successful calcium modification and vessel remodeling, as confirmed by angiographic and IVUS imaging.

“Even though the initial cases involved complex calcified chronic total occlusions, we were encouraged by the safety, deliverability, and effectiveness of the platform,” noted Dr. Kum. “We observed substantial lumen gain, improved vessel compliance, and appreciated the flexibility of the system’s adjustable energy delivery. From my perspective, this technology has the potential to become an important new tool for treating some of the most challenging cases we typically encounter.”

Building on this initial success, the forthcoming REMODEL II pivotal trial will be essential for securing regulatory approvals from bodies like the U.S. Food and Drug Administration (FDA) and for CE Mark in Europe, paving the way for widespread clinical use.

Navigating a Competitive Medtech Landscape

Cagent Vascular is entering a dynamic but challenging market. The company is not just offering an alternative; it's proposing a new, integrated approach. By combining two therapies, Cagent aims to eliminate a difficult choice for physicians.

“For years, physicians treating PAD have had to choose between two highly effective but separate technologies — SRT and IVL,” said Brian Walsh, Chief Executive Officer of Cagent Vascular. “The SONIC IVL System eliminates that tradeoff. For the first time, physicians can access both mechanisms in a single device, in a single procedure.”

This single-device solution for complex disease could streamline procedures, potentially reducing time, cost, and the need for multiple device exchanges in the catheterization lab. The company already has an established commercial foundation with its original Serranator® portfolio, which is sold across major U.S. markets and select international territories. This existing infrastructure and physician familiarity with the core serration technology could provide a crucial springboard for the launch of the new SONIC IVL system. As the company moves forward with its pivotal trials, the medical community will be watching closely to see if this combined-therapy approach can deliver on its promise to redefine the treatment of calcified arterial disease.