FastWave Medical Fortifies Global IP Ahead of Pivotal IVL Trials

MINNEAPOLIS, MN – May 19, 2026 – As the race to dominate the next generation of cardiovascular treatment intensifies, FastWave Medical has significantly strengthened its global position by securing four new international patents. The patents, issued in Australia and Japan, provide critical protection for the company’s innovative intravascular lithotripsy (IVL) systems, a technology designed to break up hardened calcium in arteries.

This intellectual property milestone expands FastWave's portfolio to 13 patents worldwide and comes at a crucial time for the Minneapolis-based company. It is currently advancing its two distinct platforms—the Artero™ electric IVL system for peripheral artery disease (PAD) and the Sola™ laser-based system for coronary artery disease (CAD)—toward pivotal U.S. clinical trials scheduled for 2026 and 2027. These trials are a key step toward regulatory approval and commercialization in the highly competitive U.S. market.

"This latest expansion of our patent portfolio strengthens the global protection around both Artero™ and Sola™ and reflects the depth of innovation behind FastWave's dual-platform IVL strategy," said Tristan Tieso, COO of FastWave Medical. "As we advance toward peripheral and coronary IDE trials, our expanding IP portfolio remains an important part of how we protect FastWave's technology and build long-term strategic value."

The High-Stakes Battle for Calcified Arteries

Intravascular lithotripsy has emerged as one of the most significant advancements in interventional medicine, offering a powerful solution to a long-standing challenge: severely calcified arteries. Over time, plaque buildup in coronary and peripheral arteries can harden into bone-like deposits, making them difficult to treat with traditional methods like balloon angioplasty and stenting. This calcification can prevent stents from fully expanding, block the delivery of devices, and lead to procedural complications.

IVL technology addresses this by adapting the principles of lithotripsy—famously used to break up kidney stones—for use inside blood vessels. A specialized catheter delivers localized sonic pressure waves that safely crack the hardened calcium without damaging soft tissue, restoring vessel flexibility and enabling successful stenting. The global IVL market, valued at nearly $1 billion in 2024, is projected to soar to almost $4 billion by 2034, driven by an aging population and the rising prevalence of cardiovascular disease.

"Calcified arterial disease remains one of the most difficult challenges in interventional medicine, particularly when calcium limits device delivery, lesion expansion, or procedural efficiency," commented Dr. Miguel Montero-Baker, CEO and Medical Director of HOPE Amputation Prevention Center. "As IVL becomes more widely adopted, physicians will continue to look for technologies that can make calcium modification fast, predictable, and easy to integrate into real-world procedures."

A Crowded Field of Medtech Giants

FastWave’s strategic patent acquisitions are not happening in a vacuum. The company is positioning itself as a nimble innovator in a market increasingly populated by medtech titans. The field was pioneered by Shockwave Medical, which was acquired by Johnson & Johnson in a blockbuster $13 billion deal, cementing its status as the market incumbent. The acquisition sent a clear signal about the perceived value and growth potential of IVL technology.

Other major players have made aggressive moves to enter the space. Boston Scientific acquired Bolt Medical for its laser-based IVL system, now branded as Seismiq, which has already received FDA clearance for certain peripheral applications. Meanwhile, Abbott Laboratories is advancing its own IVL system through a major clinical trial, and Philips is developing a combination device that integrates both laser atherectomy and lithotripsy. This competitive landscape makes robust intellectual property protection not just an asset, but a fundamental necessity for survival and growth.

FastWave aims to differentiate itself by engineering what it calls the "next generation" of IVL. The company claims its systems are designed to overcome the limitations of first-generation devices by improving speed, procedural control, and overall usability.

A Dual-Platform Strategy for a Global Market

At the core of FastWave's strategy is its unique dual-platform approach. The Artero™ system uses an electric generator to create sonic waves for treating PAD, while the Sola™ system employs a laser for the delicate and often tortuous anatomy of coronary arteries. This allows the technology to be tailored to the specific demands of different vascular beds. For example, the Sola™ system features a rupture-resistant balloon designed to deliver 360-degree pressure with each pulse, ensuring consistent therapy even in complex lesions.

The decision to secure patents in Australia and Japan is a calculated move reflecting a broader global ambition. The Asia-Pacific region is forecast to be the fastest-growing market for IVL adoption, driven by rising rates of cardiovascular disease and expanding healthcare infrastructure. By establishing an IP foothold in these key markets, FastWave is laying the groundwork for future international expansion and protecting its innovations from competitors on a global scale.

This latest patent news builds on a string of successes for the company, which was founded in 2021. Backed by over $50 million in venture funding, FastWave has garnered significant industry recognition, including being named one of Fierce Medtech's "Fierce 15" in 2024 and MD+DI's Medtech Company of the Year for 2025. Critically, the company has already completed successful 30-patient first-in-human studies for both its peripheral and coronary platforms, providing a strong foundation of clinical evidence.

With its intellectual property fortified and promising early data in hand, all eyes are now on the company's upcoming Investigational Device Exemption (IDE) trials. These large-scale studies are the gateway to FDA approval and will ultimately determine if FastWave’s next-generation technology can successfully challenge the established players and redefine the standard of care for one of medicine's toughest problems.