Heart disease remains the leading cause of death in the U.S., with calcified arterial disease posing one of the most persistent challenges in cardiovascular care. For patients with severe plaque buildup, treatment options are limited, procedures are complex, and outcomes can vary significantly.
Enter FastWave Medical, a physician-backed medtech startup based in Minnesota, making decisive strides in this critical area. With over $40 million in funding, a growing patent portfolio, and two proprietary intravascular lithotripsy (IVL) platforms—one of which has completed first-in-human trials—FastWave is garnering significant attention from clinical leaders and investors focused on scalable, high-impact innovation.
A Dual-Platform Approach to a Complex Problem
FastWave is developing two distinct IVL systems to address calcified lesions in both coronary and peripheral anatomies:
- Sola™ Laser IVL (L-IVL): This platform utilizes laser-generated sonic pressure waves to fracture arterial calcium with enhanced precision and control. A first-in-human (FIH) coronary feasibility study is currently underway.
- Artero™ Electric IVL (E-IVL): Designed for peripheral artery disease (PAD), affecting over 8.5 million Americans. An FIH feasibility study was completed in 2024, and an Investigational Device Exemption (IDE) trial is anticipated to commence in mid-2025.
Both systems feature rupture-resistant balloon catheters and streamlined device profiles, optimized for deliverability and ease of use. Early performance data is promising: recent procedures demonstrated a 94% average reduction in artery blockage, with follow-up outcomes continuing to validate procedural success.
From $215M to Nearly $1B: IVL Market Surges Past Growth Forecasts
The global market for intravascular lithotripsy (IVL) has grown far more rapidly than initially projected. In 2022, analysts estimated the IVL device market would reach approximately $215 million by 2024. But real-world data has far exceeded those forecasts. In 2023, Shockwave Medical—the only U.S. commercial provider of IVL technology—reported global revenues of $730.2 million, a 49% increase from the previous year. The company projected 2024 revenues of between $910 million and $930 million, highlighting the market's accelerating momentum.
This growth is driven by the increasing prevalence of peripheral artery disease (PAD) and coronary artery disease (CAD), aging populations, sedentary lifestyles, and rising incidences of diabetes and obesity. Investors are taking note, particularly in the wake of growing M&A activity across the medtech sector, including Boston Scientific's recent acquisition of IVL startup Bolt Medical for $900 million.
What sets FastWave apart is not just its technology, but its speed of execution. In just four years, the company has secured seven granted patents, with additional applications pending, and is steadily advancing through clinical and regulatory milestones. Its swift, yet disciplined, pace reflects a startup mindset more commonly seen in software, yet grounded in the rigor required for medical device development.
"This milestone reflects the incredible talent of our entire team and our dedication to equipping physicians with cutting-edge tools for their most challenging cases," said Scott Nelson, co-founder and CEO, following the issuance of the company's seventh patent.
Physician-Led Investment, Real-World Relevance
FastWave's funding model is closely aligned with its clinical mission. The company is backed by hundreds of physicians—cardiologists, vascular surgeons, and interventional radiologists—who don't just provide capital, but also shape the product roadmap. This depth of insight has allowed FastWave to refine usability, procedural efficiency, and treatment relevance early in development.
That clinical alignment is resonating with physician investors who see both the impact and the potential of FastWave's approach.
"FastWave is moving quickly and decisively to become best-in-class in the IVL space. We are excited to support the FastWave team, as they continue to take down milestone after milestone in their mission to save lives and offer this groundbreaking technology to all who need it," said Dr. Arthur Lee, Director of Peripheral Vascular Services at TCAVI in Gainesville, FL.
A Leadership Team with Medtech DNA
FastWave is helmed by a team with deep operational and technical experience across the medtech ecosystem, while its Medical Advisory Board includes faculty and physicians from institutions such as Harvard Medical School, UCSF, the University of Washington, Emory Healthcare, and Massachusetts General Hospital. Its ecosystem reinforces its credibility and signals strong adoption pathways.
A Notable Emerging Player, Positioned for Scalable Impact
As FastWave prepares for expanded clinical trials and future commercialization, it's clear the company is building not just a product, but a platform engineered for both technical performance and real-world scalability. In a sector where successful execution can transform care at population levels, FastWave's physician-backed model and accelerated development path offer an appealing thesis for investors.
Its most recent funding round was oversubscribed, with additional investors joining a growing waitlist—a rare signal of confidence in the company's clinical relevance, IP strategy, and leadership execution. FastWave's steady progress points to a medtech company building for long-term impact rather than following short-term trends. For those watching the future of cardiovascular innovation, FastWave is worth a closer look.
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