When FastWave Medical opened a limited investment round in mid-2024, they expected interest. What they didn’t expect was to close $19 million in less than a month, have an oversubscribed raise, and generate a waitlist almost immediately.
That kind of momentum is rare in healthcare, especially before commercial launch. But FastWave’s trajectory is anything but typical.
With a successful first-in-human study, a seasoned founding team, and a pipeline of patented intravascular lithotripsy (IVL) technologies aimed at one of the most under-addressed needs in vascular care, FastWave Medical is quickly becoming one of the most closely-watched emerging players in medtech.
Targeting a $10B+ Market with a Single Incumbent
FastWave’s entry point is bold and smart. The company is building next-generation solutions in intravascular lithotripsy (IVL), a minimally invasive therapy that uses sonic pressure waves to treat calcified cardiovascular disease, which remains one of the most stubborn challenges in vascular intervention.
In many people, especially those with heart disease, kidney conditions, or diabetes, arteries can become so calcified that they block blood flow to the heart or legs. These are the kinds of blockages that can lead to heart attacks, amputations, or strokes. IVL is a safer, more precise way to clear those blockages without relying on aggressive, high-risk tools.
“Calcified arteries remain one of the most difficult conditions to treat in our field,” says Dr. Amir Kaki. “FastWave’s IVL platform is a compelling advancement that should provide a more precise, efficient, and predictable way to manage complex arterial disease.”
It’s no surprise that IVL is already gaining rapid clinical adoption. What comes as a shock is that the market is wide open with only one commercial incumbent, acquired by Johnson & Johnson in 2023 for $13 billion.
FastWave is building IVL tools that are not just easier for doctors to use but also work in tortuous blood vessels of the body that current IVL devices struggle to reach. Their goal is to make these treatments faster, simpler, and more effective so more patients can get help without needing risky surgeries.
Clinical Proof, Not Just Promises
In January 2024, FastWave completed its first-in-human study in Mexico with 100% success across 9 limbs and 8 patients, including three challenging chronic total occlusions (CTOs), which are completely blocked.
- Success rate: 100%
- Mean residual stenosis: Just 5.9% post-treatment
- Complications: 0% adverse events, 0 balloon ruptures
The results exceeded expectations and validated FastWave’s technology in real-world cases. “We saw an almost complete resolution of blockages,” said one of the investigators, Dr. Miguel Montero-Baker, vascular surgeon and CEO of Hope Vascular and Podiatry in Houston, TX. Other physician investigators included Drs. Venkatesh Ramaiah and Antonio Muñoa.
In summary, every blocked artery in the study was successfully opened with no side effects, zero burst balloons, and no complications. For patients, this means better blood flow with less risk. For doctors, FastWave’s IVL technology is a safer tool that works well even in challenging procedures. For the healthcare system, it’s a sign that FastWave’s systems could help more patients get back on their feet faster with fewer surgeries and fewer setbacks.
Patent-Protected Technology, Built by Proven Operators
FastWave isn’t just building a better device. FastWave owns the blueprint for its technology, making it much harder for competitors to copy and much more valuable to future partners or acquirers.
- 7 patents already granted by the U.S. Patent and Trademark Office
- Freedom-to-operate (FTO) clearances, confirming they’re not infringing on others’ IP
- A proprietary system that includes custom energy delivery and a unique catheter design
The team behind the company is equally compelling. Co-founders Scott Nelson, Brady Hatcher, and JC Sun are seasoned medtech entrepreneurs with multiple exits under their belt and decades of combined experience at companies like Medtronic, Joovv, and Switchback Medical. In addition, FastWave’s proven cross-functional leadership team includes Tristan Tieso, Sukanya Iyer, Anindita Sengupta, and Trent Mengal, with previous experiences at Boston Scientific, Abbott, and Edwards Lifesciences.
They’re joined by a world-class advisory board, featuring leading cardiology and vascular surgery experts from Mass General, UCSF, UW, and other top institutions.
A Business Built for Momentum
To date, FastWave has raised more than $40 million from corporate venture capital, institutional VCs, and high-profile cardiovascular key opinion leaders (KOLs). Perhaps the clearest validation of FastWave’s potential is the number of physicians backing the company as investors.
“We are beyond thrilled to partner with physician-led investors like Epic and M&L Healthcare who see the clinical promise and commercial viability of our IVL systems,” says Scott Nelson, Co-founder and CEO of FastWave Medical.
The next phase for FastWave includes more clinical studies, regulatory approvals, and a commercial launch in 2026. And if the last raise is any indication, investors are eager to get on board.
If you’re looking for a high-upside opportunity in medtech, one with clinical proof, commercial potential, and serious market interest, FastWave Medical is a name to watch.
