FastWave Medical

10/30/2025

Big week for FastWave Medical at 🎉

We presented new first-in-human and pre-clinical data for our Sola™ coronary laser intravascular lithotripsy (L-IVL) system — and the results are incredibly encouraging.
Our FIH study was selected as a Featured Innovation, showing:
✅ 100% stent delivery success
✅ 0 in-hospital MACE and no adverse events
✅ Mean diameter stenosis reduced from 57.1% pre-procedure to 8.6% post-procedure

We also shared new pre-clinical findings that helped define our clinical dosing algorithm — reinforcing how we’re translating years of laser physics and engineering into early clinical success.

These results mark an exciting milestone as we move toward a pivotal trial in 2026.

We’re just getting started.

Scroll through the carousel for highlights and read the full release here: https://shorturl.at/hbGiC

10/09/2025

Chicago Tribune just called FastWave “a standout innovator in the IVL space.”

The reason? We’re on a mission to tackle one of the nation’s most serious health threats: Every 34 seconds, heart disease takes an American life.

Arterial calcification is a major contributor.

It builds up over years, often without warning signs, turning flexible blood vessels rock-hard. By the time symptoms become apparent, the disease can be advanced — making treatment more complex and outcomes less predictable.

While angioplasty can be effective for soft plaque, calcified arteries present a different challenge: Balloons can't expand vessels properly, or worse, they cause dangerous ruptures.

For decades, doctors have had limited options, making arterial calcification one of the most difficult cardiac conditions to treat.

Intravascular lithotripsy (IVL) changed that with a breakthrough borrowed from kidney stone treatment: controlled sonic pulses administered through balloon catheters to crack calcium deposits within arteries.

First-generation IVL opened the door, but there's a major opportunity to advance the technology further — especially for patients with tortuous anatomy. That’s what we’re working towards with Sola™, our coronary laser IVL (L-IVL) system, and Artero™, our peripheral electric IVL (E-IVL) system.

Dr. Kate Kearney from UWMC is quoted in the piece calling our L-IVL platform "promising for addressing severely calcified coronary arteries."

Apart from the novel tech, the Tribune highlighted the significant interest in FastWave among physician investors, including interventional cardiologists, vascular surgeons, and interventional radiologists.

“Their involvement signals more than financial interest; it reflects confidence in the system’s potential to address the daily challenges they face in the cath lab,” the Tribune writes.

With aging populations and rising diabetes rates, the need has never been greater.

Content oversight provided by Studio 1847 Heart disease remains the leading cause of death in the U.S., claiming a life every 34 seconds. But beyond heart attacks or other sudden events, a quieter …

10/09/2025

From prototype to pivotal trial → our U.S. IDE study is being guided by some of the field’s best. 🩺🔬🚀👏

We’re proud to announce the leadership and steering committee for the U.S. IDE pivotal trial of Artero™ — FastWave’s next-generation peripheral electric IVL (E-IVL) system.

Dr. Sahil Parikh, Director of Endovascular Services at Columbia University Irving Medical Center, and Dr. Venita Chandra, Clinical Professor of Surgery at Stanford Health Care, will serve as co-principal investigators to evaluate the safety and effectiveness of the Artero™ IVL system in treating peripheral arterial disease (PAD).

They’re joined by steering committee members:

⭐ Dr. Eric A. Secemsky, MD, MSc, RPVI, FACC, FAHA, FSCAI, FSVM of Beth Israel Deaconess Medical Center
⭐ Dr. Marc Bonaca of University of Colorado
⭐ Dr. Dan Clair of Vanderbilt University Medical Center

Together, this group will help shape the trial’s clinical strategy as we work toward FDA clearance for Artero™.

The bigger picture: PAD is a deadly condition that is still under-recognized and undertreated. Our goal is to empower physicians with an advanced IVL system to tackle this challenging disease.
https://www.prnewswire.com/news-releases/fastwave-medical-names-leading-vascular-specialists-as-principal-investigators-for-peripheral-ivl-trial-302569752.html

10/09/2025

Recent estimates suggest global IVL adoption could reach 35% of all percutaneous coronary interventions (PCIs) by 2030. Benzinga just highlighted our pursuit of this trend with this statement about FastWave: “One of the biggest opportunities in vascular intervention with a platform designed to improve outcomes and reduce complexity.”

🎉🎉🎉

The piece covered our dual-platform approach — recent advancements with Artero™, our electric IVL for peripheral artery disease, and early clinical progress with Sola™, our coronary laser-based IVL system.

Our fundraising momentum is also featured: “FastWave hasn’t relied solely on traditional venture capital — it’s drawing direct investment from the physicians who understand the clinical stakes firsthand,” Benzinga writes.

"I believe so strongly in its promise that we made a significant investment, rallying fellow physicians to support the company's groundbreaking work," Dr. Art Lee, interventional cardiologist and founding partner of Epic Venture Partners, says in the article.

We’re incredibly grateful for the continued industry and physician support in our mission to empower interventionalists with next-generation IVL systems to treat arterial calcification.

As cardiovascular disease continues to rise globally, one of the most stubborn obstacles in vascular intervention remains: calcified artery disease. Affecting millions of people suffering with peripheral artery disease (PAD) and coronary artery disease (CAD), arterial calcification is growing more p...

10/09/2025

When colleagues told him leaving his leadership role at a prestigious academic medical center was “professional suicide,” Dr. Miguel Montero-Baker realized it might be the smartest move of his career.

Instead of following the traditional path, he launched an outpatient center of excellence dedicated to patients with chronic limb-threatening ischemia (CLTI).

At HOPE Vascular and Podiatry, podiatry, wound care, vascular intervention, and other treatments come together under one roof.

The result: patient follow-up rates jumped to 90%+ — and physician training programs started asking if they could send their fellows to learn from 𝐡𝐢𝐬 model.

And the clinic is only a slice of what Dr. Montero-Baker is working on:

→ Building HENDOSYN, a clinical research accelerator in Latin America
→ Developing a patient management platform inspired by air traffic control
→ Co-hosting Life of Flow Podcast, a podcast for physician-entrepreneurs worldwide

Plus, Dr. Montero-Baker’s clinic in Houston will serve as a site for the upcoming U.S. IDE pivotal trial of our Artero electric IVL (E-IVL) platform — designed to treat peripheral artery disease.

The throughline: betting against the crowd and staying aligned with his mission.

Check out his interview:

Dr. Miguel Montero-Baker discusses his journey from specializing in what was considered "low-class" vascular surgery to establishing an outpatient "center of excellence" for chronic limb threatening ischemia.

10/09/2025

We’re excited to see FastWave’s Tristan Tieso and Sukanya Iyer featured in MedTech Spectrum discussing recent company milestones and future plans for development! 🎉

One major point of discussion in the article:
*Physician feedback* — which has been instrumental for developing our next-generation intravascular lithotripsy (IVL) systems.

In the interview, Tristan, FastWave’s COO, describes our “problem-first design” development philosophy:

“We started by spending extensive time with interventional cardiologists, vascular surgeons, and interventional radiologists to understand their daily frustrations with existing IVL technology, then engineered backward from those pain points.”

Asking questions from first principles helped identify how engineering limitations of legacy IVL systems can lead to clinical constraints, especially in coronary anatomy.

“The fixed emitter placement in traditional IVL devices leads to stiff balloons that struggle in challenging anatomy, while also producing sonic pressure that is surprisingly variable,” FastWave Head of Technology Sukanya Iyer says in the article.

She goes on to describe technical decisions aimed at enhancing deliverability and crossability within the vessel. Physician feedback also helped with the decision to “pursue fundamentally different technical architectures rather than optimizing existing designs.”

👉 We’re energized by our progress so far — and even more excited about what’s ahead as we bring both our next-gen peripheral and coronary IVL systems into IDE trials.

Fierce 15 Spotlight: How FastWave Medical is Reimagining Calcium Modification