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

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.

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