Building on a Breakout Year, a Medtech Startup Targets Calcified Arteries

As 2026 begins, intravascular lithotripsy — or IVL — stands out as one of the most closely watched technologies in cardiovascular intervention. Designed to break up hardened calcium inside arteries, IVL allows physicians to open vessels that are otherwise difficult or risky to treat.

The IVL market itself is shifting quickly with growing strategic interest and consolidation. The space drew heightened attention after two landmark acquisitions: Johnson & Johnson’s $13.1 billion purchase of Shockwave Medical in 2024, and Boston Scientific’s early-2025 acquisition of Bolt Medical — a pre-commercial IVL startup — for $900 million. Those deals underscored both the strategic value of IVL and the growing race to develop next-generation systems.

Against that backdrop, FastWave Medical used 2025 to make uncommon progress for an early-stage company, advancing not one but two differentiated IVL platforms — a rare pace in a field where progress often spans years. The company enters 2026 with early clinical data in hand, esteemed physician collaborators, and multiple studies underway. For an emerging medtech startup, it represents a notable year of momentum at a time when the broader industry continues to navigate regulatory complexity, supply-chain constraints, and unexpected hurdles from the recent government shutdown.

Turning Clinical Challenges Into Design Priorities

FastWave has focused on three things in developing its IVL platforms: strong technical performance, best-in-class safety profile, and easy-to-use workflows for operators. That approach underpins the company’s two systems — Sola, its laser-based coronary IVL platform, and Artero, its electrically powered IVL system for peripheral artery disease.

Sola is being evaluated in a 30-patient, multi-center feasibility study designed to assess safety and the ability to prepare calcified coronary vessels for stenting. According to the company, among the first nine patients treated, physicians successfully delivered stents in every case, with no in-hospital complications reported. The system’s single-emitter setup is intended to deliver energy evenly around the vessel — a feature clinicians say could help improve predictability in challenging coronary cases.

“This past year marked real momentum for Sola as it moved from concept into early clinical use,” said Dr. Arthur Lee, Director of Vascular Services at TCAVI and consultant to FastWave Medical. “The feasibility study results suggest the technology can deliver controlled, consistent, and efficient energy across challenging lesions, which is exactly what we hope to see before expanding into broader trials.”

Artero, FastWave’s peripheral platform, reached a new stage of maturity in 2025 with the selection of principal investigators for its upcoming pivotal trial, which will assess Artero’s safety and effectiveness in treating peripheral artery disease. The pivotal trial will serve as the primary evidence base for FastWave’s eventual FDA submission, signaling Artero’s transition into large-scale commercialization.

A Year of Milestones: How FastWave Gained Traction in 2025

Beyond individual platform milestones, 2025 marked an inflection point for FastWave in which the company gained traction across scientific, regulatory, and industry circles. The company shared interim data from its ongoing 30-patient Sola™ feasibility study at Transcatheter Cardiovascular Therapeutics (TCT) 2025, the world’s leading symposium in interventional cardiovascular medicine, organized by the Cardiovascular Research Foundation. The presentation drew wider notice when MassDevice — a leading news outlet covering medical device innovation — included FastWave’s first-in-human findings among its “Top Cardiovascular Tech Stories Out of TCT 2025.” FastWave completed enrollment in the study later in the year, with data now under independent core lab review.

Artero, FastWave’s peripheral IVL platform, advanced in parallel. With principal investigators appointed and its pivotal study framework in place, the system is now positioned to generate the evidence needed to move toward FDA submission — a notable step for a young company developing two separate IVL platforms simultaneously.

FastWave’s external recognition grew throughout the year as well. The company was named to Fierce Medtech’s 2024 “Fierce 15,” an annual list spotlighting the most promising private medtech companies. It was later selected as MD+DI’s 2025 Medtech Company of the Year — first advancing to the final 10 through the publication’s editorial review, then earning the top spot after securing 64% of the reader vote.

On the intellectual property front, FastWave secured patents to strengthen protection around both system architecture and next-generation energy-delivery methods.

These developments unfolded during a period marked by broader medtech slowdowns — from regulatory backlogs to lingering effects of the fall government shutdown — as well as a fundraising environment that can be challenging for early-stage medtech companies. Despite that, FastWave has continued attracting strong support from both venture firms and influential individual investors, enabling both IVL platforms to progress in parallel.

Co-Creating Technology with the Physicians Who Use It

FastWave’s development philosophy has been rooted in a simple premise: the people who use IVL every day should shape how next-generation systems are built. From its earliest prototypes, the company invited interventional cardiologists, vascular surgeons, and interventional radiologists into the engineering process — not just to test devices, but to define what problems needed solving.

That operator-first approach is what the team refers to as problem-first design. “We started by spending extensive time with clinicians to understand their daily frustrations with existing IVL technology, then engineered backward from those pain points,” said Tristan Tieso, FastWave’s Chief Operating Officer. One of the clearest themes that emerged was workflow friction: physicians described the inconvenience of reusable dongles, delays caused by generator charging, and the cognitive load of multi-step activation sequences. “That direct input led us to prioritize a plug-and-play, AC-powered unit with one-click therapy activation — no charging, no dongles, no having to hold down a button,” Tieso said.

Physicians also highlighted performance gaps that aren’t obvious in spec sheets — particularly inconsistent energy delivery in highly calcified or irregular anatomy and the stiffness caused by fixed-emitter designs. Those challenges helped shape the engineering direction for Sola™, pushing the team to rethink the underlying physics of how sonic pressure waves are generated and delivered. The result was a system built around a laser-based acoustic source and a translating optical emitter, an approach aimed at improving deliverability and consistency in challenging coronary lesions.

Clinicians say the rapid pace of innovation in IVL reflects a growing recognition of calcium as a fundamental barrier across cardiovascular care. “IVL has become one of my frontline tools for treating peripheral artery disease — it's one of the most exciting breakthroughs we’ve seen in years,” said Dr. Constantino Peña, diagnostic and interventional radiologist at Baptist Health South Florida. “Watching companies like FastWave push the envelope and bring fresh ideas to IVL technology makes this an incredible time to be in the field. The pace of innovation is truly inspiring, and it’s patients who stand to benefit most.”

Clinician-driven insights helped shape FastWave’s distinct path: developing technologies that not only perform well in controlled settings but also directly address the daily challenges operators face during procedures.

What to Watch This Year

With the foundation laid in 2025, FastWave enters 2026 with a focus on larger, more definitive studies and regulatory preparation. The year ahead will include the initiation of Artero’s pivotal trial,  full analysis of the Sola™ feasibility study, continued progress toward an IDE submission for Sola’s pivotal trial, and early groundwork for a potential 510(k) clearance for Artero™ by late 2026.

According to the company, it has raised more than $50 million to date from corporate strategics, venture capital firms, practicing physicians, and industry leaders — support that positions it to carry both IVL platforms through their next major milestones.

“Advancing two IVL systems in parallel isn’t easy, but the progress we made in 2025 reflects our team’s ability to execute,” said Scott Nelson, co-founder and CEO of FastWave Medical. “We’re looking forward to the next phase for the company, where larger studies will demonstrate the full potential of these technologies.”

With clinical momentum accelerating and expanding external recognition, the company begins 2026 with a clearer path toward scaling its platforms and generating the evidence required for broader adoption. As these IVL programs advance, FastWave moves closer to its core goal: giving physicians better tools to treat calcific artery disease and improving the options available to patients facing some of the most challenging forms of cardiovascular disease.

This article is for informational purposes only and does not substitute for professional medical advice. If you are seeking medical advice, diagnosis, or treatment, please consult a medical professional or healthcare provider.