FastWave Medical pioneers next-generation intravascular lithotripsy (IVL) technology to transform the treatment of calcific artery disease in peripheral and coronary applications. Pulse 2.0 interviewed FastWave Medical co-founder and CEO Scott Nelson to gain a deeper understanding of the company.
Scott Nelson’s Background
Could you tell me more about your background? Nelson shared bullet points of each role:
Co-founder & CEO, FastWave Medical
— Leading a growing cross-functional team in the development of next-generation intravascular lithotripsy (IVL) systems for calcified cardiovascular disease.
— Raised $50+ million to date from corporate venture, VC, physician KOLs, and industry stakeholders
Founder, Medsider
— Launched in 2010 as a podcast-first media site to highlight key learnings from medtech founders and CEOs
— 215+ interviews published
— Consistently ranked as a top medical device podcast; one of the top 2% most popular shows out of 3.6M+ podcasts globally, ranked by Listen Score
Co-founder, Joovv
— Developed the first medical-grade, full-body red light (photobiomodulation) therapy system for in-home use
— Grew Joovv from $0 to $20+ million in profitable annual revenue in 3 years entirely online without a sales team; Fully bootstrapped and has generated nearly $100 million in topline revenue since inception
— Joovv devices are widely used by pro athletes, Olympians, and popular health & wellness influencers
Previous Roles
Leadership positions at Medtronic, Covidien, Boston Scientific, C.R. Bard, and Touch Surgery (acquired by Medtronic)
Education
B.S. in Biology, Grand View University
Formation Of The Company
How did the idea for the company come together? Nelson shared:
“When we first started working on FastWave, there was (and still is) only one incumbent in the space (Shockwave Medical). They pioneered the IVL category, but as with any first-generation technology, some physician needs remained unmet — creating opportunities for continued innovation. In addition, three of Shockwave’s foundational patents were invalidated through an IPR (Inter Partes Review) process.”
“Because of these primary drivers, we decided to pursue IVL with more rigor and proceeded to cultivate a group of key opinion leaders (KOLs) who believed in our team, many of whom also invested in FastWave Medical.”
“We then embarked on the development of two differentiated IVL platforms, one of which is focused on peripheral artery disease (PAD) while the other system is specific to coronary artery disease (CAD).”
“Of note, Shockwave was acquired by Johnson & Johnson in 2024 for $13 billion, a landmark deal solidifying IVL as one of the hottest categories in the cardiovascular space.”
Core Products
What are the company’s core products and features? Nelson explained:
Artero: Next-generation electric IVL (E-IVL) system for the treatment of peripheral arterial disease (PAD).
— Artero streamlines the IVL experience with an intuitive, one-click design that delivers durable, consistent therapy at twice the speed of today’s technology.
— Seamless Usability: One-click activation, real-time feedback, hands-free operation, allowing physicians to focus on patients rather than equipment.
— Advanced Crossing Capabilities: A reduced crossing profile and optimized shaft for better deliverability, along with a rupture-resistant balloon that ensures consistent results even in complex vessels.
— Efficient and Predictable Therapy: The novel emitter design delivers sonic pressure at 4 Hz, twice the speed of current IVL technologies, providing more pulses per catheter for predictable, consistent outcomes.
— Sola: Next-generation coronary laser IVL (L-IVL) system for the treatment of coronary artery disease.
— The breakthrough, single-emitter design of Sola allows interventionalists to reach the most challenging coronary lesions and deliver more energy at faster rates with 360° pulse-to-pulse coverage. The rupture-resistant balloon catheter is designed to help physicians treat hardened calcium in blood vessels with precision and control.
— Unparalleled Deliverability: The novel single-emitter design enables exceptional crossability, even for the toughest coronary lesions.
— Untethered Energy: Sola delivers significantly more therapeutic pulses at faster rates, ideal for challenging coronary procedures.
— 360° Energy Output: Every energy pulse delivers circumferential sonic pressure to lesions, ensuring predictable and multi-directional performance for superior patient outcomes.
Challenges Faced
Have you faced any challenges in your sector of work recently? Nelson acknowledged:
“There isn’t a day that goes by where you’re not addressing a challenge within a startup company, especially in the medtech space. I often equate it to playing the startup game on hard mode. That said, two of the more significant challenges we’ve overcome are as follows:
— We’re developing two sophisticated IVL systems in parallel, which isn’t for the faint of heart. But our team is both exceptional and determined. Key learning: the people in your startup will make or break the company.
— Fundraising in medtech is never easy, but we’ve successfully raised capital from a diverse range of investors, including corporate venture, VC, and individual KOLs. We’re currently undergoing Committee on Foreign Investment in the United States (CFIUS) review due to early financing from Grand Pharmaceutical, a China-based investor involved in our Series A round. What began as a seemingly routine partnership has since evolved into a significant obstacle, requiring the U.S. government review to safeguard the company’s ability to raise capital and grow. Key learning: Don’t settle for mediocre investors and always be on the offensive when raising capital.”
Significant Milestones
What have been some of the company’s most significant milestones? Nelson cited:
1.) Completed FIH (first-in-human) peripheral feasibility study with the Artero system in Q1 2024:
a.) Treated 9 limbs and 16 fem-pop lesions that included 99% moderate/severe calcification
b.) Catheters crossed the lesions 100% of time, including 3 CTOs (chronic total occlusions)
c.) 5.9% mean residual stenosis
d.) 0% major adverse events
e.) No balloon ruptures
2.) Announcement of principal investigators and steering committee for the upcoming U.S. IDE pivotal trial of Artero.
2.) Successfully completed initial FIH procedures in the coronary feasibility study of Sola in June 2025.
3.) Raised $12 million Series A (Q3 2021) + $38 million follow-on (2023–2024) from VCs, physician KOLs, and industry stakeholders.
4.) Granted 8 utility patents from the USPTO.
5.) Selected for Fierce Medtech’s 2024 “Fierce 15,” an annual list that recognizes the most promising private medtech companies; and FastWave’s Sola made it into the Top 32 of the Minnesota Chamber of Commerce’s “Coolest Thing Made in Minnesota” contest.
Total Addressable Market
What total addressable market (TAM) size is the company pursuing? Nelson assessed:
“U.S. Market: In the U.S., the IVL market is valued between $500 million to $1 billion annually, with growth rates exceeding 20% per year. These estimates are conservative considering recent IVL transactions, such as J&J’s $13.1 billion acquisition of Shockwave Medical and Boston Scientific’s $900 million deal for Bolt Medical (a pre-commercial IVL startup).”
“Global Market: FastWave is also pursuing the $2.2 billion global IVL market in 2024, split between $1.3 billion for coronary interventions and $0.9 billion for peripheral interventions. With annual growth rates projected at 14-20% globally, there is significant room for FastWave to capture share, especially considering it’s estimated that over 25% of the market will remain available through 2029.”
Differentiation From The Competition
What differentiates the company from its competition? Nelson affirmed:
“Artero stands out with its seamless usability, featuring one-click activation and no cumbersome connector cables, real-time feedback, and hands-free operation. This user-friendly design enhances the overall speed and efficiency of IVL procedures. In addition, its novel emitter design delivers circumferential sonic pressure at 4 Hz, twice the speed of current IVL technologies, providing more pulses per catheter for predictable, consistent outcomes.”
“Sola is engineered for unmatched deliverability and almost limitless therapeutic energy, thanks to its breakthrough single-emitter design. It delivers true 360° pulse-to-pulse energy output, providing durable sonic pressure that enhances plaque modification — even in the most challenging coronary lesions. This level of precision and performance sets Sola apart in the IVL space.”
Future Goals
What are some of the company’s future goals? Nelson concluded:
— Q4 2025: Begin peripheral IDE pivotal trial for Artero.
— Q4 2025: Completion of the Sola coronary FIH feasibility study.
— Mid-2026: IDE approval to commence the Sola coronary pivotal trial.
— Q3 2026: FDA 510(k) clearance for the Artero system.
