FastWave Medical: A promising intravascular lithotripsy (IVL) startup in an $8.5 billion cardiovascular market

In cardiovascular healthcare, innovation can mean the difference between life and death. FastWave Medical is at the forefront of this innovation, designing and developing novel intravascular lithotripsy (IVL) systems led by a fast-moving team dedicated to pioneering solutions for calcific artery disease. With a market valued at over $8 billion, the opportunities for growth and impact are immense.

FastWave has made significant progress in 2024, including the completion of enrollment in its first-in-human (FIH) study in mid-January, a significant milestone that garnered attention from numerous cardiovascular publications. Building on this early success, FastWave welcomed some of the world’s most prominent physicians to its advisor board in late January.

Investors can expect the release of the 30-day follow-up data from the FastWave peripheral first-in-human (FIH) study and the granting of three more patents by the U.S. Patent and Trademark Office (USPTO) in the coming months, raising the company’s total patent count to five. These developments are a testament to FastWave’s operational speed and reinforce the company’s favorable position for long-term success.

IVL: A new category in a growing market

Data from several large-scale registries reveal an increase in complex calcific disease, with a concerning prevalence of problematic coronary calcium levels in over 30% of patients. The association of coronary artery calcium, with major risk factors such as advancing age, diabetes, renal failure and hypertension, underscores the need for comprehensive evaluation and innovative management strategies in cardiovascular care.

IVL represents a relatively new category in cardiovascular intervention that has shown immense potential. Unlike traditional modalities such as stents and balloons alone, IVL uses ultrasonic shock waves to disrupt calcified blockages within blood vessels safely and effectively.

FastWave 2
FastWave Medical Headquarters

Why invest in FastWave?

FastWave’s IVL systems elevate existing IVL technology, offering improved balloon catheter platforms with enhanced energy delivery capabilities.

FastWave has prioritized agility and speed to achieve its milestones, setting it apart from the conventional pace of many MedTech enterprises. In a remarkably short time, the young company has achieved significant milestones — from raising a $12 million Series A within six months of its inception to the successful completion of its FIH study. Moreover, by targeting the limitations of existing IVL systems, FastWave is strategically positioned to capture a substantial share of this rapidly expanding market.

For investors considering prospects in the growing cardiovascular intervention sector, FastWave represents an exceptional opportunity. With the increasing prevalence of coronary and peripheral artery diseases and the growing adoption of IVL, the demand for effective treatments is greater than ever. FastWave is a particularly attractive acquisition target to multinational corporations looking to enhance their portfolios with cutting-edge IVL technology.

FastWave stands out as an investment with immense potential for impact — financially and in the fight against calcific artery disease — led by a seasoned startup leadership team with a history of success. Scott Nelson, founder and CEO of FastWave, points to the only market incumbent — Shockwave Medical — as an example of the company’s potential. Since its 2019 IPO, Shockwave Medical has unlocked an $8B+ market with only 6% penetration and achieved a trailing five-year CAGR of over 200% despite its product’s limitations.

“At FastWave, we are solving for the clear gaps with existing IVL offerings to empower physicians with an expanded suite of treatment options,” says Nelson, “and currently, we are unique in the IVL space as the only startup concurrently developing multiple IVL energy systems.”

Dr. Arthur Lee, an interventional cardiologist at The Cardiac and Vascular Institute in Gainesville, FL, said, “It’s remarkable how quickly IVL has become a staple in the arsenal for managing calcific disease in both coronary arteries and lower extremities. FastWave’s advancements with their differentiated, next-generation IVL devices reflect impressive progress and the potential to significantly improve patient outcomes.”

As FastWave continues to innovate and push the boundaries of IVL technology, investors can be confident about the company’s trajectory for success. FastWave Medical is more than a sound financial opportunity; it’s a chance to drive meaningful change in cardiovascular care.

VentureBeat newsroom and editorial staff were not involved in the creation of this content. 

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