FastWave Medical

Industry
Medical Device
Founded Year
2021
Headquarters
Minneapolis, Minnesota, USA
Employee Count
50

Key People

Assessment

Team
Aspect: First-time 10+ yrs
Summary: The leadership team comprises first-time entrepreneurs with over a decade of experience in the medical device industry.

The leadership's background suggests a strong understanding of the market and regulatory landscape, which is crucial for the success of a clinical-stage company.

Clinical Need
Aspect: Very Strong
Summary: Intravascular lithotripsy addresses a significant unmet need in treating calcified artery disease, offering a minimally invasive alternative to traditional methods.

With cardiovascular diseases being a leading cause of mortality globally, innovative treatments like IVL that enhance safety and efficacy are highly valuable.

Competition
Aspect: Very crowded + Strategics
Summary: The IVL market is highly competitive, with established players like Shockwave Medical and recent entries by major companies such as Boston Scientific and Abbott.

Competing against companies with extensive resources and existing customer bases requires a compelling value proposition and strategic differentiation.

Technical Challenge
Aspect: Moderate
Summary: Developing IVL systems involves moderate technical challenges, including ensuring device efficacy and safety in diverse anatomical conditions.

Addressing these technical challenges is essential for gaining regulatory approval and clinician adoption.

Patent
Aspect: Strong
Summary: FastWave Medical has secured multiple U.S. patents for its IVL technology, indicating a strong intellectual property position.

Patents are critical in the medical device industry to safeguard innovations and attract investment.

Financing
Aspect: Well-funded
Summary: The company has raised over $40 million, including a $19 million round led by Epic Venture Partners in December 2024.

Adequate financing is crucial for advancing through regulatory pathways and scaling operations.

Regulatory
Aspect: Running FIH
Summary: FastWave Medical is currently conducting first-in-human (FIH) trials for its IVL system.

Successful FIH trials are pivotal for demonstrating safety and efficacy, leading to subsequent regulatory approvals.

Opportunity Rollup

Odds of Success
3.8
Peak Market Share
5.2
Segment CAGR
9.3%
Market Segment
Cardiovascular Devices
Market Sub Segment
Intravascular Lithotripsy
Year Post Launch Market Penetration (%)
1 0.26
2 0.78
3 1.82
4 3.64
5 5.20

Key Takeaway

FastWave Medical's innovative IVL technology addresses a significant clinical need, but success will depend on navigating a competitive landscape and achieving regulatory milestones.