SecondWave Systems

Industry
Medical Devices
Founded Year
2019
Headquarters
Minneapolis, Minnesota, USA
Employee Count
10

Key People

Assessment

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

Anuj Bhardwaj, the CEO and Founder, has a background in transitioning new technologies into high-impact applications. Jeff Heyman, the Chief Business Officer, brings extensive experience in the medical device industry. Their combined expertise provides a solid foundation for the company's strategic direction and operational execution.

Clinical Need
Aspect: Very Strong
Summary: The company's technology addresses significant unmet needs in treating inflammatory diseases.

SecondWave Systems is developing a noninvasive, wearable ultrasound stimulation platform targeting immune-mediated inflammatory conditions such as rheumatoid arthritis and potentially Long COVID. This technology offers an alternative to traditional treatments that often rely on costly medications with undesirable side effects, addressing a significant unmet clinical need.

Competition
Aspect: First mover
Summary: The company is pioneering in the field of bio-ultrasonic medicine with limited direct competition.

SecondWave Systems is among the first to develop a noninvasive, wearable ultrasound stimulation platform for treating inflammatory diseases. This pioneering position allows the company to establish itself as a leader in this emerging field, with limited direct competition currently present.

Technical Challenge
Aspect: Moderate
Summary: The development of the ultrasound stimulation platform involves moderate technical challenges.

The creation of a noninvasive, wearable ultrasound device that effectively modulates nerves, cells, and organs presents moderate technical challenges. These include ensuring precise targeting, consistent efficacy, and user safety. However, the company's progress, including securing FDA 'non-significant risk' designation and initiating human trials, indicates a manageable level of technical risk.

Patent
Aspect: Strong
Summary: The company has secured strong patent protection for its technology.

SecondWave Systems has developed proprietary technology in the field of bio-ultrasonic medicine. Strong patent protection safeguards the company's innovations, providing a competitive edge and potential barriers to entry for competitors.

Financing
Aspect: Well-funded
Summary: The company has secured substantial funding from reputable investors and government agencies.

SecondWave Systems has raised over $15 million in funding from entities such as the National Institutes of Health (NIH), the Defense Advanced Research Projects Agency (DARPA), and the Advanced Research Projects Agency for Health (ARPA-H). Additionally, the company closed a $7 million Series A funding round in April 2025, led by Treo Ventures. This financial backing enables the company to advance its technology through development and clinical validation stages.

Regulatory
Aspect: Running FIH
Summary: The company is conducting first-in-human trials for its ultrasound stimulation platform.

SecondWave Systems received a 'non-significant risk' designation from the FDA in early 2021, allowing the initiation of human trials. A successful first-in-human pilot study demonstrated a significant reduction in rheumatoid arthritis disease activity. These steps are crucial in the regulatory pathway, but further trials and approvals are necessary before commercialization.

Opportunity Rollup

Odds of Success
3.95
Peak Market Share
5.85
Segment CAGR
4.9%
Market Segment
Neurology Devices
Market Sub Segment
Neuromodulation Devices
Year Post Launch Market Penetration (%)
1 0.29
2 0.88
3 2.05
4 4.10
5 5.85

Key Takeaway

SecondWave Systems is well-positioned in the emerging field of bio-ultrasonic medicine, offering a noninvasive treatment option for inflammatory diseases, supported by strong leadership and substantial funding.