SecondWave Systems is revolutionizing medical treatment with a wearable, non-invasive, low-intensity focused ultrasound device that provides a promising new option for treating chronic diseases such as rheumatoid arthritis (RA) and even complex conditions like Long COVID. With significant government support and a forward-thinking team, SecondWave aims to reduce dependency on drugs and expand the boundaries of modern medicine.
Origins Rooted in Technology and Collaboration
SecondWave was founded by Anuj Bhardwaj, Jeff Heyman and Hubert Lim. The concept behind their company emerged from Bhardwaj’s leadership at The Ultran Group, a company his parents founded in 1977. Originally, Ultran focused on ultrasonic equipment for non-destructive testing in industries such as aerospace and lithium-ion batteries. Over time, Bhardwaj saw the potential of this technology beyond industrial applications, specifically in medicine. His work with researchers and medical companies, including a collaboration with Medtronic in the Minneapolis-St. Paul, laid the foundation for what would become SecondWave Systems.
In 2018, Bhardwaj and his team at the Ultran Group began exploring the therapeutic potential of low-intensity focused ultrasound to stimulate physiological responses. A key focus of their research was ultrasound’s ability to reduce inflammation by targeting the spleen, potentially treating chronic inflammatory diseases such as RA. In this effort, they partnered with Dr. Lim at the University of Minnesota, who was pioneering research in this space. This initiative received backing from the Defense Advanced Research Project Agency (DARPA), a Department of Defense Agency, resulting in several rounds of Small Business Innovation Research (SBIR) funding. This funding breakthrough marked the start of the company’s journey into healthcare.
By 2019, Bhardwaj formally launched SecondWave Systems with co-founders Jeff Heyman and Hubert Lim, capitalizing on their combined expertise and vision. Early success in small-scale clinical studies spurred further government funding from the National Institutes of Health (NIH), Advanced Research Projects Agency for Health (ARPA-H), and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), totaling over $15 million to date.
A Breakthrough in Non-Invasive Therapy
At the heart of SecondWave’s platform is a wearable ultrasound device that allows precise, low-intensity focused ultrasound energy to target specific organs. Research has shown that delivering ultrasound to the spleen can reduce disease activity in immune-mediated inflammatory conditions, such as RA.
For patients with RA, this approach offers a new treatment path. Traditional therapies for RA, such as biologics and corticosteroids, often come with high costs and side effects, and many patients show intolerance or incomplete response. “One-third of RA patients don’t respond to the standard biologic treatments, and even among those who do, many show only partial response,” Bhardwaj explained. SecondWave’s non-invasive device aims to complement these existing therapies, potentially improving patient quality of life.
The company has also tested the platform for other conditions, including Long COVID, where chronic inflammation plays a role. Positive preliminary results suggest that the technology could alleviate fatigue and improve physical endurance in Long COVID patients. Bhardwaj emphasized the need for further research but stated that the initial results are encouraging.
Rapid Progress Through Government Collaboration
SecondWave’s strategic partnerships with government agencies have been instrumental in advancing its technology. Working with the University of Minnesota and other key partners, the company has developed multiple generations of its wearable ultrasound device. One of their significant breakthroughs was achieving a “non-significant risk” designation from the FDA in early 2021, allowing the team to move quickly into human trials of its non-invasive treatment modality. With more than 100 patients treated across various studies, SecondWave is now focused on optimizing its device to enable self-administration at home.
Market Potential
RA affects 1.5 million people in the U.S., with treatment costs exceeding $20 billion annually. Bhardwaj believes that SecondWave’s technology could fill a critical gap in the market, helping patients who don’t fully respond to existing treatments. “If our device can help patients manage their symptoms with fewer side effects, it’s a win for both patients, providers, and payors,” he explained.
The company is also working toward its next milestone: a home-use version of the device. This new iteration will include on-board intelligence, making it easy for patients to administer treatment themselves. A clinical study testing this next-generation device is slated to begin in Q2 of next year.
Looking Ahead: Building Momentum Through Innovation
As SecondWave continues to grow, the company has joined Johnson & Johnson’s JLABS incubator and is actively raising Series A funding to support additional clinical trials. The company joined Fogarty Innovation’s Company Accelerator Program (CAP)t earlier this year. “SecondWave can benefit from the breadth of experience within the Fogarty team and is excited to join its network of companies,” said Bhardwaj. He credits much of SecondWave’s success to its strong team and collaborative culture, with co-founder Heyman bringing extensive medical device expertise and Lim contributing deep scientific knowledge and neuromodulation expertise. “Having a strong interdisciplinary team has been crucial,” Bhardwaj said. “I think that’s what has made us so successful over these last few years.”
With a mission to pioneer a new therapeutic modality to improve lives of patients with chronic disease, SecondWave is poised to make a lasting impact in the healthcare industry.