Funding directly supports first-in-human clinical studies in COVID-19 and other inflammation disorders, with first patient enrolled March 2021
SecondWave Systems, Inc., a pioneer in the emerging field of bio-ultrasonic medicine, has secured $4 million of additional funding from the Department of Defense (DOD), bringing the total non-dilutive investment to $7.4 million. Seed investment from the Defense Advanced Research Projects Agency (DARPA) supported the initial development of the SecondWave MINI™, a first-of-its-kind, wearable therapeutic ultrasound stimulation platform, intended for noninvasive treatment of chronic and acute inflammatory disorders. Follow-on funding from both DARPA and the Defense Health Program (DHP) in conjunction with the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), has enabled SecondWave to accelerate development of the investigational MINI™ system, readying the platform for first-in-human clinical trials to address hyperinflammation in severe cases of COVID-19 and initial production for distribution under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA), application expected in late 2021.
Chronic and acute inflammatory disorders are typically treated with various traditional pharmaceuticals and biologics, which can carry adverse side effects and high-cost. Recent research suggests that bio-ultrasonic medicine – which leverages low-intensity focused ultrasound stimulation – could provide a noninvasive alternative or complement to existing therapies to help address a wide array of inflammation disorders, such as rheumatoid arthritis (RA), sepsis, and COVID-19. However, no commercial product currently exists to bring this technology to patients.
SecondWave is developing a noninvasive, wearable ultrasound stimulation device that will give patients and their physicians a new option for treating debilitating or life-threatening disease. The SecondWave MINI™ system utilizes low-intensity focused ultrasound (LiFU) to stimulate the spleen, with the goal of modulating the immune response and reducing inflammation in the body. Proprietary sensing and imaging capabilities allow for adaptive and personalized therapy in a cost-effective, highly-scalable platform. This provides physicians an alternative to treat diseases typically reliant on costly medications, often with undesirable side effects.
The SecondWave MINI™ is initially being applied in a first-in-human clinical trial to assess utility in suppressing the "cytokine storm" observed in severe cases of COVID-19, which began in March 2021 and is expected to complete enrollment in the summer 2021. Pending positive clinical results, SecondWave expects to pursue EUA to facilitate broad deployment of the MINI™ system to support the current global pandemic. Follow-on development and clinical activities are planned to address chronic inflammation disorders such as RA.
"Investigating the utility of a noninvasive product that could possibly lessen the progression of COVID-19 adds another way to treat the warfighter and maintain readiness of the Joint Force during this pandemic," said Dr. Jason Roos, the Joint Program Executive Officer for Chemical, Biological, Radiological and Nuclear Defense. "The suggestion that this study could eventually identify other applications beyond COVID-19 treatment may also be beneficial for our service members."
"We’re very excited to deploy the SecondWave MINI™ device, which is the first of its class in a new field of bio-ultrasonic medicine," said SecondWave CEO Anuj Bhardwaj. "This product is specifically designed and optimized from the ground up to enable a new anti-inflammatory treatment modality. The effort is a culmination of our work that marries advanced technological and clinical development, made possible by critical support from the Department of Defense."
For more information on SecondWave Systems, visit www.secondwaveUS.com.
About SecondWave Systems, Inc.
SecondWave Systems is a pioneer in the emerging field of bio-ultrasonic medicine. The company is developing a first-of-its-kind noninvasive, wearable ultrasound stimulation platform that will give patients and their physicians a new option for treating debilitating or life-threatening disease. The company’s SecondWave MINI™ device uses proprietary low-intensity focused ultrasound technology to stimulate the spleen with the goal of treating acute and chronic inflammation disorders. This technology is currently being investigated in clinical studies to reduce acute inflammation in COVID-19, and additional studies are being planned to investigate use in chronic inflammatory diseases such as Rheumatoid Arthritis. For more information, visit www.secondwaveUS.com.
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Media: Jason Gray