SecondWave Systems Announces Professor Paul Peter Tak as New Advisory Board Member and Secures $3M Additional Financing to Accelerate Development of Novel Ultrasound-Based Anti-Inflammatory Therapy

SecondWave Systems, Inc., a pioneer in the emerging field of bio-ultrasonic medicine, welcomes Professor Paul Peter Tak as the inaugural member of its newly established advisory board. In addition to bringing decades of experience as an academic physician-scientist, large pharma and biotechnology business leader, and entrepreneur, Dr. Tak's prior pioneering preclinical and translational research at the Amsterdam University Medical Center was pivotal in elucidating the role of bioelectronic medicine as a therapeutic approach for autoimmune diseases. With highly relevant expertise as an internist, rheumatologist, and immunologist by training, Dr. Tak is an ideal complement to the SecondWave team to help accelerate development and commercialization of a new ultrasound-based therapeutic modality to treat rheumatoid arthritis (RA) and other immune-mediated inflammatory conditions.

SecondWave continues development of its focused ultrasound technology platform with support from U.S. government partners, and today announces that it has secured $3 million of additional funding from the Advanced Research Projects Agency for Health (ARPA-H), in partnership with the Defense Advanced Research Projects Agency (DARPA), bringing the total non-dilutive funding from U.S. government agencies to $15.3 million. Seed investment from DARPA supported the initial development of the SecondWave MINItm, a first-of-its-kind, wearable therapeutic ultrasound stimulation platform, intended for noninvasive and personalized treatment of chronic and acute inflammatory disorders. This prior investment resulted in a human-grade wearable medical device that was recently investigated in a first-in-human clinical study in RA patients (NCT05417854), with positive efficacy outcomes. This new funding enables further advancement of the MINI technology platform for implementation in a pivotal clinical trial for at-home treatment of RA.

"Despite advances in treatment, there is still a significant unmet need for better treatments for chronic inflammatory diseases, like RA", said Dr. Tak. "One area of unmet need is for therapies that specifically target the cholinergic anti-inflammatory pathway, a natural mechanism in the body that helps control inflammation. It is activated by the neurotransmitter acetylcholine, which is released within the spleen. SecondWave's MINItm system could potentially provide a noninvasive tool to control inflammation by activation of this and other anti-inflammatory pathways through the spleen."

"As we work to commercialize the SecondWave MINI as a new class of therapy for inflammatory disease, we are very excited to enter the next phase of development with continued support from our government partners at DARPA and ARPA-H, and with complementary expertise from Dr. Tak as an advisory board member," said SecondWave CEO Anuj Bhardwaj. "We continue to pursue comprehensive and rigorous scientific data to support the efficacy and broad capabilities of our novel therapeutic modality; so, it is critical to team up with highly knowledgeable and respected scientists, clinicians, and federal agencies to successfully achieve our company's mission to establish bio-ultrasonic medicine as a new standard of care for treating disease."

For more information on SecondWave Systems, visit www.secondwaveUS.com.

About Paul Peter Tak, MD, PhD, FMedSci

Paul Peter Tak received his medical degree cum laude from the Amsterdam University Medical Center (AUMC) and was trained as an internist, rheumatologist, and immunologist at Leiden University Medical Center, where he also received his PhD. He worked as a scientist at the University of California San Diego and next served as Professor of Medicine and Chair of the Department of Clinical Immunology and Rheumatology at AUMC. He has studied the role of the vagus nerve in chronic inflammation, work which provided the basis for clinical trials exploring bioelectronics as a novel therapeutic approach in rheumatoid arthritis patients.

He has published extensively in peer-reviewed journals (~600 publications, H index 146), received numerous awards, has been elected Fellow of the Academy of Medical Sciences (UK), is a PharmaVOICE100 honoree, was included in 'The Medicine Maker Power List 2023', and ranked #120 in the 2023 Edition of the World Ranking of Top 1000 Scientists in the area of Immunology.

At GlaxoSmithKline he served as Senior Vice President, Chief Immunology Officer, and Global Development Leader. He has been CEO of Tempero Pharmaceuticals and Kintai Therapeutics, is a co-founder of Sitryx, and is Chair of Citryll. In 2020, he became the President and CEO of Candel Therapeutics.

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, and personalized ultrasound stimulation platform that will give patients and their physicians a new option for treating debilitating or life-threatening disease. The company's SecondWave MINItm 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 being investigated in clinical studies to treat rheumatoid arthritis, and additional studies are planned to investigate use in other inflammatory conditions. For more information, visit www.secondwaveUS.com.