Study marks the first demonstration of novel splenic ultrasound therapy to significantly reduce rheumatoid arthritis disease activity
ST. PAUL, Minn.–(BUSINESS WIRE)–SecondWave Systems, Inc., a pioneer in the emerging field of bio-ultrasonic medicine, today announced completion of a pilot clinical study evaluating its novel noninvasive ultrasound stimulation technology in the treatment of patients with rheumatoid arthritis (RA). This study involved splenic ultrasound treatment of 13 participants, and showed significant improvement in disease activity, with 10 of 13 participants experiencing benefit during the treatment period. Participant feedback on treatment experience was positive for all 13 participants, and there were no device-related serious adverse events. The company anticipates full study data readout to be available by the end of 2024.
The SecondWave MINI™ is a first-of-its-kind, wearable therapeutic ultrasound device for noninvasive and personalized treatment of chronic and acute inflammatory disorders. The purpose of the pilot clinical study (clinicaltrials.gov: NCT05417854) was to assess safety and initial efficacy of the investigational device in the treatment of rheumatoid arthritis. The single-arm study was conducted through the University of Minnesota Medical School and funded through the Defense Advanced Research Projects Agency (DARPA). The study included splenic ultrasound treatment of 13 participants with active rheumatoid arthritis over an 8-week study period, with 5 daily stimulation sessions per week, and compared clinical outcomes from baseline to end of the 8-week treatment period.
“In this clinical trial, most study participants started with moderate or high rheumatoid arthritis disease activity. More than two-thirds of the participants showed significant clinical improvement by trial’s end, based upon a widely utilized disease activity metric. The study intervention was well tolerated and apparently safe. Results are encouraging; now larger controlled trials of splenic ultrasound as a non-invasive therapeutic for rheumatoid arthritis should be performed,” said the principal investigator of the study and rheumatologist Dr. Erik Peterson. Dr. Hubert Lim, Chief Scientific Officer at SecondWave Systems and Professor at University of Minnesota, further commented, “In the last few years, there have been multiple preclinical studies revealing significant reduction in inflammation with splenic ultrasound stimulation relevant for treating arthritis, sepsis, myocarditis, acute kidney injury, pulmonary hypertension, and other health conditions. Results from this study using the SecondWave MINI device support for the first time that splenic ultrasound has potential to modulate disease symptoms and indicators of inflammation directly in humans suffering from rheumatoid arthritis, which is a major milestone for the field of bio-ultrasonic medicine.”
Building on the positive results from the pilot study, SecondWave Systems is further advancing the MINI technology platform for implementation in a randomized controlled trial for at-home treatment of rheumatoid arthritis.
For more information on SecondWave Systems, visit www.secondwaveUS.com.
About SecondWave Systems, Inc.
SecondWave Systems is a clinical-stage company 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 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 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.
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