SecondWave has reported positive initial results from a pilot study investigating its wearable therapeutic ultrasound device to treat chronic and acute inflammatory disorders.
The ULTRA pilot study with the SecondWave MINI device enrolled 13 patients with rheumatoid arthritis, an inflammatory condition that causes joint pain, swelling and damage.
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SecondWave reported that ten patients experienced benefits during the eight weeks of non-invasive therapy with the device. The company did not elucidate on the results from the remaining three participants but reported no device-related serious adverse events.
Patients received splenic ultrasound treatment five times daily for two months. SecondWave then assessed clinical outcomes compared to baseline.
The study’s principal investigator Dr Erik Peterson said: “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.”
A full study data readout is expected by the end of this year, according to the US company.
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By GlobalDataThe wearable device is placed on the upper left abdomen area over the spleen. SecondWave is basing the validity of its approach on previous evidence in animals with hyper-inflammation that shows ultrasound applied to the spleen can suppress blood and genetic markers of inflammation.
In 2021, the US Food and Drug Administration (FDA) stated it was receiving an increasing number of therapeutic ultrasound device submissions. Applications for the cardiovascular system, brain, pain management, and immunotherapy were highlighted by the agency.
One of the most recent high-profile ultrasound therapy approvals was in the renal denervation space. In November 2023, Recor Medical received FDA approval for its ultrasound renal denervation system to treat hypertension.
SecondWave is now considering further trials beyond the pilot to evaluate the device in larger participant sizes.
Peterson said: “Results are encouraging; now larger controlled trials of splenic ultrasound as a non-invasive therapeutic for rheumatoid arthritis should be performed.”
