SoniVie’s REDUCED-1 Pilot Study of Tivus Ultrasound RDN System Completes Enrollment

February 1, 2024—SoniVie announced that the final patient was treated in the REDUCED-1 pilot study of the company’s Tivus renal artery denervation technology to treat resistant hypertension. The Israel-based company is developing the Tivus therapeutic intravascular ultrasound system to treat a variety of hypertensive disorders.

According to SoniVie, the REDUCED-1 study includes two enrollment cohorts that were conducted under an identical protocol in the United States (n = 25) and in Israel (n = 15). The study is being conducted under an FDA investigational device exemption.

The company reported that all patients (N = 40) are now in the follow-up phase of the study. Primary efficacy—change in daytime systolic ambulatory blood pressure—will be analyzed at 3 months and safety will be analyzed at 1 month and 12 months follow-up.

Renal denervation (RDN) with Tivus is a minimally invasive procedure that uses high frequency, nonfocused ultrasound energy to ablate nerves in the renal arteries in patients with resistant hypertension. The procedure causes a reduction in the nerve activity that may decrease blood pressure, noted the company.

“Initial results from the ongoing REDUCED-1 study are encouraging and we continue to diligently follow the enrolled patients,” stated Christian Spaulding, Chief Medical Officer of SoniVie in the company’s press release.

Tomaso Zambelli, Chief Executive Officer of SoniVie added, “Our next commitment towards patients, physicians and regulators is now to clinically validate the Tivus system in a global pivotal trial and expand its use under the pivotal study with radial access procedures.”