SoniVie, an Israeli company developing a novel, proprietary Therapeutic Intra-Vascular Ultrasound (TIVUS^TM) System to treat a variety of hypertensive disorders, announced that on January 8^th 2024, the last patient was treated with its Renal Artery Denervation TIVUS™ technology, as part of its FDA IDE-approved pilot study to treat hypertension (The REDUCED-1 Study).

The REDUCED-1 Study had two enrollment cohorts that were conducted under an identical protocol in the United States and in Israel. Twenty-five patients were enrolled in the U.S. and 15 patients were enrolled in Israel.  All patients (N=40) are now in the follow-up phase of the study where primary efficacy (change in daytime systolic ambulatory blood pressure) will be analysed at 3 months and safety will be analysed at 1 month and 12 months follow-up respectively.

Renal Denervation with TIVUS™ is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal arteries. This causes a reduction in the nerve activity, which may decrease blood pressure. This procedure is designed for patients who suffer from resistant hypertension.

"Initial results from the ongoing REDUCED-1 Study are encouraging and we continue to diligently follow the enrolled patients," said Christian Spaulding, Chief Medical Officer, SoniVie Ltd.

"Our next commitment towards patients, physicians and regulators is now to clinically validate the TIVUS^TM System in a global pivotal trial and expand its use under the pivotal study with radial access procedures," said Tomaso Zambelli, Chief Executive Officer, SoniVie, Ltd.