SoniVie announces enrollment completion in the REDUCED-1 pilot study
TEL AVIV, Israel, Feb. 1, 2024 /PRNewswire/ — SoniVie, an Israeli company developing a novel, proprietary Therapeutic Intra-Vascular Ultrasound (TIVUSTM) System to treat a variety of hypertensive disorders, announced that on January 8th 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 TIVUSTM 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.
SoniVie is a medical device company developing the TIVUS™ Ultrasonic Denervation System, the only platform denervation technology with active development programs in three therapeutic areas: pulmonary artery denervation for pulmonary hypertension, renal artery denervation for resistant hypertension, and total lung denervation for chronic obstructive pulmonary disease with chronic bronchitis. These diseases affect millions of patients in the United States and Europe.
SoniVie offices are located in Rehovot, Israel and in Minneapolis, MN, USA.
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