PR96560

TEL AVIV, Israel, Aug 2, 2022 /PRNewswire=KYODO JBN/ --

SoniVie, an Israeli company developing a novel proprietary Therapeutic

Intra-Vascular Ultrasound System (TIVUS™) to treat a variety of hypertensive

disorders, announced that on May 5th 2022 the U.S. Food and Drug Administration

granted IDE approval for its "REDUCED1" Pilot study to treat Resistant

Hypertension Patients with Renal Artery Denervation using TIVUS™, its

innovative Ultra-Sound Ablation System.

Resistant hypertension is defined as blood pressure higher than 140/90 mmHg

despite use of three antihypertensive medications of different classes at the

best tolerated doses, one of which must be a diuretic. Millions of people

world-wide suffer from resistant hypertension which substantially increases the

risk of heart attack, stroke and kidney failure.

"We are very pleased that FDA has approved the REDUCED1 (Renal Denervation

using Ultrasonic Catheter EmitteD energy) study. Sites initiation has

started, and many clinical teams have responded very favourably about

participating to the study. There is a significant number of patients that may

benefit from our technology and we are genuinely happy for this important step

towards the introduction of TIVUS™ in the US. There is a lack of effective

therapeutic solutions for patients suffering from resistant hypertension, and

physicians are looking forward to a safe, effective and easy to use device

treatment," says Christian Spaulding, CMO, SoniVie Ltd.

"This is a significant US Regulatory milestone for SoniVie, starting the

feasibility study using the Ultra-Sound ablation platform in the US for the

Renal Denervation indication. This is a major step and priority in the

company's history," says Tomaso Zambelli, CEO, SoniVie LTD.

The REDUCED1 study will further expand the Company's clinical experience based

on two clinical trials in Renal Denervation performed using the earlier

generation of the TIVUS™.

Renal Denervation with TIVUS™ is a minimally invasive procedure that uses

high-frequency non-focused Ultra-Sound energy to ablate nerves in the renal

artery. This causes a reduction in the nerve activity, which may decrease blood

pressure. This procedure is designed for patients who suffer from resistant

hypertension.

About SoniVie

SoniVie is a medical device company developing the TIVUS™, the only Ultra-Sound

Denervation platform with active development programs in three therapeutic

areas: pulmonary artery denervation for pulmonary hypertension, renal artery

denervation for resistant hypertension, and lung denervation for chronic

obstructive pulmonary disease with chronic bronchitis. These diseases affect

millions of patients in the United States and Europe.

Contact:

Tomaso Zambelli

+39 348 4011983

tomaso@sonivie.com

info@sonivie.com

Source: SONIVIE