PR96950

TEL AVIV, Israel, July 13, 2022 /PRNewswire=KYODO JBN/ --

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 May 30th 2022 the first patient was treated with

its Renal Artery Denervation TIVUS(TM) technology, as part of the recently FDA

IDE-approved Pilot study to treat Hypertension (the REDUCED1 study).

The procedure was successfully performed with TIVUS(TM) at the Kaplan Medical

Center by Professor Michael Jonas, Principal Investigator of the REDUCED1

study, who commented: "We were able to use the TIVUS catheter to rapidly and

efficiently perform UltraSound based renal denervation in our patient suffering

from uncontrolled HTN. TIVUS's catheter excellent ease of use and its ability

to denervate at significant depth of the perivascular space allowed for a

short, simple and straightforward procedure. We will closely follow our patient

and look forward to continuing enrolment in this exciting trial."

Renal Denervation with TIVUS(TM) 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.

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 genuinely happy for this important step forward. There is a lack of

effective therapeutic solutions for these patients" says Christian Spaulding,

CMO, SoniVie LTD.

"This procedure represents a great fulfilment for SoniVie team, whose expertise

and achievements have been focusing on developing TIVUS(TM) technology for the

Renal Denervation indication, both providing a promising treatment to the

hypertensive patient and a high performing, easy to use device to the

physician", says Tomaso Zambelli, CEO, SoniVie LTD.

About SoniVie

SoniVie is a medical device company developing the TIVUS(TM) 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.

The company's offices are located in Rosh Haayin, Israel and in Newark, NJ, USA

CONTACT: Tomaso Zambelli, tomaso@sonivie.com

Source: Sonivie LTD