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