Israeli company SoniVie receives FDA approval for innovative hypertension treatment

SoniVie’s treatment is called TIVUS – an innovative Ultrasound system that treats Hypertension patients with Renal Artery Denervation. 

 SoniVie's TIVUS medical device. (photo credit: Screenshot/SoniVie Website)
SoniVie's TIVUS medical device.
(photo credit: Screenshot/SoniVie Website)

Israeli medical company SoniVie announced that the US Food and Drug Administration (FDA) received an IDE (Investigational Device Exemption) exemption for its Pilot study to treat Resistant Hypertension Patients. 

SoniVie’s treatment is called TIVUS – an innovative Ultrasound system that treats Hypertension patients with Renal Artery Denervation. 

"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.

Renal Denervation – the primary treatment made possible by TIVUS – is a minimally invasive procedure that uses high-frequency non-focused Ultra-Sound energy to ablate – or safely remove – nerves in the renal artery, causing a reduction in the nerve activity and decreasing blood pressure. 

Signage is seen outside of FDA headquarters in White Oak, Maryland. (credit: REUTERS)Signage is seen outside of FDA headquarters in White Oak, Maryland. (credit: REUTERS)

The new 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.

SoniVie and Israeli innovation

Founded in 2014, SoniVie has patented the TIVUS – the only Ultrasound 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 – diseases that affect millions of patients in the United States and Europe.

“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, Chief Marketing Officer of SoniVie Ltd.