More companies are looking to join the burgeoning renal denervation market, with Israeli startup SoniVie completing enrolment in a pilot study for its TIVUS (therapeutic intra-vascular ultrasound) system.
The REDUCED-1 pilot (NCT05372679), which is being conducted across the US and Israel, has enrolled two cohorts of patients with uncontrolled stage 2 hypertension. The company enrolled 25 patients in the US and 15 in Israel.
Headquartered in Tel Aviv, Israel, SoniVie said that all study participants are in the follow-up phase of the study. The trial’s primary outcomes are the incidence of adverse events and the reduction in daytime ambulatory mean systolic blood pressure, the latter measured three months after the procedure.
The renal denervation sector burst into life when ReCor Medical secured the first approval for its Paradise system in November 2023. Medtronic followed soon after with clearance for its Symplicity Spyral. Whereas Medtronic’s device uses radiofrequency, ReCor’s system utilises ultrasound, as does SoniVie with its TIVUS technology.
SoniVie’s CEO Tomaso Zambelli said: “Our next commitment towards patients, physicians and regulators is now to clinically validate the TIVUS System in a global pivotal trial and expand its use under the pivotal study with radial access procedures.”
Renal denervation involves radiofrequency or ultrasound ablation of afferent and efferent nerves located in the renal artery that carry important signals to the brain that control blood pressure. Reducing the functionality of these pathways leads to various blood pressure-lowering mechanisms. It is a treatment option for patients who do not respond to blood pressure-lowering drugs.
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SoniVie is exploring the use of its technology beyond renal artery denervation for resistant hypertension. It has programmes for pulmonary artery denervation for pulmonary hypertension and total lung denervation for chronic obstructive pulmonary disease with chronic bronchitis.
In December 2023, US-based Ablative announced that its alcohol-mediated renal denervation with the Peregrine System Kit achieved the primary endpoint in a Phase III trial.
A report by GlobalData estimates the renal denervation catheter market will be worth $533m by 2033, growing at a CAGR of 26% between 2023 and then.