Boston Scientific to Acquire SoniVie

March 3, 2025—Boston Scientific Corporation announced it has entered into a definitive agreement to acquire SoniVie Ltd., a privately held medical device company that has developed the Tivus intravascular ultrasound system for denervation of renal nerves surrounding blood vessels to treat a variety of hypertensive disorders.

As a strategic investor in SoniVie, Boston Scientific currently holds an equity stake of approximately 10%; therefore, the transaction will consist of an upfront payment of approximately $360 million for the 90% stake not yet owned and up to $180 million upon achievement of a regulatory milestone, stated the company. Boston Scientific anticipates the transaction to be completed in the first half of 2025, subject to customary closing conditions.

According to Boston Scientific, the Tivus system is an investigational device not yet cleared for commercial distribution in any country. The press release stated that renal denervation (RDN) with the SoniVie Tivus system to treat hypertension can help reduce activity in the nerves and serve as an alternative or adjunctive therapy to medications that help regulate blood pressure.

SoniVie recently initiated the THRIVE global investigational device exemption (IDE) pivotal trial of the Tivus system, noted Boston Scientific. In July 2024, SoniVie announced that the FDA had approved an investigational device exemption (IDE) for the THRIVE trial. THRIVE is an international, multicenter, randomized, double-blind, sham-controlled study designed to demonstrate the adjunctive effectiveness and safety of RDN with the Tivus system in patients with resistant hypertension.

At the same time, the company announced that positive 3-month efficacy data from the REDUCED-1 IDE pilot study of the Tivus system were presented by James Zidar, MD, at the EuroPCR conference held May 14-17, 2024, in Paris, France.

On February 1, 2024, SoniVie announced completion of enrollment in REDUCED-1, which included two cohorts that were conducted under an identical protocol in the United States (n = 25) and in Israel (n = 15).