Boston Scientific to acquire SoniVie for up to $560 million to expand renal denervation portfolio

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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. An investigational technology, the TIVUS system is designed to denervate nerves surrounding blood vessels to treat a variety of hypertensive disorders, including renal artery denervation (RDN) for hypertension.

Closely associated with overactivity of the sympathetic nervous system, hypertension is a leading risk factor for cardiovascular disease, with treatment shown to reduce cardiovascular mortality and the risk of serious health issues such as stroke, heart attack or heart failure. However, lifestyle modifications and anti-hypertensive medications designed to modulate the sympathetic nervous system – partly through renal nerve activity – are often inadequate in controlling high blood pressure (BP). The TIVUS system is designed to perform RDN that can help reduce activity in the kidney's renal nerves and serve as an alternative or adjunctive therapy to these medications to help regulate BP. Compared to radiofrequency energy, ultrasound energy has the potential to penetrate the tissue more deeply, which may result in faster procedures with effective nerve ablation.

"Renal denervation for hypertension is an exciting medical advancement for the millions of patients it may help and is supported by positive results from contemporary clinical trials and ongoing research," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. "We believe the addition of the differentiated, ultrasound-based TIVUS system can complement our expansive interventional portfolio with a minimally invasive therapy for patients with hypertension and provides opportunity for future advancements in this space."

The catheter-based TIVUS system generates precise ultrasound energy that passes through the blood and into renal arteries supplying blood to the kidneys without anchoring to the artery wall, which allows for continual blood flow to cool the treatment area. This energy is designed to heat and ablate the bundles of nerves outside the arteries, stopping their ability to pass signals and reducing the sympathetic hormones that are released from the nerves. As a result, the blood vessels relax and the pressure within them is reduced. Last year, SoniVie announced positive efficacy data from an IDE pilot trial of the TIVUS system in the U.S. and Israel. The company recently initiated the THRIVE global IDE pivotal trial of the device.

As a strategic investor in SoniVie, Boston Scientific currently holds an equity stake of approximately 10 percent. Therefore, the transaction consists of an upfront payment of approximately $360 million for the 90 percent stake not yet owned and up to $180 million upon achievement of a regulatory milestone.*

Boston Scientific anticipates the transaction to be completed in the first half of 2025, subject to customary closing conditions. On an adjusted basis, the company expects the transaction to be slightly dilutive to adjusted earnings per share (EPS) in 2025, and to offset this through internal cost efficiencies and trade-offs. On a GAAP basis, the transaction is expected to be more dilutive due to amortization expense and acquisition-related charges, except for a one-time gain to be recognized at closing associated with the company's previously held equity interest in SoniVie Ltd.

^*On a 100% basis before consideration of Boston Scientific's current equity ownership in SoniVie and other closing adjustments, the transaction price consists of $400 million up front, and up to $200 million upon achievement of a regulatory milestone.