Boston Scientific announces agreement to acquire SoniVie Ltd.
Rhea-AI Summary
Boston Scientific (NYSE: BSX) has announced an agreement to acquire SoniVie , developer of the investigational TIVUS™ Intravascular Ultrasound System for treating hypertension through renal denervation (RDN). The acquisition expands BSX's Interventional Cardiology Therapies portfolio.
The transaction includes an upfront payment of approximately $360 million for the 90% stake not currently owned by BSX (which holds ~10% equity), plus up to $180 million in regulatory milestone payments. The TIVUS system uses ultrasound energy to denervate renal arteries, potentially offering deeper tissue penetration and faster procedures compared to radiofrequency alternatives.
The deal is expected to close in first half 2025, with slight dilution to adjusted EPS in 2025, which BSX plans to offset through internal cost efficiencies. SoniVie recently reported positive efficacy data from an IDE pilot trial and has initiated the THRIVE global IDE pivotal trial.
Positive
- Strategic expansion into hypertension treatment market
- Innovative ultrasound technology with potential advantages over existing treatments
- Positive efficacy data from IDE pilot trial
- Already owns 10% equity stake in SoniVie
- Milestone-based payment structure reduces upfront risk
Negative
- Expected EPS dilution in 2025
- High acquisition cost ($360M upfront + $180M milestone payments)
- TIVUS system not yet commercially approved in any country
- Additional clinical trials required for regulatory approval
Insights
Boston Scientific's $360 million acquisition of SoniVie represents a strategic expansion into the high-growth renal denervation (RDN) market for hypertension treatment. The deal structure—with $180 million in additional regulatory milestone payments—intelligently reduces upfront risk while maintaining significant upside exposure.
The TIVUS ultrasound system potentially offers competitive advantages over radiofrequency-based RDN approaches through deeper tissue penetration and more efficient procedures. With positive IDE pilot trial data already announced and the global THRIVE pivotal trial underway, BSX is acquiring this asset at a critical inflection point in its clinical development timeline.
While management expects the deal to be slightly dilutive to adjusted EPS in 2025, they've committed to offsetting this through internal efficiencies—suggesting confidence in maintaining near-term financial performance while investing in this growth vector. The technical characteristics of TIVUS (non-anchoring, continuous blood flow for cooling) could potentially address historical RDN adoption barriers related to procedural complexity and safety.
This acquisition strengthens BSX's interventional cardiology portfolio with a technology addressing hypertension—a massive market affecting over 1 billion people globally with significant unmet needs beyond pharmaceutical approaches. The transaction leverages BSX's existing 10% stake in SoniVie, allowing them to fully capture the value of an asset they've already vetted through strategic investment.
The acquisition of SoniVie adds significant technological differentiation to Boston Scientific's cardiovascular portfolio through the TIVUS ultrasound-based renal denervation system. The key technical advantage lies in ultrasound energy's deeper tissue penetration compared to radiofrequency alternatives, potentially enabling more complete denervation with shorter procedure times.
The non-anchoring, flow-preserving design represents an important engineering advancement that allows continuous blood cooling during the procedure—a critical safety feature for thermal ablation technologies. This approach minimizes the risk of endothelial damage while maximizing energy delivery to the targeted nerve bundles surrounding the renal arteries.
From a clinical development perspective, BSX is acquiring this platform at an optimal stage—positive IDE pilot data has derisked the core technology, while the pivotal THRIVE trial provides near-term value creation opportunity through potential regulatory approval. The device's mechanism of directly modulating sympathetic nervous system activity addresses a fundamental physiological driver of hypertension that pharmaceutical approaches often inadequately control.
This acquisition follows broader industry validation of renal denervation with several positive randomized trials demonstrating clinically meaningful blood pressure reductions. The ultrasound approach could potentially become the preferred technical solution in this emerging category given its favorable procedural characteristics. Integration into BSX's existing interventional infrastructure will accelerate commercial pathway if regulatory approval is achieved.
Acquisition to expand Interventional Cardiology Therapies offerings with ultrasound-based renal denervation therapy for treatment of 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.1 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
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
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
Caution: The TIVUS™ Intravascular Ultrasound System is an investigational device not yet cleared for commercial distribution in any country.
About Boston Scientific
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of health care. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and connect on LinkedIn and X, formerly Twitter.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements may be identified by words like "anticipate," "expect," "project," "believe," "plan," "estimate," "intend" and similar words. These forward-looking statements are based on our beliefs, assumptions and estimates using information available to us at the time and are not intended to be guarantees of future events or performance. These forward-looking statements include, among other things, statements regarding our business plans, the financial and business impact of the transaction and the anticipated benefits of the transaction, the closing of the transaction and the timing thereof, product performance and impact, clinical trials, and new and anticipated product approvals and launches. If our underlying assumptions turn out to be incorrect, or if certain risks or uncertainties materialize, actual results could vary materially from the expectations and projections expressed or implied by our forward-looking statements. These factors, in some cases, have affected and in the future (together with other factors) could affect our ability to implement our business strategy and may cause actual results to differ materially from those contemplated by the statements expressed in this press release. As a result, readers are cautioned not to place undue reliance on any of our forward-looking statements.
Factors that may cause such differences include, among other things: future economic, political, competitive, reimbursement and regulatory conditions; geopolitical events; manufacturing, distribution and supply chain disruptions and cost increases; disruptions caused by cybersecurity events; disruptions caused by public health emergencies or extreme weather or other climate change-related events; labor shortages and increases in labor costs; variations in outcomes of ongoing and future clinical trials and market studies; new product introductions; expected procedural volumes; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate SoniVie's operations; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the proposed transaction; demographic trends; intellectual property; litigation; financial market conditions; future business decisions made by us and our competitors; the conditions to the completion of the proposed transaction, including the receipt of any required regulatory approvals and clearances, may not be satisfied at all or in a timely manner; and the closing of the proposed transaction may not occur or may be delayed. All of these factors are difficult or impossible to predict accurately and many of them are beyond our control. For a further list and description of these and other important risks and uncertainties that may affect our future operations, see Part I, Item 1A – Risk Factors in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, which we may update in Part II, Item 1A – Risk Factors in Quarterly Reports on Form 10-Q we have filed or will file hereafter. We disclaim any intention or obligation to publicly update or revise any forward-looking statements to reflect any change in our expectations or in events, conditions or circumstances on which those expectations may be based, or that may affect the likelihood that actual results will differ from those contained in the forward-looking statements, except as required by law. This cautionary statement is applicable to all forward-looking statements contained in this document.
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Media Relations
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1 Cluett, Jennifer L., et al. Renal Denervation for the Treatment of Hypertension: A Scientific Statement from the American Heart Association. Hypertension, Vol. 81, No. 10. https://doi.org/10.1161/HYP.0000000000000240
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SOURCE Boston Scientific Corporation
FAQ
What is the total acquisition value of SoniVie by Boston Scientific (BSX)?
How will the SoniVie acquisition affect BSX's earnings per share in 2025?
What clinical trials has the TIVUS system completed for BSX's acquisition?
How does the TIVUS system's ultrasound technology differ from existing treatments?
When is the BSX-SoniVie acquisition expected to close?
