Boston Scientific Announces Definitive Agreement to Acquire SoniVie Ltd. and Its Investigational TIVUS™ Intravascular Ultrasound System for Hypertension Treatment

Recently, Boston Scientific Corporation (NYSE: BSX) announced that it has entered into a definitive agreement to acquire SoniVie Ltd., a private medical device company that developed the TIVUS intravascular ultrasound system. The TIVUS system is an investigational technology designed to treat various hypertensive disorders by performing denervation of perivascular nerves, including renal denervation (RDN) for hypertension.

Hypertension is closely related to the overactivity of the sympathetic nervous system and is a major risk factor for cardiovascular disease. Studies have shown that treating hypertension can help reduce cardiovascular-related mortality and the risk of serious health issues such as stroke, heart attack, or heart failure. However, lifestyle changes and antihypertensive medications, which partially regulate the sympathetic nervous system by modulating renal nerve activity, are often insufficient to control blood pressure (BP). The TIVUS system can reduce renal nerve activity through RDN, serving as an alternative or adjunctive therapy to antihypertensive drugs in regulating blood pressure. Compared with radiofrequency energy, ultrasound energy has the potential to penetrate deeper into tissues, which may make the procedure faster while achieving effective nerve ablation.

Lance Bates
President of Boston Scientific Corporation and Global Vice President of the Cardiovascular Intervention Division:

"Renal Denervation via the Renal Artery for Treating Hypertension is an Exciting Medical Advance with the Potential to Benefit Millions of Patients. This therapy has demonstrated positive outcomes in current clinical trials and ongoing research. We believe that the TIVUS system will enhance our comprehensive interventional product portfolio by adding a minimally invasive treatment option for patients with hypertension, offering more possibilities for the future development of this field."

The catheter-based TIVUS system generates precise ultrasonic energy that can penetrate through the blood into the renal arteries supplying blood to the kidneys without contacting the arterial walls, ensuring continuous blood flow and cooling the treatment area. This energy is designed to heat and ablate nerve bundles outside the arteries, disabling their ability to transmit signals and reducing the release of sympathetic hormones from the nerves. Ultimately, this leads to vasodilation and a reduction in intravascular pressure. Last year, SoniVie announced positive efficacy data from the IDE pilot trial of the TIVUS system conducted in the United States and Israel. The company recently initiated the global THRIVE IDE pivotal trial for the TIVUS system.

As a strategic investor in SoniVie, Boston Scientific currently holds approximately 10% of the equity. Therefore, this transaction includes an upfront payment of about $360 million for the remaining 90% equity not yet held, along with up to $180 million payable upon achieving specific regulatory approval milestones*.

Once the customary closing conditions are met, Boston Scientific expects to complete the transaction in the first half of 2025. On an adjusted basis, the company anticipates the transaction will be slightly dilutive to adjusted earnings per share (EPS) in 2025, offset by internal cost efficiencies and trade-offs. On a GAAP basis, due to amortization and acquisition-related expenses, the transaction is expected to be more dilutive but excludes a one-time gain related to the company’s previously held equity interest in SoniVie at the time of closing.

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 can be identified by words such as "anticipate," "expect," "forecast," "believe," "plan," "estimate," "intend," and similar terms. These forward-looking statements are based on our views, assumptions, and estimates derived from the information available to us at the time, and are not guarantees of future events or performance. These forward-looking statements include our statements regarding the financial and commercial impact of this transaction, our business plans, product performance, and their impacts. If our underlying assumptions prove to be incorrect, or if certain risks or uncertainties materialize, actual results may differ materially from the expectations and predictions expressed or implied in our forward-looking statements. These factors have affected, and may continue to affect (in conjunction with other factors), our ability to execute our business strategy in some cases, and could lead to actual results differing significantly from the anticipated results in this press release. Therefore, we caution readers not to place undue reliance on any of our forward-looking statements. Factors that could cause such differences include: future economic conditions, competitive conditions, compensation and regulatory environments; introduction of new products; product performance; demographic trends; intellectual property; litigation; financial market conditions; and future business decisions made by us and our competitors. All these factors are difficult or impossible to predict accurately, and many of them are beyond our control. For a detailed list and description of important risks and uncertainties that may affect our future business, please refer to Part I, Item 1A, "Risk Factors," in our latest Form 10-K annual report filed with the U.S. Securities and Exchange Commission. We may update this section in Part II, Item 1A, "Risk Factors," of our Form 10-Q quarterly reports that have been or will be filed subsequently. We have no intention or obligation to publicly update or revise any forward-looking statements to reflect changes that may occur, whether due to changes in our expectations, the events, conditions, or circumstances on which those expectations are based, or otherwise result in differences between actual results and the results described in the forward-looking statements. This cautionary statement applies to all forward-looking statements contained in this document.

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

*Without considering Boston Scientific's current equity in SoniVie Ltd and other closing adjustments, the transaction value based on 100% equity includes an upfront payment of $400 million and up to $200 million upon achieving specific regulatory milestones.
Note: The TIVUS intravascular ultrasound system is still in the experimental stage and has not been approved for marketing in any country.