Boston Scientific announces agreement to acquire SoniVie Ltd.
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.
Boston Scientific (NYSE: BSX) ha annunciato un accordo per acquisire SoniVie, sviluppatore del sistema di ultrasonografia intravascolare TIVUS™ per il trattamento dell'ipertensione attraverso la denervazione renale (RDN). L'acquisizione espande il portafoglio delle terapie di cardiologia interventistica di BSX.
La transazione include un pagamento iniziale di circa 360 milioni di dollari per la partecipazione del 90% non attualmente posseduta da BSX (che detiene circa il 10% del capitale), oltre a un massimo di 180 milioni di dollari in pagamenti legati a traguardi normativi. Il sistema TIVUS utilizza energia ad ultrasuoni per denervare le arterie renali, offrendo potenzialmente una penetrazione più profonda nei tessuti e procedure più rapide rispetto alle alternative a radiofrequenza.
Si prevede che l'accordo si chiuda nel primo semestre del 2025, con una leggera diluizione dell'EPS rettificato nel 2025, che BSX prevede di compensare attraverso efficienze interne. SoniVie ha recentemente riportato dati di efficacia positivi da uno studio pilota IDE e ha avviato lo studio clinico pivotale globale THRIVE.
Boston Scientific (NYSE: BSX) ha anunciado un acuerdo para adquirir SoniVie, desarrollador del sistema de ultrasonido intravascular TIVUS™ para tratar la hipertensión a través de la denervación renal (RDN). La adquisición amplía el portafolio de terapias de cardiología intervencionista de BSX.
La transacción incluye un pago inicial de aproximadamente 360 millones de dólares por la participación del 90% que actualmente no posee BSX (que tiene alrededor del 10% de capital), además de hasta 180 millones de dólares en pagos por hitos regulatorios. El sistema TIVUS utiliza energía de ultrasonido para denervar las arterias renales, ofreciendo potencialmente una penetración más profunda en los tejidos y procedimientos más rápidos en comparación con las alternativas de radiofrecuencia.
Se espera que el acuerdo se cierre en el primer semestre de 2025, con una ligera dilución del EPS ajustado en 2025, que BSX planea compensar a través de eficiencias internas. SoniVie reportó recientemente datos de eficacia positivos de un ensayo piloto IDE y ha iniciado el ensayo pivotal global THRIVE.
보스턴 사이언티픽 (NYSE: BSX)는 신장 신경 차단(RDN)을 통해 고혈압 치료를 위한 TIVUS™ 혈관 내 초음파 시스템 개발업체인 SoniVie를 인수하기로 합의했다고 발표했습니다. 이번 인수는 BSX의 중재적 심장학 치료 포트폴리오를 확장합니다.
이번 거래에는 BSX가 현재 보유하고 있는 약 10%의 지분을 제외한 90% 지분에 대해 약 3억 6천만 달러의 선불금이 포함되며, 최대 1억 8천만 달러의 규제 이정표 지불금이 포함됩니다. TIVUS 시스템은 초음파 에너지를 사용하여 신장 동맥을 신경 차단하여, 라디오 주파수 대안에 비해 더 깊은 조직 침투와 더 빠른 절차를 제공할 수 있습니다.
이번 거래는 2025년 상반기에 마무리될 것으로 예상되며, 2025년 조정 EPS에 약간의 희석이 발생할 것으로 보이며, BSX는 내부 비용 효율성을 통해 이를 상쇄할 계획입니다. SoniVie는 최근 IDE 파일럿 시험에서 긍정적인 효능 데이터를 보고하였으며, THRIVE 글로벌 IDE 주요 시험을 시작하였습니다.
Boston Scientific (NYSE: BSX) a annoncé un accord pour acquérir SoniVie, le développeur du Système d'Échographie Intravascualire TIVUS™ pour traiter l'hypertension par dénervation rénale (RDN). Cette acquisition élargit le portefeuille de thérapies de cardiologie interventionnelle de BSX.
La transaction comprend un paiement initial d'environ 360 millions de dollars pour la participation de 90% non détenue par BSX (qui détient environ 10% de capital), ainsi que jusqu'à 180 millions de dollars en paiements liés à des jalons réglementaires. Le système TIVUS utilise l'énergie ultrasonore pour dénerviser les artères rénales, offrant potentiellement une pénétration plus profonde des tissus et des procédures plus rapides par rapport aux alternatives par radiofréquence.
La conclusion de l'accord est prévue pour le premier semestre 2025, avec une légère dilution du BPA ajusté en 2025, que BSX prévoit de compenser par des économies de coûts internes. SoniVie a récemment rapporté des données d'efficacité positives d'un essai pilote IDE et a lancé l'essai pivot mondial THRIVE.
Boston Scientific (NYSE: BSX) hat eine Vereinbarung zur Übernahme von SoniVie bekannt gegeben, dem Entwickler des TIVUS™ Intravaskulären Ultraschallsystems zur Behandlung von Bluthochdruck durch renale Denervierung (RDN). Die Übernahme erweitert das Portfolio von BSX im Bereich interventionelle Kardiologie.
Die Transaktion umfasst eine Vorauszahlung von etwa 360 Millionen Dollar für die 90% Beteiligung, die derzeit nicht im Besitz von BSX ist (das etwa 10% Eigenkapital hält), sowie bis zu 180 Millionen Dollar an Zahlungen für regulatorische Meilensteine. Das TIVUS-System nutzt Ultraschallenergie, um die Nierenarterien zu denervieren und bietet potenziell eine tiefere Gewebedurchdringung und schnellere Verfahren im Vergleich zu Radiofrequenz-Alternativen.
Es wird erwartet, dass der Deal im ersten Halbjahr 2025 abgeschlossen wird, mit einer leichten Verwässerung des bereinigten EPS im Jahr 2025, die BSX durch interne Kosteneffizienzen ausgleichen möchte. SoniVie hat kürzlich positive Wirksamkeitsdaten aus einer IDE-Pilotstudie berichtet und hat die globale IDE-Pivotalstudie THRIVE gestartet.
- 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
- 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.
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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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FAQ
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What clinical trials has the TIVUS system completed for BSX's acquisition?
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