Boston Scientific Announces Agreement to Acquire Bolt Medical, Inc.
Boston Scientific (NYSE: BSX) has announced a definitive agreement to acquire Bolt Medical, developer of an intravascular lithotripsy (IVL) advanced laser-based platform for treating coronary and peripheral artery disease. The acquisition includes an upfront payment of $443 million for the 74% stake not yet owned, plus potential regulatory milestone payments of up to $221 million.
Boston Scientific, which already holds a 26% equity stake in Bolt Medical since helping establish it in 2019, aims to expand its cardiovascular portfolio with this complementary calcium modification platform. The Bolt IVL™ system uses novel lithotripsy technology to fracture calcium through acoustic pressure waves inside a balloon catheter.
Bolt Medical recently completed the RESTORE ATK and BTK pivotal clinical trials and received FDA approval to commence the global FRACTURE IDE clinical trial for coronary arterial disease treatment. The transaction is expected to close in first half 2025 and be slightly dilutive to adjusted EPS in 2025.
Boston Scientific (NYSE: BSX) ha annunciato un accordo definitivo per acquisire Bolt Medical, sviluppatore di una piattaforma avanzata basata su laser per la litotripsia intravascolare (IVL) per il trattamento della malattia coronarica e arteriosa periferica. L'acquisizione include un pagamento iniziale di 443 milioni di dollari per la partecipazione del 74% non ancora posseduta, oltre a potenziali pagamenti per traguardi normativi fino a 221 milioni di dollari.
Boston Scientific, che già detiene il 26% delle azioni di Bolt Medical, avendo contribuito alla sua fondazione nel 2019, mira ad espandere il proprio portafoglio cardiovascolare con questa piattaforma complementare di modifica del calcio. Il sistema Bolt IVL™ utilizza una tecnologia innovativa di litotripsia per fratturare il calcio attraverso onde di pressione acustica all'interno di un catetere a palloncino.
Bolt Medical ha recentemente completato i trial clinici fondamentali RESTORE ATK e BTK e ha ricevuto l'approvazione della FDA per avviare il trial clinico globale FRACTURE IDE per il trattamento della malattia arteriosa coronarica. Si prevede che la transazione si chiuderà nella prima metà del 2025 e sarà leggermente dilutiva per l'EPS rettificato nel 2025.
Boston Scientific (NYSE: BSX) ha anunciado un acuerdo definitivo para adquirir Bolt Medical, desarrollador de una plataforma avanzada basada en láser para la litotripsia intravascular (IVL) para tratar la enfermedad arterial coronaria y periférica. La adquisición incluye un pago inicial de 443 millones de dólares por el 74% de la participación aún no poseída, además de posibles pagos por hitos regulatorios de hasta 221 millones de dólares.
Boston Scientific, que ya posee un 26% de participación en Bolt Medical desde que ayudó a establecerla en 2019, tiene como objetivo expandir su cartera cardiovascular con esta plataforma complementaria de modificación de calcio. El sistema Bolt IVL™ utiliza tecnología novedosa de litotripsia para fracturar el calcio a través de ondas de presión acústica dentro de un catéter de globo.
Bolt Medical completó recientemente los ensayos clínicos fundamentales RESTORE ATK y BTK y recibió la aprobación de la FDA para comenzar el ensayo clínico global FRACTURE IDE para el tratamiento de la enfermedad arterial coronaria. Se espera que la transacción se cierre en la primera mitad de 2025 y tenga un ligero efecto dilutivo en el EPS ajustado en 2025.
보스턴 사이언티픽 (NYSE: BSX)은 볼트 메디컬을 인수하기 위한 최종 계약을 발표했습니다. 볼트 메디컬은 관상 동맥 및 말초 동맥 질환을 치료하기 위해 혈관 내 석회화 제거(IVL) 레이저 기반 플랫폼을 개발한 회사입니다. 이번 인수에는 현재 소유하지 않은 74% 지분에 대한 4억 4천3백만 달러의 선불 지급액과 최대 2억 2천1백만 달러의 규제 기준점 지급 가능성이 포함됩니다.
보스턴 사이언티픽은 2019년 볼트 메디컬 설립을 도우면서 26%의 지분을 보유하고 있으며, 이 보완적인 석회 변경 플랫폼으로 심혈관 포트폴리오를 확장할 계획입니다. 볼트 IVL™ 시스템은 풍선 카테터 내에서 음향 압력 파를 통해 석회를 파쇄하기 위해 새로운 석회화 기술을 사용합니다.
볼트 메디컬은 최근 RESTORE ATK 및 BTK 주요 임상 시험을 완료하고 관상 동맥 질환 치료를 위한 FRACTURE IDE 글로벌 임상 시험을 시작하기 위해 FDA 승인을 받았습니다. 이번 거래는 2025년 상반기에 완료될 것으로 예상되며, 2025년 조정된 EPS에 대해 약간의 희석 효과를 미칠 것으로 예상됩니다.
Boston Scientific (NYSE: BSX) a annoncé un accord définitif pour acquérir Bolt Medical, développeur d'une plateforme avancée de lithotripsie intravasculaire (IVL) basée sur un laser pour le traitement des maladies artérielles coronariennes et périphériques. L'acquisition comprend un paiement initial de 443 millions de dollars pour la participation de 74% qui n'est pas encore détenue, ainsi que des paiements potentiels pour des jalons réglementaires pouvant atteindre 221 millions de dollars.
Boston Scientific, qui détient déjà 26% des actions de Bolt Medical depuis l'avoir aidé à se établir en 2019, vise à élargir son portefeuille cardiovasculaire avec cette plateforme complémentaire de modification du calcium. Le système Bolt IVL™ utilise une technologie innovante de lithotripsie pour fracturer le calcium à travers des ondes de pression acoustique à l'intérieur d'un cathéter à ballon.
Bolt Medical a récemment terminé les essais cliniques pivots RESTORE ATK et BTK et a reçu l'approbation de la FDA pour commencer l'essai clinique mondial FRACTURE IDE pour le traitement des maladies artérielles coronariennes. La transaction devrait être finalisée au cours du premier semestre 2025 et aura un léger effet dilutif sur le BPA ajusté en 2025.
Boston Scientific (NYSE: BSX) hat eine endgültige Vereinbarung zur Übernahme von Bolt Medical angekündigt, dem Entwickler einer fortschrittlichen auf Laser basierenden Plattform für die intravasale Lithotripsie (IVL) zur Behandlung von Koronar- und peripheren Arterienerkrankungen. Die Übernahme umfasst eine Vorauszahlung von 443 Millionen Dollar für die noch nicht gehaltenen 74% der Anteile sowie mögliche regulatorische Meilensteinzahlungen von bis zu 221 Millionen Dollar.
Boston Scientific, die seit 2019 mit 26% der Anteile an Bolt Medical beteiligt ist, plant, ihr kardiovaskuläres Portfolio mit dieser komplementären Plattform zur Kalziummodifikation zu erweitern. Das Bolt IVL™-System verwendet neuartige Lithotripsietechnologie, um Kalzium durch akustische Druckwellen innerhalb eines Ballonkatheters zu zerbrechen.
Bolt Medical hat kürzlich die RESTORE ATK und BTK entscheidenden klinischen Studien abgeschlossen und die FDA-Zulassung erhalten, um die globale FRACTURE IDE klinische Studie zur Behandlung von koronarer Arterienerkrankung zu beginnen. Es wird erwartet, dass die Transaktion in der ersten Hälfte von 2025 abgeschlossen sein wird und einen leichten verwässernden Effekt auf das angepasste EPS im Jahr 2025 haben wird.
- Strategic expansion into fast-growing medical device segment
- Existing 26% ownership reduces acquisition risk
- Completed pivotal clinical trials for peripheral artery disease
- FDA approval received for coronary arterial disease clinical trial
- Internal cost efficiencies expected to offset EPS dilution
- Expected to be dilutive to adjusted EPS in 2025
- Additional $221M payment contingent on regulatory milestones
- Product not yet cleared for commercial distribution in any country
Insights
The
The slight EPS dilution in 2025 is manageable through internal efficiencies, while the one-time gain from the previously held equity stake will partially offset GAAP impacts. The IVL market's rapid growth trajectory and BSX's established distribution network could accelerate commercialization post-regulatory approvals. The completion of RESTORE trials and FDA approval for the FRACTURE IDE study significantly de-risks the investment.
The Bolt IVL technology represents a significant advancement in calcified lesion treatment. Think of it as using sound waves to crack calcium deposits like breaking a stone, but with precise control inside blood vessels. The visible, directional emitters are a key differentiator, enabling more consistent energy delivery compared to existing solutions.
The strategic value lies in the platform's versatility across both coronary and peripheral applications. The completion of both Above the Knee and Below the Knee trials suggests a comprehensive approach to peripheral artery disease treatment. With cardiovascular diseases being the leading global cause of death, this acquisition positions BSX to address a critical therapeutic need with next-generation technology.
This acquisition solidifies BSX's competitive position in the rapidly expanding IVL market. The timing is particularly strategic as the sector shows accelerating growth driven by aging populations and increasing prevalence of calcified arterial disease. BSX's existing
The regulatory milestone structure (
Acquisition to expand cardiovascular portfolio with complementary and differentiated calcium modification platform, furthering company's strategy to address coronary and peripheral disease
"Representing one of the fastest growing medical device segments, intravascular lithotripsy therapy addresses a significant unmet need for patients with complex calcified arterial disease through a minimally invasive approach," said Lance Bates, senior vice president and president, Interventional Cardiology Therapies, Boston Scientific. "Bolt Medical is developing a next-generation technology that is highly complementary to our existing portfolio. The addition of this system to our offerings can help us better serve physicians and their patients and provides a platform for future innovation."
Cardiovascular diseases are the leading cause of death globallyi and are commonly due to narrowing of coronary and peripheral arteries, which can restrict blood flow. These narrowed arteries are often created by cholesterol deposits and may also have buildup of calcium that can increase the complexity of potential treatments. Lithotripsy is a procedure in which a physician breaks up hardened masses such as calcium to help restore blood flow. The Bolt IVL™ system is designed with a novel application of lithotripsy to fracture calcium by creating acoustic pressure waves inside of a balloon catheter. The system also includes visible, directional emitters for consistent energy delivery in the treatment of the calcified lesions.
Boston Scientific initially developed the concept for the Bolt IVL system which helped establish Bolt Medical in 2019. As a strategic investor in Bolt Medical, Boston Scientific has an equity stake of approximately 26 percent. As a result, the transaction consists of an upfront payment of approximately
Bolt Medical recently announced the completion and results of the RESTORE ATK and RESTORE BTK pivotal clinical trials investigating the Bolt IVL™ Above the Knee (ATK) and Below the Knee (BTK) systems for the treatment of peripheral artery disease in patients with moderate to severely calcified lesions. The data from both studies will be used to support
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 via 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 Bolt Medical.
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Caution: The Bolt IVL™ system is an investigational device, which is 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, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. 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, and product performance and impact. 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 forward-looking 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; market competition for our products; expected procedural volumes; new product introductions; demographic trends; the closing and integration of acquisitions, including our ability to achieve the anticipated benefits of the proposed transaction and successfully integrate Bolt Medical's operations; business disruptions (including disruptions in relationships with employees, customers and suppliers) following the announcement and/or closing of the proposed transaction; 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 press release.
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i Cardiovascular diseases (CVDs) (who.int)
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SOURCE Boston Scientific Corporation
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