Boston Scientific Announces Agreement to Acquire Cortex, Inc.
Boston Scientific (NYSE: BSX) has announced a definitive agreement to acquire Cortex Inc., a private medical technology company specializing in diagnostic mapping solutions for atrial fibrillation (AF). The key asset is the OptiMap™ System, which received FDA 510(k) clearance in 2023. The system uses a basket catheter and proprietary algorithm to identify AF sources, enabling targeted ablation strategies.
Clinical data from the FLOW-AF trial showed OptiMap-guided treatment improved freedom from AF by 51% compared to conventional therapy. The acquisition is expected to close in first half 2025, with immaterial impact on adjusted EPS and slight GAAP dilution. The ongoing RESOLVE-AF trial is evaluating the system's effectiveness across 300 patients globally.
Boston Scientific (NYSE: BSX) ha annunciato un accordo definitivo per acquisire Cortex Inc., un'azienda privata di tecnologia medica specializzata in soluzioni di mappatura diagnostica per la fibrillazione atriale (AF). L'asset principale è il OptiMap™ System, che ha ricevuto l'approvazione 510(k) della FDA nel 2023. Il sistema utilizza un catetere a cestello e un algoritmo proprietario per identificare le fonti di AF, consentendo strategie di ablazione mirate.
I dati clinici dello studio FLOW-AF hanno mostrato che il trattamento guidato da OptiMap ha migliorato la libertà dalla AF del 51% rispetto alla terapia convenzionale. Si prevede che l'acquisizione si chiuda nella prima metà del 2025, con un impatto irrilevante sull'EPS rettificato e una lieve diluizione GAAP. L'attuale studio RESOLVE-AF sta valutando l'efficacia del sistema su 300 pazienti a livello globale.
Boston Scientific (NYSE: BSX) ha anunciado un acuerdo definitivo para adquirir Cortex Inc., una empresa de tecnología médica privada especializada en soluciones de mapeo diagnóstico para la fibrilación auricular (AF). El activo clave es el OptiMap™ System, que recibió la aprobación 510(k) de la FDA en 2023. El sistema utiliza un catéter de canasta y un algoritmo propietario para identificar las fuentes de AF, lo que permite estrategias de ablación dirigidas.
Los datos clínicos del ensayo FLOW-AF mostraron que el tratamiento guiado por OptiMap mejoró la libertad de AF en un 51% en comparación con la terapia convencional. Se espera que la adquisición se cierre en la primera mitad de 2025, con un impacto irrelevante en el EPS ajustado y una leve dilución GAAP. El ensayo RESOLVE-AF en curso está evaluando la efectividad del sistema en 300 pacientes a nivel mundial.
Boston Scientific (NYSE: BSX)는 심방세동(AF) 진단 맵핑 솔루션을 전문으로 하는 개인 의료 기술 회사인 Cortex Inc.를 인수하기 위한 최종 계약을 발표했습니다. 주요 자산은 2023년에 FDA 510(k) 승인을 받은 OptiMap™ System입니다. 이 시스템은 바스켓 카테터와 독점 알고리즘을 사용하여 AF의 출처를 식별하고, 표적 절제 전략을 가능하게 합니다.
FLOW-AF 시험의 임상 데이터에 따르면, OptiMap을 이용한 치료가 기존 치료법에 비해 AF로부터의 자유도를 51% 향상시킨 것으로 나타났습니다. 인수는 2025년 상반기에 마무리될 것으로 예상되며, 조정된 EPS에 미치는 영향은 미미하고 GAAP 희석은 약간 있을 것으로 보입니다. 진행 중인 RESOLVE-AF 시험은 전 세계 300명의 환자를 대상으로 시스템의 효과를 평가하고 있습니다.
Boston Scientific (NYSE: BSX) a annoncé un accord définitif pour acquérir Cortex Inc., une entreprise de technologie médicale privée spécialisée dans les solutions de cartographie diagnostique pour la fibrillation auriculaire (AF). L'atout principal est le OptiMap™ System, qui a reçu l'approbation 510(k) de la FDA en 2023. Le système utilise un cathéter en panier et un algorithme propriétaire pour identifier les sources d'AF, permettant des stratégies d'ablation ciblées.
Les données cliniques de l'essai FLOW-AF ont montré que le traitement guidé par OptiMap a amélioré la liberté de l'AF de 51% par rapport à la thérapie conventionnelle. L'acquisition devrait être finalisée au cours du premier semestre 2025, avec un impact immatériel sur l'EPS ajusté et une légère dilution GAAP. L'essai RESOLVE-AF en cours évalue l'efficacité du système chez 300 patients dans le monde entier.
Boston Scientific (NYSE: BSX) hat eine endgültige Vereinbarung zur Übernahme von Cortex Inc. angekündigt, einem privaten Medizintechnikunternehmen, das sich auf diagnostische Mapping-Lösungen für Vorhofflimmern (AF) spezialisiert hat. Der Schlüsselbestandteil ist das OptiMap™ System, das 2023 die FDA 510(k) Genehmigung erhalten hat. Das System verwendet einen Korbkatheter und einen proprietären Algorithmus, um die AF-Quellen zu identifizieren, was gezielte Ablationsstrategien ermöglicht.
Klinische Daten aus der FLOW-AF-Studie zeigten, dass die von OptiMap geführte Behandlung die Freiheit von AF um 51% im Vergleich zur herkömmlichen Therapie verbesserte. Der Abschluss der Übernahme wird für die erste Hälfte des Jahres 2025 erwartet, mit immateriellen Auswirkungen auf das bereinigte EPS und einer leichten GAAP-Dilution. Die laufende RESOLVE-AF-Studie evaluiert die Wirksamkeit des Systems bei 300 Patienten weltweit.
- OptiMap System demonstrated 51% improvement in AF freedom compared to conventional therapy
- FDA 510(k) clearance already obtained in 2023
- Acquisition expected to have immaterial impact on adjusted EPS in 2025
- Expected to be dilutive to GAAP earnings in 2025
- Transaction still subject to customary closing conditions
Insights
This strategic acquisition strengthens Boston Scientific's position in the lucrative electrophysiology market. The OptiMap System represents a significant technological advancement in AF treatment, addressing a $38 billion global market opportunity with 38 million AF patients worldwide. The FLOW-AF trial data showing
While financial terms weren't disclosed, the "immaterial impact" on 2025 adjusted EPS indicates a relatively modest purchase price relative to BSX's
The OptiMap System represents a significant technological breakthrough in AF treatment. Current ablation procedures primarily focus on pulmonary vein isolation, but this technology's ability to identify triggers outside the pulmonary veins addresses a critical unmet need in complex AF cases. The 51% improvement in AF freedom from the FLOW-AF trial is remarkably strong clinical data.
The ongoing RESOLVE-AF trial with 300 patients will provide additional validation. If successful, this could establish OptiMap as the new standard of care for complex AF cases, potentially expanding the addressable market for ablation procedures. The technology's FDA clearance and promising clinical data significantly de-risk the acquisition.
Acquisition to complement electrophysiology portfolio with solution to advance the treatment of complex atrial fibrillation
Cardiac ablation – the process of delivering energy to areas of the heart responsible for creating abnormal heart rhythms – is a common treatment for AF. During these procedures, physicians often use a mapping system to examine and analyze a heart's electrical patterns to guide therapeutic applications. The OptiMap™ System developed by Cortex uses a basket catheter and proprietary algorithm to identify potential active AF sources, providing physicians with precise insights to efficiently deliver an individualized ablation strategy for their patients.
"We believe the addition of the Cortex technology complements our electrophysiology portfolio with a differentiated cardiac mapping offering to assist with complex AF cases," said Nick Spadea-Anello, global president, Electrophysiology, Boston Scientific. "The OptiMap System has demonstrated it can help physicians devise a targeted ablation strategy for complex cases, which can lead to improved procedural efficiency and outcomes in patients with challenging atrial arrhythmias.2 We look forward to advancing this technology and driving future clinical evidence generation with the goal of making it accessible to physicians and patients globally in the years ahead."
Cortex received
"Cortex was established to provide physicians with a more intelligent and precise solution for patients with AF," said Duke Rohlen, chief executive officer, Cortex. "Joining Boston Scientific will allow us to further develop this technology, which we believe has the ability to transform the treatment of AF for patients around the world."
Boston Scientific expects to complete the transaction in the first half of 2025, subject to customary closing conditions. The transaction is expected to have an immaterial impact on adjusted earnings per share in 2025 and is expected to be slightly dilutive on a GAAP basis due to amortization expense and acquisition-related net charges. Specific terms of the transaction have not been disclosed.
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, clinical trials, 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 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 Cortex'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 document.
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1Lippi G, Sanchis-Gomar F., et al. Global epidemiology of atrial fibrillation: An increasing epidemic and public health challenge. Int J Stroke. 2021; Feb 16:217-221.
2Reddy VY, Langbein A, Petru J, Szili-Torok T, Funasako M, Dinshaw L, Wijchers S, Rillig A, Spitzer SG, Bhagwandien R, Metzner A, Kong MH, Neuzil P. A Randomized Trial of Electrographic Flow-Guided Redo Ablation for Nonparoxysmal Atrial Fibrillation (FLOW-AF). JACC Clin Electrophysiol. 2024 Aug;10(8):1856-1869. doi: 10.1016/j.jacep.2024.03.040. Epub 2024 Jun 5. PMID: 38842972.
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SOURCE Boston Scientific Corporation
FAQ
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