Boston Scientific to Acquire Cortex

Boston Scientific Corp. has entered into a definitive agreement to acquire Cortex Inc., an Ajax Health company. Cortex is a privately held medical technology company focused on the development of a diagnostic mapping solution which may identify triggers and drivers outside of the pulmonary veins that are foundational to atrial fibrillation (AF), a heart rhythm disorder affecting nearly 38 million people globally.¹

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," says 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 U.S. Food and Drug Administration 510(k) clearance for the OptiMap System in 2023 and recently completed the randomized, controlled FLOW-AF clinical trial with data demonstrating that OptiMap-guided treatment of AF sources in patients with persistent AF improved freedom from AF one year after an ablation by 51% compared with patients who received conventional pulmonary vein isolation therapy alone. Earlier this year, the company initiated a 300 patient, global clinical trial, RESOLVE-AF, evaluating the effectiveness of the OptiMap System in identifying extra-pulmonary vein sources. 

"Cortex was established to provide physicians with a more intelligent and precise solution for patients with AF," says 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.

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.