On November 4, local time, Boston Scientific announced that it had reached a final agreement to acquire Cortex, Inc. Subject to customary closing conditions, Boston Scientific expects to complete the transaction in the first half of 2025.

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 expenses and acquisition-related net expenses. The specific terms of the transaction have not been disclosed. Cortex is a young private medical technology company announced and funded by Ajax Health in December last year. The company develops integrated mapping and ablation solutions for the treatment of atrial fibrillation (AFib). At that time, Cortex had received a $90 million financing commitment, led by KKR and Hellman & Friedman (H&F), and other investors included AI Life Sciences, a subsidiary of Access Industries. Cardiac ablation has become a common method for the treatment of atrial fibrillation.

The OptiMap™ system developed by Cortex uses a basket catheter and proprietary algorithms to identify potential active sources of atrial fibrillation, providing physicians with precise insights and personalized ablation strategies for patients. Nick Spadea-Anello, global president of electrophysiology at Boston Scientific, said: "We believe that the addition of Cortex technology complements our electrophysiology portfolio and provides differentiated cardiac mapping services for complex atrial fibrillation cases. The OptiMap system has proven that it can help physicians design targeted ablation strategies for complex cases, which can improve surgical efficiency and outcomes for patients with atrial arrhythmias. We look forward to advancing this technology and promoting future clinical evidence generation, with the goal of making this technology available to physicians and patients around the world in the coming years." Cortex received FDA 510(k) approval in 2023 and recently completed the randomized controlled FLOW-AF clinical trial. Data showed that OptiMap-guided AF treatment increased the chance of avoiding recurrence by 51% one year after ablation compared with patients who only received conventional pulmonary vein isolation.

In 2021, Boston Scientific acquired electrophysiology company Farapulse, which has core pulse ablation technology. With the approval of PFA products, Boco is also rapidly expanding in this frontier electrophysiology market. As the most important innovative technology in the field of electrophysiology, the gradual maturity of pulse ablation technology and the approval of products may completely rewrite the electrophysiology market. In the past year, the first batch of PFA products from Boco and Medtronic rushed into the US market. Judging from the feedback, the products have a significant stimulus to the electrophysiology market. In the second quarter of 2024, Boco's global net sales of electrophysiology increased by 122%, and net sales in the third quarter maintained high growth, increasing by 177%. The Chinese market is also a major market that multinational giants pay close attention to. According to the "China Guidelines for the Diagnosis and Treatment of Atrial Fibrillation 2023", it is estimated that there are about 12 million atrial fibrillation patients in my country, and the related diagnosis and treatment needs need to be further released. At present, the PFA products of Boco and Medtronic have been approved for registration by NMPA.

The fierce innovation battle between giants never stops, and Johnson & Johnson, Abbott, etc. are also actively promoting the development and approval of PFA. Companies that have already launched PFA products are still exploring the space for technology upgrades to improve PFA products, and all parties are trying to gain more bargaining chips for subsequent market competition. Just last month, Boco announced that its FARAWAVENAV cardiac pulsed electric field ablation (PFA) catheter with magnetic positioning mapping function has been approved by the FDA for the treatment of paroxysmal atrial fibrillation (AF), and the new FARAVIEW software module has also obtained FDA510(k) clearance. The company also stated that it will immediately launch the FARAWAVE magnetic positioning cardiac pulsed electric field ablation (PFA) catheter and FARAVIEW software module in the United States. In the same month, Medtronic announced that the FDA approved its Affera™ mapping and ablation system with Sphere-9™ catheter. The former is an integrated, high-density mapping, pulsed field and radiofrequency ablation catheter. This is another FDA-approved PFA product of Medtronic after PulseSelect. The two PFA technologies work together to bring more bargaining chips to Medtronic.

Abbott also recently disclosed that the global IDE registration of the Volt™ PFA system was completed ahead of schedule; the tacticalflex™ Duo ablation catheter SensorEnabled™ is undergoing a global FOCALFLEX trial; the Advisor™ HDGridX mapping catheter SensorEnabled™ has been approved by the US Food and Drug Administration and has begun commercial release. There is also good news in the domestic market. Maiwei Medical's cardiac pulse electric field ablation catheter and minimally invasive electrophysiology's disposable cardiac pulse electric field ablation catheter have entered the special review procedure for innovative medical devices. At present, a number of domestic companies such as Jinjiang Electronics, Huitai Medical, Micro Electrophysiology, Denuo Electrophysiology, Yuanshan Medical, Aikemai, Zhouling Medical, Hanyu Medical, Maiwei Medical, Beixin Medical, Xuanyu Medical, Shangyang Medical, and Ruidi Biological have joined the PFA track, and many products have entered the clinical trial or registration approval stage. It is expected that the PFA track will usher in a wave of approvals and listings in the future, and market competition may become more intense by then.

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