Cortex will focus on developing an integrated mapping and ablation solution suite to treat atrial fibrillation. Credit: Africa Studio / Shutterstock.com.

Ajax Health has announced the formation of Cortex, a new medical technology company that will focus on developing an integrated mapping and ablation solution suite to treat heart rhythm disorder and atrial fibrillation (AFib).

Cortex secured $90m in funding, with KKR and Hellman & Friedman (H&F) taking the lead, along with participation from other investors, including Access Industries affiliate AI Life Sciences.

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KKR and H&F are making investments in Cortex through the Cordis Accelerator, Cordis-X.

Cortex is focused on creating diagnostic and pulsed-field ablation catheters, featuring a comprehensive mapping and navigation solution powered by the electrographic flow (EGF) mapping technology of Ablacon.

EGF mapping helps doctors identify the sources of AFib, enabling personalised ablation therapy for potentially better outcomes.

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Ajax Health and Cortex CEO Duke Rohlen said: “We are developing solutions that prioritise precision, simplicity, and efficiency to simultaneously improve patient outcomes and lower procedural cost.”

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A randomised, controlled study, FLOW-AF, which concluded recently, demonstrated that EGF-guided treatment of AFib sources in persistent patients significantly enhanced freedom from the disorder at one-year post-ablation.

The improvement was 51% on an absolute basis compared to patients randomised to the control group, who received conventional pulmonary vein isolation therapy only.

Based on the positive outcomes observed in FLOW-AF, the company has initiated the RESOLVE-AF trial.

This global, large, multi-centre clinical study aims to explore the advantages in patients with AFib and facilitate the application for CE mark approval.

Ablacon received 510(k) clearance from the US Food and Drug Administration (FDA) for its latest AblamapX mapping system.

KKR Health Care Strategic Growth global head and Americas Health Care co-head, partner Ali Satvat said: “Duke Rohlen and the Ajax team have cultivated an exceptional ecosystem of engineers and clinical experts with a clear plan to bring impactful new technology to clinical settings.”