The medtech startup incubator Ajax Health has launched a new venture for developing pulsed field ablation treatments to zap the common irregular heart rhythm known as atrial fibrillation.
Cortex will start off with $90 million in funding commitments, led by KKR and Hellman & Friedman, with backing from other investors that include AI Life Sciences, an affiliate of Access Industries.
The company will also get a head start toward its goal of offering an integrated system that can help diagnose arrhythmias as well as treat them. Cortex will be led by CEO Duke Rohlen, who also serves as CEO of Ajax—and, fortuitously, as CEO of the Ajax outfit Ablacon, developer of an artificial intelligence-powered, FDA-cleared heart mapping system.
Cortex will use Ablacon's Electrographic Flow technology to visualize the paths that electricity takes as it surges across the cardiac muscle and to track down the causes of the turbulent activity that leads to afib. The technology includes a basket-shaped catheter that fills the heart’s atrium with 64 electrodes and provides a real-time view of the sources of action potentials.
A randomized clinical trial of Ablacon’s Ablamap software showed that using electrographic data to chart out an ablation procedure could lead to a 51 percentage-point increase in the number of people reporting no arrhythmias after one year, compared to simply isolating the pulmonary vein.
The software received an FDA 510(k) green light this past summer, and an international study is underway to support a CE mark approval in Europe.
“We are developing solutions that prioritize precision, simplicity and efficiency to simultaneously improve patient outcomes and lower procedural cost,” Rohlen said in the announcement of Cortex’s debut.
KKR and Hellman & Friedman will be investing in Cortex through an accelerator program run by the cardiovascular devices company Cordis and known as Cordis-X; KKR will also invest additional capital in Cortex through its Health Care Strategic Growth Fund II.
It’s been a busy week for KKR, Ajax and Rohlen. On Nov. 30, they launched a lung cancer-focused accelerator in collaboration with Hologic, dubbed Maverix Medical.
Maverix—which will also be led by Rohlen—will seek to develop and acquire new diagnostic tech aimed at the leading cause of cancer deaths worldwide.
In addition, Maverix will take over the work of KKR and Ajax’s portfolio company Serpex Medical, maker of an FDA-cleared endobronchial system with steerable biopsy needles for accessing and probing suspicious lung nodules.