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CardioFocus raises $55M following positive trial results

29 May 2019

Funding will support global launch of US firm's latest laser system for treating atrial fibrillation.

CardioFocus, the Massachusetts company that has developed a series of laser systems for treating atrial fibrillation (AF), says it has raised $55 million.

The cash - partly in senior debt financing from “idiosyncratic” investor Kennedy Lewis Investment Management - will be used to support global commercialization of the firm’s latest “HeartLight X3” system.

Earlier this month CardioFocus reported that a trial of the new equipment on 60 patients had shown positive early results and the ability to treat patients much faster than previous versions of the Heartlight.

Going global
The HeartLight X3 received CE Mark approval for European markets in March, and is now said to achieve pulmonary vein isolation (PVI) - a way to stop the disruptive electrical signals thought to cause AF - in as little as three minutes.

Paul LaViolette, the executive chairman of CardioFocus, said in a company release: “This substantial investment will enable broader adoption of the HeartLight System and support a successful commercial launch of the HeartLight X3 System globally.

“We are committed to continued innovation and are very excited about the potential the HeartLight X3 System has to significantly advance the way atrial fibrillation is treated.”

Although it has received CE Mark approval, the X3 version of HeartLight is not yet approved by the Food & Drug Administration (FDA) for sale in the US. This latest version of the system delivers near-infrared energy more rapidly, and features continuous movement of the laser beam to speed up the overall procedure.

In a “live case” video posted on the CardioFocus web site, surgeons Vivek Reddy and Petr Neužil are shown talking through a PVI procedure with the X3 that took less than 12 minutes to complete.

Rogue signals
Regarded as the most common manifestation of cardiac rhythm disorder, AF is thought to affect more than 30 million patients worldwide. The condition can be treated in various ways, including with drugs and non-laser surgical intervention, but many patients subsequently suffer from relapses.

The endoscopic laser ablation technique offered by CardioFocus and its various HeartLight systems is intended to offer a long-lasting solution. Pulses of light, delivered from a 980 nm laser diode via an optical fiber and balloon catheter, create lines of scar tissue designed to block the rogue electrical signals thought to cause the extended heart palpitations associated with AF.

Back in March 2017, the Marlborough-headquartered firm raised $20 million in equity finance, although its filing with the US Securities & Exchange Commission (SEC) from the time suggested that CardioFocus had been looking for $32 million.

Subsequent SEC filings indicate that in April 2018 company raised $13 million of debt finance from Trump Securities – a New York brokerage firm that, despite the name, is not believed to have any links to the current US president.

Another SEC filing dated May 20, just over a week before CardioFocus announced the $55 million investment, shows that the firm had sold a further $8 million in equity financing, out of the $12 million it had been seeking.

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