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Miami-based Swift Sync’s novel heart pacing catheter is making its way through the FDA process

Rick Toren wears a lot of hats. He’s a co-creator of the EpiPen, a former professor at the University of Miami (who’s looking to teach again) and the CEO of Swift Sync, which makes a pacing catheter for patients with heart problems.

For Swift Sync, “what we want to do, after we get FDA approval, is build about 100 catheters and then put them into beta sites, so it proves that we can build them at scale, then deploy them and have them be used for everyday pacing,” says Toren, a longtime leader and innovator in the healthcare industry.

Swift Sync was founded in 2021 by Dr. Eduardo de Marchena and Dr. Christian Marin y Kall based on their early work at University of Miami, and the technology has been exclusively licensed to the company. The innovative temporary catheter self-positions on the right-side chambers of the heart and maintains endocardium contact for synchronous dual-chamber pacing. It can also be placed without fluoroscopic guidance.

The catheters are intended to be used in operating rooms, for open heart surgery, valve surgery, for heart transplant patients, and during a coronary artery bypass graft – a surgical procedure used to treat coronary artery disease. They’re also intended to be used in cardiac catheterization laboratories, or “cath labs” for structural heart procedures, such as ablations and transcatheter aortic valve replacements – to treat aortic stenosis. The catheters can also be used in the ER, ICU, and the CCU, for those who have suffered a heart attack, a heart block, bradycardia (when the heart beats too slowly), and conduction disturbances. 

Toren reports that clinical trials on sheep went well and were followed by successful clinical trials on 29 people in South America two years ago. “What we were looking for was the catheter to be able to sense the lack of heartbeat so that would enable the pacemaker to fire and generate voltage in both the atrium and the ventricle synchronously, which it did,” says Toren.

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Rick Toren, CEO of Swift Sync

Some of the benefits of the catheter are that it lowers perforation risk, minimizes dislodgement, has dual chamber technology, and assists in Atrioventricular (AV) synchrony with the coordinated timing of contractions between the atria (upper heart chambers) and the ventricles (lower heart chambers) for efficient blood flow.  “It connects to an outside source of energy called the pulse generator and generates a small amount of voltage,” says Toren.

Toren and his team of four, including  de Marchena and Marin y Kall, are nearing the final round of the FDA approval process and are hoping for FDA approval in three to six months. They currently have been awarded four patents.

So far, Swift Sync has raised $5 million in venture capital, and the company presented at the Florida Venture Capital Conference in March. Swift Sync is in the process of securing another million dollars to fund the production of catheters.

Talks are underway with three hospitals, including UM, to use the catheters in the future, pending FDA approval and supply.

Toren says that the plan is to find a partner to acquire the rights to the device.  “We’re planning on selling the whole thing, not going to market on our own because you need to have more than just one product,” he says.  “We did all the all the work to get it approved by the FDA and show that it could be manufactured at scale.”

As for Toren, he says that he’d like to go back to teaching Entrepreneurship at UM once they find a buyer.

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