FMT Fierce 15
CVRx's device is implanted under the collarbone and attaches to the carotid artery, and sends electrical pulses to pressure-sensing receptors to trick the brain into thinking it’s not getting enough oxygen.

Treating heart failure by tricking the brain

CEO: Nadim Yared
Founded: 2001
Based: Minneapolis

The scoop: Most treatments for heart failure focus on reducing the heart’s workload, or alleviating cardiovascular symptoms directly. They traditionally fall into two broad buckets: drugs designed to make it easier for the heart to pump blood around the body, and devices that use electricity to help control its rhythm.

CVRx takes a different angle. Instead of creating a device that interacts with the heart—which comes with all kinds of risks—the Minneapolis-based device maker is treating heart failure by sending separate messages to the brain. 

Its Barostim device secured FDA approval in 2019 for the treatment of the symptoms of heart failure. In the future, CVRx hopes to show that it can change the course of the disease and reverse the condition.

What makes CVRx fierce: CVRx CEO Nadim Yared likens heart failure to a stifling office with a broken thermostat.

“The dial is broken, so you can’t change the temperature on the thermostat, but you want to make the office cooler,” Yared said. 

Heart failure drugs aim to cool the office down. Diuretics can help reduce swelling and breathlessness by getting rid of excess water in the blood, while ACE inhibitors and ARB blockers work by relaxing blood vessels to reduce blood pressure. 

On the device side, implantable cardioverter-defibrillators monitor a person’s heart rhythm and deliver electric shocks to the heart to keep it on track, while cardiac resynchronization therapies use electricity to make the heart’s ventricles contract in a more coordinated way, and improve the efficiency of each beat.

However, these treatments only tackle the after-effects of a malfunctioning thermostat—like putting bigger fans in the ventilation system, or blasting a hole in the wall—and don’t stop the overheating in the first place.

What could help, Yared said, is lighting a match and holding it near the sensor. It's tricking it into believing the room is already much hotter than it is. 

In this analogy, CVRx’s Barostim is the match, and the brain the thermostat. An overactive sympathetic nervous system—the “gas pedal” responsible for the fight-or-flight response—is the result of the broken thermostat, leading to the symptoms of heart failure, such as fatigue, shortness of breath and swelling in the legs.

RELATED: CVRx's brain-stim implant approved to treat heart failure

Too much pressure on this gas pedal, along with suppression of the parasympathetic nervous system—the “brake pedal,” or the rest-and-digest system—have long been linked to heart failure.

The Barostim implant. (CVRx)

“The body is revved up most of the time and not getting enough rest,” Yared said. CVRx’s Barostim aims to dial down the sympathetic nervous system while boosting the parasympathetic nervous system.

The device is implanted under the collarbone with leads that attach to the carotid artery in the neck. It works by sending electrical pulses to pressure-sensing baroreceptors in the wall of the artery to trick the brain into thinking it’s not getting enough oxygen.

“The reaction is an integrated response that lowers the sympathetic tone and increases the parasympathetic tone. Arteries dilate, the heart slows down and the body is more restful,” Yared said.

The FDA approved the device in August 2019 for the treatment of patients with advanced heart failure who cannot be treated with other devices, like CRT devices. That accounts for about 60% of patients, Yared said. The approval is specifically for the treatment of the symptoms of heart failure with reduced ejection fraction, or HFrEF, a type of heart failure where the heart muscle does not contract effectively, so less oxygen-rich blood gets pumped out to the body. 

RELATED: CVRx procures $113M for heart failure implant trial

The Barostim is also approved in Europe for the treatment of hypertension, an indication CVRx could chase in the U.S. as well. The company believes the device could also be useful in other kinds of heart failure, including the 40% of HFrEF patients who are candidates for CRT devices and those with heart failure with preserved ejection fraction, or HFpEF, where the heart pumps normally, but its tissue is too stiff to fill properly.

Over the next few years, CVRx plans to conduct trials in other indications to bring its treatment to more people. And it will be busy getting the word out to patients and physicians about Barostim as an option for heart failure.

“We have to go out and train physicians how to do the procedure [and] tell them where it fits in the treatment continuum. We need to tell patients there is a solution for their disease,” Yared said.

To that end, the company has been building a marketing and sales team in the U.S. In parallel, it continues to improve the device and its implantation procedure.

Investors: Action Potential Venture Capital, DaVita HealthCare Partners, Gilde Healthcare Partners, Hatteras Venture Partners, Johnson & Johnson Innovation, New Enterprise Associates, Treo Ventures, Venrock, Vensana Capital, Windham Venture Partners and Ysios Capital.