Congestive heart failure is one of the main causes of death – only 30% of patients survive 10 years, and less than half even reach five years.
Israeli startup Restore Medical has developed a new approach to treating CHF using an implantable device.
CHF develops when the ventricles of the heart cannot pump enough blood volume. Eventually, blood and other fluids back up into the lungs, abdomen, liver, and lower body. Fluid in the lungs causes shortness of breath and fatigue. CHF affects 6.2 million people in the United States and more than 64 million people worldwide. It affects nearly 10 in 1,000 people over the age of 65, where it is the most common diagnosis in hospitalized patients.
Heart failure does not mean that the heart has stopped working; rather, because blood returns to the heart faster than it can be pumped out, the heart becomes congested.
The body tries to compensate by signaling the heart to beat faster, to take less time to fill up after it contracts. But in the long run, less blood circulates and the extra exertion can cause heart palpitations.
CHF most often damages the left ventricle, which is the part of the heart that pumps blood to the body. The role of the right ventricle is to push blood into the lungs. The damaged left ventricle expands, like a balloon, to make room for the extra blood.
The only treatment for CHF is pharmaceuticals such as ACE inhibitors, diuretics, and vasodilators.
Restore Medical has developed an implant that fits into the pulmonary artery. It alters the pressure on the healthy right ventricle, allowing it to support the failing left ventricle, explained Gilad Marom, CEO of Restore Medical.
The implant is dubbed ContraBand. “Contra”, which means “in opposition to”, refers to this counter-current pushing of one ventricle to the other.
The ContraBand implant is introduced into the heart via a catheter the same way stents are introduced – through the thigh femoral vein.
“The procedure is relatively simple and takes less than an hour,” Marom said. “Patients can be discharged the next day.”
ContraBand is not a cure for CHF. This would be an additional treatment option along with pharmaceuticals.
“It won’t make the disease go away,” Marom said. “Nobody can do that. But it will reduce symptoms and it can reduce hospitalizations or doctor visits when fluid enters the lungs.
This is important because CHF is responsible for 4% of all hospitalizations worldwide and is the leading cause of repeat hospitalizations, with 25% of patients returning one month after discharge.
Start of clinical trials
Restore Medical has conducted animal trials with CHF and treated three human patients – two in Belgium at ZNA Medical Center in Antwerp and one in Israel at Kaplan Medical Center in Rehovot.
The next step is to recruit 15 more patients and follow them for six months, to collect data for regulatory approval from the Food and Drug Administration in the United States and European Cnofrmite in the European Union.
Marom hopes to have a fully marketed version of ContraBand available to help patients by 2026. He plans to start a first conversation with the FDA this year.
He points out that the functionality of the ContraBand device is completely reversible, “which is very rare in the world of cardio implants.”
If a patient no longer needs an implant or can’t tolerate it, “with any other cardiac device, the only ‘rescue’ is surgery,” Maron said.
ContraBand, however, can be “disabled” rather than removed, he claims.
A blue ocean
Restore Medical was founded by Medical Director, Dr. Elchanan Bruckheimer; vice president clinical affairs Stephen Bellomo; and Aaron Feldman, now a board member.
Marom was recruited in 2019 from Edwards Life Sciences, where he worked for 12 years in Israel and the United States. There he focused on transcatheter heart valves, taking three cardiovascular implants from conception to clinical success.
“When I joined Edwards, the majority of the clinical community said there was no way to replace cardiac value except through surgery. We have proven otherwise,” he said.
While heart valves can be “repaired,” the ICC had no solution. That’s why he accepted the offer to run Restore Medical.
“I recognized the opportunity to be in a ‘blue ocean’ situation, to prove that there is another way to treat patients,” he said. “It was a whole new approach, so the decision to join was relatively easy.”
The company is based in Or Yehuda and employs six people. The Crunchbase website says the company raised $1 million; Marom hinted that it was much more than that.
Marom noted that COVID-19 has been difficult for CHF patients. “People were afraid to go to hospital because of COVID. And hospitals might not be as accessible.
This creates an acute need for “a device like ContraBand that helps already sick patients avoid further complications.
This story first appeared on Israel 21C.