Stent helps children with congenital heart defects recover

Nearly 18 million people die each year from cardiovascular diseases.

Three-quarters of these deaths occur in low- and middle-income countries, where preventive treatment is unavailable or too expensive. It is estimated that 92% of the world’s population does not have access to heart surgery.

This is particularly tragic in countries like India, where almost 2 million children have undetected congenital heart problems.

Israeli startup HeartPoint Global aims to bring minimally invasive treatment to heart patients wherever they are.

HeartPoint’s approach doesn’t seem that revolutionary, at least not initially. The company’s HeartPoint Global Implant System (HPGS) involves inserting a stent into the pulmonary artery. This is the same type of stent used to remove blockages to prevent a heart attack.

The difference is that the HeartPoint stent does not involve opening the artery. It is part of a system used to regulate the flow and pressure of blood entering and leaving the heart, a problem associated with congenital heart disease.

“Research shows that if you correct flow and pressure, children with congenital heart conditions can heal themselves. It’s truly amazing,” HeartPoint Global CEO Seth Bogner told ISRAEL21c.

“We are using stents in a new, minimally invasive way that can adjust flow and pressure at any time and at a reasonable cost.”

Like nested dolls

It is much less intrusive than the method of wrapping a band around the pulmonary artery to reduce blood flow.

“The problem is that doctors often get this ‘arterial banding’ wrong,” says Bogner. “They don’t know what the pressure is. And it can be a big shock to the system.

It is also traumatic, with a long recovery. Many patients who need it may not be safe candidates for surgery, a major reason why arterial banding accounts for less than 2% of heart surgeries, says Bogner, although the need is “much higher.”

HeartPoint’s alternative approach is progressive. If one stent doesn’t do the job, another can be inserted — kind of like those nested Russian dolls, notes Bogner.

Going forward, the company will develop a smartphone app that, when placed on the heart, can measure flow and pressure using a specially designed algorithm.

HeartPoint Global conducted three rounds of preclinical testing in Israel led by the company’s chief medical officer, Dr. David Planer, chief of interventional cardiology at Hadassah Medical Center.

Founder and CEO Seth Bogner with Dr. David Planer. Photo courtesy of HeartPoint Global

The company is pushing for “breakthrough approval” from the US FDA, although Bogner admits there are still a few years to go.

“When you’re dealing with a class 3 medical device, something that stays in the body, you’re in a highly regulated environment. You have to do things in terms of testing, safety, effectiveness and quality,” Bogner told ISRAEL21c.

The company is currently launching two new studies, with human trials coming in Georgia, Serbia and Azerbaijan.

Do things

Although HeartPoint’s technology can also treat a major scourge of the Western world – left-sided heart failure, the largest subset of congestive heart failure – Bogner is most excited about the potential to change outcomes for the better in the developing world.

HeartPoint works with the EurAsia Heart Foundation, a Swiss non-profit organization that performs heart surgery and trains cardiologists in developing countries. Dr. Paul Vogt of University Hospital Zurich, who founded the foundation, is the chairman of HeartPoint’s medical advisory board.

HeartPoint Global has been self-funded to date, primarily by Bogner, who served as CEO of Union Square Financial Partners for 14 years and then founded Ohr Partners, where he still hangs his hat when not helping Hearts. HeartPoint now raises a Series A round.

Bogner, born in New York, divides his time between HeartPoint’s headquarters in Manhattan and HeartPoint’s R&D facilities in Yokne’am, near Haifa. HeartPoint also has a quality and regulatory department in Ireland. But most of the employees are in Israel.

“Israelis have this great attitude that when there’s a problem, it’s not, ‘Oh my God, there’s a problem!’ but rather “Let’s figure it out and get things done.” Things happen faster here,” says Bogner. “We also plan to manufacture the device in Israel.”

From left to right, CTO Yaniv Marmur, engineer John Burke, CMO Dr David Planer, COO Hanna Ilesan, CEO Seth Bogner, consulting engineer Boaz Harari. Photo courtesy of HeartPoint Global

He notes that one in 100 children born each year worldwide has congenital heart problems.

“In the United States and Israel, defects are detected a lot, but not all the time. Until now, there was no easy and inexpensive way to fix these faults.

HeartPoint’s other market – congestive heart failure – affects more people and as such appeals more to the investment community, admits Bogner. “As the population ages, this market for treating very sick patients is growing.

The financial benefit is clear: a HeartPoint procedure that costs around $3,500 could eliminate the need for open-heart surgery later, which involves far more risk and a long hospital stay. The HeartPoint approach requires only one overnight stay.

HeartPoint’s focus on the developing world aligns with Israel’s philosophy of tikkun olam, says Bogner, “to do something good for the world. Israeli doctors regularly visit war-torn countries. This is our mission and our duty.

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