Medical Device News Magazine

A Revolution in Cardiovascular Care By Seth Bogner, Chairman, and CEO of HeartPoint Global

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Summation

  • The patented HeartPoint Global Implant System, INFLUUNTI, is placed in the main pulmonary artery or pulmonary artery branches and reduces and adjusts dangerously high arterial blood flow and partially or fully restores the heart-lung system to a healthier state which could dramatically improve the patient’s quality of life.

According to the World Health Organization, cardiovascular diseases are the world’s leading cause of death, with more than three-quarters of these deaths occurring in the developing world. An estimated 17.9 million people died from cardiovascular diseases in 2019, representing 32% of all global deaths. Of these deaths, 85% were due to heart attack or stroke. Moreover, out of the seventeen million premature deaths (under the age of 70) that were due to noncommunicable diseases in 2019, 38% were caused by cardiovascular diseases.

While this is a problem with profound global ramifications, it is also a national health dilemma in the U.S. According to the American Academy of Pediatrics, in 2010, approximately 2.4 million individuals were estimated to be living with congenital heart disease in the United States, 1.4 million of whom were adults. About 25% of children born with a congenital heart defect will need heart surgery or other interventions to survive.

These statistics are startling and sobering. HeartPoint Global is contributing to developing solutions to these issues by creating the first and only minimally invasive adjustable heart-lung system that brings affordability, accessibility, and the potential to save millions of lives in the developed and developing world.

While there have been several advances in cardiology, HeartPoint Global will bring to market the first and only patented non-surgical structural heart system that allows bi-directional adjustments of the heart-lung system at any time during and after insertion.

How the HeartPoint Global Implant System Works

A Revolution in Cardiovascular Care

The patented HeartPoint Global Implant System, INFLUUNTI, is placed in the main pulmonary artery or pulmonary artery branches and reduces and adjusts dangerously high arterial blood flow and partially or fully restores the heart-lung system to a healthier state which could dramatically improve the patient’s quality of life. INFLUUNTI is minimally invasive, fully reversible, and works well with other therapies, greatly reducing recovery times and potential complications during and after the procedure. Because it is minimally invasive, it can be employed to improve or save lives from cardiovascular disease. The technology can be used in countries with few interventional cardiologists, the medical infrastructure for surgery, or the money to pay for expensive and primarily ineffective drug treatments.

INFLUUNTI allows adjustments of pressure during or after the initial intervention to improve the structural flow of the heart-lung system and dramatically reduces mortality and the suffering associated with surgery or transplants. It also delivers improvements by two levels in cardiac function based on the NYC Heart Association Scale. It continuously expands the spectrum of heart diseases it can treat, with over ten indications now treatable.

Landmark Findings from PreClinical Study Surpassing Expectations

In March, landmark findings from a successful pre-clinical study in conjunction with Hadassah University Hospital at Lahav CRO, included long-term data showing that the HeartPoint Implant System, INFLUUNTI, successfully restricted blood flow and effectively increased pressure gradient over the five months of the study. The pre-clinical study demonstrated that a substantial reduction in the pulmonary flow did not result in thrombus, blockages, or negative biological responses. The results go against the mainstream theory that reducing the diameter in highly pressurized vessels to the extent reduced in the study would result in thrombus formation or implant occlusion. Maintaining the resulting gradient from INFLUUNTI created a leftward septal shift in study animals. This significant pronounced structural change to the heart suggests the ability to target a lower gradient, boosting safety margins for human patients.

A Humanitarian Focus

Because INFLUUNTI is non-surgical and minimally invasive, many types of doctors, not just heart surgeons and cardiac interventionalists, can be trained to perform the procedure. This will revolutionize cardiovascular care as it exists today. The device is disruptive in terms of price point in both the western and developing world. We aim to serve both markets, including the developed world through conventional well-established distribution systems, and the developing world through our Train the Doctor (TDP) program.

We partner with the EurAsia Heart Foundation (EHF), which already has ties throughout the developing world, to perform cardiac surgeries and train local doctors in these developing countries. By working with the EHF, HeartPoint Global’s program has access to an existing framework and network of doctors who will bring the HPGS to the developing world under the auspices of their foundation. HeartPoint not only performs interventions but trains in-country doctors in identifying suitable patients for INFLUUNTI and the procedure.

HPG believes its train the doctor program and relationships with existing medical care foundations will accelerate the adoption and use of INFLUUNTI. Accelerating adoption means bringing vital cardiac disease treatments to as much of the world’s population as possible, which is an essential part of HPG’s social mission.

While the challenge of treating cardiovascular disease is daunting, I am optimistic about the progress we have made by developing a revolutionary MedTech device that will provide a solution for patients with privilege and without. I am looking forward to the next milestone of our first human use trials in Europe in early 2023.

Editor’s Note: Seth Bogner currently serves as Chairman and CEO of HeartPoint Global Inc., where he merges his exceptional leadership abilities with his long-time goal of creating a business that is both profitable and socially responsible. At HeartPoint Global, he and his team provide global, breakthrough medical solutions for cutting-edge cardiac care that are affordable, safe, and minimally invasive.

Bogner began his career at Loeb Partners Realty, where he was crucial in securing many multi-million-dollar financing deals. He later served as the Chairman of Hearthstone Management Group Ltd., where he invested in and managed a portfolio of over 14,000 apartments. Seth was a pioneer in commercial mortgage-backed securities (CMBS).

With over three decades of experience in principal investing, structured finance, restructurings, and merchant banking across numerous industries, Seth Bogner is a visionary entrepreneur who has served as the CEO and president of many funded and/or financed entities. To date, he has closed over 200 investments and merger and acquisition transactions during his career.

Before joining HeartPoint Global, Bogner was the managing partner of Union Square Partners Ltd., which operated as a principal partner with institutional investors in various fields. He also founded Ohr Partners in 2007, where amongst other responsibilities, he managed and was a director of two licensed, regulated mutual funds that operated globally.

 

 

 

 

 

 

 

 

 

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Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

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