Carmella, 72, who had a heart attack and could not be transferred to a specialized facility, is seen waiting at Bellville Medical Center in Texas — one of many rural clinics in the state overwhelmed with Covid patients — on September 1, 2021. — © AFP
Medical technology continues to advance, and one area is with cardiac treatment. Pioneering many innovations are medical startups and one that has made several technological breakthroughs is HeartPoint Global.
To gain an insight into the key technology developments in this medical field, Digital Journal caught up with Seth Bogner, who serves as Chairman and CEO of HeartPoint Global Inc. At HeartPoint Global, Bogner provides global, breakthrough medical solutions for cutting-edge cardiac care that are affordable, safe, and minimally invasive.
Digital Journal: What particular cardiovascular problem are you trying to solve?
Seth Bogner: Ninety-two percent of the world’s population has no access to cardiac surgery. HeartPoint Global is a leading medical device company on a mission to provide innovative, minimally invasive, and accessible cardiac care on a global scale to ensure that those who would otherwise suffer from or die of cardiovascular disease receive the care they need.
The number of people dying from cardiovascular disease (CVD) is steadily rising, including one-third of all deaths globally in 2019, according to a paper in the Journal of the American College of Cardiology that reviewed the total magnitude of CVD burden and trends over 30 years around the world. In fact, according to the World Health Organization, cardiovascular diseases account for most non-communicable disease deaths or 17.9 million people annually.
DJ: How can technology address this?
Bogner: HeartPoint Global seeks to address these startling statistics by developing patented medical devices that are cost-effective, minimally invasive alternatives to current cardiovascular surgeries and therapies. As a pioneer of breakthrough medical solutions, HeartPoint Global is paving the way for citizens worldwide to receive affordable, cutting-edge cardiac care.
HeartPoint Global’s Implant System, INFLUUNTI, is the first and only patented non-surgical structural heart system that addresses a variety of life-threatening cardiovascular diseases in pediatric and adult patients. INFLUUNTI allows for the adjustment of blood flow during and after placement in the main pulmonary artery and/or its branches to restore the structure of the heart-lung system. The device is currently being evaluated in pre-clinical trials in Israel, and first-in-human clinical trials will soon begin in Europe. Once approved for public use, this life saving device will be distributed in both the developing and developed worlds, with an immediate focus on patients who do not have access to cardiac 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.
DJ: How does the technology work?
Bogner: INFLUUNTI 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.
INFLUUNTI provides much-needed treatment for various life-threatening cardiac diseases. Current treatments for these diseases are often too risky, ineffective, unsuccessful, or are inaccessible. The device provides solutions to cardiac diseases, including pulmonary arterial hypertension associated with congenital heart disease, ventricular septal defect, congenital corrected transposition of the great arteries, end-stage left ventricular cardiomyopathy, and more.
DJ: What data is there to support this?
Bogner: In March, landmark findings of a pre-clinical study were completed in conjunction with Hadassah University Hospital at Lahav CRO, Israel’s largest contract research organization pre-clinical center specializing in large animal studies. As a result of these studies, INFLUUNTI proved that it can navigate the most torturous curves in vivo, deliver successful deployments, and accomplish sent recapture. This new milestone follows our successful exploration of INFLUUNTI in the arterial branches.
We are encouraged by the positive results we have seen thus far and look forward to starting our in human trials.
DJ: How do you think this might change the world?
Bogner: In the U.S. and Western Europe, Heartpoint Global treats left heart issues, the largest subset of congestive heart failure, the leading cause of mortality in the world. However, most of the market for HeartPoint Global’s flagship product, INFLUUNTI, is in the developing world. Heartpoint Global will not only treat left heart issues but also children and adults who have developed various conditions due to undetected congenital defects. We aim to serve both markets, the developed world through conventional well-established distribution systems, and the developing world through our Train the Doctor (TDP) program.
Though INFLUUNTI is a breakthrough and unique device, it will be used everywhere in the world.
It is interventional and not surgical and can be employed to improve and save lives from serious cardiovascular disease and can be used almost anywhere, in countries that do not have the medical infrastructure for surgery, or many interventional cardiologists, or the money to pay for mostly ineffective drug treatments. Because INFLUUNTI is non-surgical and minimally invasive, it means that many types of doctors, not just heart surgeons and cardiac interventionalists, can be trained to perform the procedure.
Recognizing these facts, HeartPoint Global developed the train the doctor program. To accelerate the train the doctor program throughout the developing world, we chose to partner with the EurAsia Heart Foundation (EHF) which already had ties throughout the developing world to both perform cardiac surgeries but also to train local doctors in developing countries.
HeartPoint Global believes its train the doctor program and relationships with existing medical care foundations, and organizations with a focus on treating cardiac diseases in the developing world will not only accelerate the adoption and use of the INFLUUNTI but also bring vital cardiac disease treatments to as much of the world’s population as possible, which is a key part of HeartPoint Global’s social mission.