HeartPoint Global is leading the way to saving children’s lives.
In the past year, HeartPoint Global (HPG) has made significant advances in the areas of clinical research for congenital heart disease (CHD) treatment. These developments have been recently showcased in an article published in the Journal of the American College of Cardiology (JACC), highlighting our commitment to pushing the boundaries of medical innovation.
The article highlighted the following from pre-clinical study results:
- Successfully implanted in main and branch pulmonary arteries with a 100% success rate for stent delivery.
- A Notable reduction in pulmonary pressure post-implantation, indicating improved cardiovascular function.
- No indications of artery damage, thrombosis, or valve-related issues were observed, affirming safety and efficacy.
- Sustained reductions in pulmonary pressure and complete endothelialization were demonstrated over nine months, showcasing long-term effectiveness.
Acknowledging the global prevalence of CHD, we’ve intensified efforts to revolutionize treatment, especially in regions with economic disparities leading to delayed diagnoses.
One key innovation is our transformative approach to treating CHD, focusing on dilated cardiomyopathy (DCM) and pulmonary arterial hypertension (PAH). Acknowledging the global prevalence of CHD, which affects approximately 1% of newborns worldwide and millions in the United States alone, we have intensified our efforts to revolutionize treatment options. Our focus has been on addressing the economic constraints and delayed diagnoses prevalent because of economic disparities in the U.S. and in many developing nations, where access to timely treatment is often limited.
With these challenges, much needs to be taken into consideration in making devices that are appropriate for the size and differences in children’s growing bodies, and technical concerns, such as how smaller versions of medical devices can be most effective. There are also ethical considerations, such as making testing safe for children. In addition to these hurdles in the development of MedTech devices for pediatrics, the lack of funding puts an even higher barrier on bringing much needed medical devices to the market for children. Some studies show that advances in devices for children are at least 10 years behind devices for adults, and a lot of therapeutics and devices coming to market cannot be afforded by those in low to mid-income countries. Only about one quarter of medical devices designed, reviewed, and approved are for children.
This research reaffirms our commitment to pushing medical innovation boundaries and improving cardiac care outcomes globally. Intellistent stands out as an advanced percutaneous alternative to PAB surgery, addressing the critical unmet need for safer and more effective interventions in pediatric PAH and LV-DCM.
In October, HeartPoint Global was named the winner of the Shark Tank Innovation Competition at the Transcatheter Cardiovascular Therapeutics conference, the annual scientific symposium of the Cardiovascular Research Foundation, underscoring our commitment to innovation and excellence. The award recognized HeartPoint Global’s breakthrough innovation for Intellistent, paving the way for citizens worldwide to receive affordable, cutting-edge cardiac care.
Here are some additional highlights of this past year:
- Next month, we have been invited to not only present at the Cardiovascular Research Technologies Conference (“CRT2024”), but they have also nominated us for the CRT2024 Top Innovation Award. https://crtmeeting.org/Default.aspx
- We have also been chosen as a finalist for the UCSF-Stanford Pediatric Device Consortium Competition 2024. This is a significant milestone for us. This prestigious competition, supported by the Bay Area and Silicon Valley’s leading children’s hospitals and the FDA, has a proven track record of assisting companies like ours to advance. We are honored to be recognized as a contender and look forward to the opportunities this recognition may bring. In 2018, UCSF and Stanford University joined forces to establish the UCSF-Stanford Pediatric Device Consortium, integrating the renowned innovation methodology of Stanford Biodesign. This collaboration combines the expertise of two leading institutions to foster the development of pediatric medical devices. Stanford Biodesign’s proven model for device development has already resulted in the launch of 46 successful startup companies, impacting over a million patients worldwide.
- We are in the process of finalizing our Breakthrough Device Application for submission to the FDA. While we understand that there are no guarantees, we are optimistic about receiving a Breakthrough designation. Our confidence stems from the innovative nature of our product and its potential to address unmet needs in pediatric cardiology. Securing this designation would substantially streamline our regulatory pathway, particularly given that our initial focus is on pediatric use. As a result, we anticipate that the size of our required clinical trials will be significantly smaller than typical expectations.
- By concentrating our resources and efforts on our initial pediatric indications, we aim to expedite FDA market authorization compared to pursuing a broader range of indications from the outset. Focusing on pediatric approvals serves as a strategic anchor, facilitating the potential approval process for additional indications in the future. This approach positions us to navigate regulatory pathways more efficiently than if we were to prioritize adult indications initially.
- HPG is poised to initiate its first-in-human clinical trials, marking a significant milestone in the company’s journey. Concurrently, HPG is actively engaged in securing strategic partnerships and enrolling patients for clinical trials both in the United States and abroad. This strategic approach underscores the company’s commitment to advancing its innovative therapies and expanding its global reach.
Our innovative multi-lumen technology sets us apart, offering precise adjustment of pressure and flow within the main pulmonary artery or its branches. This adjustability ensures customization to meet individual patient needs and accommodate growth following the initial intervention.
Our wellness offerings have evolved to embrace cutting-edge solutions that empower children and families with congenital heart disease to live healthier, fuller lives. Through continuous innovation and collaboration, we are dedicated to creating a brighter future for all those affected by CHD.
Our ongoing efforts include research publications, nominations for innovation awards, and strategic partnerships to advance our therapies and expand our global reach.
Seth Bogner is chairman and CEO of HeartPoint Global, Inc. He first introduced us to his company in “HeartPoint Global’s ROI Is Survival for Children with Congenital Heart Disease.” Also see our exclusive Social Capital interview with him, “Millions of Children Aren’t Getting the Cardiac Care They Need. Seth Bogner Is Changing That.”
