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Award Recognizes Company for Adjustable Pulmonary Stent for Pediatric Congenital Heart Disease

SAN FRANCISCO – October 26, 2023 – The Cardiovascular Research Foundation (CRF) is pleased to announce that HeartPoint Global has won the TCT 2023 Shark Tank Innovation Competition for its novel multi-lumen stent system for interventional adjustment of pulmonary blood flow in congenital heart disease. The competition took place during Transcatheter Cardiovascular Therapeutics (TCT), the world’s premier educational meeting specializing in interventional cardiovascular medicine, October 23-26 in San Francisco. The winner was also presented with the Jon DeHaan Foundation Award for Innovation in Cardiology.

“We are thrilled to name HeartPoint Global as this year’s TCT Shark Tank Innovation Competition winner,” said Juan F. Granada, MD, President and Chief Executive Officer of CRF, the sponsor of TCT. “Their INTELLISTENT® device has the potential to transform the course of treatment for pediatric patients suffering with congenital heart disease (CHD). CHD affects over 20% of newborns globally, including 2.4 million in the United States alone. Millions more are undiagnosed globally.”

The INTELLISTENT® device is a non-invasive solution intended to adjust pulmonary blood flow via a percutaneous intervention with a self-expanding nitinol stent to treat congenital heart disease and pulmonary arterial hypertension. Pre-clinical results where the INTELLISTENT® was implanted in the main/branch, left/right pulmonary arteries demonstrated 100% success in delivery of the first and second stents, with significant pulmonary pressure reduction and no evidence of pulmonary artery damage/dissection, no thrombosis, and no damage to the pulmonary valve or tricuspid valve.

“It is an honor to be recognized by CRF and the Jon DeHaan Foundation,” said Seth Bogner, Chairman and CEO of HeartPoint Global. “Our team is grateful to have been selected from a group of innovative companies that presented at this year’s TCT Shark Tank Innovation Competition. The ability to meet a critical need with a less-invasive interventional procedure shows great promise for this most vulnerable patient population.”

“Now in its tenth year, the TCT Shark Tank Innovation Competition highlights the most current innovative device concepts and technological developments with the potential to disrupt the cardiovascular field and dramatically change how patients are treated,” said Greg L. Kaluza, MD, PhD, Senior Director of Research, CRF Skirball Center for Innovation. “This year six companies were chosen from over 50 submissions to present their technologies at the TCT 2023 Shark Tank. A distinguished panel of multidisciplinary experts judged the entrants on the six criteria established for the competition at its inception: unmet clinical need, technology differentiation, IP position/viability, biological proof of concept, regulatory pathway, and commercialization potential.”

For the sixth year in a row, the TCT Shark Tank Innovation Competition partnered with the Jon DeHaan Foundation to provide a $200,000 award for the winner. The Jon DeHaan Foundation is dedicated to supporting those working to advance cardiac medicine and provides grants and awards to individuals and companies who focus on innovative developments in cardiovascular medicine, including research, prevention, diagnosis, treatment, or rehabilitation.

“We are delighted to support the ground-breaking work of HeartPoint Global as it has the potential to benefit countless pediatric congenital heart disease patients,” said Robert Schwartz, MD, President of the Jon DeHaan Foundation. “We wish them the best of luck as they continue their research endeavors. The DeHaan Foundation remains committed to its primary mission of supporting cardiovascular disease and medical innovation. Our strong partnership with CRF and TCT is an ideal collaboration to further this goal.”

“CRF is truly grateful to the Jon DeHaan Foundation for their generous continued support of pioneers in the field dedicated to developing novel technologies for the diagnosis and treatment of cardiovascular disease,” added Dr. Granada.