AngioInsight’s SMARTFLOW Clinical Study Patient Enrollment Underway

AngioInsight Inc. has enrolled the first patient in the SMARTFLOW clinical study that will evaluate AngioAI+, its investigational software platform designed to assess coronary physiology from routine coronary angiographic images.

SMARTFLOW represents AngioInsight’s first prospective, multicenter clinical study evaluating the AngioAI+’s performance and uniting internationally recognized leaders in coronary physiology, premier cardiovascular centers, and experienced clinical research partners.

The prospective, multicenter SMARTFLOW study is co-led by internationally recognized cardiologists Dr. Carlos Collet (Columbia University and the Cardiovascular Research Foundation (CRF) and Dr. Todd C. Villines (University of Virginia), who serve as co-principal investigators. The study will assess the diagnostic performance of AngioAI+ for providing angiography-derived fractional flow reserve (FFR) and coronary microvascular disease (CMD) detection without requiring additional invasive instrumentation or changes to existing clinical workflow. The study incorporates established invasive physiologic reference standards as benchmarks for success.

“This milestone marks the beginning of a new era in the angiographic assessment of coronary artery disease,” Dr. Collet said. “The investigational software is designed to process angiograms fully automatically, without user interaction, providing a comprehensive assessment of coronary lesions while also helping to identify microvascular disease. This is an important step toward supporting physicians in making faster, more accurate diagnoses through the use of artificial intelligence.”

The first patient in the SMARTFLOW study was enrolled by Dr. Yader Sandoval and his research team at the Minneapolis Heart Institute Foundation (MHIF) at Allina Health Minneapolis Heart Institute, Abbott Northwestern Hospital. Dr. Sandoval is also co-chairman of the Center for Coronary Artery Disease at MHIF, a cardiovascular research and education institution, and the first site to be activated and enrolled in the SMARTFLOW study.

“We are excited to enroll the first patient in the SMARTFLOW study and to help lead this clinical investigation,” Dr. Sandoval stated. “Building on recent advances that have established angiography-derived physiology as an important component of contemporary coronary physiology for the assessment of epicardial coronary artery disease, SMARTFLOW aims to expand physiologic assessment to include coronary microvascular disease, a major unmet clinical need. The ability to assess both epicardial and microvascular disease from routine coronary angiography could simplify physiologic evaluation and expand access to coronary functional testing.”

The study is expected to enroll approximately 600 patients across 17 cardiovascular centers in the United States and Europe. SMARTFLOW will evaluate the performance of AngioAI+ to assess FFR and CMD using established invasive physiologic reference standards as benchmarks while also evaluating the software’s advanced three-dimensional vessel reconstruction and stenosis assessment. The study is being conducted in collaboration with the CRF, whose expertise in cardiovascular clinical research supports the execution and scientific rigor of the SMARTFLOW program.

“The enrollment of our first patient is an important milestone for AngioInsight and reflects years of scientific collaboration, engineering innovation, and dedicated preparation by physicians, researchers, engineers, and clinical partners,” AngioInsight CEO Scott Burger commented. “SMARTFLOW represents an important step in building the clinical evidence that will support future regulatory filings for AngioAI+. For me, this milestone is especially meaningful because it begins here in Minnesota at Minneapolis Heart Institute Foundation. Having referred family members and many friends to the great cardiologists at Allina Health Minneapolis Heart Institute and Abbott Northwestern Hospital, I have seen firsthand the care provided by its physicians and care teams. MHIF has shown a commitment to leading innovations in cardiology as well as clinical expertise and commitment to patients. It is truly an honor to partner with Dr. Sandoval and team. They have earned my deepest respect and appreciation, and I am thankful to work closely with them as we begin the SMARTFLOW clinical study.”

“Innovative science supported by rigorous clinical evidence is the foundation of everything we do,” Burger added. “SMARTFLOW is an important step toward evaluating how artificial intelligence can help unlock new physiologic insights from routine coronary angiography. We believe studies like SMARTFLOW are essential to advancing the science of angiographic intelligence, expanding our understanding of coronary physiology across diverse and underrepresented patient populations—including women—and supporting more informed cardiovascular care.”

AngioInsight is advancing the science of angiographic intelligence through the development of next-generation software only based solutions for cardiovascular imaging. The company is pioneering technologies that analyze routine coronary angiographic images to provide real-time insights into both anatomical and functional coronary physiology. Driven by a vision to unlock the full diagnostic potential of coronary angiography, AngioInsight is developing AI-powered solutions that integrate seamlessly into existing clinical workflows, expanding access to physiologic assessment, supporting more informed physician decision-making, and advancing precision cardiovascular care.

AngioAI+ is AngioInsight’s investigational, software-only platform designed to provide artificial intelligence (AI)-powered analysis of routine coronary angiographic images. The platform is being developed to assess coronary physiology—including anatomical and functional parameters without requiring additional invasive instrumentation or procedural workflow changes. AngioAI+ is intended to integrate into existing catheterization laboratory workflows to support physician evaluation during diagnostic and interventional coronary procedures.