AngioInsight™ Announces First Patient Enrolled in SMARTFLOW™ Clinical Study

Enrollment by Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital marks a significant milestone in the clinical evaluation of AngioInsight's investigational AngioAI+™ platform.

MINNETONKA, Minn.--(BUSINESS WIRE)--AngioInsight Inc.^TM, a company advancing AI-powered cardiovascular diagnostics, today announced the enrollment of the first patient in the SMARTFLOW^TM clinical study, marking a significant milestone in the clinical evaluation of AngioAI+^TM, the company's investigational software platform designed to assess coronary physiology from routine coronary angiographic images.

SMARTFLOW represents AngioInsight's first prospective, multicenter clinical study evaluating the performance of AngioAI+ and bringing together 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 and Dr. Todd C. Villines, who serve as Co-Principal Investigators. The study aims to evaluate the diagnostic performance of AngioAI+ for providing angiography-derived fractional flow reserve (FFR) and detection of coronary microvascular disease (CMD). The study incorporates established invasive physiologic reference standards as benchmarks for success.

Dr. Carlos Collet, principal investigator of the SMARTFLOW study commented, “This milestone marks the beginning of a new era in the angiographic assessment of coronary artery disease. 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, one of the nation's leading cardiovascular research and education institutions and the first site to be activated and enroll in the SMARTFLOW study.

“We are excited to enroll the first patient in the SMARTFLOW study and to help lead this important clinical investigation,” said Dr. Sandoval. “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 (CMD), 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 enrollment of our first patient is an important milestone for AngioInsight and reflects years of scientific collaboration, engineering innovation, and dedicated preparation by an exceptional team of physicians, researchers, engineers, and clinical partners," said Scott Burger, Chief Executive Officer of AngioInsight. “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 extraordinary care provided by its physicians and care teams. MHIF has shown a commitment to leading innovations in cardiology as well as exceptional clinical expertise and unwavering commitment to patients. It is truly an honor to partner with Dr. Sandoval and team. They have earned my deepest respect, 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."

About the SMARTFLOW™ Clinical Study

SMARTFLOW™ is a prospective, multicenter clinical study designed to evaluate the performance of AngioAI+™, AngioInsight's investigational AI-powered software platform being developed to assess coronary physiology from routine coronary angiography without requiring additional invasive instrumentation or changes to existing clinical workflow.

The study is expected to enroll approximately 600 patients across 17 leading cardiovascular centers in the United States and Europe. Co-led by Principal Investigators Dr. Carlos Collet, Columbia University and the Cardiovascular Research Foundation (CRF), and Dr. Todd C. Villines of the University of Virginia. SMARTFLOW will evaluate the performance of AngioAI+ to assess Fractional Flow Reserve (FFR) and coronary microvascular disease (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 Cardiovascular Research Foundation (CRF), whose world-class expertise in cardiovascular clinical research supports the execution and scientific rigor of the SMARTFLOW program.

About AngioInsight™

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.

About AngioAI+™

AngioAI+™ is AngioInsight's investigational, software-only platform designed to provide 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.

CAUTION: Investigational device. Limited by Federal (or United States) law to investigational use.