AngioInsight Gearing Up for SMARTFLOW Clinical Study

AngioInsight Inc. is preparing for the start of its pivotal clinical study, SMARTFLOW, which will evaluate the diagnostic accuracy and effectiveness of its AngioAI+ platform.

Designed to revolutionize angiography imaging and cardiovascular diagnosis, AngioAI+ is a software-only platform that leverages cutting-edge AI/ML algorithms to enhance the precision and efficiency of angiography image interpretation. AngioAI+ is being developed to provide real-time 3D reconstruction, non-invasive FFR estimations, stenosis measurements, and to identify coronary microvascular dysfunction (CMD) presence.

The SMARTFLOW study is a key milestone in AngioInsight’s path to AngioAI+’s regulatory clearance and commercial adoption, executives claim. The company is focused on bringing precision to cardiovascular disease and, coronary microvascular disease assessment and diagnosis, the latter of which is difficult to diagnose, especially in women.

“We are excited to launch this pivotal clinical study for AngioInsight,” AngioInsight CEO Scott Burger said. “This study aims to validate the robustness of our AI-powered platform using data from real-world clinical settings. By harnessing AI’s power, the AngioAI+ platform will equip cardiologists with rapid and enhanced cardiovascular diagnostic capabilities, as well as identifying patients with CMD, with the goal of improving patient care outcomes.”

Slated to begin in mid 2025, the study will enroll patients suspected of coronary artery disease (CAD) undergoing coronary angiography and clinically indicated coronary physiologic assessment in the cardiac catheterization lab. The primary objective is to evaluate the diagnostic performance of the AngioAI+ platform in providing estimated fractional flow reserve (FFR) and CMD detection. Crucially, current CMD detection methods involve invasive wires with added challenge and patient risk, and advanced tests for non-invasively assessing CMD are often not available, expensive, and (in the case of PET) require radiation. As such, the condition remains challenging to diagnose through conventional methods—especially in women, who account for more than 50% of CMD cases. Research suggests that CMD is a leading cause of ischemic heart disease in women, yet it often goes undiagnosed. The AngioAI+ platform is being designed to provide an accurate CMD assessment, non-invasively within minutes.

The study will be led by Dr. Todd C. Villines of the University of Virginia (UVA) and Dr. Carlos Collet of OLV Hospital in Aalst, Belgium. The trial will be conducted across approximately 15 U.S. and European centers. Upon completion, AngioInsight plans to submit the results to regulatory authorities for review and marketing authorization, advancing the pathway for commercialization and widespread use.

AngioInsight Inc. is developing an advanced artificial intelligence/machine learning solution to change the way cardiovascular diseases are diagnosed and managed. The company’s proprietary platform is expected to provide clinicians with real-time insights for both anatomical and functional assessment, as well as detection of coronary microvascular disease often missed or misdiagnosed, especially in women.

The AngioAI+ platform under development is a software-only design, positioned to integrate seamlessly into existing healthcare workflows, offering cardiologists advanced tools to expedite angiographic assessment and aid in the functional evaluation and CAD diagnosis. The platform’s AI-based algorithms are being trained on vast datasets to detect subtle patterns and anomalies in angiography images, providing actionable insights that support informed clinical decisions.