AngioInsight, Inc. Announces the SMARTFLOW Pivotal Clinical Study

MINNETONKA, Minn.–(BUSINESS WIRE)–AngioInsight, Inc., a leader in AI-driven cardiovascular solutions, today announced the upcoming launch of its pivotal clinical study, SMARTFLOW ™, to evaluate the diagnostic accuracy and effectiveness of its innovative AngioAI+ platform. Designed to revolutionize angiography imaging and cardiovascular diagnosis. The AngioAI+™ is a software only platform which leverages cutting-edge AI/ML algorithms to enhance the precision and efficiency of angiography image interpretation. AngioAI+ is being designed to provide real-time 3D reconstruction, non-invasive FFR estimations, stenosis measurements, and to identify the presence of CMD.

“We are excited to launch this pivotal clinical study for AngioInsight,” said Scott Burger, CEO of AngioInsight, Inc. “This study aims to validate the robustness of our AI-powered platform using data from real-world clinical settings.”

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The SMARTFLOW study is a key milestone in AngioInsight’s path to regulatory clearance and adoption of its transformative technology. The company is laser-focused on bringing precision to the assessment and diagnosis of cardiovascular disease and, importantly, coronary microvascular disease, which is difficult to diagnose, especially in women.

“We are excited to launch this pivotal clinical study for AngioInsight,” said Scott Burger, CEO of AngioInsight, Inc. “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 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 FFR and the detection of CMD. Crucially, current detection methods for CMD involve invasive wires with added challenge and patient risk, and advanced tests for the non-invasive assessment of 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 assessment of CMD, 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 centers in the US and Europe. Upon completion, AngioInsight plans to submit the results to regulatory authorities for review and marketing authorization, advancing the pathway for commercialization and widespread use.

About AngioInsight, Inc.

AngioInsight, Inc. is a pioneering developer of an advanced AI/ML solution aimed at transforming 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 goal is to enable more accurate and actionable patient care, aiming to reduce the cost of care through AI’s accuracy and efficiency.

About AngioAI+

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 diagnosis of CAD. 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. Investigational disclaimer: CAUTION the AngioAI+ is an investigational device. Limited by Federal (or United States) law to investigational use.