CathWorks Announces the Completion of Enrollment for Landmark ALL-RISE Randomized Controlled Trial

ALL-RISE Study Included Over 1,924 Patients in 59 Sites Across 
North America, Asia, Europe and the Middle East

NEWPORT BEACH, Calif., Jan. 3, 2025 /PRNewswire/ -- CathWorks, a global leader in medical device digital health innovations, announced today the successful completion of enrollment of the Advancing Cath Lab Results with FFRangio Coronary Physiology Assessment (ALL-RISE) randomized controlled trial (RCT). This landmark study represents a significant milestone in the field of interventional cardiology, evaluating the clinical and economic benefits of the CathWorks FFRangio^® System in diagnosing and treating coronary artery disease (CAD), offering potentially groundbreaking evidence that could redefine the standard of care.

The ALL-RISE Study included over 1,924 patients across 59 sites in North America, Asia, Europe and the Middle East. Participants presenting with coronary stenoses of intermediate significance and requiring physiology assessment were randomized to receive either FFRangio-guided treatment or invasive pressure wire-guided treatment. Notably, this was the first-ever randomized controlled trial in the United States to assess clinical outcomes using an angiography-based tool for physiologic lesion assessment.

In a joint statement, the ALL-RISE Study Chair, Dr. Ajay J. Kirtane (NewYork-Presbyterian/Columbia University Irving Medical Center) and Principal Investigators, Dr. William Fearon (Stanford University) and Dr. Allen Jeremias (St. Francis Hospital & Heart Center), stated, "On behalf of the study executive committee, we would like to congratulate and thank all the global investigators, study coordinators and patients who collectively enabled this incredible accomplishment. The high level of engagement and record speed of enrollment parallel the growing adoption of FFRangio globally. We look forward to sharing the results of this landmark study after clinical follow-up is completed."    

CathWorks Sr. Director of Clinical Affairs, Alex Froimovich M.D., added, "The completion of ALL-RISE enrollment marks a significant milestone for our company and team's mission to transform how cardiovascular disease is diagnosed and treated. We believe this study, adding to FFRangio's growing body of clinical evidence, has the potential to significantly advance the field of coronary physiology and close the gap between its current adoption and the appropriate use guidelines recommendations. FFRangio has already demonstrated higher diagnostic accuracy over all other angio-based technologies, highlighting the fact that not all angio-based technologies are created equal, and therefore technology-specific clinical data are needed."

Cardiovascular disease (CVD) remains the leading cause of death in the United States. According to the American Heart Association's (AHA) 2024 Heart Disease and Stroke Statistics Update, CVD accounted for 931,578 deaths in the U.S. in 2021, and close to 18 million deaths globally. Coronary artery disease (CAD) is the single largest contributor, responsible for over 40% of CV deaths. CathWorks believes the results from the ALL-RISE study will build on what the company refers to as a new era in physiology, underscoring FFRangio as the new standard of care with the potential to drive better patient outcomes while delivering tangible economic and resource utilization benefits to healthcare systems.

ABOUT CATHWORKS

CathWorks is the leader in digital health innovations that can improve the lives of patients globally. The CathWorks FFRangio^® System combines artificial intelligence and advanced computational science, transforming how cardiovascular disease is diagnosed and treated. The FFRangio System obtains physiologic information from routine angiograms, eliminating the need for drug stimulation and invasive pressure wires. It provides physicians with quick and reliable intraprocedural FFRangio values for the entire coronary tree. For more information on CathWorks, visit www.cath.works and follow @CathWorks on  LinkedIn. 

Investors:
Mike Feher
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Media:
Sarita Monico
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