Fourth Generation CathWorks FFRangio® System Receives Regulatory Approval in Japan

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Oct. 06, 2022

KFAR-SABA, ISRAEL & IRVINE, CA (October 6, 2022) CathWorks announced today the approval of the fourth generation CathWorks FFRangio® System by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). The FFRangio System is also commercially available in the United States and Europe.

“The FFRangio System enables us to quickly perform a comprehensive physiologic assessment of coronary artery disease (CAD) without the need for invasive pressure wires or hyperemic agents, providing significant benefits to clinicians and patients,” said Dr. Yutaka Hikichi, Director, Heart Center, Saga-Ken Medical Center Koseikan. “The approval of the fourth-generation application offers significant automation and enhancements, further simplifying the utilization of the platform.”

“CAD is a life-threating disease, and it is critical that we can quickly, effectively, and cost-effectively diagnose the disease and determine the appropriate treatment plan,” said Dr. Mamoru Nanasato, Chief Director, Department of Cardiology, Sakakibara Heart Institute. “We have been able to experience firsthand how FFRangio can transform the diagnosis and treatment of our patients with CAD.”

The CathWorks FFRangio® System has been the first non-invasive device of its kind to receive Japan PMDA and Ministry of Health, Labour and Welfare (MHLW) approval for diagnosis of functional ischemia for patients with ischemic CAD. The fourth-generation application includes significant automation and enhancements, while offering the same exceptional 93% diagnostic accuracy when compared to invasive wire-derived FFR.1

“The PMDA approval of the fourth generation CathWorks FFRangio® System is another significant milestone for CathWorks, physicians and patients,” said Ramin Mousavi, President and CEO of CathWorks. “With this approval, along with our recently announced strategic partnership with Medtronic that includes global co-promotion, we are well positioned to significantly expand our presence in Japan, making the FFRangio technology available to more physicians and patients. The FFRangio platform enables physicians to optimize the diagnosis and treatment of CAD, while eliminating unnecessary invasive wires and drugs, all while reducing cost.”

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 Twitter and LinkedIn.

 

1 Witberg G, De Bruyne B, Fearon WF, et al. Diagnostic performance of angiogram-derived fractional flow reserve: a pooled analysis of 5 prospective cohort studies. J Am Coll Cardiol Intv. 2020;13(4):488-97.

 

Contact

Media: Natalie Sickler    [email protected]

Investors: Mike Feher     [email protected]

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