CathWorks FFRangio™ System Receives National Reimbursement Approval in Japan

CathWorks FFRangio™ System Receives National Reimbursement Approval in Japan

FFRangio System Receives National Reimbursement Approval in Japan

CathWorks announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved the application to provide reimbursement for the CathWorks FFRangio™ System, making it more broadly available for coronary artery disease decision-making in Japan. The CathWorks FFRangio™ System has already received regulatory approval from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) in December 2019 and is also commercially available in the United States and Europe.

“The FFRangio System enables us to quickly identify the physiologic significance of coronary artery disease (CAD) without the need for traditional pressure wires or hyperemic agents, which provides significant benefits to clinicians and patients,” said Hiroyoshi Yokoi, M.D., President of Fukuoka Sanno Hospital and Vice Chairman, Japanese Association of Cardiovascular Intervention and Therapeutics. “The Japan reimbursement approval is an important step to enable more physicians and patients to have access to this innovative technology.”

“When patients present with suspected CAD, it is important that we can quickly and cost-effectively determine the appropriate treatment plan,” said Hitoshi Matsuo, M.D., President of Gifu Heart Center. “Our facility has been able to experience firsthand how FFRangio combines artificial intelligence, machine learning, and a streamlined user experience to improve the way we manage and treat our patients.”

The FFRangio System is non-invasive and performed intra-procedurally during coronary angiography without adding additional clinical risk or per procedure costs. Clinical trials have demonstrated the FFRangio system is highly accurate compared to traditional wire based fractional flow reserve (FFR) methods. The technology has the potential to positively impact a significant patient population in Japan, where heart disease is the second leading cause of death and coronary artery disease accounts for approximately half of these deaths.1

“The reimbursement approval in Japan is a significant and important milestone for CathWorks” said Ramin Mousavi, CEO of CathWorks. “We are pleased with the early adoption of FFRangio in Japan, and grateful for the tremendous physician support of the technology. We look forward to expanding our commercial presence to make FFRangio and non-invasive CAD decision-making available to more clinicians and patients in Japan and around the world.”

ABOUT CATHWORKS

CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize coronary artery disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers. The company’s focus today is specifically on bringing the CathWorks FFRangio™ System to market to provide quick, precise, and objective intraprocedural wire-free FFR guidance that is practical for every case. For more information, visit www.cath.works.

1 Iso H. Changes in Coronary Heart Disease Risk Among Japanese. Circulation.2008;118:2725-2729

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Contact Information:

Ben Brockman, 1.949.966.0284, ben.brockman@cath.works

CathWorks Announces Appointment of Ramin Mousavi as Chief Executive Officer and Board Member

Ramin Mousavi appointed as CEO of CathWorks

KFAR-SABA, ISRAEL & ALISO VIEJO, CA (June 14, 2021), CathWorks , a global leader of digital health innovation focused on helping patients with cardiovascular disease, today announced that Ramin Mousavi has been appointed Chief Executive Officer, effective June 21, 2021. Mr. Mousavi has also been appointed to the company’s Board of Directors. Mr. Mousavi succeeds Jim Corbett, who served as the company’s CEO since October 27, 2017.

A rising star of the medical device industry, Mr. Mousavi has executive leadership and operational experience in general management, marketing, strategy, product development, and commercialization across multiple market segments. Most recently, Mr. Mousavi led the patient monitoring and digital health portfolio at Baxter International. Prior to Baxter, he held various leadership assignments at Edwards Lifesciences. Mr. Mousavi served as CathWorks Vice President of Global Marketing & Strategy and the company’s Chief Marketing Officer from 2019 to 2020. Ramin holds B.S. degrees in Computer and Electrical Engineering from University of California, Irvine. He also earned an M.B.A. from Paul Merage School of Business at UC, Irvine, and received a Healthcare Executive Leadership certificate for Business Innovation in Global Healthcare from Harvard Business School. 

“On behalf of the Board of Directors, I would like to thank Jim for his leadership and many important contributions to Cathworks and I am very pleased to welcome Ramin back to our company,” said Scott Ward, Chairman of the Board of CathWorks. “Ramin’s extensive knowledge of CathWorks innovative technologies—combined with his proven track record of building high-performing teams that design, develop, and launch breakthrough innovative products and programs that help patients—makes him uniquely positioned to lead CathWorks. The Board is confident that under Ramin’s leadership, CathWorks is well-positioned for our next phase of technology innovation, market adoption, and global commercial growth.”

“I am honored and delighted to have the opportunity to lead CathWorks, a company with a transformational product portfolio, exceptionally talented people, and committed investors as well as strategic partners,” commented Ramin Mousavi. “CathWorks’ innovative FFRangio technology has the potential to become the standard of care, enhancing the diagnostic decision making of cardiologists around the world. I look forward to working with our clinician partners, employees, the executive management team, and the Board in our mission to provide clinicians with practical, objective physiology information for every patient they treat, and to deliver meaningful value to our patients, customers, and shareholders.”

About CathWorks

CathWorks is a medical technology company focused on applying its advanced computational science platform to optimize Coronary Artery Disease (CAD) therapy decisions and elevate coronary angiography from visual assessment to an objective FFR-based decision-making tool for physicians. FFR-guided PCI decision-making is proven to provide significant clinical benefits for patients with coronary artery disease and economic benefits for patients and payers. The company’s focus today is specifically on bringing the CathWorks FFRangio™ System to market to provide quick, precise, and objective intraprocedural wire-free FFR guidance that is practical for every case.

Learn how the CathWorks FFRangio System can impact your practice.

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