PR90758

KFAR-SABA, Israel and ALISO VIEJO, Calif., July 26, 2021/PRNewswire=KYODO JBN/--

CathWorks announced that the Japanese Ministry of Health, Labour and Welfare

(MHLW) has approved the application to provide reimbursement for the CathWorks

FFRangio(TM) System, making it more broadly available for coronary artery

disease decision-making in Japan. The CathWorks FFRangio(TM) 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.

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"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(TM)

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: Masashi Yamamoto

         +81-(0)3-6300-6927

         masashi.yamamoto@cath.works

SOURCE:  CathWorks