Market Overview

CathWorks FFRangio™ System Files FDA 510(k) Submission


CathWorks announced that it has submitted its CathWorks FFRangio™ System
to the United States Food & Drug Administration (FDA) for review and
510(k) market clearance.

The CathWorks FFRangio System is the non-invasive FFR
platform that quickly and precisely delivers objective multi-vessel
physiologic measurements to cost-effectively optimize and confirm
intraprocedural PCI therapy decisions. It is designed to deliver the
objective FFR guidance needed to optimize percutaneous coronary
intervention (PCI) therapy decisions for every patient.

The FDA 510(k) submission was filed on August 7, 2018. This submission
was made possible following early, full enrollment of the FAST-FFR trial.

CathWorks CEO Jim Corbett said, "The FAME trials clearly demonstrated
the clinical and economic value of FFR in PCI decision-making. We are
confident that the CathWorks FFRangio System meets a real
need for patients and physicians, and we expect the system to make
non-invasive, wire-free FFR possible in coronary angiograms; reducing
wire-related risks and costs."

Corbett went on to add, "We anticipate 510(k) market clearance by the
end of 2018. Given the CathWorks System's compatibility with major
coronary angiogram platforms and a clear CPT code, we expect the system
to start benefitting physicians and their patients very soon."

The CathWorks FFRangio System is in development and is not
yet FDA cleared or available for sale within the United States.

About CathWorks

CathWorks is a medical technology company focused on applying its
advanced computational science platform to optimize PCI 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 FFR guidance that is practical
for every case.

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