Market Overview

CathWorks FAST-FFR Trial Enrollment Completed Early

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CathWorks announced that its FAST-FFR trial is fully enrolled ahead of
schedule. The trial is designed to evaluate efficacy of the CathWorks FFRangio™
System in terms of sensitivity and specificity when compared to
conventional invasive Fractional Flow Reserve (FFR). Enrollment in the
trial began on September 27, 2017 and enrollment of all 382 subjects was
completed just eight (8) months later on June 7, 2018.

FFR is an invasive technique used to measure pressure differences across
a stenosed area in the coronary arteries. CathWorks FFRangio
System is non-invasive and performed intra-procedurally, during coronary
angiography. The System is designed to enable physicians to objectively
and cost-effectively determine if PCI (percutaneous coronary
intervention) is indicated, without an additional intervention during
the course of a routine diagnostic angiography.

The FAST-FFR trial is being conducted at ten leading cardiovascular
centers around the world using various coronary angiography platforms.
These sites include:

         
  • OLV Aalst, Belgium
  • Rabin Medical Center, Israel
  • Rigs Hospital CPH, Denmark
  • St. Francis Hospital, NY, USA
  • University of Erlangen, Germany
  • Stanford University, CA, USA
  • Share Zedek Medical Center
  • Columbia University, NY, USA
  • HaSharon Medical Center, Israel
  • University of Pennsylvania, PA, USA
 

William F. Fearon, MD, Director of Interventional Cardiology at Stanford
University Medical Center, is the FAST-FFR trial principal investigator.
"As interventional cardiologists, we want objective multi-vessel
physiologic measurements to make PCI decisions, which can be performed
easily and with as low risk and cost as possible," Dr. Fearon said. "We
look forward to the data analysis and understanding how CathWorks FFRangio
System data compares to pressure wire-derived FFR."

Jim Corbett, CathWorks CEO, added, "Early enrollment of the FAST-FFR
trial population confirms interventional cardiologists' excitement about
cost-effectively adding a new level of objectivity in PCI
decision-making."

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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