Pathway Medical Technologies Receives FDA Clearance for Jetstream(TM) Pathway PV(TM) Atherectomy System

KIRKLAND, WA, Sep 05 (MARKET WIRE) --
Pathway Medical Technologies, Inc., an innovator of endovascular
treatments for peripheral arterial disease (PAD), today announced that
the U.S. Food & Drug Administration (FDA) has given the company clearance
to market Jetstream(TM), a peripheral atherectomy catheter designed for
use in the treatment of PAD in the lower limbs. The clearance marks the
company's second 510(k) clearance and the first device on the market
capable of treating an entire spectrum of disease found in the PAD
patient, including hard and soft plaque, calcium, thrombus and fibrotic
lesions with consistent clinical results.

Pathway Medical Technologies President and CEO Tom Clement commented, "The
market introduction of Jetstream(TM) represents a major business milestone
for our organization and a dramatic new treatment option for the
endovascular community in fighting PAD. We expect the device to provide
interventionalists with the clinical versatility they seek, while
providing patients suffering from peripheral arterial disease with more
predictable outcomes. Jetstream(TM) is truly the next logical evolution in
atherectomy."

Approximately 12 million Americans suffer from the effects of PAD and many
in this rapidly expanding patient population go undiagnosed. Commonly
associated with high blood pressure, diabetes, heart disease, stroke and
aging, PAD causes a build-up of plaque within the arteries that limits
blood flow to the extremities. PAD can lead to severe limb pain,
non-healing ulcers and critical limb ischemia and, if left untreated, can
lead to gangrene, amputation and even death. The most common intervention
for PAD has historically included highly-invasive procedures, including
bypass surgery. Unfortunately, many patients are poor surgical candidates
for whom surgery can be life threatening.

Jetstream(TM) represents an innovative and minimally invasive solution to
clear blockages in the peripheral vasculature, restoring blood flow and
effectively treating PAD. Jetstream(TM) consists of a sterile, single-use
catheter and control pod and a reusable, compact console that mounts to a
standard I.V. stand. The catheter has an expandable cutting tip with
rotating blades that safely debulk and preemptively remove both hard and
soft plaque, as well as calcium, thrombus and fibrotic lesions. Excised
tissue and thrombus are continually aspirated from the peripheral
treatment site through ports in the catheter tip to a collection bag
located on the console. The distal portion of the catheter also possesses
infusion ports that provide continuous infusion of sterile saline during
the atherectomy procedure. Active aspiration is a safety feature that
minimizes the risk of distal embolization.

According to William A. Gray, M.D., director of endovascular services,
Center for Interventional Vascular Therapy, New York-Presbyterian
Hospital, "Clinical data suggests that Jetstream(TM) is quite effective
at debulking and treating vascular disease in the peripheral vasculature.
I have seen the efficacy of the Pathway technology first hand in several
cases in Germany and look forward to treating future atherectomy
candidates."

With simple set up and an ergonomic design for easy operation by trained
clinicians, Jetstream(TM) maximizes treatment effectiveness with an
average device activation time of about three and a half minutes during
atherectomy treatment. For patients, Jetstream(TM) offers renewed hope
for non-surgical candidates and the benefits of a minimally invasive
treatment option, including faster recovery and decreased systemic
complications.

Jetstream(TM) delivers several cosmetic and user interface improvements
from the company's first-generation product, the Pathway PV(TM)
Atherectomy System, which was used in the company's Pathway PVD Study, a
pivotal 172 patient European multi-center clinical trial completed in
Germany at three primary centers: Abteilung Angiologie in Bad Krozingen,
Germany, Hamburg University Cardiovascular Center in Hamburg, Germany,
Clinical and Interventional Angiology, Heart Center-University of Leipzig
in Leipzig, Germany.

About Pathway Medical Technologies, Inc.

Pathway Medical Technologies, Inc. was founded to design, market and
manufacture medical devices for the treatment of arterial disease. The
company's initial focus is treating peripheral arterial disease (PAD) more
quickly and effectively than existing technologies. An estimated 12
million people are afflicted by PAD in the U.S. and that number is
projected to grow to over 20 million during the next 10 years. The
company's Jetstream(TM) device allows for a minimally invasive procedure
designed to restore circulation in the peripheral arteries by removing
both hard and soft diseased tissue. For further information, visit the
company's Web site at www.pathwaymedical.com.

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Media Contact:
Marisa Borgasano
Schwartz Communications for Pathway Medical Technologies
Tel: (415) 512-0770
PathwayMedical@schwartz-pr.com

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