XableCath Catheters Demonstrate Ability to Cross Chronic Venous Occlusions

Opens New Market Opportunity; Expected to Improve Care for Patients
with CVI

SALT LAKE CITY–(BUSINESS WIRE)–XableCath, a commercial-stage medical device company, announced today
that it has demonstrated initial safety and efficacy of its unique
catheters for use with chronic venous occlusions, commonly characterized
by recalcitrant lesions that have historically proven difficult to cross
with standard catheter technologies. XableCath catheters are FDA-cleared
for use in the peripheral vasculature and may be used in both peripheral
arteries and veins.

The unique design of both the blunt- and abrasion-tip XableCath
catheters — with their excellent columnar support and pushability —
crossed tough venous lesions quickly and with relative ease, even in
cases where other products could not. Failure rates in crossing venous
occlusions have historically been high due to inadequacies in currently
available technologies. Also, crossing devices used in arterial lesions
have not been validated in the venous system for lesions that are
pathologically different: dense fibrous collagen versus atherosclerotic,
often calcified, plaque. Safe and effective crossing is necessary to
facilitate angioplasty or stenting that can relieve the venous
hypertension and improve the functional status of the limb.

More prevalent than peripheral artery disease, chronic venous
insufficiency (CVI) afflicts more than 30 million patients in the United
States alone. Left untreated, patients with CVI suffer from debilitating
eczema, lipodermatosclerosis, pain and venous ulcers. While endovascular
treatments exist in the form of drug-coated balloons and stents,
interventionalists are often unable to administer these treatments due
to a lack of reliable options to cross occlusions. With several new
products available and many more in clinical trials for use in the
venous vasculature system, interventionalists are shifting their
practice to the treatment of CVI, resulting in a burgeoning need for a
safe and effective crossing solution.

“The clinical results of our first small series of venous use cases are
outstanding, and we are delighted with the early results showing the
unique ability of our catheters to successfully and safely cross venous
occlusions,” said Lisa Dunlea, XableCath’s President and CEO. “This is a
great market opportunity for XableCath, because few solutions exist for
safe and effective crossing of challenging venous lesions. Physicians
have long voiced their demand for such a product, and we look forward to
continuing to address their needs, helping to improve patient care and
empowering interventionalists to tackle more difficult cases.”

Patricia Thorpe, MD, an interventional radiology specialist at St.
Luke’s Medical Center in Phoenix, AZ was the first in the world to use
the XableCath blunt-tip catheter in a venous case, which was also the
first use of XableCath technology in the venous system. “The XableCath
blunt-tip catheter provided excellent support for crossing chronic
femoral iliac and caval thrombus as the catheter resists buckling and
allows a twisting technique to advance over an .018″ or .035″ wire,”
said Dr. Thorpe. “An advantage is that the lumen is designed to use with
either size wire. This eliminates need to exchange catheters.”

Ramsey A. Al-Hakim, MD, Assistant Professor & Director of Inpatient
Services at Oregon Health & Science University, was the first in the
world to use the XableCath abrasion-tip catheter in a venous case. “When
my conventional crossing catheters failed, I was able to successfully
cross an iliac chronic total occlusion using the abrasion tip catheter
and complete the iliocaval reconstruction to help my patient with a
non-healing venous ulcer,” said Dr. Al-Hakim.

As a next step, XableCath plans to complete a venous registry study in
the United States.

About XableCath

XableCath was founded in 2014 to commercialize catheters for the
treatment of vascular disease. XableCath technology is revolutionary and
allows effective treatment, improving the lives of patients and
transforming the ease of vascular interventions for physicians. For more
information visit www.xablecath.com.


XableCath, Inc.
Lisa Dunlea
President and CEO

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