Vascular Solutions to Transfer PolarCath(TM) Distribution Rights to NuCryo Vascular LLC
November 16 2015 - 4:05PM
Vascular Solutions, Inc. (Nasdaq:VASC) and NuCryo Vascular LLC
today announced that they have mutually terminated the agreement
under which Vascular Solutions has been serving as exclusive
distributor of the PolarCath Peripheral Dilatation System in the
United States. Effective December 31, 2015, Vascular Solutions will
no longer distribute the PolarCath products, and NuCryo Vascular
will take over all sales, marketing, and customer service
activities for the PolarCath products, which are manufactured by
NuCryo.
The termination of the PolarCath distribution agreement does not
alter Vascular Solutions’ preliminary outlook for 2016 revenues and
adjusted earnings that the company provided on its third-quarter
conference call. Vascular Solutions continues to be comfortable
with 2016 revenue growth projections of between 10%-12% and a
similar rate of growth in adjusted earnings. More detailed
financial projections for Vascular Solutions will be provided on
its fourth quarter earnings call in January.
The PolarCath system was invented by Dr. James Joye. PolarCath
was originally developed by CryoVascular, Inc. and received its
first FDA clearance in 2002. In 2005, CryoVascular was acquired by
Boston Scientific, which discontinued manufacturing PolarCath at
the end of 2012. NuCryo Vascular was formed by Dr. Joye and several
of the former CryoVascular executives and employees for the purpose
of acquiring PolarCath and resuming manufacturing of the device.
NuCryo Vascular has established a manufacturing facility for
PolarCath in Sunnyvale, CA.
The PolarCath Peripheral Dilatation System consists of a
disposable catheter, an inflation unit, and a nitrous oxide
cartridge. The system is used to perform balloon cryoplasty®, a
catheter-based treatment that combines the inflation of a balloon
with controlled cooling of the artery. PolarCath is used to dilate
peripheral arteries with the same basic technique as balloon
angioplasty, except that PolarCath uses nitrous oxide, rather than
liquid, to inflate the balloon. The nitrous oxide cools the balloon
to minus ten degrees Celsius, which freezes the built-up plaque in
the artery.
The PolarCath Peripheral Dilatation System has FDA clearance to
dilate stenosis in the peripheral vasculature (iliac, femoral,
popliteal, infrapopliteal, renal, and subclavian arteries) and for
the treatment of obstructive lesions of polytetrafluoroethylene
(PTFE) access grafts or arteriovenous dialysis fistulae. The
PolarCath system is also indicated for post-deployed stent
expansion of self-expanding peripheral vascular stents.
About Vascular Solutions
Vascular Solutions, Inc. is an innovative medical device company
that focuses on developing unique clinical solutions for coronary
and peripheral vascular procedures. The company’s product
line consists of more than 90 products and services that are sold
to interventional cardiologists, interventional radiologists,
electrophysiologists, and vein specialists through its direct U.S.
sales force and international independent distributor network.
The information in this press release contains forward-looking
statements about Vascular Solutions that involve risks and
uncertainties. Those statements include expectations about the
company’s 2016 revenues and adjusting earnings and growth rates in
revenues and adjusted earnings. Vascular Solutions’ actual
results could differ materially from those anticipated in these
forward-looking statements. Important factors that may cause such
differences include those discussed in the company Annual Report on
Form 10-K for the year ended December 31, 2014 and other recent
filings with the Securities and Exchange Commission. The risks and
uncertainties include, without limitation, risks associated with
the need for adoption of the company’s new products, defense of
criminal litigation, exposure to potential shareholder litigation,
exposure to intellectual property claims and litigation,
significant variability in quarterly results, exposure to possible
product liability claims, doing business in international markets,
the development of new products by others, the company’s reliance
on the development of new products and services, constraints or
interruptions in production from key suppliers, breaches or other
failures of information technology and communications systems, the
availability of third party reimbursement, and actions by
government regulatory agencies.
For further information, connect to www.vasc.com.
Contacts:
Vascular Solutions, Inc.
Phil Nalbone, VP-Corp. Dev.
PNalbone@vasc.com
(763) 656-4371
NuCryo Vascular LLC
Kevin Beedon, General Mgr.
KBeedon@nucryovasc.com
650-279-1653
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