MINNEAPOLIS, Nov. 16, 2015 (GLOBE NEWSWIRE) -- 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.
Source:Vascular Solutions, Inc.