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QualiMed Innovative Medizinprodukte GmbH, Based In Winsen Germany Has Received Notice Of CE Approval For Its Line Of Peripheral Balloons For The Treatment Of Peripheral Vascular Obstructions

HAMBURG, Germany, February 5, 2013 /PRNewswire/ --

It is estimated that the global interventional peripheral device market will exceed 4 Billion euros by 2015. The three largest portions of this market ranked in order based on global market size are:
  1. Peripheral Vascular Stents which account for approximately 34% of the market
  2. PTA Balloon Catheters representing the 2 nd largest market segment
  3. Aortic Stent Graft claiming the third largest portions respectively.

The interventional peripheral market sector has been experiencing rapid growth in technological advancements as well as significant consolidation over the last 3 to 5 years. The mid cap consolidation is the primarily result of acquisitions by large multinationals looking to establish an entry into the peripheral markets, broaden their product portfolio, and expand their sales reach and expertise in this area. Companies such as EV3 acquired by Covidien, Invatec by Medtronic, Atrium by Marquette, Clear Stream by Bard, as well as a number of others has left a void of peripheral vascular interventional technology companies in the mid cap market. Further the consolidation of the mid cap distribution channel into that of the acquirers has left an excess channel capacity of well-trained distributors that have significant relationship with existing clinicians, administrators, and support staff in the geographies they represent.

Qualimed believes the availability of its current line of peripheral stents coupled with its new line of innovative PTA Balloons in .035, .018, and .014 guide wire compatibility up to 280 mm lengths that minimize inflation and deflation time as well as a line of AV Shunt balloons in .035 and .018 guider compatibility with high pressure to 22 RBP allows the company to provide one of the largest independent balloon production and product offerings globally. This advanced balloon technology is available for sale through Qualimeds OEM, Private Label, and Own Branded sales channels. This new offering, coupled with the companies currently approved line of peripheral vascular stents, aspiration devices, as well as future peripheral technologies that will be launched in the 1 st half of 2013, uniquely position Qualimed to take advantage of this channel opportunity and execute on its growth plans for in the Asian-Pacific and Middle East regions.

Eric Mangiardi, Investor in Qualimed commented: "We are very pleased to announce this significant milestone and to further execute on our strategy to expand our product offering and technology advancements in the areas of Interventional Cardiology, Peripheral Vascular, and Non-Vascular areas. This new balloon technology will be the platform the company utilizes to complete its illuminating balloon platform that allows visibility under x-ray without the use of contrast media and its entrance into the drug eluting balloon space."

QualiMed was founded in 1997 in Winsen, Germany near Hamburg, where it develops, manufactures, and sells implantable medical devices in the Cardiology, Peripheral Vascular, and Non Vascular areas. The innovations are focused in the areas of Biodegradable Products, Drug Device Combination Technologies, Catheter, and Mechanical implant areas. Originally founded as an OEM, the company's products are now sold in over 50 countries worldwide through its OEM, Private Label, and Own Brand Networks. The company and its development partners have obtained CE and FDA approvals for more than 70 different products including 3 different drug eluting stents.

This announcement includes "forward-looking statements" which include all statements other than statements of historical facts, including, without limitation, those regarding the Group's financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to the Group's products and services), and any statements preceded by, followed by or that include forward-looking terminology such as the words "targets", "believes", "estimates", "expects", "aims", "intends", "will", "can", "may", "anticipates", "would", "should", "could" or similar expressions or the negative thereof. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors beyond the Group's control that could cause the actual results, performance or achievements of the Group to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. Such forward-looking statements are based on numerous assumptions regarding the Group´s present and future business strategies and the environment in which the Group will operate in the future. Among the important factors that could cause the Group's actual results, performance or achievements to differ materially from those in forward-looking statements include those relating to QualiMed's funding requirements, regulatory approvals, clinical trials, reliance on third parties, intellectual property, key personnel and other factors. These forward-looking statements speak only as at the date of this announcement. The Group expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained in this announcement to reflect any change in the Group's expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, readers are cautioned not to rely on any forward-looking statement.

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