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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

February 5, 2013

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 2nd 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 1st 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.

For further information or product inquiries please contact:

QualiMed Innovative Medizinprodukte GmbH

        Investor Relations
        Tel: +49(0)417165780 (main office)

http://www.qualimed.de

SOURCE QualiMed Innovative Medizinprodukte GmbH


Source: PR Newswire