Balda AG

EANS-News: Balda AG
Medical subsidiary obtains regulatory approval for an innovative product under its own name for the first time

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Bad Oeynhausen (euro adhoc) - Balda AG: Medical subsidiary obtains regulatory approval for an innovative product under its own name for the first time

Successful system integration of hardware and software for a unique pharmaceutical dispenser

Bad Oeynhausen, 6 October 2010 - Balda Medical GmbH & Co. KG, Bad Oeynhausen, an affiliated company of Balda AG listed on the SDax on the Frankfurt Stock Exchange, has successfully completed the development of an innovative product on behalf of a global pharmaceutical client. "The device supports the effect of the medicine by timely, precise and regular use. This unique pharmaceutical dispenser combines both mechanical components and electronic assistance systems in one. We are responsible for both, the complete implementation of hardware as well as software", explains Dr. Rolf Eilers, CEO of Balda Medical. In addition, the company satisfies all regulatory requirements. Balda Medical has obtained the regulatory approval for the pharmaceutical dispenser under its own name for the first time for the European market (CE-symbol). The core business of the company, based in Bad Oeynhausen, comprises the development, the set up for mass production and the production of disposable articles as well as complex products manufactured from plastic. The main customer base comes from the pharmaceuticals, diagnostics and medical technology market segments.

The product, which is also intended for the U.S. market, was developed in accordance with the requirements of the U.S. Food and Drug Administration (FDA). Balda Medical will provide comprehensive product documentation for the approval procedure, called "Device Master File". The company has been registered as a manufacturer by the FDA since 2009.

With the new drug dispenser Balda Medical is following important market trends in two ways. The rapidly increasing self-care of patients with hand-held devices occurs more frequently now using electronic support. The appropriate and controlled intake of medicine allows for a significantly improved treatment of patients.

The successful system integration of software and hardware, as well as the lead responsibility for regulatory requirements, demonstrates the broad service portfolio and the competitive strengths of the system partner Balda Medical. "The demand from our customers for a variety of capabilities from one source is constantly increasing," said Eilers.

* * * Company Profile Balda AG The Balda Group develops and produces complete plastic assemblies, electronic products and products for the medical industry. The customers of Balda are leaders in business from the mobile, entertainment and electronic communications as well as pharmaceutical and medical technology markets. The group has an international position with product sites in China, Malaysia and Germany. A subsidiary in the United States serves North American customers in product design and development. As part of a shareholding in a leading manufacturer of touch screens in China, Balda participates in the dynamic touch screen displays market.

* * *

This corporate news announcement includes "forward-looking statements" which are based on the current expectations of the management of Balda. They are subject to risks and uncertainty because they relate to events and depend on circumstances that will occur in the future, such as, for example, developments in the mobile communications industry, changes in technology and the ability to timely and successfully develop new products and various other factors. Balda does not undertake any obligation to update publicly or revise forward-looking statements except to the extent legally required. This corporate news announcement is not an offer of securities for sale or a solicitation of an offer to purchase securities in the United States or elsewhere. The shares in Balda AG (the "Shares") may not be offered or sold in the United States or to or for the account or benefit of U.S. persons (as such term is defined in Regulation S under the U.S. Securities Act of 1933, as amended (the "Securities Act") unless registered under the Securities Act or pursuant to an exemption from such registration. The Shares have not been and will not be registered under the Securities Act.

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ots Originaltext: Balda AG
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Branche: Semiconductors & active components
ISIN:      DE0005215107
WKN:        521510
Index:    CDAX, Prime All Share
Börsen:  Frankfurt / regulated dealing/prime standard
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