Medical device producer receives US and EU export approval

Dubai, UAE, 16 June 2011: Regional manufacturers look to meet demands of western markets as Salalah based producer of medical guide wires is set to supply the heavily regulated markets of the United States of America (USA) and the European Union (EU) following its fourth regulatory endorsement in two years.

The Salalah Medical Device Manufacturing Company (SMDM) has the green light to use the coveted Certificate of Conformity Europe (CE Mark) on its medical guidewire devices giving supply access to the 27 countries that make up the European Economic Area.

The CE Mark indicates alignment with strict EU directives in product safety, a must before a product can be used by the EU member states. The mark is also endorsed by the four member countries of the European Free Trade Association (EFTA).

This follows a bumper year of certifications in 2010, when the company was awarded the USA's FDA 510K, as well as two significant ISO standards - ISO 9001 and ISO 13485.

According to Ciaran Hood, SMDM's President and CEO, the company's own brand label (OBL) has been fast to spike interest accounting for one third of sales.

"The portfolio of certifications indicates our ability to manufacture and supply a safe and effective device. We have been swift to secure business in USA, Turkey, Poland, India, Egypt and the United Kingdom.

"There is great interest the OBL product, which makes excellent use of our on-site sterilisation facilities."

Hood confirmed that the Salalah facility, which opened in 2008 as the first medical device manufacturer in the Middle East, is geared up to provide a turnkey service from product design through to packaging.

Guidewires are small diameter spring coils that facilitate the guided placement of catheters and other medical devices used in the diagnosis and treatment of numerous medical conditions. 

The Certificate of Conformity Europe (CE Mark) is a mark to indicate that the product to which it is affixed is in conformance with EU Product Safety Directives. These EU Directives apply to all products that are to be put into service for the first time inside the European Economic Area.  SGS is the global leader and innovator in inspection, verification, testing and certification services. http://www.uk.sgs.com/about_us_uk

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About Ascent Group
The Ascent Group comprises companies that provide public capital market and private equity market products and services to institutions and high net individuals. Ascent Medical Technology Fund, LP is the first of the two funds dedicated to funding innovative medical device and life science companies.

Peggy A. Farley is a Managing Director of the General Partner and co-founder of the Ascent Medical Technology Funds. She is the President and Chief Executive Officer of Ascent Capital Management, Inc. Karl Groth Ph.D. is a co-founder with Farley of the Ascent Medical Technology Funds and is President and CEO of the General Partner.

Dr. Karl Groth and Peggy Farley have a long history of working together to fund innovation.

The Ascent Medical Technology Fund II, L.P. (the Fund) was established in year 2006. The Fund is dedicated to advancing medical innovation through investing in early-commercialization stage companies that have technologies sufficiently innovative to effect dramatic changes in the treatment of serious global health issues such as cardiovascular disease and cancer. The Fund has also established companies in the Middle East, specifically in Jordan and Oman, which provide the necessary infrastructure for the Middle East to have a medical technology industry.

The Philadelphia BioMed Product Development Centre, PSC is the first of its kind medical centre in the Middle East It is a private shareholding company based in Amman, Jordan, and owned by the Ascent Medical Product Development Centre Inc., based in the United States.

© Press Release 2011