AOR.L Regulatory News (AOR)

25 Nov 2008 07:00



FDA Approval Granted to Key AorTech International plc Customer

AorTech International plc (AIM: AOR) the biomaterials and medical device development company, today announces that one of its key customers, Avalon Laboratories, LLC has received 510(k) approval from the US Food and Drug Administration (FDA) for general market release of their specialty Avalon Elite™ Catheter line of products made exclusively with Elast-Eon. This announcement follows previous releases made by AorTech and Avalon Laboratories and highlights continued developments between the companies.

The Avalon Elite is a premium brand of catheters, which incorporates innovative engineering and broad proprietary manufacturing technologies. The new Avalon Elite line will provide a superior product and help facilitate better care for patients suffering from debilitating diseases.

This FDA approval will permit the full commercial launch of these products in the US. The product was introduced for limited clinical use in Europe earlier this year and has performed extraordinarily well in these trials.

The use of Elast-Eon in the Avalon Elite will comprise substantive volumes of polymer sales for AorTech next year as well as in successive years.

Frank Maguire, AorTech CEO said, "The relationship with Avalon Laboratories is an excellent fit for AorTech. Our ISO-certified manufacturing facility was designed specifically with this type of bulk polymer business in mind. Avalon's longstanding position as market leader in its segment makes is an ideal customer at this stage of AorTech's development. We look forward to working with Avalon on other projects in the near future."

Robert Foster, CEO of Avalon Laboratories commented, "The Elast-Eon material has some remarkable properties and it has found important applications in several implantable products. We have been extremely impressed with this innovative material and believe it will provide a tremendous benefit to the Avalon Elite."

-Ends-

For further information please contact:

AorTech International plc

Frank Maguire, Chief Executive

Tel: + 1 801 201 4336

Evolution SecuritiesBobbie Hilliam / Chris Clarke

Tel: +44 20 7071 4300

AorTech International plc

Sarah Price, Investor Relations

Tel: + 1 801 550 4349

e-mail sprice@aortech.com

Notes to Editors:

About AorTech International plc

AorTech develops and manufactures biostable, implantable polymers, including Elast-Eon, the world's leading long-term implantable copolymer. With hundreds of thousands of successful long-term human implants, Elast-Eon is currently used in cardiology, orthopaedic, urological and gastroenterological applications, including pacing leads, cardiac cannulae and stents. Devices manufactured from Elast-Eon have multiple US FDA PMA approvals, CE Marks and Japanese Ministry of Health approval.

Elast-Eon's biostability is comparable to silicone while exhibiting excellent mechanical, blood contacting and flex-fatigue properties. It can be processed using conventional thermoplastic extrusion and molding techniques. AorTech provides a range of materials in a variety of application-specific formulations for use in medical devices and components.

For additional information go to: www.aortech.com

About Avalon Laboratories, LLC

Avalon Laboratories of Rancho Dominguez, CA is the world's leading supplier of cardiopulmonary vascular cannulae, manufacturing more than three-quarters of all cannulae used globally. In 2007, Avalon produced more than 1.8 million cannulae on a contract basis to the world's leading healthcare suppliers.

For additional information go to: www.avalonlabs.com