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CosyTherm US FDA Clearance

13th Dec 2006 07:03

Inditherm PLC13 December 2006 Press Release 13 December 2006 Inditherm plc ("Inditherm" or "The Company") Granted US FDA Clearance for CosyTherm Neonatal Warming System Inditherm plc (AIM: IDM), the provider of innovative heating solutions to thefood, industrial process, utility, medical, construction and sport industries,has been granted 510(k) clearance by the US Food and Drug Administration ("FDA")to sell its CosyTherm neonatal warming systems in the USA. This follows asimilar clearance for the Company's patient warming products granted in May2006. FDA clearance opens the way for Inditherm to market its innovative neonatalproducts in the US market. The CosyTherm system is ideally suited for use inSpecial Care Baby Units (SCBU), Neonatal Intensive Care Units (NICU), post-natalwards and delivery suites. It can also be adapted for use in transportapplications. Commenting on the news, Nick Bettles, Medical Division Director at Inditherm,said, "We are delighted that we can now market our full range of medicalproducts into the USA. Given the importance of FDA clearance, not just in termsof US legislation, but also as reassurance to potential purchasers worldwide,this further underpins the growth plans for our medical business." - Ends - For further information contact: Inditherm plc Richard Harpum, CEO +44 (0) 1709 761000 [email protected] www.inditherm.com Nick Bettles, Division Director - Medical +44 (0) 1709 761000 [email protected] http://www.indithermplc.com/default.asp?ContentID=141 Abchurch Justin Heath/ Louise Thornhill Tel: +44 (0) 113 203 1340 [email protected] www.abchurch-group.com Notes: Inditherm plc is an AIM-listed provider of low voltage, cost-effective heatingtechnology. It designs, manufactures and installs its specialised, patentedheating technology in a range of applications that require heating, temperaturemaintenance or frost protection, including industrial, utility, medical,construction, and sports turf heating. The Rotherham-based company operates ina global environment and has a blue-chip customer base. Inditherm's technology uses a carbon-based, electrically conductive polymer,also called Inditherm, to produce a cost-effective, flexible and adaptableheating surface. Powered by a low voltage supply, Inditherm generates uniformheat over its entire surface with no hot spots. Inditherm recently signed an agreement with Smiths Medical to distribute itsmain line of patient warming products, for the operating room, associateddepartments and the emergency room, into the US market. This information is provided by RNS The company news service from the London Stock Exchange

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