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CosyTherm US FDA Clearance

13 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 rharpum@indithermplc.com www.inditherm.com Nick Bettles, Division Director - Medical +44 (0) 1709 761000 nbettles@indithermplc.com http://www.indithermplc.com/default.asp?ContentID=141 Abchurch Justin Heath/ Louise Thornhill Tel: +44 (0) 113 203 1340 justin.heath@abchurch-group.com 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
Date   Source Headline
26th Jun 202611:00 amRNSAnnual Report and Notice of AGM
16th Jun 20267:00 amRNSFinal Results
2nd Jun 20267:01 amRNSNotice of Results
2nd Jun 20267:00 amRNSTransfer of Non-Core Products to Focus on Neonatal
14th Apr 20267:00 amRNSChange of Adviser
16th Mar 20269:33 amRNSHolding(s) in Company
16th Mar 20269:33 amRNSHolding(s) in Company
5th Mar 20267:00 amRNSUK neonatal division wins NHS framework agreement
26th Feb 20269:23 amRNSHolding(s) in Company
12th Feb 20267:00 amRNSFull year trading update
10th Feb 20269:05 amRNSHolding(s) in Company
3rd Feb 20267:00 amRNSAppointment of Joint Broker
2nd Feb 202611:01 amRNSHolding(s) in Company
28th Jan 20261:40 pmRNSHolding(s) in Company
28th Jan 20267:00 amRNSPurchasing agreement in the US
27th Jan 20269:46 amRNSHolding(s) in Company
26th Jan 202610:02 amRNSHolding(s) in Company
22nd Jan 20261:37 pmRNSHolding(s) in Company
26th Nov 20257:00 amRNSChange of auditor
16th Oct 20251:51 pmRNSHolding(s) in Company
7th Oct 20257:00 amRNSHalf-year Report
23rd Sep 20257:00 amRNSResults presentations for analysts and investors
19th Sep 20257:00 amRNSDirectorate Change
20th Aug 20257:00 amRNSTrading update and notice of results
24th Jul 20251:37 pmRNSResult of AGM
24th Jul 20257:00 amRNSAGM Statement
13th Jun 20259:16 amRNSPublication of AR, accounts & notice of AGM
6th Jun 20257:00 amRNSBoard Change
28th May 20257:00 amRNSUnaudited Preliminary results
23rd May 20257:00 amRNSNotice of Results
15th May 20255:01 pmRNSHolding(s) in Company
15th May 202510:06 amRNSHolding(s) in Company
1st Apr 202511:36 amRNSHolding(s) in Company
21st Mar 20252:49 pmRNSGrant of Options
12th Mar 20256:01 pmRNSHolding(s) in Company
12th Mar 20256:00 pmRNSDirector/PDMR Shareholding
24th Feb 20254:16 pmRNSDirector/PDMR Shareholding
21st Feb 20252:52 pmRNSDirector/PDMR Shareholding
18th Feb 20257:00 amRNSTrading update
10th Feb 20259:54 amRNSHolding(s) in Company
28th Jan 20257:00 amRNSDirectorate Change
14th Jan 20254:08 pmRNSHolding(s) in Company
12th Dec 20247:00 amRNSAppointment of Chief Executive Officer
14th Nov 20247:00 amRNSBoard Change
4th Nov 20247:00 amRNSGrant of Covenant Waiver and Covenant Reset
2nd Oct 20247:00 amRNSHalf-year Report
17th Sep 202412:26 pmRNSResult of AGM
3rd Sep 20247:00 amRNSTrading update for the six months to 31 July 2024
5th Aug 20243:41 pmRNSHolding(s) in Company
2nd Aug 20247:00 amRNSNominated adviser and broker

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