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sojourner

04/27/08 12:17 PM

#18930 RE: rocketeer357 #18929

Re: "The last 10K made it clear that LTC wasn't being pursued in Europe..."

To which 10-K do you refer? The 28 March 2008 10-K offers this appraisal. (Underlining mine.) The LTC generator (the heart and soul of LTC) is approved in the largest economy on earth, the European Union. It would be nothing short of madness for DR to forego that gaping opportunity. Following the opportunity, DR has every intention to move forward in the EU while he girds up for FDA approval. After all, CSMG/LTC, unveiling its clinical LTC results to the medical world in Prague, has strong mutual ties to the Old World.

http://www.secinfo.com/d12TC3.thNg.htm

"Live Tissue Bonding/Welding Equipment. To move the Live Tissue Bonding/Welding product into market, we are currently working with retained medical device experts, manufacturers, and FDA consultants to move the product into the commercial market in the United States and Europe.

We completed the development of the first generation of United States devices and instruments in the second quarter of 2007 and filed our Section 510(K) notification with the FDA for our duct and vessel sealer.

We expect to manufacture the tissue bonding/welding units in Eastern Europe for the Eastern Europe, China, and India markets.

We expect to manufacture the tissue bonding/welding units for the United States and Western European markets in the United States and Europe, respectively.

To date, we have received CE Mark approval in Europe on the duct and vessel sealer electrosurgery generator but we have not received marketing approval for any product from the FDA."