Pilot study demonstrates feasibility of 'sedationless' colonoscopy; Data disclosed at Digestive Disease Week(R) (DDW) 2007: "In our pilot study using the new invendoscope(TM) SC40 and no sedation, 92% of patients experienced no pain. This device may significantly enhance acceptance of colonoscopy for early detection of colon cancer." Prof. Thomas Rosch, M.D., Charite University Hospitals Berlin (Germany)

invendo medical GmbH (http://www.invendo-medical.com), an emerging medical device company, announced today that it will disclose clinical data at Digestive Disease Week(R) 2007 from a pilot study using its breakthrough technology--called the invendoscope(TM) SC40, which is CE-marked and hence approved for sale in Europe, with market launch expected in 2008--that demonstrates patients can undergo a colonoscopy without sedation and still feel no pain. (Podcast available at http://www.medtechmatters.com.) DDW is the largest international gathering of physicians and researchers in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery.

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Quote startThere are several reasons for lack of acceptance of colon cancer screening, but certainly the pain associated with conventional colonoscopy and the subsequent need for sedation are what keep a majority of eligible patients from being screened. We therefore believe that our new device might play a major role in significantly increasing the number of persons who will undergo a colonoscopy.Quote end

WASHINGTON (PRWEB) May 23, 2007

    A Prospective Pilot Study to Assess Technical Performance of a New Single use Colonoscope with Inverted Sleeve Technology. (Abstract W1344)

The pilot study's results will be disclosed by Prof. Thomas Rosch, M.D., of Charite University Hospitals Berlin (Germany), in a poster session at DDW 2007 today. The poster is entitled: "A prospective pilot study to assess technical performance of a new single-use colonoscope with inverted sleeve technology." The study was a proof-of-principle study on 28 asymptomatic paid volunteers (12 males, 16 females, mean age 48 years, range 23-68 years), who consented to undergo sedation-free total colonoscopy with the new invendo medical device. The study was approved by the Charite Ethical Committee and University of Frankfurt Ethical Committee.

"Our pilot study with invendo's new colonoscope--the invendoscope(TM) SC40--was performed without pain in 92% of the cases. No sedation was given to any patient, and no complications occurred," said Prof. Rosch, who is Chief of Endoscopy at Charite University Hospitals Berlin (Germany). "These data are very exciting, because this new technology has the potential to significantly advance the acceptance of patients who should have colonoscopy but are afraid to do so, because they fear pain and have to be sedated. While further research is needed, of course, to determine if the invendo device will best serve the goal of a simple, pain-free, sedationless and accurate colonoscopy, nevertheless these early data are very encouraging."

"Colon cancer has the second-highest incidence of cancers worldwide. It can be beaten if diagnosed early. Unfortunately, while colonoscopy is the undisputed gold standard for diagnosis of colon cancer, it has very low acceptance by patients. Indeed, only a relatively small percentage of the eligible population worldwide undergoes colon cancer screening. Given the dire need for improved acceptance by potential screenees, we are extremely pleased with the results of this pilot study," said Konstantin Bob, M.D., Chief Technical Officer and Co-Founder of invendo medical. "There are several reasons for lack of acceptance of colon cancer screening, but certainly the pain associated with conventional colonoscopy and the subsequent need for sedation are what keep a majority of eligible patients from being screened. We therefore believe that our new device might play a major role in significantly increasing the number of persons who will undergo a colonoscopy."

About DDW

Digestive Disease Week(R) (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 19-24, 2007, at the Washington Convention Center, Washington, D.C. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. For more information, visit http://www.ddw.org.

About the single-use invendoscope(TM) SC40

invendo's patented device combines a highly flexible endoscope shaft and proprietary 'inverted sleeve' technology that makes possible a potentially painless colonoscopy, as there are no direct forces applied against the intestinal walls while the device passes through narrow intestinal convolutions, thus enabling a fast and potentially painless examination of the large intestine. The invendoscope(TM) SC40 is CE-marked in Europe. Market launch is expected in 2008.

About invendo medical GmbH

Headquartered in Kissing (Munich), Germany, invendo medical (http://www.invendo-medical.com) intends to be a globally leading developer and distributor of novel disposable endoscopy products in the field of gastroenterology that are simple to use and reduce pain compared to conventional modalities. The Company's initial product focus is in the area of 'sedationless and painless' colonoscopy. The Company's investors include Heidelberg Innovation, Manfred Lautenschlaeger and Mannheim Trust.


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invendo medical GmbH (www.invendo-medical.com) has disclosed clinical data from a pilot study using its breakthrough technology-the invendoscope(TM) SC40-which demonstrates patients can undergo a colonoscopy without sedation and still feel no pain. (Podcast available at www.medtechmatters.com.) (Photo: Business Wire)