invendo medical discloses further clinical data at United European Gastroenterology Week 2007 in Paris
KISSING, GERMANY, Nov 26, 2007 – invendo medical, developer of the breakthrough single-use invendoscope™ SC20 which will potentially allow for sedation- and painless colonoscopy, announced that it disclosed further clinical data at United European Gastroenterology Week 2007 from a feasibility study using its invendoscope™ SC40, which is CE-marked and hence approved for sale in Europe, that demonstrate patients can undergo a colonoscopy without sedation and still feel no pain. An earlier set of results from that study had already been published at DDW 2007 in Washington.
The study’s results have been disclosed by Prof. Thomas Rösch, M.D., of Charité University Hospitals Berlin (Germany), in a poster presentation at UEGW 2007. The study included 39 healthy asymptomatic volunteers (19 males, 20 females, mean age 50.3 years), who consented to undergo sedation-free total colonoscopy with the new invendo medical device. In the second phase of the study a longer instrument type (180/200cm vs. 170 cm in the first phase) were used in 11 cases.
Overall the cecum was reached in 82% of the successful cases, with the cecum rate rising from 79% to 90% in the second phase of the study. No sedation was required in any case. In terms of pain, volunteers rated the examination on an overall score (1 = no discomfort to 6 = severe pain) at a mean of 1.7 except for two volunteers with sigmoid adhesion. Prof. Rösch concluded that the invendoscope holds promise to achieve painless colonoscopy in the majority of cases with a reasonable cecal intubation rate.
“Further technical refinements have already improved clinical performance of the invendoscope significantly and will further do so up to the status of routine usability,“ said Berthold Hackl, Chief Executive Officer of invendo medical. “We are confident that the invendoscope will have a strong impact on the market, especially in the United States, where reimbursement for sedation in colonoscopy is under severe pressure. Observational studies have shown that sedation accounts for approximately 75% of the total time a patient spends in an endoscopy unit, and for 40% of the procedure cost of colonoscopy. Invendo aims at reducing those inefficiencies greatly.”
About the single-use invendoscope™ SC20
invendo’s patented device combines a highly flexible endoscope shaft and proprietary ‘inverted sleeve’ technology that potentially enables a painless colonoscopy, as there are no direct forces applied against the intestinal wall while the device passes through narrow intestinal convolutions, thus enabling a safe and potentially painless examination of the large intestine. invendo’s colonoscope is CE-marked in Europe. Market launch is expected later in 2008.
About invendo medical GmbH
Headquartered in Kissing (Munich), Germany, invendo medical (www.invendo-medical.com) is a leading developer 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.
Contact: Timo Hercegfi, CFO, invendo medical GmbH, +49 8233 74498 0; timo.hercegfi@invendo-medical.de
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Caution: Investigational Device. Limited by U.S. federal law to investigational use. The invendoscopy™ System is not available for sale in the United States. Only for clinical investigational use and exhibition purposes.