Gentle Colonoscopy with invendoscopy™

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invendo medical files 510(k) notice with FDA for clearance of the computer-assisted colonoscopy system

Clearance by FDA would make new endoscope for colon cancer screening available to U.S. patients More

invendo medical completes pivotal clinical study

invendo medical, developer of a single use, no touch/no manual push and potentially pain-reduced colonoscope, announced ... More

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The invendoscopy™ System

Company

invendo medical aims to become a globally leading developer and distributor of disposable, highly flexible and easy-to-use endoscopy products in the field of gastroenterology.

Innovation activity in gastroenterological endoscopy has in the past decades nearly exclusively focused on the improvement of optical capabilities. However, invendo medical´s goal is to improve the convenience and tolerability of gastroenterological endoscopic procedures, resulting in a better patient compliance and thereby an increase in the number of procedures performed.

In order to achieve its goal the company first focussed on an application in the diagnosis and treatment of colorectal cancers (CRC). CRC is the second leading cause of cancer death with an estimated annual worldwide death toll of 510,000 people. More than 1 million new cases are diagnosed every year. However 90-100% of colorectal cancers can be avoided if diagnosed early on.

Current screening options for CRC include fecal occult blood test (FOBT), flexible sigmoidoscopy, the combination of FOBT and flexible sigmoidoscopy, and colonoscopy. Colonoscopy is the undisputed gold standard for colorectal screening because it provides very high sensitivity (> 90%) with a false negative rate of 6% for adenomas 1 cm or more in diameter.

Nevertheless the use of colonoscopy as a screening method is underpenetrated due to patient concern about:

  • associated pain (mainly due to looping caused by the semi-rigidity of conventional colonoscopes).
  • potential cross-infection risks (due to the inability to sterilize conventional colonoscopes).
  • potential complications related to sedation, which is frequently applied.

In addition, in many countries endoscopic capacity can not currently satisfy the growing demand for colonoscopies, because conventional colonoscopy is not an easily learned technique and requires extensive training prior to routinely performing the procedure.

Therefore invendo medical is addressing these issues by developing a new "no-touch/no-push" technology in combination with a highly flexible, single-use endoscope which aims to simplify colonoscopy so that:

  • patients experience a well-tolerable procedure.
  • possible cross-infection risks are significantly reduced.
  • it is easily learned and more ergonomical than conventional practice.
  • work processes can be efficiently organised.

It is invendo’s goal to continue to develop this innovative highly flexible single-use endoscopy technology into a complete product portfolio and establish it in the market.

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.