Insight into unseen recesses of the human body only previously partially accessed by endoscopic surgery or radiation has been made possible with Given Imaging's patented technology. The patented M2A Imaging Capsule holds great promise in the diagnosis and healing of gastro intestinal disorders. GIVEN IMAGING (GIVEN is an acronym for GastroIntestinal Video Endoscopy), founded in January 1998 has audaciously pursued and achieved the goal of miniaturizing a video camera and encapsulating it so that it could be swallowed, traverse smoothly through the digestive tract and then be naturally excreted. Currently, the broadly used method for gastrointestinal diagnostic is endoscopy, which uses flexible scopes inserted through the mouth or rectum. Typically the length of a gastroscope exceeds 2.5 meter. Most patients whose physicians suspect ulcerations, lesions, tumors, Crohn's disease, inflammatory bowel disease (IBD) and irritable bowel syndrome (IBD) undergo endoscopic procedures, which most individuals find stressful due to patient discomfort and the need for sedation. Dr. Paul C. Swain of the London Royal College Hospital, who participated in the development of the M2A Imaging Capsule describes it as an "added and not replacement" technology. "It is non-invasive, not expensive, eliminates anxiety and allows the individual to continue a daily routine while being examined." Most of the diseases affecting the small intestine relate to infarcts, hemorrhages and ulcerations in areas of the small intestine and are not observable by endoscopy or radiology. "Radiology does not pick up polyps of less than 5 millimeter in size but M2A has no difficulty delivering resolutions at 0.1 millimeters," Dr. Gavriel Meron, the company's chairman and CEO points out.
The advantages of a video camera capturing pictures with small bowl disease are of invaluable assistance to the GI physician.
The response by the medical community has been both positive and enthusiastic. At the annual meeting of GI specialists the capsule was viewed, in closed sessions, by nearly 1,000 specialists.
How does it work?
IHTIR visited the brand new and enlarged Israeli headquarters of Given Imaging in Yokneam's high-tech center in the Carmel Mountain range and learned the background of the M2A Imaging Capsule. Dr. Arkady Glukhovsky, immigrated to Israel from Moscow in 1970, the same year that Dr. Meron moved to Israel from South Africa. The Russian was employed by Raphael Development Corporation, a company established in partnership with Discount Investment and Elron Electronic. The company was formed to commercialize the highly vaunted technology developed by Rafael, Israel's Armament Development Authority. Dr. Meron reviewed Dr. Glukhovsky's work and decided that it merited further development, applying for patent protection and positioning the project in its commercial direction. All this was done during the past 32 months.
The biggest market for Given Imaging's M2A Imaging Capsule is the US, where between 60 to 70 million people are affected by gastrointestinal diseases. Moreover, more than 10 million endoscopic procedures are performed yearly and according to the National Institutes of Health the annual cost of the gastrointestinal disease is more than $100 billion. The US Food and Drug Administration's approval last August has led the company to initiate clinical testing.
"Our time to market goal is Q1 2001," estimates CEO Meron.
Should Given Imaging initially market 100,000 diagnostic procedures it could easily reach sales of $30 million.
With positive comments being received from gastrointestinal specialists the miracle of "seeing the unseen" holds out the promise for a major revolution in how we perceive our bodies.
Insight into unseen recesses of the human body only previously partially accessed by endoscopic surgery or radiation has been made possible with Given Imaging's
patented technology.
The procedure is simple. The patient swallows the capsule. A wireless recorder equipped with sensor arrays worn on a belt around the waist receives signals transmitted by the capsule. The use of the belt allows users to continue their daily activities as they undergo the "GI" examination". Any conventional PC equipped with Given's proprietary RAPID (Reporting and Processing of Images and Data) software produces a short video clip of the small intestine. The workstation allows the viewing, editing and archiving of the video and the saving of individual images and short video clips. These in turn may be e-mailed for further diagnostic evaluation. The proprietary software is very sophisticated and provides features such as the ease of intensive viewing of the digital video clip, which has a backward and forward feature. Still pictures can of course be studied. The video clip is downloaded into a conventional computer. The GI specialist who receives the video can review it for easy examination. 