Diagnostics & Imaging Week

PARIS — The $100 million market for pill cameras is no longer a given for Given Imaging (Yokneam, Israel), which pioneered this lower-cost and less-invasive technique for an optical diagnostic of gastrointestinal maladies.

Three competing mega-vitamin-sized capsules carrying cameras and lights for the fantastic voyage through the digestive tract were presented during United European Gastroenterology Week (UEGW).

The models from Korea and the People’s Republic of China are approved for European distribution.

In mid-September, the EndoCapsule from Olympus (Tokyo) received approval from the FDA, the first to break into a critical market where Given Imaging has enjoyed exclusivity since 2003. Olympus’ EndoCapsule has been available in Europe since October 2006.

While meeting the competition head-on with an upgrade for its best-selling small-bowel capsule, the PillCam SB 2 video capsule, Given Imaging also reported a flanking maneuver at the European gastroenterology get-together with the launch of the PillCam Colon, a product variation that aims for the colorectal cancer (CRC) screening holdouts, some 90% of the U.S. population over 55 years old that is non-compliant with colorectal cancer screenings, stubbornly refusing to submit to the rigors of a colonoscopy procedure.

The three new endoscopic capsules presented at UEGW compete in the established market for small-bowel optic diagnosis, which is difficult to reach with conventional endoscopes.

Millennium Research estimates this market will grow to $180 million in sales in the U.S. by 2009.

In the face of the new competition, Nachum Shamir, CEO of Given Imaging, said he remains confident the company will claim the lion’s share of these sales.

“With over 600,000 capsules ingested to date and an installed base of 4,000 systems, we enjoy an unrivaled position among practitioners,” he told Diagnostics & Imaging Week. “We have 90 endoscopy clinical trials and 700 peer-reviewed articles. There are not so many companies of our size who have done so much to document their products.”

• The fourth quarter of this year will see the active marketing and distribution of the new Olympus EndoCapsule in the U.S., with the accent on the word endoscope for market positioning.

Olympus currently dominates the endoscope manufacturing market with a 70% share worth $1.34 billion.

Among the small-bowel capsule cameras coming onto the market, Olympus’ EndoCapsule uniquely offers real-time observation of images with radio frequency transmission at two frames per second. The camera provides higher resolution images than competitors and the capsule features automatic lighting control for six white LED lights with continual depth of field readings and automatic adjustments of the flash.

Sold for upwards of $750, the software suite for the EndoCapsule automatically detects blood in the images and marks those frames for highlights during playback. The software also can cut redundant images to reduce playback time for the tens of thousands of images taken during the 10-hour recording.

“Image quality is our advantage,” said product manager Stephan Kohlmann, demonstrating the model at UEGW. “We are bringing 20 years of experience in endoscopy to this product.”

• IntroMedic (Seoul, South Korea) began shipping the MiroCam for small bowel optic diagnosis to the Korean market in May and received the CE mark in August.

Slightly smaller and easier to swallow at 11 mm by 24 mm, the MiroCam delivers three frames per second at the highest resolution of 102,400 pixels and the widest field of view at 150 degrees. It also boasts the best battery life at 11 hours of operation.

“The major difference for MiroCam is the transmission technology,” said Agnus Bromley, sales manager for IntroMedic.

He explained that MiroCam does not use the radio frequency identification (RFID) transmission technology used by competitors that requires an antenna and pulsing signals sent through the air.

Mirocam uses a pioneering technology called e-field transmitting that takes advantage of the human electrical field to send data from the capsule to a receiving device.

The circuit of the bi-polar capsule is closed when submerged in body fluids and it modulates the body’s natural electrical field, much as a radio signal modulates the airwaves, to send the signal to multiple captors placed on the patient’s torso, which are common to all pill camera technologies.

Using the human body as a transmission channel greatly lowers the power usage by the capsule compared to competitors.

Images are recorded on a device worn around the belt as patients move about in everyday activities during the roughly 10 hours of capsule passage. Images on the recorder are downloaded to a software suite that can detect blood for highlighting and also cuts redundant images to shorten viewing time.

• “Half of our booth traffic is due to this poster of bowel images,” said a Dutch sales rep from Albyn Medical (Navarra, Spain), which is the European distributor for the OMOM Capsule Endoscopy System from Jinshan Group (Bejing).

Easily the most modest presentation of a capsule camera for the small bowel, the poster and workstation were squeezed into a corner of the Albyn Medical stand.

Still it required an appointment to speak with the very busy Alex Zhou, overseas marketing manager for Chongqing Jinshan Science & Technology, who crisply delivered the benefits of the new product, which received a CE mark in March.

Introduced in China and then greater Asia at the Southeast Asian Healthcare Show in Kuala Lumpur, Malaysia, in late 2005, the OMOM capsule provides a 140-degree view and runs for eight hours, lower than other products due to a unique feature for bi-directional signaling.

Both the lighting and the rate of image capture, up to 15 per second, can be adjusted with this capability, which is the first commercial demonstration of two-way transmission for a gastrointestinal MEM.

Another unique feature for OMOM is a vest-jacket to be worn by patients, a more elegant approach for bringing captors in contact with the body to receive the micro-radio signals. The data recorder is carried in a pocket.