Israeli military scientist Gabriel Iddan spent years working on missile technology as the head of the electro-optical design section of the Rafael Armament Development Authority at the Ministry of Defense. Iddan had worked on the seeker, or the “eye” of the missile, which captures the targets and guides it, and believed the same technology could be applied to the medical field.
While on sabbatical eight years ago in Boston, Iddan decided to design a tiny capsule containing a guided missile optical camera that could be swallowed, and would send images in real time as it traversed a patient’s intestines. His inspiration for the idea was the invasiveness and other shortcomings of the endoscope. Iddan and his colleagues designed a prototype, and he applied for a patent. “I decided to make a little capsule and start some experiments,” he said..
But money for the project was scarce. “I tried in vain to raise money,” he said. “People thought the idea was farfetched. They thought it was good for a movie but not for a business. Rafael told me to raise money by myself. They allowed me to use their labs but they were not willing to invest in it.”.
Iddan pressed on, creating the M2A Swallowable Imaging Capsule, or the “missile pill.” During the next four years, Iddan developed a three-dimensional camera capable of creating, distributing and displaying video content. He established 3DV Systems Ltd. in Yokneam, near Haifa..
As Iddan and his team worked on the capsule, numerous technological breakthroughs occurred that made his concept more realistic. First, a new silicon, called CMOS, made it possible for all of the components of the camera to be placed on a single chip – reducing both its size and power consumption. Advances in ASIC design allowed the integration of a tiny video transmitter with sufficient output, efficiency and bandwidth to fit inside the capsule. White light emitting diode illumination made it possible for the images taken to eliminate internal reflections..
They went to work. Dov Avni, whom Iddan calls “the guru of video cameras” at Rafael, invented a camera the third of the size of a dime. The color video camera sits on a chip that is 4 mm square and 1 mm wide. On another 3 mm chip sits a transmitter and an optical sensor. Altogether, the camera, transmitter, battery, a tiny floodlight and an antenna fit into a disposable pill that is 2.5 cm long and 1.5 cm wide..
“It’s like swallowing a missile that doesn’t explode,” says Gavriel Meron, chief executive officer of Given Imaging, the company established three years ago to produce the pill. Meron, who volunteered to swallow the pill, said: “It was easier than swallowing an aspirin.”.
Once swallowed, the missile pill travels through the small intestine propelled by the contractions of the gastrointestinal tract. The squeezing motion acts as a squeegee, wiping the lens clean for clear pictures. Along the way it films digital images and transmits them to a receiver worn by the patient. The recorder also tracks the capsule’s location within the body..
The capsule is capable of transmitting up to eight hours of video before being naturally expelled. No hospitalization is required. The film is downloaded to a computer workstation and processed using a software program called RAPID (reporting and processing of images and data), also developed by Given Imaging. It condenses the film into a 30-minute video. The software also provides an image of the pill as it passes through the small intestine so the physician can match the image to the location of the capsule. The company has applied for more than 20 patents for the capsule and for future capsules to be developed using its basic platform. It is not inconceivable that this same technology can be used to pump medication locally and directly..
In August, a year after Given Imaging received U.S. Food and Drug Administration approval to begin clinical trials in the United States, the FDA granted Given Imaging permission to begin marketing the capsule. In FDA testing, the Given Imaging Diagnostic System detected physical abnormalities more successfully than push enteroscopy and surgical techniques..
“In my study, the M2A capsule was able to identify pathologies in the small intestine that were not identified by standard methods,” said Blair S. Lewis, associate clinical professor of medicine at Mount Sinai School of Medicine in New York and a member of Given Imaging’s Medical Advisory Board, who headed the clinical tests..
As a result of the FDA approval, the company, which has already released its product in Europe, Australia and Israel, now has access to the U.S. market. The swallowable pills, which will cost about $300 each, can be used for diagnostic tests and treatments for gastrointestinal diseases such as cancer, Crohn’s disease and irritable bowel syndrome..
Given Imaging raised $60 million when it issued its initial public offering on the NASDAQ market at the beginning of October. It floated 5,000,000 ordinary shares at an opening price of $12 in the exchange’s first public offering in seven weeks. Lehman Brothers served as global book-running manager for the offering and Credit Suisse First Boston was joint lead manager with Robertson Stephens acting as co-manager..
The company so far has no revenue or profits, and as of June 30 had accumulated losses of $19.5 million. When its innovative product started receiving recognition, people wondered if, like so many hot technologies coming out of Israel, it would end up on the block for some high-priced acquisition..
“The trend in Israel is to develop something and wait for someone to buy it,” said Arkady Glukhovsky, Given’s vice president of research and development. “Not in our case. We want to develop, manufacture and sell the M2A. We are not a one-shot company but a multiple shot.”.