Remember the science fiction stories about a tiny capsule that journeys around in the body for intelligence and spy purposes? According to GIven Imaging of Yokne'am, the future is almost here. The company is developing a tiny capsule capable of navigating in your small intestine, a difficult place for diagnosticians, and transmitting to the doctor a range of new, unequivocal findings.
The tiny capsule, the size of a juicy vitamin capsule, equipped with missile technology - without the bombs - can do just that. Inside the two centimeter capsule will be an optic window, light, sensor, transmitter and power cell which will transmit information to an external transmitter.
Company president and CEO Gabi Miron reached the idea not through biotechnology but rather through his fancy experiments for various uses of video technology. Miron served as COO and general manager of Optibase (video compression) and CEO and president of Applitec (develops video cameras for endoscopy - internal imaging for medical purposes). He presented the idea to RDC, a company 50% owned by Rafael (Israel Armament Development Authority) which deals with applying military technologies for civilian usage. RDC adopted the idea.
The concept involves improvement of the medical diagnosis of the digestive system (Miron: "The only two-ended bodily system. All other systems are closed.") The market for the treatment and diagnosis of digestive system disorders in the US stands at an annual $120 billion.
The hardest place in the digestive system to diagnose is the small intestine, and this is the area it was decided to focus on. GIven Imaging's capsule, still in initial development stages, is likely to provide doctors with comprehensive mapping of the small intestine and save patients much discomfort. Here is how it works: the patient arrives on an empty stomach, after fasting all night. He takes the capsule and goes on his way wearing a belt with an antenna and receiver the size of a cellular telephone. The capsule is monitored as it journeys around the body. At the end of the examination, the doctor can review the recorded material. Processing the findings takes place at the work station, after the patient disposes of the equipment.
The capsule has no trigger. (Miron: "It is triggered by the body.") During its journey in the intestine, the capsule absorbs the picture and transmits it to a regular, low cost COS sensor inside it. Miron says, "If you sat inside the capsule, it would appear to be similar to a car wash, or pilot's cabin - you would be in the center of an optic cone."
At First Glance
by Shalom Teshuva
- Significant improvement in diagnostic ability, examination quality and efficacy of use.
- Large potential market.
- Health insurance companies expected to participate in the examination cost.
- Patent backed innovative technology.
- Focused marketing to doctors specializing in the field (8,000 in the US).
- Successful market penetration expected to serve as high barrier and lead to large revenues from perishable products.
- Leading companies in Israel and overseas as shareholders, and experienced consulting team.
"Globes": Are there any blind spots?
Miron: "I cannot say there are none. We cover close to 100%. We will know after we have conducted experiments."
How do you map the precise location of a tumor, for example?
"Tracing the exact location of a finding is a very difficult problem. We can know approximately. The length does not help. We can know by the capsule's location in relation to the antenna."
Just like any biotechnology start-up, one of the major obstacles is the FDA (US Food and Drug Administration). Miron finds it hard to estimate how long the procedure will take. "It's an innovation and therefore it's difficult to forecast. It's impossible to commit to a date. There are precedents, such as the capsule that transmits the body temperature, approved by the FDA. Apart from that, in contrast to a pacemaker for example, it remains in the body for a limited number of hours. We hope it will be approved quickly."
What is considered 'quickly' by FDA standards?
When will you submit the request for approval?
"In the year 2000."
Miron is not waiting until the year 2001 to prepare a meticulous marketing program. The company's target market comprises doctors and gastroenterologists who specialize in the digestive system. They number only 8,000 professionals, but included is a large number of patients and high income for the doctor for every examination paid by the patient or his medical insurance company. Miron believes the capsule will increase doctors' profitability not only from the increase in the number of examinations, but also through the reduced amount of time devoted to the patient's visit and examination.
- In initial development stages, 18 months away from beginning of trials.
- The device requires FDA approval on a route not yet determined.
- Uncertainty regarding the health insurance companies' refund.
- Market penetration and education efforts required for relatively conservative customers.
- Significant resources required until the time to sell.
- Patent coverage is incomplete.
Shalom Teshuva is the managing director of Foresight consultancy company.
The company has not yet determined the price, but Miron says it will range between $300-$2,300, the price of similar examinations today. The tendency is to place the major part of the charge, or all of it on the capsule.
The company so far employs seven workers and several consultants, among them a gastroenterologist, a physicist and a FDA regulations expert. The company has raised to date $1.3 million through RDC and ThermoTrex, a US company that civilianizes military technologies it develops. The company is acting to raise "a few million" by the end of the year. Miron estimates that the company will require $8-$10 million until it starts to sell.
GIven Imaging has been granted a patent in the US. Miron says the company has no direct competition. 90% of the endoscopy equipment market is controlled by world famous Japanese companies: Olympus, Pentax and Fujinon. The MRI computerized imaging technology could also pose a threat to the company but Miron claims this is a much more expensive examination.
Miron does not deny that the project is a complicated, multi-disciplinary one. He is not worried about implementation of the vision's development. He says that the building blocks exist, they merely need to be integrated. Beside that, it is an entirely new market with millions of capsules a year in potential sales.