RA’ANANA, Israel — In just a few months, Hanan Keren hopes to secure patents on a nanotech-based concept that could dramatically change conventional X-ray technology. But despite the progress, he is far from relaxed.
Keren nervously fields a series of phone calls while discussing the new device from the empty offices of MediRad, his startup company based in Ra’anana near Tel Aviv. Of his six employees, two have been drafted into reserve duty for the Israeli army. The company’s finances are running thin. And after Keren’s desperate, six-month search for funding, Israeli venture capitalists have failed to cough up the $1 million he needs to complete development of his product.
“The business plan is not the issue, they want me to come with orders” says Keren, pulling out a 250-page business program. “They are not really venture capitalists, since they don’t want to take any risks. All they want is to be on the safe side.”
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Being safe may not be conducive to business, but it is a key part of the new X-ray technology that Keren describes, as he opens a small plastic bag and pulls out a silvery bullet-like tube attached to a neat spiral of wire. The X-Mat, as he calls the device, could revolutionize the field by allowing doctors to safely take precision X-rays inside the human body, both for diagnostic and therapeutic purposes, without damaging any surrounding tissue.
Conventional X-ray technology has not been applicable inside the body because the devices operate by heating up a cathode to generate the emission of electrons. Putting a heated device inside a patient’s body is dangerous and unacceptable to the U.S. Food and Drug Administration, and the technology needed to cool down an X-ray machine rendered it too big to be used internally. External X-rays are often not precise enough for various imaging and treatments, meaning patients get a larger dose than they really need.
But about two years ago, Keren, a physicist with 20 years of experience in medical electronics, set out to replace the hot filaments used in a standard X-ray device with a needle-like structure made of carbon nanotubes. While the device itself may be on the millimeter scale, the core breakthrough is strictly small tech.
“I realized that the only technology that could generate such a small X-ray tube at the minimum needed delivery dose would be a cold cathode,” Keren says. “The only solution to creating a cold cathode is a carbon nanotube.”
Despite his financing problems, Keren is continuing to plan the next stages of product development, and has fostered relationships with several manufacturers of carbon nanotubes, including Applied Nanotech Inc. of Austin, Texas.
And if current animal testing is successful, the device could be on the market in two years for use in a wide range of medical fields, ranging from gastroenterology to gynecology to urology. Keren expects it would be particularly useful for treatments known as intraoperative radiation therapy, or IORT, when doctors radiate the area where a tumor has been removed to make sure that there are no cancerous remnants.
Luther Brady, editor of the American Journal of Clinical Oncology and professor of medicine at Drexel University in Philadelphia, says that MediRad’s device would be “very interesting” to oncologists if the company can prove its efficacy in animal testing.
“There is a tremendous amount of interest in being able to deliver focal radiation to a point without damaging the surrounding normal tissue,” he explains. “The problem in miniaturization is to do that in such a way that you limit the amount of heat yet you are able to focus where you want.”
According to Brady, there is also a “very large population” in the United States that could benefit from safe and effective precision radiation therapy, including some 400,000 people who have undergone balloon angioplasty treatment and 190,000 women who have suffered from breast cancer.
“The critical issue is going to be results from testing in animals and early phase-one trials in humans,” he adds.
Even should the X-Mat pass its tests, tapping into medical markets will be no easy task. But Keren believes he already has a good sales pitch to make to the medical community and insurance companies, arguing that his new device will eliminate the need for certain treatments involving radioactive material. In turn, the decreased danger will eliminate the peripheral staff members needed for conventional therapy involving radioactive material, and the costs associated with the extra staff.
But Keren will not speculate about the cost of his device, saying pricing issues are “extremely complicated” when it comes to new medical machines. “In the medical arena there is no connection whatsoever between production cost and sale price to end customers because a lot of money has to be paid for compliance with FDA regulations, training, services and literature,” he says.