Medical engineer Leslie Organ likes to borrow astronomer Carl Sagan's famous line about billions and billions of stars when he talks about the market potential of his device to screen for breast cancer with a painless electrical current instead of X-ray mammography.
"We always have to be careful . . . not to get carried away with the billions and billions [of dollars]to be made, but suffice to say, the market for this is huge," the 70-year-old physician and engineer said.
With controversy swirling about the benefits of breast self-examinations and the screening vagaries of mammograms that often lead to unnecessary ultrasounds and biopsies, Dr. Organ's Z-Tech Breast Cancer Detection System, which is still two years away from regulatory review, seems well-timed.
"[Mammography]is the best we have right now, but it is very far from good," said Karina Bukhanov, a radiologist and head of breast imaging at Mount Sinai Hospital's Marvelle Koffler Breast Centre in Toronto. "We're looking for anything that can replace what we have right now."
Luc Marengère, lead manager of VenGrowth Advanced Life Sciences Fund, agrees.
"According to our due diligence, up to 40 per cent of women in the United States over the age of 40 do not go for annual mammograms because it's a painful procedure, involves radiation and there's fear of the outcome," he said. "We can't overcome fear, but Z-Tech is painless and radiation-free. Taking breast cancer screening out of X-ray clinics and putting it in doctors' offices in an easy-to-use, inexpensive 10-minute procedure is a win for everybody around."
Last month, VenGrowth Capital Partners of Toronto, a venture capital firm, injected $12-million into Dr. Organ's company, Z-Tech (Canada) Inc., boosting its investment to $13.6-million.
VenGrowth now has a controlling interest in the closely held firm, which plans to use the money for a pivotal clinical trial and for regulatory filings in Europe and the United States.
Dr. Organ, who graduated from the University of Toronto with degrees in medicine and electrical engineering in 1957 and 1965 respectively, said the "Z" in Z-Tech is the electrical engineering symbol for impedance, which measures resistance to the flow of an electrical current.
Researchers have known for decades that electricity moves more easily through malignant breast tissue than healthy tissue.
But attempts to construct an impedance image of a breast malignancy, including Dr. Organ's own research in the mid-1990s at U of T, failed because of the inability to manage and control so much variable data.
"I suddenly realized that you don't have to see breast cancer, you only have to establish a high probability that it exists and then send the patient for a mammogram," he said. "This is an electrical marker for cancer."
The Z-Tech system consists of two, 16-arm electrode arrays that fit over each breast, delivering an electrical current equivalent to two flashlight batteries.
The device generates 120 electrical measurements that are fed into a laptop computer to establish a numeric index comparing the impedance variation of one breast against the other.
"What makes this unique is that it uses one breast as the control for the other breast," said Steven Arless, president of Montreal-based CryoCath Technologies Inc. and a Z-Tech director.
Next January, Z-Tech plans to begin recruiting 3,000 women for a pivotal 18-month clinical trial at 10 hospitals in North America and Europe in an attempt to prove that the "diagnostic capabilities of the device are superior to mammograms," Dr. Organ said.
Half of the patients will be tested by Z-Tech prior to receiving a normal mammogram and will form a control group, while another 1,500 patients will be tested prior to undergoing a needle biopsy for an already suspicious breast lump.
Z-Tech initial studies with 380 patients at three North American hospitals "established accuracy equal to a mammogram, which we viewed as quite encouraging," he added.
The company is targeting a market of about 20 million screening mammograms now performed annually in North America that represents, according to Dr. Organ, an estimated annual market of about $500-million (U.S.) for his disposable electrode array.
He said the company will likely sell the array for $30 (Canadian and U.S.) per test, compared with traditional mammograms that cost $60 to $100 each, while the hardware and software will be sold to doctors at cost, or around $5,000.
Even though the electrode array still needs to finish testing, Mr. Marengère said Z-Tech has already hired a consultant to come up with a strategy to have the procedure reimbursed under "existing U.S. insurance plans, if possible, or to establish a new reimbursement code for it."