To: StockDung who wrote (6005 ) 12/11/2002 9:08:29 AM From: RockyBalboa Read Replies (1) | Respond to of 6039 FDA - Computerized Thermal: Vote Close Against Device Tuesday December 10, 6:46 pm ET By Otesa Middleton, Of DOW JONES NEWSWIRES WASHINGTON (Dow Jones)--Computerized Thermal Imaging Inc. failed Tuesday to persuade a key federal panel to back its device that the company said will reduce the number of biopsies done on suspicious breast lumps that turn out to be harmless. The majority of the panel wasn't swayed by the device's data that showed it can spare a small number, 5% to 7%, of patients from undergoing biopsies after having a irregular mammogram. Each year 1.3 million American women have a biopsy to determine if a suspicious mammogram is indeed cancerous. About 80% of those biopsies show the lump isn't cancer. The panel, which is made up mostly X-ray experts, voted four to three against recommending the product, called the Breast Cancer System 2100 for approval. Usually when the Food and Drug Administration's outside advisers overwhelmingly vote against endorsing a device, the agency denies the company's request to market the product. However, when votes are close, the agency often gives more weight to all of the comments advisers made. Computerized Thermal Imaging's President and Chief Operating Officer John Brenna wouldn't comment on the company's plans after the panel meeting but said the company plans to release a statement early Wednesday morning. The future of the small Lake Oswego, Ore., company appears to hinge on winning approval for the breast device, since the company isn't making a profit selling pain management devices. The company reported $264,000 in revenue, but recorded a net loss of $3.4 million for the September-ended first quarter of its fiscal year. Tuesday's news of the panel's rejection sent the company's stock, which just recently climbed above $1, down 66 cents, or 63%, to 39 cents on heavy volume. In the studies the company's Breast Cancer System typically didn't miss many cancers, said FDA radiologist Dr. William Sacks. Based on the data, the device will miss 1% to 6% of cancerous lumps. This will delay diagnosis and treatment from four to six months, when the patient returns to the doctor for a follow-up exam. Panelists who voted against approving the device were concerned that the small number of cancers missed would outweigh the potential benefit of a small percentage of women avoiding biopsies, which can be painful procedures. "Before we allow a half million women to be subjected to this let's make sure the benefit is real, that's why I voted for disapproval," said Dr. Minesh P. Mehta, the panel's chairman and interim chairman of human oncology at the University of Wisconsin-Madison. Dow Jones Newswires 12-10-02 1846ET