The following was taken off the news wire. Does anyone follow this company?
Wednesday May 21 1:30 PM EDT
Breast "Thermometer" to be Marketed
NEW YORK (Reuters) -- A new device aimed at improving the detection of breast tumors will go
on sale in the U.S. next month.
The BreastAlert Differential Temperature Sensor is to be marketed by HumaScan Inc. According
to a statement from the company, the device may "improve chances for detection of fast-growing...
tumors in the intervals between mammographic screenings."
The device, which consists of two mirrored pads that use chemical sensors to detect changes in
breast temperature, was approved by the Food and Drug Administration in 1984, but was not
developed for sale until now. HumaScan licensed the technology from the inventor, Dr. Zgsimond
Sagi, in 1995.
"When early-stage breast cancer is present, metabolic activity increases, producing excessive heat
which most often escapes at the surface of the breast," according to a statement issued by
HumaScan last December. "The BreastAlert device records skin temperatures on three large areas
of each breast... alerting the physician to possible underlying breast disease in need of further
examination."
The BreastAlert is used by inserting it into the bra for 15 minutes before a clinical breast exam by a
physician. The device changes color to indicate a rise in temperature, which can indicate the
presence of a tumor, explained Donald Brounstein, HumaScan's president and CEO.
HumaScan officials do not know whether the device will be covered by insurance, but say that
Cigna and Oxford Health Plans have asked to participate in ongoing, larger clinical trials. Insurance
coverage could be in doubt, however, as the Medicare program in 1984 ruled that thermography
was not a valid diagnostic screening tool for breast cancer. And in 1993, the American Medical
Association said that it wouldn't recommend thermography for diagnostic purposes.
Brounstein emphasized to investors that BreastAlert is not a diagnostic, but an "adjunctive
screening" device. HumaScan Inc. officials told investors at the Cruttenden Roth Health Care
conference on Monday that the company will begin selling the device in the Northeast by the end
of June. The Cranford, New Jersey-based firm plans to begin selling the BreastAlert device
nationally by October. |
