guess Dan, you not keeping up or your memory is failing. :-)
Now here is another trivia question -- be honest Dan, did I stump you on any of the bold items below?
_________________________
CEO JOINS BREAST CANCER FIGHT WITH LASER INVENTION
TED B. KISSELL Special to the Sun-Sentinel
08/20/96
Sun-Sentinel Ft. Lauderdale
FINAL
Page 1D
(Copyright 1996)
For Richard Grable, chief executive officer of Imaging Diagnostic Systems Inc. in Sunrise, the most vexing questions of the past two years have all begun with the word "when."
Whether the question is from an investor, a doctor, or even Phil Donahue, the big question has always been some variation of: "When is IDSI's product, which scans for breast cancer using a painless laser process, actually going to be available to the public?"
"Everybody asks that," Grable said. {Donahue tried to pin him down on a show about breast cancer a year ago.) "I just say, 'Soon."'
The machine, called the computed tomography laser mammography (CTLM) scanner, is now in clinical testing. An application for market approval is on file with the U.S. Food and Drug Administration. Even if the machine proves effective in detecting tumors and other lesions, it is uncertain if and when it will be cleared by federal regulators to be sold for medical use.
But up to 50 women in South Florida will be at the forefront of its research. Sometime this fall, the CTLM scanner will be in use at the Strax Diagnostic Breast Center in Lauderhill, where it will be used as a follow-up exam to traditional X-ray mammography. Patients will have the option if they want to participate in the program.
Dr. Stuart Kaplan, medical director of Strax, has worked closely with Grable, and is eager to see results. "We need to evaluate if it can produce adequate images, and if these images contain useful clinical information," Kaplan said.
Despite the great promise of the CTLM scanner (IDSI has trademarked the name "The Original Painless Mammogram"), Grable and others emphasize that the device, even if it makes it through clinical tests, will be used as a secondary test to X-ray mammography.
"In no way is this being thought of to replace mammography," said Kaplan. "It is being thought of as an adjunctive diagnostic tool. We're certainly not going to make any clinical diagnoses with it. Women must continue to have a yearly mammogram."
The promise of the device is significant: a means of locating abnormalities that uses neither breast compression nor X-ray radiation, the two aspects of mammography women find least appealing.
To be scanned by the CTLM, a woman lies face down on the bed-like machine with her breast placed through an opening. Inside the imaging chamber, a laser is shined through the breast. A computer then reconstructs images of the breast in 5-millimeter slices.
Grable says he hopes that, even if it doesn't replace mammography, the CTLM scanner will become another powerful diagnostic weapon in the fight against breast cancer .
"Mammography is very sensitive; it will find nine of 10 cancers," Grable said. "But it's not very specific. If you see something in a mammogram that looks suspicious, you do a biopsy. Why? Because of the litigation tendency in this country. The doctor is going to err on the conservative side and have a biopsy done if he's the least bit suspicious. Our goal with this machine is to increase the specificity to about 60 to 65 percent, so we, hopefully, will reduce the number of cases that go to biopsy. If we can do that, we can have a tremendous impact on the cost of health care."
After the Strax clinic in Lauderhill, the scanner will move on to five or six other test sites, where another 400 to 600 scans will be performed. The FDA will evaluate results and decide whether to grant IDSI market approval.
The CTLM scanner is the culmination of an idea that Grable - an electrical engineer with a master's of business degree from the University of Miami - had in 1989. The idea emerged from his experiences in the medical-imaging field - including his invention of a breast translumination device that used a bright light to illuminate the breast and a video camera to look for possible tumors.
The FDA never approved that product for use in the United States. Grable said he has sold the product overseas.
Grable added that his experience with that device convinced him of two things: First, that light could be used as a means for finding breast cancer ; second, that there was room in the market for a new breast exam.
"Mammography is a 40-year-old technology and people want something else," Grable said. "Mammography is not comfortable. Between 25 and 40 pounds of pressure is applied to the breast to squeeze it as uniformly as possible to get the image quality."
He became familiar with computed tomography while training technicians in the use of some of the earliest CAT scanners in the 1970s. CAT scanners use X-rays to produce images; Grable hoped to use lasers instead of X-rays to scan breasts for tumors. He built a laser computed tomographyscanner in 1989, but neither lasers nor computers had reached the level of sophistication to make the machine practical.
In the next five years, both lasers and computers made great strides. In March 1994, Grable, his wife Linda and their partner Allan Schwartz formed IDSI and set to work assembling a team to build the scanner and write the software to interpret the data.
IDSI is a publicly held company that trades on the Over the Counter bulletin board under the symbol IMDS. The company's application for a Nasdaq listing is pending.
Grable is not the only one who believes in the potential of laser tomography. Dr. Britton Chance, a professor of biochemistry and biophysics at the University of Pennsylvania, has been working with this technology since the late '80s. He is convinced that laser scanning will end up being considerably more accurate and specific than mammography.
"An X-ray measures density and shows calcium precipitates in the breast," Chance said. "It requires a skilled radiologist to read it and a very hard compression to get an image. Optical laser technology uses a different set of signals and is based on biochemical characteristics rather than density."
Chance said Phillips, Siemens and Zeiss are among major comanies experimenting with optical tomography.
Grable says his firm plans to charge $300,000 for the CTLM scanner, which is more than three times the cost of a mammography machine.
"Once this thing demonstrates that it is effective, I'm not sure we can install them fast enough," Grable said.
IDSI STATS
-- COMPANY: Imaging Diagnostic Systems Inc.
-- HEADQUARTERS: Sunrise; new headquarters being built in Plantation
-- PRODUCT: Company still in development stage with its laser imaging
technology, awaiting federal Food and Drug Administration approval
-- INCOME/LOSS: Loss of $900,000 in 1995; loss of $1.3 million through the
first three quarters of 1996
-- STOCK: Trades OTC under the symbol IMDS; reached a 52-week high of $8.75 on March 22; Monday's close at $3.687, up 18.75 cents.
X-RAY VS. LASER
X-RAY MAMMOGRAPHYCTLM
Mammography is the stan-Computer Tomography Laser
dard for detecting breast Mammography uses a laser beam
cancer . It has been evolvinginstead of x-ray for breast
for more than 40 years.exam.
-- Recommended for women over 50-- No age restriction
-- Uncomfortable for many-- Is painless
women because it requires
breast compression
-- Difficult to perform on -- Augmented and petite breasts are
augmented breasts and petiteeasily scanned
breasts
-- Cannot differentiate a cyst-- Can differentiate a cyst from
from a massa solid mass
-- X-ray is carcinogenous and-- Does not use x-ray and can be
and not recommended for pregnantperformed as often as desired
-- Will not detect 10 out of 100 -- Produces cross-sectional breast cancersimages
-- Provides a digital image that can
be manipulated by computer to provide
multiple views.
PHOTO; Caption: Staff photo (color) Richard Grable, left, inventor of the CT Laser Mammography machine, his wife, Linda Grable, and tehir partner ALl Schwartz.
|
