Apparently ccsi has been "building inventory of units", from their latest 10Q, they added 1.0 mil in value of colormate units to their balance sheet from 12/31/98 to 3/31/99
In connection with the Company's efforts to distribute the ColorMate(Registered)
TLc-BiliTest(Trademark) System the Company commenced purchasing equipment and
component parts in the second quarter of 1998 (approximately $2,100,000 in the
aggregate through March 31, 1999). At this time, the Company is uncertain as to
whether it will sell or lease such equipment to customers; accordingly, the cost
of such items, as well as units previously obtained from Avon Products, Inc. in
connection with a prior license agreement, has been classified as a non-current
asset in the accompanying consolidated balance sheets.
Here's something from the trade. The article mentions the cost of the device as 3-5k and indicates the accuracy is 95% that of a blood test. Peculiar statement is that each test costs about $10 or the cost of a blood test. Is this what he expects hospitals/doctors et al to charge? BTW this article states CCSI started to fill orders in Feburary. If so the most they would have billed would have been 6-10 devices through March 31st as CCSI reported revenues of 31,000 for the 1st quarter. Must be getting a bit of a slow start.
Best Regards, Mad2
Medical Industry Today
March 24, 1999, Wednesday
SECTION: DEVICE AND DIAGNOSTICS
LENGTH: 672 words
HEADLINE: Chromatics Launches Noninvasive Jaundice Test
BODY:
Nearly two years after its FDA approval, CHROMATICS COLOR SCIENCES INTERNATIONAL (New York, NY) recently began shipping its commercial noninvasive, handheld jaundice test for newborns.
Chromatics finished its first round of manufacturing the Colormate TLc BiliTest and started shipping to fill orders in February.
"It's a victory for Dr. Mom," said Chromatics president Darby McFarlene, one of the inventors of the test.
Chromatics is hoping the jaundice test will help restore it to profitability, according to an Associated Press report. The company lost $5 million in 1997 on revenues of $250,000. The company estimates about $330 million is spent annually in the United States on blood tests for jaundice.
The TLc device costs between $3,000 and $5,000 depending on the model, and then each test cost about $10, about the same as a blood test, McFarlene said in the AP report.
More than 2,000 newborns were tested on the device before it won FDA approval. Although the device was approved in July 1997, it took until earlier this year for the company to get its manufacturing process approved, AP reported.
Jaundice occurs in most newborns because of increased bilirubin production, a waste product produced by red blood cell breakdown and decreased clearance of bilirubin by the liver. Prior to birth, the bilirubin in a fetus is processed through the mother's liver and excreted. But certain infants, including those who are born prematurely or who are underfed, are at increased risk of hyperbilirubinemia.
The BiliTest is important because it can be used in all races and can replace the standard method of of bilirubin monitoring by drawing blood and shipping it to a laboratory for analysis, as reported earlier by Medical Industry Today.
Containing a light source and optical filters, the device obtains measurements when it is placed on the newborn's body in various physical sites for five to 10 seconds, the company said. The instrument is battery-powered, handheld or can be used as a portable briefcase unit using an external power source, with a battery backup.
The TLc test has proven to be 95 percent accurate compared to traditional blood tests, according to a study published in the Pediatrics medical journal last September.
"It should make a big difference,'' said Dr. Alan Greene, a pediatrician in San Mateo, Calif., who also runs a pediatric website.
The test uses a small light sensor that measures the yellow pigment in the baby's skin. The more yellow the skin, the higher the bilirubin level. The key to the device is that it can account for more than 210 different natural skin color types, and the effect on skin color change from light therapy, which is the most common treatment for jaundice.
McFarlene was able to develop the new test because Chromatics already had much experience using computers to get precise measurements of colors, according to the AP report. Chromatics, for example, has worked with Clairol in developing hair coloring and also with Avon's cosmetic products. The company also was aided by researchers at New York's Mt. Sinai Hospital, which spent more than a decade conducting studies on the device.
"Our research demonstrates that the Colormate TLc.BiliTest provides an accurate and linear estimate of serum bilirubin in a wide range of babies," said Dr. Ian Holzman, Chief of Newborn Medicine at Mt. Sinai Hospital, in an earlier Medical Industry Today report. He said the device may be used in hospitals, doctor's offices and home healthcare agencies.
About 60 percent of the 4 million babies born annually in the United States become jaundiced in the first three or four days after birth, and it is the most common cause of newborn readmission to hospitals. Nearly all premature babies are born with the condition, which can cause brain damage.
Copyright 1999 Medical Data International Inc. All rights reserved. Reprints may be obtained by permission. Contact MDI account representatives at (800) 826-5759.
LANGUAGE: ENGLISH
LOAD-DATE: March 23, 1999
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