NEWS - LAUNCH OF DEVICE IN EUROPE
Chromatics' New Non-Invasive Bilirubin Infant Jaundice Monitoring Device Launches in Europe
NEW YORK, Aug. 13 /PRNewswire/ -- Chromatics Color Sciences International, Inc. (Nasdaq: CCSI - news) announced today that it launched its Colormate(TM) TLc.BiliTest(TM) to the European medical community at the XXII International Congress of Pediatrics and the First International Congress on Pediatric Nursing in Amsterdam on August 9th through August 14th.
The conference, which takes place every four years, is one of the largest pediatric conferences in Europe, attended by approximately 8,000 pediatricians, neonatologists and health care professionals.
The Colormate TLc.BiliTest is a non-invasive device which provides a pain-free test for monitoring bilirubin infant jaundice in infants of all races. Currently, if the clinical assessment warrants it, bilirubin infant jaundice is monitored by drawing blood from the infant and the sample is sent to a lab to determine the blood serum bilirubin levels.
The Colormate TLc.BiliTest received clearance from the U.S. Food and Drug Administration in July 1997 for commercial marketing to hospitals, physicians and health care professionals. The ''Tender Loving Care'' device measures the skin color in newborns of all races and provides a result correlating to the mg/dl of the blood serum bilirubin within a clinically useful range to assist health care providers in non-invasively monitoring bilirubin infant jaundice. Containing a light source and optical filters, the device obtains measurements from an infant by placing it on the skin of the newborn at different physical sites for five to ten seconds. The device operates as a battery-powered, hand-held instrument, or as a portable briefcase unit using an external power source, with a battery backup.
''It is with great pride that this product is introduced to the neonatal medical community,'' said Ms. Darby Macfarlane, chairperson and chief executive officer of Chromatics and one of TLc.BiliTest's inventors along with David Macfarlane. ''Its birthright comes not only from the field of color science, but from a neonatal ICU where many years ago our child was born prematurely at two pounds. As we watched her having blood drawn repeatedly to monitor her bilirubin level, we decided then and there to research and develop color science technology to provide pain-free monitoring of bilirubin for newborns of the future.''
At the conference, Dr. Ian Holzman, Chief of Newborn Medicine, Mt. Sinai Hospital in New York City, and a principal investigator of the new device, presented a paper outlining the results of extensive clinical studies of the Colormate TLc.BiliTest.
Conducted at two New York hospitals with 900 infants of all races, the clinical trials showed a 95 percent correlation to invasive blood serum bilirubin levels. The infants in the trials were measured every six to eight hours, and included premature and full-term babies with birth weights from two to 10 pounds and those with and without phototherapy.
''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. Holzman, noting that the device could be used by hospitals, pediatricians' offices, and home health care agencies. Dr. Holzman's paper is to be published in the September 1998 issue of Pediatrics, and will be embargoed until 5:00 p.m. EDT on September 8th.
Although most likely to occur in babies born prematurely, bilirubin infant jaundice develops in the first ten days of life to some degree in most newborns. If left untreated, very high levels in extreme cases may lead to permanent brain damage or death (Kernicterus). The condition occurs in most newborns because of a combination of increased bilirubin production, a waste product produced from the breakdown of red blood cells 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. Certain infants, including those who are born prematurely, or who are underfed, are at increased risk of hyperbilirubinemia (defined as a level above that considered in a normal range for infants).
Chromatics Color Sciences is in the business of color science.....
The Company's technologies and intellectual properties also have other applications, including the scientific color measurement and classification of human skin, certain color-sensitive consumer products, and in determining the color compatibility of such skin and product color classification for use in a variety of industries including the cosmetic, beauty and fashion industries.
Certain of the matters discussed in this announcement contain forward- looking statements..... |
