Colormate TLc-Bilitest (TM) -> News From The Confernce
Chromatics' New Non-Invasive Bilirubin Infant Jaundice Monitoring Device to be Showcased by Pediatric Academic Societies at Annual Convention
- Mt. Sinai (New York) Researcher Presents Clinical Evaluation -
NEW ORLEANS, May 4 /PRNewswire/ -- An innovative, non-invasive device for monitoring bilirubin in infants of all races is one of the new technologies being showcased by the Pediatric Academic Societies (PAS) to over 4,000 physicians at its annual meeting in New Orleans from May 1 - 5.
Chromatics Color Sciences International, Inc.'s (Nasdaq: CCSI) new device -- Colormate(TM) TLc-BiliTest(TM) -- represents a pain-free alternative to the current method of invasive heelstick blood tests performed millions of times globally each year to monitor bilirubin levels in newborns.
The Colormate TLc-BiliTest received regulatory clearance from the Food and Drug Administration in July 1997 for commercial marketing to hospitals, physicians and health care professionals.
The "Tender Loving Care" device measures the incremental changes of the yellow content of the skin in newborns of all races to assist health care providers in monitoring bilirubin infant jaundice.
Containing a light source and optical filters, the device obtains color 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," says 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."
On Sunday, May 3, at 4:45 p.m., Ian Holzman, M.D., of Mt. Sinai Hospital's Division of Newborn Medicine in New York, reported the clinical results of an extensive evaluation of the technology. Conducted at two New York hospitals with 900 infants of all races, the clinical trials showed a 95 percent correlation to serum bilirubin levels. The infants, measured every six to eight hours, 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.
Although most likely to occur in babies born prematurely, bilirubin infant jaundice develops in the first three to 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. Infants who are born prematurely, who are underfed, or who belong to certain ethnic groups are at increased risk of hyperbilirubinemia (defined as a level above that considered in a normal range for infants).
The initial screening of the condition is the observation of the yellowing of the skin by physicians or nurses; however, published studies have shown that this screening is a subjective determination and prone to errors due to differing skin colors. Currently, if the clinical assessment warrants it, blood is drawn by lancing the infant's heel (heelstick) and the sample is sent to a lab.
Chromatics Color Sciences is in the business of color science and has developed technologies and intellectual properties which it believes may have other medical applications involving the detection and monitoring of certain chromogenic diseases or disorders in addition to bilirubin infant jaundice. The Company defines chromogenic diseases or disorders as those diagnosed or monitored by the coloration of the human skin, tissue or fluid being affected.
These other medical applications will require additional clinical trials and FDA clearance. 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....... |
