News - Pediatrics Article - Study
Headline: Newborn Babies May Face Fewer Needles
Study Finds that Chromatics' Non-Invasive Device is Effective in Detecting and Monitoring Infant Jaundice
NEW YORK, Oct. 6 /PRNewswire/ -- A study involving nearly 2,500 newborn babies has confirmed that bilirubin infant jaundice can be detected and tracked effectively utilizing a skin color measurement of infants by a non-invasive bilirubinometer.
The monitoring device, called the Colormate(TM) TLc-BiliTest(TM), was developed by Chromatics Color Sciences (NASDAQ:CCSI), a New York-based color science technology company. The Company has received Food and Drug Administration (FDA) clearance for commercial marketing of the device.
Once the monitor is commercially available and used widely by the medical community, the common practice of drawing blood from the heels of infants to test for the condition may be greatly reduced.
The study involved 2,441 male and female infants of diverse ethnic/racial groups, both full-term and premature, who were tested shortly after birth, including the monitoring of infants who underwent phototherapy treatment for infant jaundice. The bilirubinometer was used to measure skin tone shortly after birth and used to track skin color changes while current methods of infant jaundice detection and tracking (blood testing and physician visual estimates) also were being used.
The study found that the bilirubinometer was effective in diagnosing and tracking jaundice, compared to current invasive methods involving taking blood from the infants -- often repeatedly. The researchers reported, "This instrument can provide valuable clinical information that obviates the need for serum bilirubin determinations. Its use in newborn nurseries may allow physicians to shorten lengths of stay more safely and decrease the use of invasive blood tests."
The study was led by Dr. Ian R. Holzman, chief of newborn medicine at New York's Mt. Sinai Medical Center, along with two Mt. Sinai-based pediatricians -- Dr. Donald Gribetz and Dr. Irwin Gribetz -- and Dr. Roland Tayaba, who is director of the neonatal intensive care unit at City Center Hospital Center of Elmhurst in New York City. The results were reported in Pediatrics, published by the American Academy of Pediatrics.
Chromatics Chief Executive Officer Darby Macfarlane said the Company is currently negotiating manufacturing agreements to produce its monitoring device and agreements for global distribution of the TLc-BiliTest(TM).
Ms. Macfarlane said, "From personal experience I know how parents feel when their newborn babies are stuck repeatedly in order to draw blood and determine blood serum bilirubin levels. If the use of this technology can help to remove those heart-wrenching moments and if more parents can safely bring their babies home sooner, as the report also suggests, our mission will have been successful."
Chromatics Color Sciences is in the business of color science and has developed technologies and intellectual properties that it believes have medical applications involving the detection and monitoring of certain chromogenic diseases or disorders such as 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.
Medical applications in addition to the detection and monitoring of bilirubin infant jaundice 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-aid and fashion industries.
Certain of the matters discussed in this announcement contain forward-looking statements........
SOURCE Chromatics Color Sciences
CONTACT: Darby Macfarlane, Chief Executive Officer of Chromatics Color Sciences International, 212-717-6544; or Peter Rosenthal, 212-843-8030, or Rick Matthews, 212-843-8007, both of Rubenstein Associates Inc., for Chromatics Color Sciences/ |
