NEWS - SHIPMENTS TO BEGIN
Chromatics Color Sciences Completes First Manufacturing Run For Non-Invasive Bilirubinometer
February 9, 1999 03:03 PM NEW YORK, Feb. 9 /PRNewswire/ -- Chromatics Color Sciences International, Inc. CCSI said today that the first manufacturing run of the Company's transcutaneous bilirubinometer -- the Colormate(R)TLc.BiliTest(TM) System for monitoring newborn jaundice -- has been completed by the Company's ISO 9001-certified contract manufacturer. The Company will now begin scheduling shipments for in-servicing to commence at hospitals and with physicians who have placed initial orders for the Colormate(R) TLc.BiliTest(TM) System and TLc.Lensette(TM) calibration standards.
The Company also said it will begin scheduling a team of neonatal nurse clinical specialists to provide in-service training to physicians and hospital staffs who will be using the System.
The Company is introducing the TLc.BiliTest(TM) System with a limited-time offer for use and evaluation of the TLc.BiliTest(TM) System for the cost of a minimum monthly supply of the TLc.Lensette(TM) calibration standards for single patient use @ $10.00 per TLc.Lensette(TM). Thereafter, various pricing structures and packages will be offered, based on the different markets being supplied.
The Colormate(R)TLc.BiliTest(TM) System, which has FDA clearance for commercial use, is the first device available for pain-free, non-invasive monitoring of bilirubin infant jaundice for babies of all races -- even those under phototherapy treatment. A study of the device published in Pediatrics, the publication of the American Academy of Pediatrics, found that the TLc.BiliTest(TM) System was effective in monitoring jaundice compared to current invasive techniques that involve taking blood from infants -- often repeatedly.
Chromatics Chief Executive Officer Darby Macfarlane commented, "We're very pleased to be able to provide this breakthrough technology for the management of infant jaundice to the medical community and a pain-free alternative for the babies and their parents."
The Company said that the strong initial interest in the device followed a series of successful exhibitions and presentations at international medical conferences during 1998. In addition, in early January 1999, the Company announced it had formed a sales unit with years of experience in sales of fetal and neonatal ICU monitoring products.
As also announced, the System is being manufactured under FDA QSR as well as ISO 9001 manufacturing regulatory requirements. The Company's third party contract manufacturer is an ISO 9001-certified facility. The System includes a proprietary TLc.Lensette(TM) calibration standard for each infant's non-invasive measurement taken while being monitored for hyperbilirubinemia.
Chromatics remains in ongoing negotiations to reach a definitive agreement with potential global distributors, and continues to move toward the completion of required due diligence. In the meantime, in order to provide the TLc.BiliTest(TM) System to hospitals and physicians already placing orders, and to expedite evaluation of the product by the medical community, the Company will be operating the distribution of the newly-manufactured monitors from its own Connecticut office.
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 ...... |
