News - Launch Of Hand-Held And Console Model
CCSI Announces Launch of New Medical Product at International Medical Conference May 1, 1998
NEW YORK--(BUSINESS WIRE)--March 16, 1998--Chromatics Color Sciences, International Inc. (NASDAQ:CCSID) announced today that it will be introducing both its new hand-held device and new console model of the device for the non-invasive detection and monitoring of bilirubin infant jaundice at the 1998 Pediatric Academic Societies' Annual International Exposition in New Orleans May 1-5, 1998.
This is the largest Pediatric Research Conference held. The introduction to the international pediatric and neonatal medical community will be in the New Products section of the conference, featuring only those products newly given FDA clearances for commercial marketing.
Dr. Ian Holzman, Chief of Newborn Medicine, Mt. Sinai Hospital, NYC will be presenting to the conference his medical papers on the positive results of the device in extensive clinical trials conducted on infants of all races and those under phototherapy treatment at Mt. Sinai Hospital and Elmhurst Hospital in New York City.
The initial results of multi-site clinical studies of the device for the same indications, the first of which commenced under Dr. Jeffrey Maisels, Chairman, Dept. of Pediatrics at William Beaumont Hospital in Detroit will be presented at a reception for the introduction of the new product to pediatricians and neonatologists.
The company is currently finalizing its mass-manufacturing production schedule under FDA QSR and GMP as well as ISO 9000 manufacturing regulatory requirements for both the console model and the light weight (360 gms.) hand-held battery operated device, each of which includes a proprietary calibration disposable for each non-invasive measurement taken on an infant while being monitored for hyperbilirubinemia.
The company has received a letter from the American Medical Association permitting 3rd party insurance reimbursement in all U.S. states for each use of the company's non-invasive device under AMA Code CPT 82250, which is the same reimbursement code for the laboratory blood test currently used to monitor hyperbilirubinemia.
The company has been in ongoing discussions with potential partners for international medical distribution of its new product and is currently conducting negotiations to reach definitive agreements.
The company is engaged in the business of color science and has developed technologies with medical applications involving the detection and monitoring of certain chromogenic diseases. These technologies 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. The company's common stock is traded on NASDAQ under the symbol "CCSID".
Certain of the matters discussed in this announcement contain forward-looking statements ............. |
