NEWS - CHINA - MINISTRY OF HEALTH
Chromatics Color Sciences Signs Memorandum of Understanding with China's International Health Exchange Center, Ministry of Health
Also Announces Letter of Intent With China National Medical Equipment and Supplies Import and Export Corporation, Ministry of Health
NEW YORK, June 22 /PRNewswire/ -- Chromatics Color Sciences International, Inc. (Nasdaq: CCSI - news) today announced that, following earlier discussions and recent meetings in China, CCSI has signed a Memorandum of Understanding (''M.O.U.'') with the International Health Exchange Center, Ministry of Health (''M.O.H.'') of the People's Republic of China in Beijing regarding the Company's TLc-BiliTest(TM) non-invasive newborn bilirubin detection and monitoring device.
The M.O.U. states that ''whereas bilirubin infant jaundice occurs in most newborns 36 to 72 hours following birth and as per the China Population Statistics '97 Year Book there were more than 20,000,000 newborn babies during the years 1995 and 1996 in China,'' and
''as CCSI has FDA clearance for commercial marketing in the U.S. of a non-invasive bilirubin monitoring device for newborns and as the health of newborns is a vital aspect of China's medical program of the Ministry of Health,
'' the M.O.H. will ''launch a nationwide marketing study'' and develop a plan on ''the most advantageous structure to implement the device's use in the People's Republic of China,'' based on the results of the study.
The M.O.H. expects that the first phase of the Plan will be completed within three months.
The Company also announced that it signed a Letter of Intent with the China National Medical Equipment and Supplies, Import and Export Corporation, Ministry of Health, People's Republic of China, which is interested in supporting the distribution of CCSI's device and collaborating on next steps including investigations for acceptable price structures for marketing the TLc-BiliTest, considering that China has approximately 57,000 hospitals that encompass a variety of sizes and structures.
These important milestones were reached during the launch of the TLc-BiliTest at the recently concluded SINOMED Exhibition in Beijing which was attended by over 80,000 physicians, healthcare professionals, hospital administrators and medical equipment manufacturers and distributors.
In conjunction with SINOMED, doctors from Chromatics' Medical Advisory Board conducted seminars on the technology and use of the TLc-BiliTest at two hospitals in Beijing, and further arrangements have been made for clinical studies of the TLc-BiliTest by the Beijing Children's Hospital, the largest children's hospital in China.
Darby Macfarlane, chief executive officer of the Chromatics stated, ''CCSI's medical business plan is to reach definitive agreement for global distribution of the TLc-BiliTest with international
medical companies.
In support of any potential distribution partner and the relationships established between CCSI and the M.O.H., other officials, physicians and the Chinese business community, CCSI will continue to support these collaborations with the People's Republic of China by opening an office in Beijing staffed by two Chinese Representatives of the Company to expedite the Company's potential for manufacturing, marketing, and distribution of the TLc-BiliTest in China.''
Chromatics Color Sciences is in the business of color science and has developed technologies and intellectual properties which 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. In this regard, the Company has received Food and Drug Administration (FDA) clearance for commercial marketing of its medical device for detection and monitoring of bilirubin infant jaundice.
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-aid and fashion industries.
Certain of the matters discussed in this announcement contain forward-looking statements..... |
