10Q dated 8/14/98 Recent Events (Part 2)
The Company has recently hired two employees in South Africa and has initiated arrangements for the conducting of clinical trials of the Colormate(TM) TLc - Bilitest(TM) in monitoring bilirubinemia in several hospitals in South Africa, including Baragwanath Hospital (Johannesburg) and King Edward Hospital (Durban). These trials are anticipated to commence in the third quarter of 1998, although there can be no assurance of the exact timing.
In addition, in 1998 and early 1999 the Company anticipates commencing multicenter studies of the Colormate(TM) TLc - Bilitest(TM) in monitoring bilirubinemia in a number of hospitals located in the United States, England, China, Israel, Brazil and Argentina although there can be no assurance of the exact timing of implementation at each hospital. These studies, as well as those to be conducted in South Africa, are being coordinated by Dr. Jeffrey Maisels pursuant to international testing protocols developed by Dr. Maisels.
All of these medical marketing, manufacturing and support activities were contemplated by the Company for distribution of the Colormate(TM) TLc - Bilitest(TM), to ensure that no time was lost in the regulatory, technical, manufacturing sales and training transition following the Company entering into agreements with distribution partners to distribute the Colormate(TM) TLc - Bilitest(TM). There can be no assurance the Company will be able to successfully conclude negotiations or enter into definitive manufacturing or distribution agreements or that its efforts to market the TLI Bilitest(TM) will be successful.
In July, 1998 following internal review board approval from Mt. Sinai, Dr. Mark Lebwohl, chairman of the Department of Dermatology at Mt. Sinai, commenced clinical trials of the Colormate non-invasive medical technology for dermatological use in determining the appropriate levels of phototherapy to treat various skin diseases, and patient tolerance for such levels of phototherapy by quantifying the amount of pigmentation and hence, photo-sensitivity in the skin of patients.
This potential dermatological application of the Company's proprietary technology and device would be for patients for a variety of diseases including psoriasis, excema, cutaneous T-cell lymphoma, vitiligo, and others. Post inflammatory hyperpigmentation also would be a condition subject to monitoring by the Colormate(TM) System.
The noninvasive measurement of the skin by the Company's Colormate (TM) system will be tested and verified against minimal erythema dose-testing including the Fitzpatrick skin type test. The results of these studies are intended to be used in support of future applications for FDA marketing clearance of the Company's technology for such uses.
The Company launched the Colormate(TM) Bilirubin Device to the Chinese medical community at the Sinomed '98 Exhibition, the 7th China International Medical Equipment and Facilities Exhibition ("Sinomed"), held from June 9 to June 12 in Beijing, the People's Republic of China. This exhibition was attended by over 80,000 physicians, healthcare professionals, hospital administrators and medical equipment manufacturers and distributors. In conjunction with Sinomed, doctors from the Company's Medical Advisory Board conducted seminars on the technology and use of the Colormate(TM) TLc - Bilitest(TM) at two hospitals in Beijing, and further arrangements have been made for clinical studies of the Colormate(TM) TLc - Bilitest(TM) by the Beijing Children's Hospital, the largest children's hospital in China.
In connection with SINOMED, the Company 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 Colormate(TM) TLc - Bilitest(TM) non-invasive newborn bilirubin detection and monitoring device.
Under the M.O.U., the M.O.H. will launch a nationwide 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 Company also announced that it signed a letter of intent with the China National Medical Equipment and Supplies, Import and Export Corporation, M.O.H., People's Republic of China, which is interested in supporting the distribution of the Company's device and collaborating on next steps including investigations for acceptable price structures for marketing the Colormate(TM) TLc - Bilitest(TM).
In support of any potential distribution partner and the relationships established between the Company and the M.O.H., other officials, physicians and the Chinese business community, the Company will continue to support these collaborations with the People's Republic of China and in this regard is in the process of opening an office in Beijing and has hired two Chinese representatives of the Company to expedite the Company's potential for manufacturing, marketing and distribution of the Colormate(TM) TLc - Bilitest(TM) in China.
The Company launched the Colormate(TM) Bilirubin Device to the European medical Community at the International Congress of Pediatrics and the First International Congress of Pediatric Nursing, held in Amsterdam on August 4 to August 14.
The conference, held every 4 years, is one of the largest pediatric conferences in Europe, with attendance of approximately 8,000 pediatricians, neonatologists and health care professionals. At the conference, Dr. Ian Holzman, Chief of Newborn Medicine at Mt. Sinai Hospital, New York, presented a paper on the results of extensive clinical trials of the Colormate Bilirubin Device at two hospitals in New York. Dr. Holzman's paper on the studies is expected to be published in the September 1998 issue of Pediatrics. |
