Letter to shareholders dated 5/1/97
Came across this today and thought it had good information that was worth posting.
May 1, 1997
Dear Shareholder:
I would like to take this opportunity to bring you up to date on the activities of your company during the past year.
In the medical applications area, during 1996 the Company, in participation with Mt. Sinai hospital in New York City, completed many years of the initial clinical studies demonstrating positive results for its proprietary technology and instrumentation in detecting and monitoring the presence of hyperbilirubinemia (yellow jaundice) in newborn infants. In November 1996, the Company filed an application with the FDA requesting market clearance for use of the technology as an aid to the physician in monitoring the status of newborn babies for the development of hyperbilirubinemia. In December 1996, the FDA notified the Company that its application was being reviewed under the 510(k) review process. The Company's submission is currently under review by the FDA's Center for Devices and Radiological Health. According to FDA's Office of Device Evaluation Annual Report Fiscal Year 1996, during fiscal year 1996 the average 510(k) review time was 145 days, or approximately 5 months, although there can be no assurance that the Company's application will not take more than 5 months.
Following the closing of private placement financing in 1996, which raised net proceeds of approximately $4,200,000, we are continuing initial implementation of the Company's long range business plan for commercial medical and dental applications. The Company has begun preliminary discussions with distributors for potential industrial, medical and dental applications, as well as exploring business relationships to develop strategic alliances, acquisitions or joint ventures for distribution of these applications. The Company has also retained an expert Regulatory Monitoring consulting firm to assist with filing and obtaining all requisite regulatory approvals for commercially marketing its medical applications internationally. In this regard, the Company has retained an expert pediatric medical consultant to assist with conducting multi-center studies at various teaching hospitals and assembling the Company's Medical Advisory Board.
The Company continues its commitment to expanding its business in the Cosmetics and Beauty fields. In 1996 the Company completed consumer market studies with companies in the Cosmetics and Beauty field including product formulation chromaticity studies for Mary Kay Cosmetics and hair color consumer market tests with Clairol and Regis Corporation. Although no definitive agreements have been reached with these companies, if the R&D efforts to develop the mass manufacturing prototype of the miniaturized Colormate(tm) II are successful, the Company intends to reopen business discussions for these applications. Additionally, the Company entered into a licensing agreement for development and test marketing of the Company's custom blended foundation system with Gordon Laboratories, a national distributor who represents a strong resource in launching and developing new business in the Specialty Store and Beauty Salon market of the Beauty Industry. This approach has been carefully developed and if development and preliminary test markets prove successful, will offer an opportunity to expand into these key markets.
We are also proud to announce that the staff of the Company's new engineering facility in Spokane, Washington completed the working prototype of the new Colormate(tm)III System transcutaneous bilirubinometer with all necessary UL and FCC approvals for submission in its 510(k) application to the FDA in November 1996. The Company anticipates that its R&D effort to develop the mass manufacturing prototype of the new miniaturized Colormate III will be completed in 1997. The Company is also proud to announce that it has acquired new patents in Australia, Mexico and Taiwan during 1996.
These and other projects in more preliminary stages of development, continue to confirm to us that your company has proprietary technology with broad-reaching commercial potential in fields which offer the Company the opportunity to build a significant and profitable business.
We thank you for your continued support of our company.
Chief Executive Officer
Chromatics Color Sciences
International, Inc |
