To: Bill Wexler who wrote (732 ) 4/15/1999 7:11:00 PM From: Peter V Read Replies (1) | Respond to of 10293
From the CCSI 10-K, released today:In April 1999, the Company raised gross proceeds of $5 million from the private placement of 14% Senior Convertible Debentures due April 15, 2002, the proceeds of which the Company intends to use to support its marketing efforts and obligations under the arrangements with the marketing and distribution partner selected. Is this a floorless convertible? Anyone have details handy (so I don't have to look it up myself) And is it possible that CCSI may actually have a distributor soon???The Company has agreed on definitive basic terms with two potential marketing and distribution partners for the exclusive distribution of the Colormate(Registered) TLc Bilitest(Trademark) System in the hospital, pediatrician and home healthcare markets. Both of these proposals include terms requiring minimum annual placements of the Colormate(Registered) TLc Bilitest(Trademark) System and TLc Lensette(Trademark) calibration standards and/or charges per use. The Board is reviewing both sets of terms as well as recommendations of its advisors and the Company anticipates selecting one of these distributors shortly. Uh, they have been at this for over a decade??The Bilirubin Project. Since 1988, the Company has been engaged with Mt. Sinai Hospital, and more recently with Elmhurst Hospital in clinical research studies (the "Bilirubin Project") involving the use of the ColorMate(Registered) TLc BiliTest(Trademark) System in the monitoring of newborn bilirubinemia (infant jaundice) in infants. The initial studies conducted in Mt. Sinai Hospital tracked, on a parallel basis, (i) the non-invasive skin color measurements made of each infant by the ColorMate(Registered) Bilirubin Device and (ii) simultaneous blood samples drawn from the infant to obtain a laboratory report on the patient's bilirubin count. The first phase of testing in 1988 and 1989 resulted in a positive feasibility study demonstrating that the ColorMate(Registered) TLc BiliTest(Trademark) System skin color measurements corresponded in direct ratio to the laboratory reports of the blood samples drawn. The second phase, which was concluded in November 1992, studied a larger volume of patients and demonstrated the same results. In October 1993, the Company and Mt. Sinai Hospital published the research results to that date. From October 1993 to April 1996, the Company and Mt. Sinai Hospital conducted the third phase of clinical testing involving the compiling of certain additional clinical data relating to expanded testing on a larger group of patients, with emphasis on skin color measurement at birth and while under phototherapy (the current standard treatment for the disorder). We still don't have any numbers for production, and it looks like they are cannibalizing prototypes to manufacture "early stage maketing samples," despite the initial production run.In February 1999, the first manufacturing run of the Company's ColorMate(Registered) TLc BiliTest(Trademark) System (under FDA QSR as well as ISO 9001/EN46001 manufacturing regulatory requirements) for monitoring newborn jaundice was completed by the manufacturer. The Company commenced shipping the ColorMate(Registered) TLc BiliTest(Trademark) System to those hospitals having placed purchase orders for the systems under a limited time offer. The Company also has begun in-servicing at hospitals and with physicians who have placed initial orders. The Company believes, based on discussions with suppliers of components used in its ColorMate(Registered) TLc BiliTest(Trademark) System and published price lists, that the components can be purchased in quantities of 1,000 or more on terms acceptable to the Company. However, there can be no assurance the Company will be able to obtain such terms or order in such quantities, and manufacture of limited quantities of the ColorMate(Registered) units would be significantly more expensive. To the extent the Company successfully markets the ColorMate(Registered) TLc BiliTest(Trademark) System for medical application, the Company will use the nonproprietary and proprietary components of a portion of the existing ColorMate(Registered) units in its possession for the production of a limited number of such devices for early stage marketing and sales efforts and for commercial use.