AUG 12, 1997 CONFERENCE CALL (Part 2 of 2) PRINT 4 Pages
Questions from the Floor
DARBY MACFARLANEAt this point I would like to open up the floor for questions.
QUESTION:First question regards any other medical applications for the product. You mentioned other diseases. Have you submitted any FDA 510(k)submissions to diagnose other diseases? Thank you.
DARBY MACFARLANE: Not at this juncture. We focused all of our attention on getting through the FDA process with bilirubin infant jaundice. We have conducted some R & D on a couple of the other diseases such as anemia and tuberculosis but we have not begun any formal clinical trials.
QUESTION: "Hi Peter" Hello. This is Bruce. "Hi Bruce" Hi, it's Bruce onthe same line - I just wanted you to review one more time the market size for the medical application, bilirubin and you know, what is your projected time for entering the market and capturing the marketplace.
DARBY MACFARLANE: Okay, I thought I had covered that. What we are doing Bruce, is we are going to answer those questions with the best due diligence that we can put together, and I would say within the next few weeks time-period we will have finished our studies on the actual market size internationally.
This task is so huge that to define it carelessly would be wrong of our Company and we want to do that all in one public release, not try and piecemeal it with little pieces here and there of what we are dealing with. So I really can't at this juncture say more than I have already.
QUESTION: Hi Darby, congratulations. "Thanks Dan." My question is a little bit focused more on manufacturing. What kind of goals are you looking to formulate with regard to capacity. You said that you have I guess 1000 briefcase models right now? Yes. But that is not what you're talking about.
DARBY MACFARLANE: No, that's just ready to go out the door. What we have as a next step there is OEM manufacturers that can put together instruments on an interim basis for us until we are ready with our own instrument. We can't anticipate exactly when that will be so we have to be able to be ready to supply a large volume of instruments in an interim period, and we feel that we can meet market requirements on an interim phase by using the OEM process. When we are ready with our own instrument we will start manufacturing ourselves.
QUESTION: Darby, congratulations. "Thank you James. It feels good." "It sure does - its been a long wait. "Yes it has." I guess you are anticipating obviously the exercising of the warrants to help your cash position?
DARBY MACFARLANE: We have about $4,000,000 in the bank and we had extended the warrants a couple of times so that the investment community could have the news of the FDA material announcement one way or the other before they made the decision to exercise. So I wouldn't say that we need the money, but we certainly will take it when it is time for the warrants to be exercised. It will probably assist us in some of our manufacturing requirements.
QUESTION: Good afternoon Darby. "Hi Steve." Just a few questions if I could...I guess what I am curious on are three things. One is, maybe... but then again I am new to the Company and new to the area but maybe you could spend a few minutes addressing - does this product identify all three types of jaundice, number one, and number two, what are the alternatives that people are doing today. Is it just blood tests, and how frequently are they doing this. If we were to start from when a newborn comes out and try to analyze that process as its done. How frequently do you have to test and what percentage of those folks do require periodic testing over the course of days, hours or weeks, and what competitive products are out there? Thank you.
DARBY MACFARLANE: Okay. One at a time. The instrument monitors the forms of bilirubin infant jaundice identified by the blood test. Your second question was how often is the baby tested for the blood test. This varies for different babies - it is really the doctor's call. Premature infants are tested on average I would say between 2 and 3 times a day. The newborn infant - different hospitals have different procedures. But they are monitored periodically so, I would say at least 1 or 2 tests per infant occur, depending on some hospital's procedures.
As far as competition is concerned we are aware of 2 other companies who have tried to, or have monitored Bilirubin infant jaundice in various stages of research or in actual marketing efforts. One of
them is Minolta Camera Company. Minolta Camera Company came out with a bilirubinometer in 1981 which has been marketed in many parts of the world.
From medical publications, it seems there was a problem monitoring the disease for all races and providing an uncomplicated correlation to the mg/dl of the blood, even under phototherapy. The second company we are aware of is a company called Spectrex whose technology is licensed by a company called Healthdyne which has stated that it has technology for monitoring bilirubin infant jaundice but it has not announced data from extensive formal clinical trials. So that is what we know at this point in time on competition. We will certainly be doing more research to find out anything else that exists.
QUESTION: Darby, hi. "Hi Eric." The last time we talked I think the hand-held was undergoing some kind of ability to pass a standard color differentiation test, D: That is correct. E: Where does that stand and can you discuss any remaining technical hurdles to achieve this 2-Q `98 introduction?
DARBY MACFARLANE: The little machine? (Eric: Yes)
DARBY MACFARLANE: The technical hurdles at this point in layman's language are to get the the instrument to read according to what are called the CIE international color standards which is a process that involves the machine being able to measure thousands and thousands of different color spaces standardly. That is being conducted still as we speak - that is a lengthy process.
We don't see or anticipate really any other hurdles, other than defining each one of the components that have to go into the machine. It is now zeroing in on each little piece that goes into the unit and then costing that for mass production. You know its an LED instrument and there are patent cases going on regarding some blue LED's right now and of course this uses blue LED's and some of them have patent problems.
Assistant: There are no further questions at this time.
DARBY MACFARLANE: Well, thank you all for joining us today and should you need any more clarification or request any more information on the Company, as I said at the beginning of our conference call, please feel free to contact us here at the Company, myself or Mr. Connor and/or Jennifer Marlar who will be happy to send out an investment pack. Thank you so much for your attendance. It was good to speak with you.
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