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As drug companies continue their research, with more protocols (i.e. drug-disease treatment procedures) advancing into FDA Phase 2 and Phase 3 (final) trials, it becomes obvious that the current source of light activation for these photo-activated drug compounds, the laser, is a highly expensive, even uneconomic, tool. For example, the most inexpensive laser system currently available for the approved photo-activated drug Photofrin® sells for approximately $65,000. The FDA facility rules may add further to this capital cost.
After the acquisition outlays come the cost of training personnel to operate the lasers in the clinical environment. These specially-trained laser personnel must be involved in the clinical uses of the PDT drugs. In addition, there are numerous FDA-mandated rules associated with the laser-based system. Such operational requirements increase the overall costs of the PDT medical procedure and impede the widespread use of these new protocols.
Many of the universities and medical research centers that undertook the initial drug protocol testing had an installed laser system and therefore did not design new equipment for this work. However, almost all medical facilities that are the market for the new PDT drugs would have to acquire these expensive laser facilities and add trained personnel. (One major European distributor of Photofrin has told Ci-Tec that the laser system required to use the drug in the approved protocol costs the equivalent of $169,000 plus all the add-ons.) These high costs are severe obstacles to the widespread market acceptance of PDT drugs.
The LumaCare™ Noncoherent Light Sources eliminate both the high acquisition and operational costs of lasers while performing the identical light activation required for the approved drug protocols. With the LumaCare™ light sources, no special personnel training or facility improvements are necessary.
The current LumaCare™ Model LC-122 starts at $5,000 end user price. The total price depends on the features and flexibilities the drug protocol and the medical facility requires. Thus the costs associated with equipment acquisition and operation for LumaCare™ devices are a fraction of the costs of the laser system.
From the operating standpoint, the cost of administering the drugs to patients is far less, as the costs of laser-trained technicians are eliminated. Any existing personnel in a medical facility can be trained to handle the LumaCare™ equipment. In practice, this means that the PDT protocol can be moved out of the hospital environment and into the office of the individual practitioner, thus eliminating hospital overhead charges and expanding the market for PDT drugs by making the delivered cost to patient lower. This last economic advantage is key to the acceptance and approval of new drug protocols by cost-conscious HMO's.
The LumaCare™ management team realizes even the best products need adequate resources if they are to succeed. To that end we will offer investment opportunities to those investors who share our vision. In exchange for this investment, management will grant the investors an equity position in the company. This will amount to an ownership in the LumaCare™ product line and all future revenues generated by it (subject, however, to dilution for future offerings).
All investments will be used to fund the current marketing program and the continuing engineering and improvement efforts and development of the next generation of patented LumaCare™ light sources.
The potential market for the LumaCare™ lamps is substantial, a result of the tremendous market potential for PDT drugs, particularly in the areas of dermatology, oncology, optometry, dentistry, and arthritis relief. The large drug companies and their affiliates have spent well over a half-billion dollars in PDT research to date. If PDT drugs continue to grow in acceptance and usage, there will be a huge demand for light sources to activate them. The demand for the LumaCare™ lamps could grow to many thousands of units per year within a few years of the drugs' release to the market.
Presently, LumaCare™ units are under evaluation at several academic universities and research clinics. In return for the use of these LumaCare™ units, the research centers have agreed to refer to the LumaCare™ devices in their published research and conference proceedings, as well as in any specific drug protocols that they develop.
LumaCare™ units are now in stock and available for sale. They are available for basic research, protocol development, and patient use (currently not available for patient use in the USA).
Research institutions or private clinics wishing to pursue research in PDT protocols may purchase LumaCare™ devices without regulatory approvals.
Currently, the LumaCare™ company, founded in 1994, is self-funded by the existing management team and our parent company, MBG Technologies Inc. LumaCare™ is registered to do business in the United Kingdom and subject to the laws thereof.
Photofrin is a registered trade name of QLT PhotoTherapeutics.
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