The MelaFind device only works on melanoma, whereas the Aura works on melanoma, basel cell and squamous cell carcinoma. Only 4% of skin cancers are melanoma so our market is potentially 25 times bigger. The Mela probe is very large (about the size of a pineapple) and the Aura is very small so that it can get into the nooks and crannies around the eyes, ears and in between the fingers and toes. Mela takes two minutes and requires a few minutes of preparation such as shaving hair off the area to be examined and applying some oil to the skin, and the Aura takes a couple of seconds with no preparation. Even after multiple attempts 8.6% of the lesions in the Mela pivotal study were un-evaluable (and it turned out that 17% of those were later confirmed to be melanoma). So the Mela device is only practical on one or two lesions per patient due to the time it takes and the size and weight of the probe. The Aura is almost instant and could be used on dozens of lesions on at-risk patients who typically have dozens of moles and other assorted lesions. Moreover, because our device is a spectrometer - if one can characterize the spectral markers of a disease or skin condition, then the label can be expanded. We will be looking to expand our label to include Actinic Keratosis. Our initial study was focused on more serious lesions and so we want more data for an AK indication - but the AK market is massive and we are very confident that based on our initial AK test analysis that we can do that as well. AK is a pre-cancerous lesion that is even more common than BCC and SCC. There is a generic drug called ALA5 that is FDA approved for photo dynamic therapy of AK. One doctor I know in Australia did PDF for 2000 patients in one year at his skin cancer clinic @ $700 each (the drug costs $40). So doctors could use the device to recruit more patients for high margin PDF treatments. This means we can offer upgrades as we go along just by upgrading the software on the device. It is like adding new products without the costs associated. Just more data collection and then upgrade in the software is all that would be needed
These things all sound nice as hypotheticals but Aura has not yet proven it can do these things clinically. You are also wrong about the two minutes per lesion for Mela. It takes that long to Process but the dr need not wait before scanning the next lesion. They can process while other lesions are scanned.
Your product also is going to cost $30,000 vs. $7,500 and is not going to be approved in the U.S. until at least 2013...according to the CEO's interview on CNN on Youtube. In this economy, getting physicians to fork over that much money has proven very difficult. It killed Dendreon...as the out-of-pocket cost for Provenge was prohibitive and physician cash flows are not enough to front huge purchases. MELA is first to market in U.S., two years ahead and with a very low out of pocket cost.
I agree. Even with medicare approval for DNDN, the $90,000 upfront cost to the doctor is a lot. Of course, they may overcome that with a financing deal until full reimbusement. This is an important drug.