Can you imagine living in a world where breast cancer could be identified much earlier than it is possible now, using no ionizing radiation whatsoever? While all this sounds too good to be true, there is still hope that Imaging Diagnostic Systems, Inc. (OTC:IMDS) could eventually serve as the light at the end of the tunnel.
Ever since its inception in 1993, IMDS has been pursuing the sole purpose of constructing a novel laser breast imaging system known as Computed Tomography Laser Mammography System (CTLM) TM. Why novel? First, CTLM does not use X-Rays, so patient can easily be examined as often as they wish without fearing for any adverse side effects. Second, CTLM can easily image through dense breast tissue in a non-invasive way. Last but not least, CLTM is able to visualize tumor angiogenesis which could otherwise remain hidden in routine mammography.
In spite of all these advantages, however, the CTLM has not been approved by the Food and Drug Administration yet, which means that the company does not have the right to sell it nationwide. What is more, although IMDS has submitted a (501)k application to the FDA, there are currently no indications whether CLTM will receive market clearance any time soon. At least, its international sales have received the green light and, as of Sept. 30, 2011, as many as 16 devices have already been sold by the company’s various distributors.
Imaging Diagnostic Systems, Inc. has been managed by 74-year-old Linda B. Grable for quite a while. Holding a BA in Journalism and Marketing, Mrs. Grable has gained broad experience in negotiating funding with various institutions, which is why the fact that she has so far attracted a staggering $42 million to keep the company’s R&D division going is hardly a surprise to anyone. Unfortunately, when it comes to financial management, IMDS’s situation does not look as rosy.
The latest 10-Q report which IMDS filed with the SEC in mid-November is indicative of the sheer imbalance between the company’s $400K in current assets and its $5.1M in current liabilities. As it turns out, IMDS has been receiving promissory notes as if they were on a conveyor belt. All the notes are subsequently converted into stock, which puts regular shareholders under never ending dilution.
The aforementioned negative features will all vanish into thin air as soon as IMDS has started generating considerable revenues. To do this, Mrs. Grable will have to both get the long-awaited FDA approval and increase product awareness among American citizens. Only then will the company be able to gradually increase stockholder value. First, however, it will have to cover the net loss of $112 million accumulated for the last 18 years.
IMO the only people throwing money to the FDA are the lobbyists from GE. IMDS is a thorn in their side. I think they had a hand in the last FDA outcome. Only my opinion.
There's no money to get anything there too. Do the math. It will take over 30 BILLION shares!
Your suggestion that IMDS pay off the FDA, besides being illegal, has another problem too.... They only have 1500 in cash at the end of last quarter and no way to finance it. They're already running out of shares.