BSDM filed a 510K for the MTX-180 with the FDA on March 22. Review period is usually 90 days OR LESS. That puts approval on or before June 22, 2010. About 3-4 weeks from today at the latest.
About the MTX-180
The MTX-180 will work well, and will the be-all, end-all of the ablation market. Every doctor doing ablations will end up with one.
Remember BSDM has done it before, with the device they built for treating BPH. The TherMatrx100.
That device dominated the market, put Urologix (competitor) out of business, and became the system of choice when treating BPH. I believe BSDM sold the rights to it to American Medical Devices Inc. for about 40 million dollars, and that is how they have funded themselves, and the development of the MTX-180 over the last 5 years.
The MTX-180 should be, by all accounts, a cash cow that puts BSDM back on the map, and will draw much attention to their other more expensive hyperhtermia products.
MTX-180 is cheap (maybe 25,000 $$$ ?) but the replaceable parts for surgeries are $900-$3,200 PER SURGERY, and those parts will be sold by BSDM at a 50-60 percent margin. A "razor blade" business if you will.
You do the math.
If BSDM gets just one hundred MTX-180's out there, just 2 for every state in America, and each one does 5 ablations a day, 30 per week, that's 1,560 per year for each one. Multiply by 100 systems, that's, 156,000 ablations per year in the U.S. alone.
At $900-$3,200 x 156,000 you get 140 million to 561 million dollars in revenues generated in 1 year from 100 machines. That's some serious revenues! For a company with just 22 million shares outstanding!
Getting the picture now? What if they end up selling 500 MTX-180's???
Over 600 of the TherMatrx100 BPH treatment systems were sold in the last 6 years. BSDM can do it agian, and the MTX-180 is expected to dominate the marketplace and sell MORE.
MTX-180 could be all this company needs to get the stock into the double digits. Any sales from BSD-2000 is just gravy on top of the meat, the MTX-180.
June will be here in 2 weeks.
All those revenues will now be spread out over just 23 million shares, 11 million of them closely held.
No debt, cash rich now (7.5 million $$) and a new product launch in June. That is the reality. And don't forget, China is buying BSD-2000's, there is an ongoing clinical trial for Thermodox combined with the BSD-500, and the HDE submission for the BSD-2000 can be approved any day now.
This stock's chart looks like there has been a lot of selling. Why do you think this will suddenly go positive? If the expectation s that they will pass the approval process, shouldn't this stock be going up?
Approval will push this stock to 3-4$ easily = Great buying opportunity !!!
Heat helps in cancer treatment
By Kate Kelland, Reuters
BERLIN - Cancer patients whose tumours are targeted with heat treatment as well as chemotherapy are more likely to stay alive and cancer-free for longer than those who receive only chemotherapy, researchers said on Tuesday.
The finding suggests it may be possible to cut the dose of chemotherapy drugs by using heat, although more research is needed to establish this, they said.
German researchers looking at cancers in soft tissues such as muscle, fat and tissue around the joints, found that heat treatment more than doubled the proportion of patients whose tumours responded to chemotherapy.
Importantly, the process did not increase the harmful effects of chemotherapy treatment.
BSD Medical makes the heat treatment system used in the German study.
"We expect our findings will encourage other researchers to test the approach in other locally advanced cancers," said Rolf Issels, a professor of medical oncology at the University of Munich in Germany.
"Targeted heat therapy has already shown promise in recurrent breast and locally advanced cervical cancer in combination with radiation, and studies combining it with chemotherapy in other localized tumours such as those in the pancreas and rectum are ongoing."
Heat therapy for cancer involves a technique known as regional hyperthermia, which uses focused electromagnetic energy to warm the tissue in and around the tumour to between 40 and 43 degrees Celsius (104 to 109.4 degrees Fahrenheit).
The heat not only kills cancer cells, but also seems to make chemotherapy work better by making cancer cells more sensitive, Issels said. It also improves blood flow, allowing chemotherapy to be more effective.
Issels said his findings, presented at the ECCO-ESMO European cancer congress in Berlin, showed that soft tissue sarcoma patients receiving the targeted heat therapy plus chemotherapy "fared better on all outcome measurements."
"Almost three years after starting treatment, they were 42 percent less likely to experience a recurrence of their cancer at the same site or to die than those who were getting chemotherapy alone," he said.
The average length of time that patients remained disease free was 32 months in the group that got both treatments, compared with 18 months in the group that got chemotherapy alone -- an improvement of 30 percent.
Issels said the equipment and specialist knowledge to be able to offer such heat therapies is only currently available in a handful of clinics and hospitals in Germany, the Netherlands, Switzerland, Norway and the United States.
But he urged cancer doctors to take note.
"The clear results of this trial show that the field has now matured to the point where we must step up efforts to explore its potential to offer an entirely new way of treating locally advanced disease in several major cancers," he said.
(BSDM) FDA approval in June ..Top Pick !!!
Posting Permissions 
