FDA Aproval
Hier die NEWS:
August 18, 2010 07:00 AM Eastern Daylight Time
BSD Medical Receives FDA 510(k) Clearance to Market the MicroThermX Microwave Ablation System
SALT LAKE CITY--(BUSINESS WIRE)--BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market its MicroThermX Microwave Ablation System (MTX-180) for ablation of soft tissue. Clearance from the FDA of BSD’s 510(k) Premarket Notification submission authorizes the commercial sale of the MTX-180 in the United States. The MTX-180 was designed to provide a higher power, optimized system targeted to the growing therapeutic interventional and surgical oncology market.
“The MTX-180 represents a significant advance in our strategy to diversify BSD’s products and increase revenue”
The MTX-180 utilizes innovative synchronous phased array technology that was developed and patented by BSD to deliver targeted microwave energy to ablate (destroy) soft tissue. BSD employed its extensive 32-year background in developing thermal therapy systems in the design of the MTX-180. BSD’s patented and patents pending technology allows the MTX-180 to provide larger and more uniform zones of ablation during a single procedure. Third party independent testing was conducted at a U.S. university medical center that is a world leader in ablation treatments. The testing data demonstrated that the MTX-180 is a user-friendly system that delivers larger, more uniform ablation zones in shorter periods of time.
The MTX-180 is a compact, mobile, state-of-the-art, proprietary system that includes a microwave generator, single-patient-use disposable antennas, and a thermistor-based temperature monitoring system. The innovative design of the MTX-180 is the first of its kind that allows delivery of higher power levels using a single generator. The delivery of microwave energy is controlled utilizing an interactive, touch screen monitor that allows the operator to quickly and easily control the treatment.
“The MTX-180 represents a significant advance in our strategy to diversify BSD’s products and increase revenue,” said Harold Wolcott, BSD President. “The MTX-180 introduces into the Company’s product line an innovative, high-end disposable that is used in each ablation treatment, and will provide a significant ongoing revenue stream. The soft tissue ablation world market potential is estimated to exceed $2 billion. We believe that the MicroThermX System provides significant advantages over currently available devices that will allow us to capitalize on this rapidly expanding market.”
Currently, radiofrequency (RF) energy is utilized most frequently in the interventional oncology ablation market. Published studies have demonstrated that the use of microwave energy has numerous advantages over RF energy for the delivery of ablation therapy, including faster set-up, shorter ablation times, larger ablation zones, and higher intratumoral temperatures. For these reasons, interventional oncology key opinion leaders regard microwave as the future of soft tissue ablation therapy. The MTX-180 has been designed to provide optimized microwave ablation therapy.
The MTX-180 provides minimally invasive access to the target tissue and can be used in open surgical as well as in percutaneous ablation procedures, which will allow the MTX-180 to be used by both surgeons and interventional radiologists.
CE Marking approval for the MTX-180 System is imminent and will allow BSD to initiate a European market launch.
http://www.businesswire.com/portal/site/home/...05181&newsLang=en
There is a replaceable part (antennae) for the BSD Medical MTX-180 ablation system that will be sold for $1,200 to $1,800 dollars. A new one is needed for each procedure.
There is over 65% margin on the part for BSDM.
If BSDM sells just 100 MTX-180's (easily done in the first year, in my opinion based on prior system TherMatrx100 sales)
they could generate over 150 million dollars in revenue in one year.
How?
You can do 10 procedures a day easily with one of these systems.
Conservatively.
ONE MTX-180 working just 3 days a week can do 30 procedures a week. Multiply by 52 weeks equals 1,560 ablations per year for ONE MTX-180. With 100 machines in the market it could be upwards of 156,000 procedures a year.
Multiply that by $1,200 and you get revenues of 187 million dollars, of which nearly 65% go straight to BSDM's bottom line. That's 121 million dollars NET to a company with just 25 million shares outstanding, and no debt....not to mention they have tax-loss carry forwards and won't pay any taxes either.
They could sell 800 sytems in 4 years, like the TherMatrx100 did in 2002-2006, and you could have over 1 BILLION dollars in revenues! No joke!
We will never reach that poiny.
Know why?
A TAKEOVER WILL HAPPEN FIRST.....In my opinion this stock could be worth well north of 20 dollars a share, FAST.
IMHO.
Denkt dran hier in D völlig unbekannt und deshalb auch kaum Volumen die letzten Monate.
Wenn ordert in den USA dort ist es fair denn die Makler taxen wenigstens gescheit.
BSD Medical Corporation (Public, NASDAQ:BSDM) Watch this stock Find more results for BSDM
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Inst. ow
Die Urzeit stimmt zwar nicht zumindest steht Sie gerade erst bei Ariva drin.
Aktie versucht gerade einen Boden irgendwo zu finden.
2.28 +1.15 (101.77%)
Real-time: 10:00AM EDT
Wahnsinn der Tag hat doch gerade erst angefangen.
Es werden Erinnerungen an DNDN oder Human Genom wieder wach.
Mal abwarten aber schade das sich niemand für den Wert interessiert.
Ne FDA Zulassung gabs heute und die NEWS ist gigantisch für den niedrig bewerteten Wert.
- Die Zulassung bringt BSDM in einen Billionen Dollar Markt
- Sehr geringer Free Float von nur 14,76 Millionen Aktien
- Sehr geringe MK von nur knapp 60 Millionen (bei einem Kurs von 2,40 Dollar)
Also alles in allem siehts bisher richtig gut aus.
Lese mich selber gerade erst ein wegen der FDA NEWS obs wirklich so ne große Sache ist.
Denk aber dran wenn kauf in den USA und ich würde die Aktie dann heute auch weiter beobachten und ab morgen mit nem Stop arbeiten.
Bin selber heute zu Handelsbeginn in den USA rein gott sei dank noch weit unter 2 Dollar.
Viel Glück das es wirklich nen Highflyer wird die kommenden Wochen.
Chali
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Wertpapier: Perseon |
Für jede Behandlung neue antenne ???? Und das soll die Krankenkasse bezahlen ??!!??
Wenn nicht,dann gande euch gott mit dieser aktie !!
Chalifmann
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Wertpapier: Perseon |
Was ich sehe ist allerdings reges Interesse in diesem Wert in den USA.
Size of MTX-180 ablation market, read this: 23-Jun-10 10:37 am
http://mediligence.com/blog/2008/07/11/a...
The article I link above tells you the true size of the ablation market. It is far greater than what is stated in the pres release. The press release gives you a number for SALES of DEVICES, in ONE year, for use in "interventinal oncology" only.
The MTX-180 can be used for many more types of ablations, and is expected to replace many systems which currently use RF technology, another market worth 335 million dollars a year.
Keep in mind that the end sale of an MTX-180 is only the BEGINNING of the revenue stream that will come to BSDM. It is the replaceable probe that is required for every procedure performed, that will generate hundreds of millions in revenues.
Each probe is expected to sell for $900 and have a margin of 50-60 percent. And each procedure can use up to 4 probes. The multiple probes are part of the large breakthrough and advance in the science that BSDM is bringing to market with the MTX-180.
Basic math:
Sell 100 MTX-180's (easily done, previously 800 TherMatrx100 DOT systems, invented by BSDM, were sold)
These machines are always kept in use by the facilities/doctors who buy them. Ever wait days/weeks for an MRI or CAT scan? There is never a moment the machine is not in use.
Being conservative, say the end user does 30 ablations per week with just ONE probe each week. Multiply by 52 weeks and you have 30 x 52 = 1,560 probes used in one year by one machine. Multiply by 100 machines (expected to sell in one year, as did the TherMatrx100 DOT system) and you have 156,000 probes used.
156,000 probes x $900 = 140,400,000 dollars revenues generated in one year.
All that revenue for a company that sells for $1.40 with only 23 million shares outstanding. A 32 million dollar market cap? Revenues could be almost 5 times the value of the company 1 year down the road?!
What if they sell 800 MTX-180's over time?
8 x 140 million dollars = 1.12 Billion dollars in revenues generated. That's "B" for Billion.
The upside for this company's stock is ridiculously high. Almost unheard of in the medical device community.
Yet there are those trying to put them out of business. Why? To save thier own skins. When BSDM came out with the TherMatrX100 it dominated the market so much so that the nearest competitor Urologix almost went bust. Their stock went from $30 to $2.
There are many companies out there who do not want MTX-180 to see the light of day. But that's a whole 'nuther story for another day.
I am buying all I can here, days away from 510k approval and the first sales of MTX-180's, which by the way, I believe they already have lined up, just waiting for the FDA nod.
With potential 100 million $$$+ in sales in the first year, the stock can easily support a 200 million dollar market cap, giving it a share value of $8.70 as soon as this is realized. From there it is straight up as revenues grow, much like the chart of LSCP or ISRG.
All of course, IMHO, which by the way, has made me a lot of money in the medical device industry before.
Good Day to all.
Dann direkt bei US Eröffnung gekauft und jetzt bin ich bisher zufrieden.
So kanns gehen manchmal braucht man Glück.
Ansonsten wäre ich vielleicht schon zu 1,55 - 1,65 Dollar rein.
So halt erst bei 1,78 Dollar.