BSD Medical.... The Heat Is On!

BSD Medical says NCI publishes research using hyperthermia to turn chemotherapy into a 'smart weapon'
Briefing.com - February 20, 2007 8:10 AM ET



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Co announces that an article published in the Journal of the National Cancer Institute describes laboratory research at Duke University into the use of hyperthermia therapy to turn chemotherapy into a "smart weapon" for attacking cancer. Further, co says researchers at Duke University have now begun testing the use of encapsulated chemotherapy drug using a BSD Medical system to provide precision heat therapy in women whose breast cancers have recurred in their chest wall. The chemotherapy drug is packed into tiny heat-sensitive capsules. Co says when the capsules are delivered by blood flow into a tumor, the tumor is heated, with the object of causing the capsule to release the chemotherapy into the tumor without subjecting the rest of the body to the toxicity of chemotherapy. When chemotherapy drugs are injected into the blood stream they circulate through the body with the hope that they will be able to penetrate and effectively attack cancerous tumors where they find them.
 
Update* (from SeekingAlpha)


Many of us following the stock focus on the company’s prospective launch of the BSD 2000. The company anticipates that this device will be utilized to treat cancer with heat while boosting the effectiveness of radiation and chemotherapy through a number of biological mechanisms. The clinical trials featuring this device are successful and show significant cure rates in comparison to using chemotherapy alone. Upon FDA approval, these machines will be available for approximately $350,000 to $500,000, with the company gaining a 60% profit margin on sales. Not bad for a company boasting a market cap of under $200 million.

This is good news, but may not be the key factor pushing the stock higher.

I had a chance to speak with company CEO, Mr. Hyrum Meade, last week. It was his feeling that the recent move in the stock could be attributed to the company’s plan to unveil the MicroThermX 100 microwave ablation system. Mr. Meade says that the company is approaching the FDA with the MicroThermX 100, which is used to treat cancer with heat alone. The device is smaller than the BSD 2000 and is expected to sell for considerably less. According to Mr. Meade, the corporate sales outlook for the device is rosy with initial expected annual revenues somewhere around $100 million. Couple this with prospective sales from the BSD 2000 and it is not difficult to see why the stock is climbing.

The company is filig a 510(k) with the FDA for the approval of the MicroThermX 100. This type of application is favorable for the company because this process is not as lengthy. The company expects to hear something on the MicroThermX 100 within three months.

Meanwhile, BSM continues working with the FDA for the approval of the BSD 2000. Thus, it appears the company could launch two new products in the cancer therapy market within the next few months. This is great news for prospective patients as well as BSM shareholders.

One other positive note that may feed into the stock’s recent momentum is the company’s upcoming exhibition at the Annual American College of Radiation Oncology [ACRO] meeting in San Diego being held from Feb. 22-24.

I always tell investors to never fall in love with any given stock. I am finding it difficult to follow my own advice with this particular security. I think BSM, which closed last week at $7.47 goes much higher from here.

>> Stoney is wondering weather this great new machine which is cheaper than the BSD2000 could cannibal sales? Stoney is also wondering weather we get an additional spike today or tomorrow.... and while everyone else is holding for this great future....
do we step off????

:confused:
 
I've been struggling with that question all morning.

I will note despite SeekingAlpha's success at tracking down the CEO they have not replied to me. I took that as a " quiet period " for them because almost every company gets back to you with some gobblygook explanation. I just don't know. There is a growing fear here for me nkhoi but I'm just not sure if it's the fear
of giving back a lot or thye fear of the story really going mainstream and the stock exploding. With all the behind the scenes stuff that we know-- it would make a real nice non hype NYT article. And I have not seen the story on Briefing or Street.com or in any major daily, IBD etc... I mean it is sort of our own private party and we may be really helping a lot of people with cancer... but we don't want to be greedy. As long as volume stays in control let's see what tomorrow brings... I'd like one more super spike personally and the story to go mainstream...
 
Another conference coming I think for BSD.

Mar 01 - 06 Society for Interventional Radiology - Seattle, WA...

Also phase 111 results which wrapped up in December we would be due for those as well. FDA ok could come any day.... I'm hearing 50% to 100% total remission in cases treated with the heat but that's a wide range.

Don't know the real numbers >company very tightlipped at the moment. They will indeed drop a secondary on us at some point... I think closer to $12.

I still want to see this story go mainstream before tapping out. CNBC is just so lame these days, but an interview with our CEO would really help at this point.

Now I have spotted a competitor <CLN> They are slightly different, further behind (phase 1 vs phase 3 ) and have a stock that's starting to move as well. *With some insider buying last year at higher prices. nkhoi I'm just starting my research into this name but let's keep it on the watch list.

Celsion Corporation was founded in 1982. Celsion is a biotechnology company dedicated to furthering the development and commercialization of treatment systems for cancer and other diseases using focused heat energy in combination with other therapeutic devices, heat-activated drugs or heat-activated genes. In 2001 the Company narrowed its focus and concentrated its resources on commercializing a second generation treatment system for Benign Prostatic Hyperplasia with the ultimate goal of using the funds generated from that product to develop cancer treatment drugs based on a heat activated liposome technology licensed from Duke University. The Prolieve Thermodilatation® system for the treatment of BPH was approved by the FDA in 2004 and is being marketed by Celsion's exclusive distributor Boston Scientific Corporation. Celsion is currently engaged in a Phase I, dose escalation study, in the treatment of primary liver cancer and expects to start enrolling patients in a second Phase I study to treat recurrent chest wall breast cancer during the second quarter of 2006. The Company intends to focus on developing drugs for the treatment of various cancer indications. The first of these development projects involves ThermoDox, its proprietary heat activated liposome containing doxorubicin. Thermodox: Conventional liposomes are manufactured lipid spheres that can carry drugs and delay their elimination by the body, allowing the drugs to remain in the bloodstream for extended periods of time. However, the currently available liposome drug delivery products used to treat cancer do not provide for active targeting of organ specific tumors. Prolieve Thermodilatation System: Celsion's minimally invasive transurethral microwave system, the Prolieve Thermodilatation system, combines heat transmitted through a transurethral microwave thermotherapy device with pressure applied by a unique balloon catheter to produce a natural stent to reopen the urethra. At the same time, the microwave applied heat kills prostate cells outside the wall of the urethra, creating space for the enlarged natural opening. Celsion markets the Prolieve system through an exclusive Distribution Agreement with Boston Scientific Corporation, to which Celsion granted Boston Scientific exclusive rights to market and distribute Prolieve and its component parts for the treatment of BPH. Under the terms of this agreement Boston Scientific markets and distributes Prolieve in the United States and has a license to market and distribute the product worldwide, with the exception of Greater China, Mexico and Central and South America.

~ stoney
 
Well CLN was up 5% today... not in it of course.

BSD Med took a whopping hit of 10% Still in of course.

Typical stonedinvestor madness. I was expecting a sell the news approach to whatever PR they put out today following the conference but it got out of hand-- market conditions did not help.
 
Well Update time. BSD Got some GOOD NEWS TODAY!

>> BSD Medical: FDA requires no further response on warning letter
Briefing.com - April 11, 2007 8:05 AM ET



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Co announces that the FDA has informed the co by letter that BSD's written response to the FDA warning letter (previously announced) is adequate. "Implementations of the corrective actions you have developed and implemented appear to be adequate," the FDA replied, noting further that "no response to this letter is necessary." The FDA's concerns had been limited to research conduct at a clinical site, and had nothing to do with the safety, efficacy, quality, design or manufacture of BSD's equipment.

>> Ok the market is slow today giving you all a nice chance to follow and get in if you want to-- I'm still holding initial position!!!! Pretty good by my standards I better watch out it may become a Long Term Holding!!! Anyway I'm considering buying more at these levels we'll look for some mid day maneuvering into the stock any vol spikes to the upside will probably force my hand. ~ stoney
 
ATTENTION STONEDINVESTORS! DOUBLE THE SURVIVAL RATE, DOUBLE THE FUN!> BSM

It's decision time once again for our friend BSD Med. I've just gotten through reading their presentation at the cancer conference and it wowed me. Now we no longer view this as a spec single digit investing play-- do we dare start building in some financial assumptions? I'm not sure but I dumped a load at $8 that now it retrospect is not looking so smart I do still have my initial purchase which is looking brilliant. Nkhoi get out your charts after today> let's see if BSM can get some afternoon volume. there's a lot of biotech competition this morning which makes this tough but read this PR for yourself>> if you are a Bio investor like me, these numbers have to strike a greedy nerve. ~ stoney.

>Hyperthermia Plus Chemotherapy Nearly Doubles Disease-Free Survival Compared to Chemotherapy Alone for Sarcoma Cancer Patients
PR Newswire - June 04, 2007 10:24 AM ET
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BSD Medical Corp. (Amex: BSM) announced today that the results of a 340 patient randomized Phase III clinical trial testing the benefit of adding hyperthermia therapy to chemotherapy were presented at the annual American Society of Clinical Oncology (ASCO) conference underway in Chicago, Illinois. According to the results of this clinical study, which was conducted at nine major European cancer treatment institutions and at Duke University Medical Center in the USA, both disease-free survival time and local progression free survival time for patients with locally advanced, high-grade soft tissue sarcomas nearly doubled when hyperthermia therapy was added to chemotherapy, as compared to patients who received chemotherapy alone.

The patients enrolled in this clinical study were very ill, with high-grade (II/III) soft tissue sarcomas and were at significant risk of local failure and metastasis. The patients were randomly assigned to receive either chemotherapy alone or chemotherapy combined with hyperthermia therapy. The patient characteristics were well balanced between these two groups. Their treatments were administered in 4 cycles every 3 weeks before and after surgery and radiation therapy. For patients who received both hyperthermia therapy and chemotherapy the median disease free survival was 31.7 months, compared to 16.2 months for those who received chemotherapy alone (p=0.004), a 95% increase. The median local progression free survival rate was estimated at 45.3 months for patients who received chemotherapy plus hyperthermia therapy, compared to 23.7 months for patients who received chemotherapy alone (p=0.01), a 91% increase.

The study was conducted under the direction of the European Society of Hyperthermic Oncology (ESHO RHT-95) and the European Organization for Research and Treatment of Cancer (EORTC 62961). Rolf Issels, MD PhD of the Munich University Medical School in Germany, was the principal investigator. Duke University was a participant in the international study listed on the National Cancer Institute's website at http://www.cancer.gov/clinicaltrials/EORTC-62961 under the NCI number NCT00003052.

All hyperthermia treatments performed in the study were conducted using BSD-2000 hyperthermia systems developed and produced by BSD Medical Corp. The BSD-2000 hyperthermia therapy system non-invasively delivers precision focused hyperthermia therapy to cancerous tumors, including tumors located deep in the body. The BSD-2000 is a recipient of the Frost and Sullivan Technology Innovation of the Year Award for cancer therapy devices.
 
they must have been reading your post, need a bit more buying vol to convince me tho, check out CMED another slow but steady mover.
 

Attachments

Will do That is " China " related though!

That BSM chart is one bullish wedge after another
Why is this not $16?? I'm going to do deep diligence on this one back in a few days.

remember folks* 10 mil float competitor in same heat field... you can find the name in this thread.
~SI
 
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