THIS UNDISCOVERED STOCK IS THE NEXT HIGHFLYER!!! BSDM HAS HUGE UPSIDE POTENTIAL !! PLEASE READ ....


BSD Medical (BSDM)

Market Cap: 38 Mio$
Price: 1,78 $

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BSD Medical Corporation provided today an update on the U.S. Food and Drug Administration’s (FDA) review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company’s BSD-2000 Hyperthermia System.

The FDA’s review process continues, and the FDA has submitted additional questions to the Company for which the Company is preparing responses. Although the Company remains optimistic, it is unable to predict when the review process will be completed and its ultimate outcome.

On May 15, 2009, the FDA granted Humanitarian Use Device (HUD) designation for the Company’s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. The HUD for the BSD-2000 confirmed that the intended use population is fewer than 4,000 patients per year. Following receipt of the HUD designation, the Company filed a Humanitarian Device Exemption (HDE) marketing submission with the FDA, and the FDA review process of this submission is ongoing.

If received, the HDE approval of the BSD-2000 Hyperthermia System would authorize the commercial sale of the BSD-2000 in the United States.


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Cancer Decisions® - A Victory for Hyperthermia in Bladder Cancer

A Victory for Hyperthermia in Bladder Cancer
Sunday, 15 November 2009


There was another victory for the use of regional deep hyperthermia in the treatment of cancer. The latest victory occurred in the treatment of high-risk bladder cancer. Heat treatment, delivered via the BSD 2000 machine, improved such patients' five-year survival rate from 67 to 80 percent. The local tumor control rate went from 63 to 81 percent. In addition, the disease-specific survival was 88 percent, metastasis-free survival was 89 percent, and the bladder-preserving rate was 96 percent at three years.


The median number of weekly hyperthermia treatments that patients received was five (with a range of 1-7). So some of the patients received just a single hyperthermia treatment, yet their results were averaged with the rest. Not surprisingly, there was a correlation between the number of hyperthermia treatments patients received and their overall survival rate -simply put, those who received more frequent treatments did better (Wittlinger 2009).


The study was published in Radiotherapy and Oncology by Dr. Michael Wittlinger of the Department of Radiation Oncology at Erlangen University Medical School in Germany and seven colleagues. Radiotherapy and Oncology is the official publication of the European Society for Therapeutic Radiology and Oncology.



Other Studies Show the Same Effect


This is not the only study to demonstrate improved results when hyperthermia is added to conventional treatment for bladder cancer. Thus, Renzo Columbo, MD, of Milan, Italy, reported on a multi-center trial in which 83 patients with intermediate or high-risk bladder tumors who were randomized to receive either the drug mitomycin-C alone or the same drug plus hyperthermia (following bladder-sparing surgery). The recurrence rate for those receiving mitomycin C alone was 57.5 percent, but it plummeted to 17.1 percent in those who also received hyperthermia. That study appeared in the Journal of Clinical Oncology (Colombo 2003).


In addition, Jacoba van der Zee, MD, and colleagues at the Erasmus Medical Center in Holland reported on a prospective, randomized trial that included 101 bladder cancer patients. The addition of hyperthermia to radiotherapy significantly increased the complete tumor response rate (the disappearance of all local tumor) from 51 percent for those treated with radiotherapy alone to 73 percent in patients also treated with hyperthermia, a 22 percent improvement. The duration of local control was also significantly longer. That study was published in the Lancet (van der Zee 2000).


For the record, the same trial also included patients with cervical or rectal cancer patients. The treatment worked in all cancer types, but the response was even greater in cervical cancer, where hyperthermia increased the complete response (CR) rate from 57 to 83 percent, a 26 percent difference. The three-year survival rate went from 27 to 51 percent (Van der Zee 2000). As I reported in my ********** of June 15, 2009, hyperthermia has now become part of standard treatment for cervical cancer in Holland and has been recommended as such by the German Cancer Society (Frankena 2008 and Frankena 2009). By contrast, the device used in the latest German trial, the BSD 2000, although made in the United States, is restricted to investigational use by the Food and Drug Administration (FDA).


The accumulating data on the benefits of hyperthermia gives the lie to the idea that American oncologists will adopt any therapeutic measure, provided that it is proven effective in clinical trials. In my opinion, a great many American patients will die needlessly before the cancer establishment wakes up to the fact that hyperthermia is a relatively harmless way of prolonging the lives of many cancer patients.