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News Breaks
11:06 EDTBSDM
theflyonthewall.com: BSD Medical reports continuation of FDA review on hyperthermia system
BSD Medical provided an update on the FDA's review of the company's Humanitarian Device Exemption 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. :theflyonthewall.com



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February 9, 2010
11:42 EDTBSDM
theflyonthewall.com: BSD Medical initiates Phase III study using BSD-2000 Hyperthermia System
BSD Medical reports initiation of a randomized, multicenter Phase III clinical study using the BSD-2000 Hyperthermia System in combination with chemotherapy for the treatment of pancreatic cancer patients after R0/R1 surgical resection of their tumor. The Phase III study, which is being sponsored by the European Society for Hyperthermic Oncology, will compare hyperthermia with chemotherapy to chemotherapy alone. The Phase III study was initiated following completion of a Phase II study that utilized chemotherapy and hyperthermia to treat 21 inoperable pancreatic patients who were resistant to or had failed previous chemotherapy gemcitabine treatments, a patient population with a dire prognosis. :theflyonthewall.com