BSD Medical Hyperthermia Reports Initiation of Clinical Study Using Hyperthermia and Proton Therapy to Treat Patients with Soft Tissue Sarcoma

BSD Medical Corporation today reported initiation of a Phase I/II study using hyperthermia, delivered using either the BSD-2000 Hyperthermia System or the BSD-500 Hyperthermia System, combined with proton radiotherapy to treat patients with unresectable soft tissue sarcoma.

SALT LAKE CITY - BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, today reported initiation of a Phase I/II study (HYPROSAR) using hyperthermia, delivered using either the BSD-2000 Hyperthermia System (BSD-2000) or the BSD-500 Hyperthermia System (BSD-500), combined with proton radiotherapy to treat patients with unresectable soft tissue sarcoma. The clinical study has been designed in joint cooperation with Kantonsspital Aarau, Paul Scherrer Institute, Villigen, Uniklinik Balgrist, Zurich, and University Hospital, Zurich. The Phase I/II study will include 28 adult patients with primary and unresectable soft tissue sarcomas of extremities and trunk (excluding abdominal tumors). The trial has been registered at ClinicalTrials.gov (NCT01904565) and is open for patient enrollment.

The researchers announced the study initiation at the European Society for Hyperthermic Oncology (ESHO) Annual Conference. Dr. N.R. Datta presented the basis for the study, "Thermoradiobiological basis of ''HYPROSAR'': A clinical trial with hyperthermia and proton radiotherapy in unresectable soft tissue sarcoma." During the presentation, Dr. Datta stated that studies have demonstrated that hyperthermia increases the efficacy of radiation with minimal morbidity, is especially cytotoxic for large bulky tumors, and prevents the repair of radiation induced DNA damage. He also reported that proton beam radiotherapy has superior physical dose distribution profiles, as compared to conventional radiotherapy. Datta concluded, "Consequently, for unresectable primary and recurrent soft tissue sarcomas, the thermoradiobiological and physical advantages of hyperthermia and proton beam radiotherapy could be expected to produce a greater tumour regression, higher tumour downstaging, superior resectability with organ and limb preservation and improved survival outcome without significant treatment related morbidity."

About the BSD-2000 Hyperthermia System

The BSD-2000 – developed and patented exclusively by BSD – delivers localized therapeutic heating (hyperthermia) by applying radiofrequency (RF) energy. The BSD-2000 creates a central focusing of energy that can be electronically focused to target the shape, size and location of the tumor, thus providing dynamic control of the heating delivered to the tumor region. The BSD-2000 has Humanitarian Device Exemption (HDE) marketing approval from the U.S. Food and Drug Administration (FDA) for use in conjunction with radiation therapy for the treatment of cervical cancer patients who are ineligible for chemotherapy. The BSD-2000 also has CE (Conformité Européenne) Marking approval for the commercial sale in Europe. CE Marking approval is also recognized in many countries outside of the EU.

About BSD Medical Corporation

BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy, which is delivered using focused radiofrequency (RF) and microwave energy. BSD’s product lines include both hyperthermia and ablation treatment systems. BSD’s hyperthermia cancer treatment systems, which have been in use for several years in the United States, Europe and Asia, are used to treat certain tumors with heat (hyperthermia) while increasing the effectiveness of other therapies such as radiation therapy. BSD’s microwave ablation system has been developed as a stand-alone therapy to employ precision-guided microwave energy to ablate (destroy) soft tissue. The Company has developed extensive intellectual property, multiple products in the market and established distribution in the United States, Europe and Asia. Certain of the Company’s products have received regulatory approvals and clearances in the United States, Europe and China. For further information visit BSD Medical's website at www.BSDMedical.com.

This press release may be deemed to contain forward-looking statements, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Readers are cautioned that these forward-looking statements are only predictions and may differ materially from actual future events or results due to a variety of factors, including, among other things, the demand for the Company’s products, the ability of the Company to produce the products to meet the demand, global economic conditions and uncertainties in the geopolitical environment and other risk factors set forth in the Company’s most recent reports on Form 10-K and Form 10-Q. Any forward-looking statements in this release are based on limited information currently available to the Company, which is subject to change, and the Company will not necessarily update the information.

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