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

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

Business Wire

SALT LAKE CITY -- July 15, 2014

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.

Contact:

Financial Profiles
Tricia Ross, 310-622-8226
tross@finprofiles.com
 
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