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BSD Medical Reports Seminal Study Published in The Lancet Oncology Demonstrates Impressive Long-Term Results from Hyperthermia

  BSD Medical Reports Seminal Study Published in The Lancet Oncology
  Demonstrates Impressive Long-Term Results from Hyperthermia Treatment of
  Children and Adolescents with Recurrent or Refractory Germ Cell Tumors

  *Seminal study shows significantly improved survival from the addition of
    hyperthermia to chemotherapy for children and adolescents with recurrent
    germ cell tumors
  *Study published in The Lancet Oncology, the premier journal for the
    highest quality oncology research
  *BSD-2000 Hyperthermia System activated chemotherapy drugs that had
    previously failed these patients

Business Wire

SALT LAKE CITY -- July 17, 2013

BSD Medical Corporation (BSD) (NASDAQ:BSDM) announced today that The Lancet
Oncology has published the results of a Phase II clinical study of
hyperthermia, using the BSD-2000 Hyperthermia System (BSD-2000), combined with
chemotherapy and tumor resection to treat malignant germ cell tumors in
children and adolescents, “Regional deep hyperthermia for salvage treatment of
children and adolescents with refractory or recurrent non-testicular malignant
germ-cell tumours: an open-label, non-randomised, single-institution, phase 2
study.” (Rüdiger Wessalowski et al.; The Lancet Oncology, Early Online
Publication, July 1, 2013, doi: 10.1016/S1470-2045[13]70271-7.) The Lancet
Oncology is the premier worldwide journal for the highest quality oncology
research.

The published study demonstrated an objective tumor reduction in 86% of the
patients, with a 5-year overall survival rate of 72%, which is unmatched by
any other clinical report on recurrent childhood malignant germ-cell tumors.
The study was conducted in the renowned University Paediatric Oncology Clinic
in Dusseldorf, Germany. This clinical study was unique in that the patients
received the identical chemotherapy regimen that is delivered as first-line
treatment at a 20% reduced dose; thus, the only variable in the treatment was
hyperthermia using the BSD-2000 Hyperthermia System. This seminal study showed
that hyperthermia activated chemotherapy drugs that had previously failed
these patients.

Forty-four patients aged 7 months to 21 years who had either recurrent tumors
or tumors that were resistant to chemotherapy (refractory) were treated with
hyperthermia, combined with cisplatin, etoposide, and ifosfamide (PEI
chemotherapy), to reduce the tumor size to allow surgical resection of the
residual tumor.

The researchers stated that, “In conclusion, we report the long-term results
of a salvage protocol for paediatric patients with refractory or recurrent
malignant germ-cell tumours; this protocol allows clinicians to provide a
long-term cure for most of these patients with poor prognosis. These
encouraging results for local tumour control, which is essential for a
long-term cure, strongly suggest that the use of microwave-induced regional
deep hyperthermia at temperatures of 41–43°C in combination with standard
platinum-based chemotherapy should be introduced soon after initial treatment
failure. This regimen has the potential to become a first-line treatment for
tumours with locally difficult characteristics.”

Rüdiger Wessalowski MD, author and Associate Professor at the Paediatric
Oncology Clinic, Haematology and Immunology, Centre for Child and Adolescent
Health, Heinrich-Heine University, Dusseldorf, Germany, led the
multidisciplinary research team from the authoritative MAKEI study group.
Other researchers included O Mils, V Friemann, O Kyrillopoulou, J Schaper, C
Matuschek, U Göbel and R Willers of Heinrich-Heine University; DT Schneider of
Pediatric Clinic Dortmund City Hospital; K Rothe of Charité-Virchow-Klinikum,
I Leuschner of Institute of Pathology, UMS Kiel; S Schönberger of University
Children's Hospital Bonn; and G Calaminus of University Children's Hospital
Münster. All participating institutions are located in Germany.

About Heinrich-Heine University, Dusseldorf, Germany

The University Paediatric Oncology Clinic at Dusseldorf has taken the lead on
multiple national and international studies designed to optimize pediatric
oncology therapy. For more than 14 years the renowned Dusseldorf Pediatric
Oncology Department has pioneered the application of hyperthermia therapy for
treating children’s cancers using a BSD-2000 for the treatment of soft tissue
sarcomas and germ cell tumors.

About The Lancet Oncology

The Lancet is the world's longest running and leading medical journal. The
Lancet is one of the world's best-known, oldest and most respected medical
journals. The Lancet is an authoritative voice in global medicine and
publishes high-quality clinical trials that will alter medical practice. The
Lancet Oncology is The Lancet's oncology journal that publishes the highest
quality original research relevant to clinical cancer specialists worldwide.
The Lancet Oncology is the leading clinical research journal in oncology and
is in the top 0.5% of all scientific journals. Between the first online
publication in 1996 and today, over 1.8 million users have registered at
thelancet.com.

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 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, including the expected use of proceeds relating to the
recently completed offering. 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:

BSD Medical Corporation
William (Bill) S. Barth, 801-972-5555
fax: 801-972-5930
investor@bsdmc.com
 
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