BSD Medical Reports Initiation of Clinical Study by University of Utah
School of Medicine, Huntsman Cancer Center, Using MicroThermX® Microwave
Ablation System to Treat Liver Tumors
SALT LAKE CITY -- June 11, 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,
announced initiation of a clinical study by the University of Utah School of
Medicine using BSD’s MicroThermX^® Microwave Ablation System (MicroThermX) to
treat liver tumors. The study is a prospective, non-randomized, single arm
trial that involves 20 patients. The study objective is to clinically evaluate
the size of the ablation zones produced in liver tissue by BSD’s patented
Synchronous Wave Alignment™ technology developed for MicroThermX. Both
cirrhotic and non-cirrhotic liver tissue will be evaluated in this clinical
study. The study is open for patient enrollment at the University of Utah
School of Medicine. The principal investigator for the study is Ryan O’Hara,
M.D., Assistant Professor of Radiology, Chief, Department of Interventional
Radiology, Director of Interventional Oncology, University of Utah School of
Medicine, Huntsman Cancer Hospital.
“This trial will allow us to study the effects of the Synchronous Wave
Alignment technology in both cirrhotic and non-cirrhotic liver tissue, and to
determine if there is a difference in how the energy is absorbed in the two
types of tissue,” stated Dr. O’Hara.
The MicroThermX ^ utilizes patented, innovative, Synchronous Wave Alignment
technology developed by BSD to provide larger and more uniform zones of
ablation across all tissue types during a single procedure. The University of
Utah study will evaluate the ability of MicroThermX ^ to create larger heating
zones, using multiple antennas, than achieved by other available microwave
ablation systems. Simultaneously utilizing multiple antennas gives physicians
the ability to create a large, contiguous zone of necrosis with large margins.
Larger, hotter heating zones may also decrease the occurrence of inadequate
treatment of larger tumors.
About the MicroThermX Microwave Ablation System
The MicroThermX is a compact, mobile, state-of-the-art proprietary system that
includes a microwave generator, single-patient-use disposable antennas and a
thermistor-based temperature monitoring system. The innovative design of the
MicroThermX is the first of its kind that allows delivery of higher power
levels using a single generator.
The MicroThermX utilizes patented, innovative Synchronous Wave Alignment
technology developed by BSD to provide a wide range of uniform ablation zones.
The MicroThermX includes innovative, high-end disposables (SynchroWave
antennas) that are used in each ablation treatment and will provide a
significant ongoing revenue stream.
The soft tissue (tumor) ablation world market potential is estimated to exceed
$2.3 billion. The U.S. Food and Drug Administration (FDA) has granted the
Company a 510(k) clearance to market the MicroThermX ^ for ablation of soft
tissue. BSD has also received CE Marking for the MicroThermX System, which
allows BSD to market MicroThermX in Europe. CE Marking is also recognized in
many countries outside the EU, providing BSD the ability to market MicroThermX
to a number of international markets.
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
microwave energy and radiofrequency (RF). BSD’s product lines include ablation
and hyperthermia treatment systems. BSD’s microwave ablation system has been
developed as a stand-alone therapy to ablate and destroy soft tissue. The
Company has developed extensive intellectual property, multiple products in
the market, and well established distribution in the United States, Europe and
Asia. 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. Certain of the Company’s products have
received regulatory approvals in the United States, Europe, China and Taiwan.
For further information visit BSD Medical's website at www.BSDMedical.com.
Statements contained in this press release that are not historical facts,
including statements relating to our 2014 plans, are forward-looking
statements, as defined in the Private Securities Litigation Reform Act of
1995. All forward-looking statements are subject to risks and uncertainties
detailed in the Company's filings with the Securities and Exchange Commission,
including the market demand for our MicroThermX® products and the regulatory
requirements we face. These forward-looking statements speak only as of the
date on which such statements are made, and the Company undertakes no
obligation to update such statements to reflect events or circumstances
arising after such date, except as required by law.
BSD Medical Corporation
William Barth, 801-972-5555
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