BSD Medical’s China Distributor Receives China Food & Drug Administration Marketing & Import License Approval for the BSD-2...
September 29 2014 - 9:15AM
Business Wire
Creates Sales Pathway for BSD-2000 in Largest
and Most Receptive Hyperthermia End-Market in the World
BSD Medical Corporation (NASDAQ:BSDM) (the “Company” or “BSD”),
a leading provider of medical systems that treat cancer and benign
diseases using heat therapy, announced today that BSD’s exclusive
distributor in the People’s Republic of China, Dalian Orientech Co.
LTD (“Orientech”), has informed BSD that China’s Food and Drug
Administration (the “CFDA”) has approved and renewed the marketing
and import license application for the BSD-2000 Hyperthermia System
(BSD-2000).
“Receiving renewal of the approval from the CFDA is a
significant milestone for us and for Orientech, and it is a step
forward in our vision to deliver the best healthcare products to
hospitals and their patients around the world,” said Sam Maravich,
Vice President of International Sales and Marketing of BSD Medical.
“While this was a long and difficult process, we are very excited
that the process is now complete, and we look forward to the
subsequent revenue opportunities this will yield for our product in
the world’s largest end-market for hyperthermia. Orientech is
committed to increasing the number of BSD-2000 systems installed in
China.”
BSD has a long-term exclusive distributor agreement with
Orientech. The agreement requires Orientech to make yearly minimum
purchases of the BSD-2000 over a four year period commencing upon
receipt of the marketing and import license renewal. Orientech is
recognized as a leading hyperthermia company in China and is one of
the pioneers in commercialization of hyperthermia equipment in
China. Orientech is also a leader and key contributor in
hyperthermia education. Orientech has established strong
relationships with physicians throughout China.
China has the world’s largest population and ranks as one of the
fastest growing markets in the world. China increased medical and
healthcare spending by 26% in 2013 and 15.1% in 2014 to $133
billion. McKinsey & Company forecasts expect healthcare
spending to increase to $1 trillion annually by 2020 due in large
part to an aging population. China has over 10,000 hospitals with
oncology departments. The Chinese medical device market is mostly
supplied by imported products or devices made locally by
multinational joint ventures.
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 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 and China. For further information visit BSD Medical's
website at www.BSDMedical.com.
Forward-Looking Statements
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 CorporationTricia
Ross310-622-8226investor@bsdmc.com