Company News »

BSD Medical’s China Distributor Receives China Food and Drug Administration Marketing and Import License Approval for the BSD-2000 Hyperthermia System

Business Wire
Share on StockTwits
Published on

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 (Conformit’e Europ’eenne) 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(R) 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.

Share on StockTwits