Healthcare Industry News: MicroThermX
News Release - July 21, 2010
BSD Medical Provides Information Requested by FDA for the MicroThermX Ablation System 510(k) SubmissionSALT LAKE CITY--(HSMN NewsFeed)--BSD Medical Corporation (NASDAQ: BSDM ) (Company or BSD) today announced that it has provided the additional information requested by the U.S. Food and Drug Administration (FDA) for review of the 510(k) submission the Company filed for premarket clearance of the Company's Phase II MicroThermX® Microwave Ablation System (MTX-180) for ablation of soft tissue.
“We responded quickly to the request for additional information from the FDA in order to expedite the review process,” stated Harold Wolcott, President of BSD. “While we cannot predict the ultimate outcome or when the review will be completed, we are optimistic about the outcome.”
The clearance from the FDA of the 510(k) submission will authorize commercial distribution of the MTX-180 in the United States and allow the Company to provide an optimized system targeted to the growing therapeutic interventional oncology market. The interventional oncology worldwide market for 2009 was estimated at $210 million, and this market is projected to grow to $480 million by 2015.
The MTX-180 employs precision-guided microwave energy to ablate (destroy) soft tissue using a single-patient-use disposable antenna. The MTX-180 was developed to provide treatments as a stand-alone therapy.
BSD has also applied for a Humanitarian Device Exemption (HDE) approval for its BSD-2000 Hyperthermia System, and this submission is still under review by the FDA. The 510(k) and the HDE marketing submission and review processes differ significantly and are completely independent of each other. There is no relationship or similarity between the 510(k) filing and the HDE filing.
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 radio frequency (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 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. 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.
Statements contained in this press release that are not historical facts 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. 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.
Source: BSD Medical
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