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.
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