News | March 06, 2009

BSD Files Humanitarian Use Petition With FDA for BSD-2000 Hyperthermia System

March 5, 2009 - BSD Medical Corp. said today that the company has filed a Humanitarian Use Device Petition for the BSD-2000 Hyperthermia System with the FDA.

BSD Medical currently has a submission under review by the FDA seeking Pre-Market (PMA) approval for the BSD-2000. Due to the lengthy nature of the PMA review process, the length of time that the submission has been under review by the FDA, and the company's strong desire to bring the BSD-2000 to market as quickly as possible, the company has been working closely with FDA to seek the most expeditious pathway that can lead to marketing approval for the BSD-2000, according to BSD. FDA has recommended that BSD pursue a Humanitarian Device Exemption (HDE) marketing approval. BSD has evaluated FDA's recommendation and consequently filed the Humanitarian Use petition.

The system is designed to perform hyperthermia – heating the tumor to 40-45° C – which, combined with radiation and/or chemotherapy, is reportedly a proven treatment for malignant tumors.

An HDE approval of the BSD-2000 Hyperthermia System would authorize the commercial sale of the BSD-2000 in the U.S. in the same intended use population as the pending PMA application. BSD Medical's sales and marketing department believes that an HDE approval would fulfill the same practical needs in bringing the BSD-2000 to market as would a PMA. Obtaining an HDE approval for the BSD-2000 would not preclude BSD from also pursuing a PMA for the device should the company choose to do so.

Prior to submitting an HDE application, an applicant submits a request for the HUD designation, and upon approval the company will file the HDE application with the Office of Device Evaluation (ODE), Center for Devices and Radiological Health (CDRH). The data previously submitted to FDA in the company's pending PMA application can be used to support HDE approval, which requires BSD Medical to demonstrate the device's safety and probable benefit. FDA is working closely with the company on the approval process. BSD believes this will expedite the marketing approval for the BSD-2000.

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