-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, AzFTq4GjH3KL26YIepnXdGf8uoY9f6SiBudCXDqScYfF9+3VDwwh9ZdoO6POlppU azM0JkvFBZFxzN3NgIHseg== 0001096906-08-001528.txt : 20080814 0001096906-08-001528.hdr.sgml : 20080814 20080814080512 ACCESSION NUMBER: 0001096906-08-001528 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080814 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080814 DATE AS OF CHANGE: 20080814 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BSD MEDICAL CORP CENTRAL INDEX KEY: 0000320174 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 751590407 STATE OF INCORPORATION: DE FISCAL YEAR END: 0831 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32526 FILM NUMBER: 081015389 BUSINESS ADDRESS: STREET 1: 2188 W 2200 SOUTH CITY: SALT LAKE CITY STATE: UT ZIP: 84119 BUSINESS PHONE: 8019725555 MAIL ADDRESS: STREET 1: 2188 WEST STREET 2: 2200 SOUTH CITY: SALT LAKE CITY STATE: UT ZIP: 84119 8-K 1 bsd8k081408.htm BSD MEDICAL CORPORATION FORM 8-K AUGUST 14, 2008 bsd8k081408.htm

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C.  20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported) August 14, 2008

BSD MEDICAL CORPORATION
(Exact name of registrant as specified in its charter)

Delaware
0-10783
75-1590407
(State or other jurisdiction of incorporation)
(Commission File Number)
(IRS Employer Identification)


2188 West 2200 South
Salt Lake City, Utah 84119
(Address of principal executive offices, including Zip Code)
Registrant’s telephone number, including area code:  (801) 972-5555


N/A
(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
 
¨ 
 
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
¨ 
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
¨ 
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
¨ 
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 
 


Item 7.01
Regulation FD Disclosure.

BSD Medical Corporation issued a press release on August 14, 2008.  A copy of the press    release is hereby furnished as Exhibit 99.1 attached hereto.

Item 9.01.                   Financial Statements and Exhibits.

(d)
Exhibits

99.1
Press Release of BSD Medical Corporation dated August 14, 2008







SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

Dated:  August 14, 2008
 
By:
/s/  Hyrum A. Mead
   
Hyrum A. Mead
   
President

 
 
 


EXHIBIT INDEX

Exhibit No. Description99.1 Press Release of BSD Medical Corporation dated August 14, 2008
 
 
 

 EX-99.1 2 bsd8k081408ex99-1.htm PRESS RELEASE OF BSD MEDICAL CORPORATION DATED AUGUST 14, 2008 bsd8k081408ex99-1.htm
Exhibit 99.1



 
For Immediate Release
 
BSD Medical Provides to FDA Data Requested Regarding 510(k) Premarket Notification for MicroThermX®-100 Microwave Ablation System

SALT LAKE CITY, August 14, 2008—BSD Medical Corporation (AMEX:BSM) today announced that the company has provided to the Food and Drug Administration (FDA) additional data requested pertaining to its 510(k) Premarket Notification submission for the MicroThermX-100 Microwave Ablation System.  Clearance from the FDA of the 510(k) Premarket Notification submission is required before a Class II product can be sold commercially in the United States.

On April 10, 2008, BSD Medical submitted a 510(k) Premarket Notification for the MicroThermX-100 Microwave Ablation System.  A 510(k) Premarket Notification includes documentation regarding compliance to applicable standards (UL, IEC, EMC, EMI, etc.), demonstration of substantial equivalence to predicate devices, documentation of required testing—including biocompatibility, shelf life, sterilization, software, hardware, and other required performance testing and documentation.  The company’s 510(k) submission involved 1,251 pages.  Today BSD Medical announced that the company has responded to the eight additional items requested by the FDA regarding the submission that were mentioned in the company’s June 30, 2008 press release.  All of these items were technical, not clinical, in nature.  BSD’s response covers all of the items requested by the FDA regarding this submission.

BSD Medical’s product line includes systems that have been strategically designed to offer a range of thermal treatment products using microwave and RF (radiofrequency) technology. BSD is the leading developer of hyperthermia systems.  Hyperthermia is used to treat cancer using heat to increase the effectiveness of companion radiation therapy. The MicroThermX-100 Microwave Ablation System represents an expansion of BSD’s products into new applications, as the MicroThermX-100 is designed as a stand-alone therapy that is used to ablate diseased tissue using heat alone.  These two approaches to therapy are highly complementary.

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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.
 

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