-----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, CV+08Qh1WxKvLsuapwD9xxZsfuKIJjb4XzxmOFROM+GgberCyhIziMd7udl2SnwW +QU2B8j6nFvjMuVYMLj8ag== 0001096906-08-001737.txt : 20080911 0001096906-08-001737.hdr.sgml : 20080911 20080911080529 ACCESSION NUMBER: 0001096906-08-001737 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080911 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080911 DATE AS OF CHANGE: 20080911 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: 081066327 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 bsd8k091108.htm BSD MEDICAL CORPORATION FORM 8-K SEPTEMBER 11, 2008 bsd8k091108.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):  September 11, 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 No.)


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:

o           Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o           Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o           Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o           Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 

 

Item 8.01  Other Events.
 
FDA 510(k) Marketing Clearance Letter
 
On September 11, 2008, BSD Medical Corporation (“BSD”) issued a press release announcing that it received a letter from the United States Food and Drug Administration granting BSD 510(k) clearance to market its MicroThermX-100 Microwave Ablation System.  A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein.
 
Stock Purchase Agreement
 
Based on a prior agreement, the company executives and directors, Hyrum A. Mead and Paul F. Turner, have agreed, subject to the satisfaction of certain closing conditions, to exercise stock options and sell up to an aggregate of four hundred fifty thousand shares from among their vested stock options in an off-market transaction to institutional investors at this time.  The sale is subject to certain closing conditions, including (1) the achievement of Food and Drug Administration marketing clearance for the company’s MicroThermX®-100, and (2) requirements relating to the trading volume and share price of BSD Medical’s common stock.  More than half of the stock options anticipated for use in this off-market sale have been held for approximately nine years since granting, and are due to expire in between approximately eleven and sixteen months.  Together Mr. Turner and Mr. Mead beneficially own approximately 2.9 million shares in the form of common stock and stock options.  BSD Medical has traditionally used stock options as a primary means of recognizing its employees and executives for their contributions to the company.
 
Item 9.01  Financial Statements and Exhibits.

(d)        Exhibits.
 
 

 
 

 

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:  September 11, 2008
 
 
BSD MEDICAL CORPORATION
 
 
By:
/s/ Hyrum A. Mead
 
 
Name:
Hyrum A. Mead
 
 
Title:
President and Chief Executive Officer
 

 
 

 

EXHIBIT INDEX

 
 

EX-99.1 2 bsd8k091108ex99-1.htm PRESS RELEASE OF BSD MEDICAL CORPORATION DATED SEPTEMBER 11, 2008 bsd8k091108ex99-1.htm


BSD MEDICAL CORPORATION
Telephone: (801) 972-5555
2188 West 2200 South
Facsimile: (801) 972-5930
Salt Lake City, Utah 84119-1326
Email: investor@bsdmc.com
Contact: Hyrum A. Mead
NASDAQ:BSDM
 
For Immediate Release
 
BSD Medical Receives FDA Clearance to Market the MicroThermX®-100 Microwave Ablation System
 
SALT LAKE CITY, September 11, 2008—BSD Medical Corporation (NASDAQ:BSDM), a leading developer of microwave systems that are used primarily in the treatment of cancer, announced today that the U.S. Food and Drug Administration (FDA) has granted the company a 510(k) clearance to market its MicroThermX-100 Microwave Ablation System (MTX-100). Clearance from the FDA of BSD Medical’s 510(k) Premarket Notification submission authorizes the commercial sale of the MTX-100 in the United States.
 
The MTX-100 represents a major part of BSD Medical’s business plan moving forward, and receipt of FDA clearance to proceed to market with this system is a very important milestone in the history of the company.   The MTX-100 was developed by BSD to provide treatments as a stand-alone therapy, rather than only in combination with other therapies.  It also introduces into the company’s product line a major disposable used in each treatment, providing an ongoing revenue stream after the system sale.
 
The MTX-100 was designed to introduce new versatility and capabilities for use in ablation therapy and to provide ease and simplicity of use for busy interventional radiologists and surgeons.  Using microwaves in treatments, the MTX-100 competes head-on with RF ablation technologies that require patient grounding pads. BSD employed its extensive background in designing systems that deliver thermal medicine by equipping the MTX-100 with the ability to use up to four treatment applicators simultaneously, working intelligently together through BSD’s phased array technology to provide larger and more uniform zones of ablation during a single procedure.
 
To evaluate the ease of use of the MTX-100, BSD conducted usability testing on the MTX-100 at nine clinical sites involving 35 medically trained users who were experienced in thermal ablation procedures.  Measures of effectiveness and satisfaction were taken during testing that was designed to evaluate satisfaction in using the system, user performance of work tasks, user interface design and the instructions for use. The participants were able to effectively complete a simulated ablation procedure with no prior training on the system operations by using the instructions for use and the interactive screen displays.  The system operations, instructions for use and user interface designs were shown to be user friendly and intuitive, and the participants confirmed the favorable ease of use of the MTX-100.
 
 The MTX-100 is a compact, mobile system that includes a state-of-the-art computer, a microwave generator, single-patient-use disposable applicators and a proprietary thermistor-based temperature monitoring system.  The delivery of microwave energy is controlled by time and power parameters set by the operator utilizing an interactive touch-screen monitor that allows the operator to quickly and easily control the treatment.  The MTX-100 provides minimally invasive access to the target tissue and can be used in open surgical as well as in percutaneous ablation procedures, which will allow the MTX-100 to be used by both surgeons and interventional radiologists.  The MTX-100 is indicated for use in ablation of soft tissues.
 

 
 

 
BSD MEDICAL CORPORATION
Telephone: (801) 972-5555
2188 West 2200 South
Facsimile: (801) 972-5930
Salt Lake City, Utah 84119-1326
Email: investor@bsdmc.com
Contact: Hyrum A. Mead
NASDAQ:BSDM

About BSD Medical Corporation
 
BSD Medical’s product line includes systems that have been strategically designed to offer a range of thermal treatment systems. 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 (MTX-100) represents an expansion of BSD’s products into new applications and new markets, as the MicroThermX-100 is designed as a stand-alone therapy that is used to ablate diseased tissue using heat alone. Hyperthermia and thermal ablation are complementary therapies for use in medical practice.   For further information visit BSD Medical's website at www.BSDMedical.com.
 
 
#####
 
 
Statements contained in this press release regarding the MicroThermX 100 Ablation System that are not historical facts are forward-looking statements, as that item is defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to risks and uncertainties. We wish to advise readers that a number of important factors could cause actual results to differ materially from historical results or those anticipated in such forward-looking statements. These factors include, but are not limited to, those risks and uncertainties detailed in the Company’s filings with the Securities and Exchange Commission, including the Company’s Form 10-K for the fiscal year ended August 31, 2007, and future filings with the SEC. 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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