0001096906-13-000486.txt : 20130408 0001096906-13-000486.hdr.sgml : 20130408 20130408144305 ACCESSION NUMBER: 0001096906-13-000486 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20130408 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20130408 DATE AS OF CHANGE: 20130408 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: 13748159 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 bsd8k04082013.htm BSD MEDICAL CORPORATION FORM 8-K bsd8k04082013.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):  April 8, 2013
 
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 7.01 Regulation FD Disclosure.
 
On April 8, 2013, BSD Medical Corporation (the “Company”) announced that it entered into an exclusive distribution agreement with Terumo Europe NV, a wholly owned subsidiary of Terumo Corporation, for the MicroThermX® Microwave Ablation System.  A copy of the press release is attached hereto as Exhibit 99.1.  Under the terms of the distribution agreement, Terumo Europe NV will have the exclusive right to market MicroThermX® in 100 countries in Europe, Western Asia, and Northern Africa.  The Company has received CE Marking regulatory approval for the MicroThermX® Microwave Ablation System required by the European Union (EU) which addresses the majority of countries covered by this agreement.  However, sales of the products in non-EU countries may require additional regulatory approvals and such sales are subject to obtaining any required regulatory approvals.  Although the Company expects to sell MicroThermX® Microwave Ablation Systems as a result of entering into this distribution agreement, there can be no assurance that the Company will make any such sales until the actual sales occur.  In addition, the sales of the products as described in the distribution agreement are subject to standard requirements imposed upon the Company.  If the Company is not able to comply with such requirements, it may not be able to sell its products pursuant to the distribution agreement.

Cautionary Statement Regarding Forward-Looking Statements

This Form 8-K and the press release furnished as an exhibit to this Form 8-K may contain statements regarding the Company’s expectations plans, goals, objectives, assumptions or information about future events, any and all of which may constitute forward-looking statements or information under applicable securities laws. Such forward-looking statements or information are based on a number of assumptions which may prove to be incorrect. Although the Company believes that the expectations reflected in such forward-looking statements or information are reasonable, undue reliance should not be placed on forward-looking statements because the Company can give no assurance that such expectations will prove to be correct.

All forward-looking statements or information are based on current expectations, estimates and projections that involve a number of risks and uncertainties which could cause actual results to differ materially from those anticipated by the Company and described in the forward-looking statements or information. These risks and uncertainties include those described in the Company’s reports to the SEC, and, among others, the demand for the Company’s products, conditions in the Company’s industry, certain global and regional economic conditions. If one or more of these risks or uncertainties materialize (or the consequences of such a development changes), or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected.

Item 9.01 Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit No.
 
Description
99.1
 
Press release dated April 8, 2013 regarding distribution agreement with Terumo Europe NV

 
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.
 
 
   BSD MEDICAL CORPORATION
   
 Date: April 8, 2013  
   
   By: /s/ William S. Barth
   Name: William S. Barth
   Title: Chief Financial Officer
 
 

 
EX-99.1 2 exhibit99-1.htm EXHIBIT 99.1 exhibit99-1.htm
Exhibit 99.1


 
   Contact: William (Bill) S. Barth
 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
   NASDAQ:BSDM
   
 
 
For Immediate Release
 

BSD Medical Announces Exclusive Multi-Million Dollar Distribution Agreement with Terumo Europe NV for MicroThermX® Microwave Cancer Ablation System

·  
Terumo Europe NV is a wholly owned subsidiary of  global medical device leader Terumo Corporation; which has nearly $5 billion in annual sales and operations in over 160 countries
·  
Exclusive agreement for distribution in 100 countries; potential market size in excess of $1 billion in annual sales
·  
Agreement expected to drive BSD revenue growth toward profitability

SALT LAKE CITY—April 8, 2013 — BSD Medical Corporation (NASDAQ:BSDM) (Company or BSD) (www.BSDMedical.com), a leading provider of medical systems that utilize heat therapy to treat cancer, announced today that the Company has signed an exclusive, long-term, multi-million dollar distribution agreement with Terumo Europe NV, a wholly owned subsidiary of Terumo Corporation (Terumo), for the MicroThermX® Microwave Ablation System (MicroThermX®).

A world leader in state-of-the-art medical devices and interventional oncology, Tokyo-based Terumo Corporation (TYO: JP:4543) reported 2012 sales of nearly $5 billion and has a market cap in excess of $8 billion. Through the sale and promotion of a high quality line of devices used for tumor embolization, the closing or blocking of blood vessels, Terumo Europe NV has established itself as a pioneer in the field of interventional oncology. Embolization and ablation are "hand-in-hand" clinical procedures for the treatment of cancerous tumors and, when used together, enable a less invasive course of treatment. This agreement therefore creates an ideal product synergy with BSD’s MicroThermX® product line and enables Terumo Europe NV to offer interventional oncologists a complete and compelling solution for the treatment of cancerous tumors.

Under the terms of the distribution agreement, Terumo Europe NV will have the exclusive right to market MicroThermX® in 100 countries in Europe, Western Asia, and Northern Africa. The potential market size for MicroThermX® in these countries is estimated to be in excess of $1 billion in annual sales. This agreement validates the large market opportunity for MicroThermX® ablation products and is expected to drive market adoption for the MicroThermX® as a leading ablation therapy system. Strategically, MicroThermX® will benefit from Terumo Europe NV’s extensive market reach, focus on interventional oncology, and well-established relationships with key interventional oncology opinion leaders throughout Europe.

“Our distribution agreement with Terumo Europe NV is the result of a collaborative effort between BSD Medical and Terumo. Importantly, it represents one of the most significant milestones in BSD’s corporate history," said Harold Wolcott, BSD President and CEO. "Revenues from our agreement with Terumo Europe NV should commence by the end of the third quarter of our fiscal year 2013 and are expected to make a substantial contribution to our overall revenue over the next few years. Longer term, we expect this agreement will make a strong contribution toward our objective of achieving profitability."
 
About the MicroThermX® Microwave Ablation System
The MicroThermX® is a compact, mobile, state-of-the-art, proprietary system that includes a microwave generator, single-patient-use disposable antennas, and a thermistor-based temperature monitoring system.  The innovative design of the MicroThermX® is the first of its kind that allows delivery of higher power levels using a single generator.  The MicroThermX® utilizes innovative synchronous phased array technology that was developed and patented by BSD to provide larger and more uniform zones of ablation during a single procedure.  The MicroThermX® introduces into the Company’s product line innovative, high-end disposables (SynchroWave antennas) that are used in each ablation treatment and will provide a significant ongoing revenue stream.  The soft tissue ablation world market potential is estimated to exceed $2.3 billion. The U.S. Food and Drug Administration (FDA) has granted the Company a 510(k) clearance to market the MicroThermX® for ablation of soft tissue. BSD has also received CE Marking for the MicroThermX® System, which allows BSD to market the MicroThermX® in Europe. CE marking is also recognized in many countries outside of the EU, providing BSD the ability to market the MicroThermX® to a number of international markets.

About BSD Medical Corporation
BSD Medical Corporation develops, manufactures, markets and services systems to treat cancer and benign diseases using heat therapy, which is delivered using focused radiofrequency (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 employ precision-guided microwave energy to ablate (destroy) soft tissue.  The Company has developed extensive intellectual property, multiple products in the market and established distribution in the United States, Europe and Asia.  Certain of the Company’s products have received regulatory approvals and clearances 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.