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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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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): December 30, 1996
Biofield Corp.
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(Exact name of registrant as specified in its charter)
Delaware 0-27848 13-3703450
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(State or other jurisdiction of (Commission (I.R.S. Employer
incorporation or organization) File Number) Identification No.)
1225 Northmeadow Parkway, Suite 120, Roswell, GA 30076
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (770) 740-8180
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Not Applicable
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(Former name or former address, if changed since last report)
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Item 5. Other Events
Attached hereto as Exhibit A is a copy of a press release dated
December 30, 1996 of Biofield Corp. announcing that Biofield Corp.
submitted an application for Pre-Market Approval to the U.S. Food
and Drug Administration for a new breast cancer diagnostic device
called the Biofield(R) ALEXA(TM) 1000 System.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits.
(c) Exhibits
99.1. Press Release issued by Biofield Corp. on December 30, 1996.
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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, thereunto duly authorized.
Biofield Corp.
Dated: January 3, 1997 By: /s/KENNETH W. ANSTEY
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Kenneth W. Anstey
President, Chief Executive
Officer and Director
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EXHIBIT 99.1
For more information, contact:
Michael R. Gavenchak Laurie Flatt Claudia D'Avanzo
Executive Vice President (404) 659-4446 X:121 (404) 659-4446 X:107
General Counsel (404) 816-4815 (home)
(770) 740-8180
FOR IMMEDIATE RELEASE
BIOFIELD CORP. SUBMITS PMA FOR
NEW BREAST CANCER DIAGNOSTIC SYSTEM
ATLANTA, December 30, 1996 -- Biofield Corp. (NASDAQ NMS: BZET)
announced today that it has submitted an application for Pre-Market Approval
(PMA) to the U.S. Food and Drug Administration for a new breast cancer
diagnostic device called the Biofield(R) ALEXA(TM) 1000 System. The Company has
been granted expedited review by the FDA.
Biofield's PMA application is based on the findings of a multi-center
study conducted at six major medical institutions in the United States. The
study results, which are subject to review and acceptance by the FDA,
demonstrated that the Biofield ALEXA 1000 System was approximately 95 percent
accurate in identifying malignant breast lesions. This compared favorably to
other currently used diagnostic tests performed on many of the patients who
participated in the study. The PMA application is based on more than 1,000
women who were scheduled for open surgical biopsy.
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Biofield's unique test, called the ALEXAGRAM(SM), may provide women with
previously identified breast lesions, and their physicians, an accurate
alternative to other diagnostic procedures. Potential benefits of this
non-invasive test include immediate and objective results, ease of use, and no
exposure to radiation. The ALEXA 1000 System is not available for use in the
United States at this time and will not be available until FDA approval, the
receipt and timing of which are uncertain.
Approximately eight million women in the United States will have a
diagnostic evaluation for breast cancer this year because of a suspicious
lesion. According to the American Cancer Society, breast cancer is the leading
cancer among women today, with more than 184,000 new cases diagnosed this year.
An estimated 44,000 women will die of breast cancer this year*.
Biofield Corp. is a medical technology company that has developed an
innovative system for detecting breast cancer through the skin in a
non-invasive and objective procedure. The company is based in Atlanta.
Note: This press release contains "forward looking statements" which are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. Investors are cautioned that all forward looking statements
involve known and unknown risks, uncertainties, including, without limitation
to: the company's limited operating history and anticipated future losses,
uncertainties and other factors which may cause actual results, performance or
achievements of the Company to be materially different from any future results,
performance or achievements expressed or implied by such forward looking
statements. Factors that might cause such differences include risks and
uncertainties related to the company's future profitability and ability to meet
its capital needs, product development, FDA approval, government regulation,
competition, market acceptance and other factors discussed in the company's
Prospectus dated March 19, 1996 filed with the Securities and Exchange
Commission pursuant to Rule 424(b).
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* American Cancer Society, Cancer Facts & Figures, 1996.
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