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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): February 27, 1997
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 99.1 is a copy of a press release dated
February 27, 1997 of Biofield Corp.
Item 7. Financial Statements, Pro Forma Financial Information and Exhibits
(c) Exhibits
99.1. Press Release issued by Biofield Corp. on February 27,
1997.
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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: March 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
[BIOFIELD LETTERHEAD]
CONTACT: KENNETH W. ANSTEY TONY DEMARTINO
MICHAEL R. GAVENCHAK CLAUDIA D'AVANZO
BIOFIELD CORP. FLEISHMAN - HILLARD, INC.
(770) 740-8180 (404) 659- 4446
FOR IMMEDIATE RELEASE
FDA RESPONDS TO BIOFIELD SUBMISSION FOR
NEW BREAST CANCER DIAGNOSTIC SYSTEM
ATLANTA, GEORGIA, February 27, 1997 -- Biofield Corp. (NASDAQ: BZET)
announced today that the U.S. Food and Drug Administration (FDA) has completed
an initial review related to the filing status of the company's premarket
approval application (PMA) for its ALEXA(TM) 1000 System for breast cancer
diagnosis. In a letter to Biofield Corp., the FDA informed the company that
its application has not been accepted for filing at this time and has requested
that the company address deficiencies in the PMA as a condition to continuing
with the review process.
Specifically, the FDA has not accepted the findings from the company's
U.S. multi-center study as submitted due to the FDA's issues concerning the
study design and, in particular, the development and selection of the
algorithms used on the supporting data set. In its letter, the FDA advised the
company that it must select a final algorithm and then test it with an
independent data set. Further, the FDA stated that a clinical trial design
that supports the indications for use of the ALEXA 1000 System should include
the impact on patient management. The company remains confident in the
findings of its multi-center study conducted at six major medical institutions
in the United States and intends to work closely with the FDA to advance the
PMA process. The FDA also advised the company that its application, upon
resubmission, will continue to be considered under its Expedited Review
policy.
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Pursuant to FDA guidelines, the company may request an informal
conference with the Director of the Office of Device Evaluation within ten (10)
working days to review the FDA's decision. The company may also meet with the
FDA to discuss remedies to the issues raised in the letter. Biofield is
presently evaluating its options and plans to respond to the FDA promptly.
The company's PMA for the ALEXA 1000 System is based principally upon
the results of its U.S. multi-center study, which results have not been
accepted by the FDA based upon its initial review of the company's PMA.
Accordingly, it may be necessary for the company to submit additional data to
the FDA, which data may be based upon completed clinical studies and/or
additional clinical trials. If the company is required to submit additional
data to the FDA or conduct additional clinical trials, there may be significant
delays in the approval process for the ALEXA 1000 System. Conducting
additional clinical trials could also require the expenditure of substantial
additional funds, for which additional financing may be required. Furthermore,
there can be no assurance that results obtained in any other studies that may
be conducted by the company will be consistent with the results obtained in the
U.S. multi-center study or that any such results will be accepted by the FDA.
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.
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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