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 4, 1998
BIOCONTROL TECHNOLOGY, INC.
(Exact name of registrant as specified in its charter)
Pennsylvania 0-10822 25-1229323
(State of other jurisdiction (Commission File Number) (IRS Employer
of incorporation) Identification No.)
300 Indian Springs Road, Indiana, Pennsylvania 15701
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (412) 349-1811
_________________________________________________________________
(Former name or former address,
if changes since last report.)
<PAGE>
Item 1. Change in Control of Registrant.
Not applicable.
Item 2. Acquisition or Disposition of Assets.
Not applicable.
Item 3. Bankruptcy or Receivership.
Not applicable.
Item 4. Changes in Registrant's Certifying Accountant
Not applicable.
Item 5. Other Events.
At the FDA's request last month, Biocontrol
submitted a copy of the Diasensor Technical File to the agency.
The original file had been submitted to TUV Rheinland in
Cologne, Germany, by the company earlier this year, and
resulted in approval being granted to market the Diasensor in
Europe. Review of the file, which included data from patient
testing was completed early by FDA reviewers, making the
meeting with Biocontrol, scheduled for September 9,
unnecessary. Biocontrol top management was contacted and given
the FDA's recommendations for the company's next submission
to the agency.
Item 6. Resignation of Registrant's Directors.
Not Applicable.
Item 7. Financial Statement, Pro Forma Financial Information
and Exhibits.
(a) Financial Statements and Businesses Acquired - Not
Applicable.
(b) Pro Forma Financial Information - Not Applicable.
(c) Exhibits - Press Release.
SIGNATURES
Pursuant to the requirement 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.
BIOCONTROL TECHNOLOGY, INC.
by /s/ Fred E. Cooper
Fred E. Cooper, CEO
<PAGE>
DATED: September 4, 1998
BIOCONTROL TECHNOLOGY, INC.
2275 Swallow Hill Road, Building 2500
Pittsburgh, PA 15220
Investors Media
Diane McQuaide Susan Taylor
1.412.429.0673 phone 1.412.279.9455 phone
1.412.279.9690 fax 1.412.279.9447 fax
BIOCONTROL CONTINUES PLAN TO GAIN FDA APPROVAL FOR ITS
DIASENSOR 1000 NONINVASIVE GLUCOSE SENSOR
Pittsburgh, PA - September 4, 1998 - Biocontrol Technology,
Inc. (Nasdaq:BICO) announced today that it will proceed with its
plans to continue working with the FDA to obtain approval to
market its noninvasive glucose sensor, the Diasensor(R)I000, in
the US.
At the FDA's request last month, Biocontrol submitted a copy
of the Diasensor Technical File to the agency. The original file
had been submitted to TUV Rheinland in Cologne, Germany, by the
company earlier this year, and resulted in approval being granted
to market the Diasensor in Europe. Review of this file, which
included data from patient testing, was completed early by FDA
reviewers, making the meeting with Biocontrol, scheduled for
September 9, unnecessary. Biocontrol top management was
contacted and given the FDA's recommendations for the company's
next submission to the agency.
"Although the details will not be released at this time, the
FDA has suggested specific paths to marketing approval for the
Diasensor that will assist us greatly in preparing a formal
submission in a format acceptable to the FDA," said Biocontrol
President, David L. Purdy.
The Company is currently selling the Diasensor 1000 in
Europe.
Biocontrol Technology, Inc. (www.bico.com) has its corporate
offices in Pittsburgh, PA and is involved in the development and
manufacture of biomedical devices and environmental products.
XXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXX
This press release contains forward looking statements and
shareholders and potential investors are cautioned that
such statements are predictions and actual events or results may
vary significantly.
