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) January 6, 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.)
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.
On January 6, 1998, Biocontrol Technology, Inc.(NASDAQ:BICO)
announced that it passed the rigorous audit for ISO 9001
certification without any deficiency findings and expects the actual
certificate to be issued in mid-January. The CE Mark will allow
Biocontrol to tap into international glucose monitoring markets which
the company's research has shown to contain eight to ten times the
number of diabetics as the US market.
Biocontrol further announced the resubmission of the Diasensor
1000 to the Food and Drug Administration (FDA) for US marketing
approval will be delayed until the CE Mark is obtained.
Biocontrol also announced that the Company has been advised
by its Philippine distributor to delay introduction of the Diasensor
1000 into that market as the economy there and in much of Asia is
currently in strong decline.
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
DATED: January 6, 1998
BICO BIOCONTROL TECHNOLOGY, INC.
2275 Swallow Hill Road, Building 2500
Pittsburgh, PA 15220
Press Release
Release: Immediate
For More Information, Call:
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 UPDATES DIASENSOR 1000
Pittsburgh, PA, January 6, 1998 - Biocontrol Technology, Inc.
(Nasdaq:BICO) announced today that it passed the rigorous audit for ISO
9001 certification without any deficiency findings and expects the actual
certificate to be issued in mid-January. This is the second audit in
Biocontrol's pursuit of a CE Mark necessary to market its Diasensor 1000
noninvasive glucose sensor and other medical products in the 15-country
European Union (EU).
The first audit in the process (for ISO9002) was passed in October
1997, and Biocontrol expects to obtain the CE Mark for its Diasensor
1000 in February. ISO 9002 is the manufacturing standard, while ISO 9001
is certification of a total quality system.
The CE Mark will allow Biocontrol to tap into international glucose
monitoring markets which the company's research has shown to contain eight
to ten times the number of diabetics as the US market. Targeted first will
be London in the United Kingdom as marketing efforts have already begun
there.
Biocontrol further announced the resubmission of the Diasensor
1000 to the Food and Drug Administration (FDA) for US marketing approval
will be delayed until the CE Mark is obtained. Fred E. Cooper, Chief
Executive Officer of Biocontrol, stated, "Because the prestigious CE Mark
is a third party approval of the Diasensor 1000 that will make the
product available to millions of diabetics outside the US, management
feels that it would be in the best interest of the Company and its
shareholders to resubmit the Diasensor 1000 after the CE Mark is
obtained."
Biocontrol also announced that the Company has been advised by
its Philippine distributor to delay introduction of the Diasensor 1000
into that market as the economy there and in much of Asia is currently in
strong decline.
Therefore, Biocontrol will redirect its team of scientists and
physicians from Asia to the Middle East. Groundwork has already been laid
there in the last few months, and, along with the team,
sensors will be shipped later this month to Abu Dhabi, the capital of the
United Arab Emirates (UAE). The UAE has a very affluent economy and a
large diabetic population which will give Biocontrol an excellent market
there for the sensor. Biocontrol Technology, Inc. has its corporate
offices in Pittsburgh, PA and is involved in the development and
manufacture of biomedical devices and environmental products.
