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) July 2, 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.
Biocontrol Technology announced today that it
has received approval to apply the Conformite
Europeenne (CE) Mark to its Diasensorr1000, the
company's noninvasive glucose sensor for diabetics. A
worldwide standard for safety and quality assurance,
the CE Mark permits Biocontrol to market the Diasensor
in the European Union.
The company intends to first enter the market in
the United Kingdom with sales through its distributor,
EuroSurgical Ltd., which entered into an agreement with
Biocontrol in May of this year.
The CE Mark approval was granted by TUV Rheinland
Product Safety GmbH, Cologne, Germany, an organization
recognized by the European Union as a Notified Body for
Product Certification.
With this affirmation of the safety and quality of
the Diasensor, Biocontrol plans to resubmit its
application to the FDA for approval to market its
device in the U.S.
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.
<PAGE>
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
July 2, 1998 Fred E. Cooper, CEO
<PAGE>
BICO
BIOCONTROL TECHNOLOGY, INC
2275 Swallow Hill Road, Building 2500
Pittsburgh, PA 15220
Press Release
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'S DIASENSOR APPROVED FOR EUROPEAN MARKET
Pittsburgh, PA - July 2, 1998 - Biocontrol Technology, Inc.
(Nasdaq:BICO) announced today that it has received approval to
apply the Conformite Europeenne (CE) Mark to its Diasensorr1000,
the company's noninvasive glucose sensor for diabetics. A
worldwide standard for safety and quality assurance, the CE Mark
permits Biocontrol to market the Diasensor in the European Union
(EU), which consists of the following countries: Austria;
Belgium; Denmark; Finland; France; Germany; Greece; Ireland;
Italy; Luxembourg; Netherlands; Portugal; Spain; Sweden; and the
United Kingdom.
The company intends to first enter the market in the United
Kingdom with sales through its distributor, EuroSurgical Ltd.,
which entered into an agreement with Biocontrol in May of this
year.
David Purdy, president of Biocontrol, said, "The market
potential in the EU is tremendous. The World Health Organization
estimates that out of the approximately 470 million people living
in the European Union, there are over 30 million people with
diabetes, many of whom would benefit from using our device."
With the CE Mark completed, the Company can now exert more
effort in other markets, such as the Middle East, where the CE
Mark is not required but is looked to for reinforcement of the
quality and safety of a medical device.
The CE Mark approval was granted by TUV Rheinland Product
Safety GmbH, Cologne, Germany, an organization recognized by the
European Union as a Notified Body for Product Certification. In
order to receive this approval, the company had to verify that
its device could meet the requirements of the EU's Medical Device
Directive (MDD) by undergoing TUV's audits and certification of
its quality system, rigorous safety testing, and clinical trials.
Biocontrol completed several months of clinical studies and
submitted the data for TUV's review and approval.
With this affirmation of the safety and quality of the
Diasensor, Biocontrol plans to resubmit its application to the
FDA for approval to market its device in the U.S.
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.
