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) November 4, 1997
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 November 4, 1997, Biocontrol Technology, Inc. (NASDAQ:BICO)
announced today that it is actively pursuing obtaining the CE mark required to
market the Diasensor 1000 noninvasive glucose sensor and other medical products
in the European Union (EU). With the CE mark, the company is permitted to
market the Diasensor in the 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.
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, CEO
DATED: November 4, 1997
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 SEEKING CE MARK ON DIASENSOR 1000 FOR EUROPEAN SALES
Pittsburgh, PA - November 4, 1997 - Biocontrol Technology, Inc. (Nasdaq:BICO)
announced today that it is actively pursuing obtaining the CE mark required to
market the Diasensor 1000 noninvasive glucose sensor and other medical products
in the European Union (EU). With the CE mark, the company is permitted to
market the Diasensor in the 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
CE mark is provided by the regulatory bodies of the EU or private "notified
bodies," which are third-party companies certified by the EU as also able to
provide the mark. The CE mark indicates that the device adheres to quality
systems guidelines of the International Organization for Standardization (ISO)
and its European signatory, European Norm Standards for Medical Devices (EN).
By rigorous audits to certify that the Company's development and manufacturing
procedures and standards, as well as the Diasensor 1000 itself, meet the
international standards laid down by the Medical Device Directive (MDD) or the
Active Implantable Medical Device Directive (AIMD), a Medical Device
Certificate is awarded and the CE mark is physically placed on the product.
Biocontrol is working with one of the most highly respected recognized notified
bodies in the European Union and recently underwent the first audit phase for
the certification to manufacture products (ISO-9002). Yet to come are audits
for product development (ISO-9001) and product technical file review for the
Diasensor 1000 and the other medical products. Fred E. Cooper, CEO of
Biocontrol, stated, "If the various audits go as well as we expect them to,
then we should be in the European marketplace by the first quarter of 1998."
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.
