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 21, 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 21, 1998, Biocontrol Technology, Inc. (NASDAQ:BICO)
announced that it has received registration to the ISO 9001/08.94
international standard for its Indiana, PA manufacturing and product
development facilities, together with certification to EN 46001/09.96,
which shows conformance with the European Medical Device Directives
(MDD) for medical products.
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
Fred E. Cooper, CEO
DATED: January 21, 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 RECEIVES REGISTRATION TO ISO 9001
Pittsburgh, PA - January 21, 1998 - Biocontrol Technology, Inc.
(Nasdaq:BICO) announced today that it has received registration to the
ISO 9001/08.94 international standard for its Indiana, PA manufacturing
and product development facilities, together with certification to
EN 46001/09.96, which shows conformance with the European Medical Device
Directives (MDD) for medical products (Certificate number SY 9810002 01).
Obtaining these certifications is the second important step in the
Company's efforts to gain the CE Mark for its Diasensor 1000 noninvasive
glucose sensor, which will allow the device to be marketed in the 15-member
European Union (EU) with a diabetic population of approximately 15 million.
The first step entailed another audit that the Company passed in October
1997.
For the third and final step in the process to market the Diasensor in
the EU, Biocontrol is currently preparing a technical file for its sensor for
submission to, and approval by, its notified body in order to receive a CE
Mark. Placement of a CE Mark on a medical product signifies that the product
meets the requirements for distribution into the European Community.
An Authorized Representative to legally represent Biocontrol in the EU has
been secured, and the Company has had discussions with potential European
distributors for the Diasensor 1000 and its other medical products.
Following approximately eighteen months to complete documentation and
implementation of the company's quality system, TUV Rheinland of North America,
Inc., an accredited third-party registrar and recognized "notified body" to the
European Union, audited Biocontrol's quality system. The system passed the ISO
9001 and EN46001 audits with no deficiencies, leading to certification to these
standards.
David L. Purdy, president of Biocontrol, said: "Because the necessary
audits are so rigorous and demand a great deal of preparatory effort from the
Company and its employees, we are very pleased to have earned the
certifications, especially with no deficiencies. We anticipate that the
certifications will open markets and enhance our worldwide competitiveness."
The ISO 9001 standard is the most comprehensive of three ISO 9000 series
standards, covering design, manufacturing, installation, and servicing systems.
All ISO standards are set by a specialized international agency for
standardization, at present comprising the national standards bodies of 91
countries. Its objective is to promote the development of standardization and
related world activities to facilitate the international exchange of goods and
services, and to develop cooperation in intellectual, scientific,
technological, and economic activity.
The MDD registration, which is geared toward European standards,
specifically states that Biocontrol has shown that it has established and
maintains a quality management system for the design, development,
manufacturing and distribution of noninvasive blood glucose monitors, vascular
access systems, and hand function restoration neuroprosthesis systems
(functional electrical stimulators - FES), products currently manufactured
at the Indiana facilities.
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.
