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) February 5, 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 February 5, 1997, Biocontrol Technology, Inc.
(NASDAQ:BICO) announced that it's subsidiary, IDT, Inc., in
conjunction with HemoCleanse, Inc. of West Lafayette, IN, has
received FDA approval to conduct a feasibility study under an
Investigational Device Exemption utilizing the BioLogic-HT System
for extracorporeal whole-body hyperthermia treatment of patients
with metastatic non-small cell lung cancer. The study will be
conducted at the University of Texas Medical Branch at Galveston.
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: February 3, 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 SUBSIDIARY, IDT,
RECEIVES FDA APPROVAL FOR CANCER STUDY
Pittsburgh, PA - February 5, 1997 - Biocontrol Technology,
Inc. (Nasdaq:BICO) announced today that its subsidiary, IDT,
Inc., in conjunction with HemoCleanse, Inc. of West Lafayette,
IN, has received Food and Drug Administration (FDA) approval to
conduct a feasibility study under an Investigational Device
Exemption (IDE) utilizing the BioLogic-HT System for
extracorporeal whole-body hyperthermia (WBH) treatment of
patients with metastatic non-small cell lung cancer.
This is the first such study ever approved by the FDA and
will be conducted at the University of Texas Medical Branch at
Galveston.
Non-small cell lung carcinoma is cited as a major cause of
cancer morbidity and mortality in the United States. At
diagnosis, the majority of these patients have detectable
metastatic disease and less than half of them with operable
disease will remain free of disease following initial surgery or
radiotherapy. With current treatment modalities, including
radiation therapy, chemotherapy, and surgery, only limited relief
from the disease is realized and patient survival extends to only
approximately 15 months beyond treatment.
Cancer is the second indication for which the FDA has given
approval to conduct studies utilizing the BioLogic-HT System.
Thus far, the System has been involved in three studies of whole-
body extracorporeal hyperthermia treatment of HIV, and approval
was recently granted to conduct a fourth HIV study.
The BioLogic-HT System consists of the BioLogic-HT, the
BioLogic-HTA, and the disposables kit, which can also be used
separately with each unit. Use of the System has made whole-body
hyperthermia safe as the body's chemistries are monitored and
balanced on a real-time basis.
All of the studies conducted thus far have been for whole-
body treatment and have used the entire system, but IDT is now
investigating the possibility of utilizing only the HTA for
regional hyperthermia in the treatment of cancer. European
oncologists have shown sincere interest in regional and whole-
body hyperthermia, both alone and in combination with
chemotherapy and radiation for treatment of different types of
cancer. IDT has participated as an exhibitor in overseas
conferences and plans to continue exhibiting at upcoming
conferences such as the Second International Gastric Cancer
Congress to be held in Munich, Germany.
Biocontrol Technology, Inc. has its corporate offices in
Pittsburgh, PA and is involved in the development and manufacture
of biomedical devices and environmental products. IDT, Inc., a
wholly-owned subsidiary of Biocontrol also located in Pittsburgh,
PA, develops the hyperthermia treatment procedure and holds
exclusive worldwide marketing rights to the BioLogic-HT System
and related disposables.
