UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 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): September 5, 2005
ADM TRONICS UNLIMITED, INC.
(Exact name of registrant as specified in its charter)
Delaware 000-17629 22-1896032
(State or other (Commission (IRS Employer
jurisdiction of File Number) Identification
incorporation) No.)
224-S Pegasus Avenue, Northvale, New Jersey 07647
(Address of principal executive offices) (Zip Code)
(201) 767-6040
Registrant's Telephone Number
Check the appropriate box below if the Form 8-K is intended to
simultaneously satisfy the filing obligation of the registrant under
any of the following provisions (see General Instruction A.2 below):
[ ] Written communications pursuant to Rule 425 under the Securities
Act (17 CFR 230.425)
[ ] Soliciting material pursuant to Rule 14a-12 under the Exchange
Act (17 CFR 240.14a-12)
[ ] Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b))
[ ] Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)).
Item 8.01. Other Events.
A majority-owned subsidiary of ADM Tronics Unlimited, Inc. (the "Company"),
Ivivi Technologies, Inc. ("Ivivi"), has been notified that the Cleveland
Clinic Florida, a not-for-profit multi-specialty medical group practice (the
"Clinic"), has approved Ivivi's application to conduct a study relating to
the use of Ivivi's non-invasive pulsed electromagnetic field technology
("PEMF") on patients with ischemic cardiomyopathy. The study, which will be
the first controlled human clinical trial using Ivivi's PEMF for a cardiac
indication, will have the following three objectives:
o to establish the safety of PEMF in treatment of patients with
ischemic cardiomyopathy (a heart condition resulting from decreased
blood flow to the heart);
o to evaluate the efficacy of PEMF on myocardial perfusion (the flow
of blood through the heart), ventricular function (the function
performance of the ventricle of the heart), clinical symptoms of
angina (severe chest pains from the heart) and exercise tolerance
after one and three-month treatments in patients with ischemic
cardiomyopathy; and
o to assess the sustainability of PEMF on ischemic myocardium (the
decrease in blood flow to the heart) two months after completion
of the therapy.
The Company expects that the human clinical trials will commence during its
fiscal quarter ending December 31, 2005 and will be completed during 2006.
The primary endpoint of the study is improvement in regional myocardial
perfusion and function. The secondary endpoint of the study is improvement
in patient angina and exercise tolerance. The Company believes that the
effects of PEMF on increasing blood flow and angiogenesis (the regeneration
of new blood vessels) in chronically injured tissues, along with its non-
invasive and non-pharmacological features, could provide potential as a
therapeutic alternative for revascularization (the creation of new blood
vessels), especially in patients for whom standard percutaneous or surgical
revascularization is not suitable treatment.
The human clinical trials are a pre-requisite to the filing of applications
to the U.S. Food and Drug Administration to market PEMF for the indications
set forth above; however, there can be no assurance that the results of such
trials will be positive or even if the results are positive, that the
Company will receive the requisite FDA clearance or approval for such
indications. Further, there can be no assurance that the trials will
commence or be completed within the timeframes anticipated by the Company.
Except for historical information contained herein, the matters set forth in
this report are "forward looking" statements (as defined in the Private
Securities Litigation Reform Act of 1995). Although the Company believes
the expectations reflected in such forward-looking statements are based upon
reasonable assumptions, there can be no assurance that its expectations will
be realized. Forward-looking statements involve certain risks and
uncertainties that could cause actual results to differ materially from the
Company's expectations. Factors that could contribute to such differences
include those identified in the Company' Form 10-KSB for the fiscal year
ended March 31, 2005 and those described from time to time in the Company's
other fillings with the Securities and Exchange Commission.
SIGNATURES
Pursuant to the requirements 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.
ADM Tronics Unlimited, Inc.
By: /s/ Andre' DiMino
Name: Andre' DiMino
Title: President
Dated: September 6, 2005