Current Report Filing (8-k)
23 März 2015 - 2:06PM
Edgar (US Regulatory)
UNITED STATES
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):
March 23, 2015
ARCH THERAPEUTICS, INC.
(Exact name of registrant as specified in
its charter)
Nevada |
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000-54986 |
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46-0524102 |
(State or other jurisdiction |
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(Commission |
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(I.R.S. Employer |
of incorporation) |
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File Number) |
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Identification No.) |
20 William Street, Suite 270 |
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Wellesley, Massachusetts |
02481 |
(Address of principal executive offices) |
(Zip Code) |
Registrant’s telephone number, including
area code: (617) 431-2313
Check the appropriate box below if the Form 8-K filing is intended
to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
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¨ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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¨ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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¨ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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¨ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
On March 23, 2015, Arch Therapeutics,
Inc. (the “Company”) issued a press release announcing positive safety results for its AC5 Surgical Hemostatic Device™
in preclinical toxicity studies. The text of the press release is attached hereto as Exhibit 99.1 and is incorporated
by reference herein.
| Item 9.01 | Financial Statements and Exhibit |
(d) Exhibits
Exhibit |
|
Description |
99.1 |
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Press Release issued by Arch Therapeutics, Inc. on March 23, 2015 |
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.
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ARCH THERAPEUTICS, INC. |
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Dated: March 23, 2015 |
By: |
/s/ Terrence W. Norchi, M.D. |
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Name: Terrence W. Norchi, M.D. |
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Title: President, Chief Executive Officer |
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EXHIBIT INDEX
Exhibit |
|
Description |
99.1 |
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Press Release issued by Arch Therapeutics, Inc. on March 23, 2015 |
Exhibit 99.1
Arch Therapeutics Announces Positive
Safety Results for AC5 Surgical Hemostatic DeviceTM in Preclinical Toxicity Studies
Data Further Supports Non-Toxic Profile
of AC5™
WELLESLEY, MA – March 23, 2015 -- Arch Therapeutics, Inc. (OTCQB: ARTH) (“Arch” or the “Company”),
developer of the AC5 Surgical Hemostatic Device™ (AC5TM) for use in controlling bleeding and fluid loss in order
to provide faster and safer surgical and interventional care, obtained additional favorable preclinical data from two (2) planned
standardized medical device safety studies in which AC5 was assessed for toxicity to cells and for contamination from pyrogens
(toxins that cause fever) produced by bacterial cells. The tests are major components of the panel of biocompatibility testing
that medical devices must typically complete successfully prior to use in humans.
In the cytotoxicity test, which is an in vitro study
that assesses AC5 for toxicity to cells using cell cultures, AC5 tested in clinically relevant amounts was found to be non-toxic
to cells (non-cytotoxic).
In the pyrogenicity test, which is an in vitro study
that assesses AC5 for the presence of pyrogens, AC5 tested in clinically relevant amounts was found to be non-pyrogenic, which
is a desirable characteristic. Pyrogens, also known as bacterial endotoxins, are certain toxins made by bacteria. A product that
were to contain sufficient amounts of pyrogen or other cell-toxins could trigger immune responses with the potential for tissue
damage and significant harm to patients.
The tests were conducted under guidelines provided by the International
Organization for Standardization (ISO), the United States Pharmacopeia (USP), the American National Standards Institute (ANSI)
and the Association for the Advancement of Medical Instrumentation (AAMI).
Arch Therapeutics President and CEO Terrence Norchi, MD, stated,
“The favorable results demonstrated in these safety tests represent additional important milestones in the development of
AC5 for planned use in humans. We continue to be pleased with the data generated, which continues to support a desirable safety
profile for AC5.”
About Arch Therapeutics, Inc.
Arch Therapeutics, Inc. is a medical device company developing a novel approach to stop bleeding (hemostasis) and control leaking
(sealant) during surgery and trauma care. Arch is developing products based on an innovative self-assembling peptide technology
platform to make surgery and interventional care faster and safer for patients. Arch's flagship development stage product candidate,
known as the AC5 Surgical Hemostatic Device, is being designed to achieve hemostasis in minimally invasive and open surgical procedures.
Find out more at www.archtherapeutics.com.
Notice Regarding Forward-Looking Statements
This news release contains "forward-looking statements" as that
term is defined in Section 27(a) of the Securities Act of 1933, as amended, and Section 21(e) of the Securities Exchange Act of
1934, as amended. Statements in this press release that are not purely historical are forward-looking statements and include any
statements regarding beliefs, plans, expectations or intentions regarding the future. Such forward-looking statements include,
among other things, references to novel technologies and methods, our business and product development plans and projections, or
market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors.
Such factors include, among others, the inherent uncertainties associated with developing new products or technologies and operating
as a development stage company, our ability to retain important members of our management team and attract other qualified personnel,
our ability to raise the additional funding we will need to continue to pursue our business and product development plans, our
ability to develop and commercialize products based on our technology platform, and market conditions. These forward-looking statements
are made as of the date of this news release, and we assume no obligation to update the forward-looking statements, or to update
the reasons why actual results could differ from those projected in the forward-looking statements. Although we believe that any
beliefs, plans, expectations and intentions contained in this press release are reasonable, there can be no assurance that any
such beliefs, plans, expectations or intentions will prove to be accurate. Investors should consult all of the information set
forth herein and should also refer to the risk factors disclosure outlined in the reports and other documents we file with the
SEC, available at www.sec.gov.
On Behalf of the Board,
Terrence W. Norchi, MD
Arch Therapeutics, Inc.
Contact:
ARTH Investor Relations
Toll Free: +1-855-340-ARTH (2784) (US and Canada)
Email: investors@archtherapeutics.com
Website: www.archtherapeutics.com
Or
Richard Davis
Chief Financial Officer
Arch Therapeutics, Inc.
Phone: 617-431-2308
Email: rdavis@archtherapeutics.com
Website: www.archtherapeutics.com
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