Current Report Filing (8-k)
October 28 2013 - 3:16PM
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
October 28, 2013 (October 28, 2013)
Date of Report (Date of earliest event reported)
MEDGENICS, INC.
(Exact name of registrant as specified in its charter)
Delaware |
1-35112 |
98-0217544 |
(State or other jurisdiction of
incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer
Identification No.) |
555 California Street, Suite 365
San Francisco,
California 94104
(Address of principal executive offices,
zip code)
(415) 568-2245
(Registrant’s telephone number, including area code)
Not Applicable
(Former name or former address, if changed since last report)
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):
| ¨ | 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)) |
Medgenics, Inc. (the “Company”)
has announced the results of a new study showing that the Company’s second-generation gene therapy vectors provided substantial
improvements in levels and durability of therapeutic protein secretion in vitro and in vivo. In addition, the new
vectors incorporated improvements in surgical technique, including co-administration of Depo-Medrol® (methylprednisolone acetate)
on implantation. More specifically, when Depo-Medrol was applied to second-generation vectors, animals serum hEPO levels remained
40-50 folds higher for over 100 days post implantation when compared to first generation vector with no Depo-Medrol.
The Company plans to initiate human trials
with a Biopump containing the second-generation viral vector and new implantation protocol in the first half of 2014.
This Current Report on Form 8-K contains
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange
Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other
than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development
and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends
that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes
identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,”
“anticipate,” “plan,” “planning, “expect,” “believe,” “will,” “will
likely,” “should,” “could,” “would,” “may” or the negative of such terms and other
comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties.
These risks and uncertainties include, but are not limited to, those discussed in the section titled “Risk Factors”
of the Company’s Annual Report on Form 10-K for the year ended December 31, 2012, and any updates to those risk factors included
in the Company’s Quarterly Reports on Form 10-Q. Should any of these risks or uncertainties materialize, or should any of
the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking
statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date
made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking
statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions
or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking
statements contained in this Current Report on Form 8-K may not occur.
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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MEDGENICS, INC. |
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By: |
/s/ Phyllis K. Bellin |
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Name: Phyllis K. Bellin Title: Vice President – Administration |
Date: October 28, 2013
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