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
February
17, 2009
Date of Report (Date of earliest event
reported)
___________________________________________________________
SAFESTITCH
MEDICAL, INC.
(Exact
Name of Registrant as Specified in Charter)
___________________________________________________________
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Delaware
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0-19437
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11-2962080
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|
(State
of Other Jurisdiction
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(Commission
File Number)
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(I.R.S.
Employer
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of
Incorporation)
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|
Identification
Number)
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4400
Biscayne Boulevard, Suite 670, Miami, Florida
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33137
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(Address
of principal executive offices)
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(Zip
Code)
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(305)
575-4145
(Registrant’s
telephone number, including area code)
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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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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|
o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
o
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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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|
o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17CFR
240.13e-4(c))
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Item
7.01
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Regulation
FD Disclosure
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On February 17, 2009, SafeStitch
Medical, Inc. (the “Company”) issued a press release announcing that the United
States Food & Drug Administration has approved the Company’s domestic
marketing of its SMART DilatorTM for
dilation of strictures of the esophagus under endoscopic visualization in adults
18 years or older. A copy of the press release is furnished as
Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference
herein.
The
information contained in Item 7.01 of this Current Report on Form 8-K, including
Exhibit 99.1, shall not be deemed “filed” with the Securities and Exchange
Commission for purposes of Section 18 of the Securities Exchange Act of
1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities
of that section, nor shall it be deemed incorporated by reference in any filing
under the Securities Act of 1933, as amended, or the Exchange
Act. This Current Report on Form 8-K shall not be deemed an admission
as to the materiality of any information contained herein, including
Exhibit 99.1.
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Item 9.01
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Financial Statements and
Exhibits
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Exhibit Number
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Description
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99.1
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Press
release dated February 17,
2009.
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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 thereunto
duly authorized.
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SAFESTITCH
MEDICAL, INC.
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||||
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By:
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/s/ Adam S. Jackson
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|||
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Name:
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Adam
S. Jackson
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|||
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Title:
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Chief
Financial Officer
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|||
Date:
February 18, 2009
Exhibit
Index
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Exhibit Number
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Description
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99.1
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Press
release dated February 17,
2009.
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SafeStitch
Medical, Inc. Announces FDA Approval to Market Its SMART DilatorTM
MIAMI--(BUSINESS
WIRE)--SafeStitch Medical, Inc. (OTCBB: SFES - News) announced that the U.S.
Food and Drug Administration (“FDA”) has approved the Company’s 510(k)
application to begin U.S. marketing of its SMART DilatorTM, the
first esophageal dilator to indicate the pressure level being applied at the
esophageal stricture. “Having this information should reduce the
incidence of esophageal perforation – a devastating complication for patients –
in the approximately 2,000,000 esophageal dilations performed annually
worldwide” said Dr. Charles J. Filipi, SafeStitch’s Medical
Director. Dr. Filipi added that “the SMART Dilator is expected to
simplify and shorten the dilation process, which will help endoscopic clinics
operate more safely and efficiently.”
Jeffrey
Spragens, SafeStitch’s President and CEO, noted that “this FDA approval marks
the completion of the development phase of our three introductory products: the
SMART DilatorTM,
Standard BiteBlock and Airway BiteBlock - and we will now begin our
commercialization efforts for these products. Our product development
efforts are now focused on SafeStitch’s hernia skin stapler and its minimally
invasive gastroplasty devices for obesity and GERD procedures.”
About
SafeStitch Medical, Inc.
Miami-based
SafeStitch Medical, Inc. is a medical device company primarily developing
endoscopic and minimally invasive surgical devices. SafeStitch’s
product portfolio includes endoscopic gastroplasty devices for bariatric
(obesity) surgery and repair of gastroesophageal reflux disorder (GERD), as well
as a hernia skin stapler, a standard bite block, an airway bite block and the
SMART Dilator. The Company has also started development of devices
for excision and diagnosis of Barrett's esophagus and natural orifice
transluminal endoscopic surgery (NOTES). Information about the
Company may be found on its website at: www.safestitch.com.
This
press release contains "forward-looking statements," as that term is defined
under the Private Securities Litigation Reform Act of 1995 (PSLRA), which
statements may be identified by words such as "expects," "plans," "projects,"
"will," "may," "anticipates," "believes," "should," "intends," "estimates," and
other words of similar meaning, including statements regarding our product
development efforts, our ability to significantly improve clinical outcomes in
patients, and our ability to develop a preclinical pipeline of novel agents for
ophthalmic diseases, as well as other non-historical statements about our
expectations, beliefs or intentions regarding our business, technologies and
products, financial condition, strategies or prospects. Many factors could cause
our actual activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors
include those described in our filings with the Securities and Exchange
Commission, as well as risks inherent in funding, developing and obtaining
regulatory approvals of new, commercially-viable and competitive products and
treatments. In addition, forward-looking statements may also be adversely
affected by general market factors, competitive product development, product
availability, federal and state regulations and legislation, the regulatory
process for new products and indications, manufacturing issues that may arise,
patent positions and litigation, among other factors. The
forward-looking statements contained in this press release speak only as of the
date the statements were made, and we do not undertake any obligation to update
forward-looking statements, except as required under applicable
law. We intend that all forward-looking statements be subject to the
safe-harbor provisions of the PSLRA.
Contact:
SafeStitch
Medical, Inc., Miami
Dr.
Stewart B. Davis, 305-575-4145