SafeStitch Medical® Announces Encouraging Result of Transluminal Procedure
to Correct GERD and Obesity with Two Years Follow Up
MIAMI -- January 22, 2013
SafeStitch Medical®, Inc. (OTCBB:SFES), SafeStitch Medical today reported
positive findings in a seven patient preliminary pilot clinical trial using
its proprietary transluminal devices to restrict gastric acid reflux in three
patients and to cause meaningful weight reduction in two obese patients after
“It’s encouraging to see the objective findings of esophageal pH normalization
in the three patients with gasatroesophageal reflex disease and weight loss of
30-60% in the two obese subjects two years after the procedure. This provides
the level of confidence that our transluminal devices and procedure will have
durability, which is essential for the success of the procedure,” said Dr.
Charles Filipi, Chief Medical Officer at SafeStitch Medical; lead on the
clinical trial and inventor of the devices. “To the best of our knowledge no
other transoral devices have achieved these results. By going through the
mouth, there is less risk of infection, and only conscious sedation is
required. This should result in lower costs for bariatric and GERD surgery.”
“SafeStitch plans to expand the pilot study to include additional subjects and
to submit an Investigational Device Exemption (IDE) with FDA this year. We
plan to seek FDA approval in due course,” stated by Dr. Jane Hsiao, Chairman
of SafeStitch Medical.
About SafeStitch Medical, Inc.
Miami, Florida-based SafeStitch Medical, Inc. is a publicly traded medical
device company founded in 2006. Our mission is to develop and market the best
in class disposable medical devices to advance minimally invasive surgery for
hernia repair, treatment of obesity and other gastroesophageal disorders.
SafeStitch Medical has developed and obtained FDA approval to market the AMID
Hernia Fixation Device (HFD) for both inguinal and ventral hernia repairs. The
AMID HFD allows for faster mesh manipulation, mesh fixation and skin closure.
Information about the Company may be found on its website
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," "anticipate," "believes," "should," "intends,"
"estimates," and other words of similar meaning, including statements
regarding our product development and commercialization efforts, and our
ability to significantly improve clinical outcomes in patients, 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, including those described herein and in
our filings with the Securities and Exchange Commission, could cause our
actual activities or results to differ materially from the activities and
results anticipated in forward-looking statements. These factors include, but
are not limited to: whether the limited pilot study will have similar results
if expanded to include more patients; whether the transluminal device will
have adequate durability; whether any other transoral devices have achieved
similar results to our study; whether conducting the procedure through the
mouth will result in lower costs; whether we will submit an IDE and whether we
will seek FDA approval in due course. 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.
SafeStitch Medical, Inc.
Jeffrey G. Spragens, 305-575-4146
Jim J. Martin, 305-575-4207
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