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SafeStitch Announces FDA Approval to Market Its SMART Dilator

February 18, 2009 |

SafeStitch Medical, Inc. (OTCBB:SFES) 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:

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.

SOURCE: SafeStitch Medical, Inc.

SafeStitch Medical, Inc., Miami
Dr. Stewart B. Davis, 305-575-4145

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