Healthcare Industry News:  OPKO Health 

Devices Surgery

 News Release - October 1, 2012

SafeStitch Medical(R), Inc. Announces Sales of the AMID(TM) Hernia Fixation Device

MIAMI--(Healthcare Sales & Marketing Network)--SafeStitch Medical®, Inc. (SFES), today announced it has shipped the AMID™ Hernia Fixation Device (AMID HFD™) to over half a dozen medical facilities nationwide, just four months after its launch on April 17, 2012. These facilities include Santa Monica UCLA General Surgery, North Carolina Medical Center, Ohio Hernia Center, New York-Presbyterian and Hernia Center of Southern California. In addition, more than 90 physicians have already operated with the AMID HFD and more than a dozen facilities are in the process of obtaining committee approval to make the AMID HFD available for physicians to purchase.

“The AMID HFD is gaining momentum since its introduction in April 2012. The AMID HFD has received positive feedback from physician surveys completed after operating room evaluations, including a 97% positive rating on the AMID HFD's ease of use and a 95% positive rating for wanting to use the AMID HFD to adhere mesh to internal tissue,” said Jeffrey Spragens, President and CEO of SafeStitch Medical.

Dr. David Grischkan, Medical Director at the Hernia Center in Ohio has used the AMID HFD and is impressed with the benefits of the AMID HFD. Dr. Grischkan remarked, “As a very busy surgeon specializing in hernia surgery, finding a device that effectively reduces operative time and provides improved mesh fixation has been an ongoing quest. The AMID HFD is a remarkable new instrument that allows for faster and more effective mesh fixation in hernia repairs. I have personally used this device in a large number of patients and have found it to be revolutionary. It is easy to use, has mesh manipulators that aid in the alignment of the mesh and requires less retraction than suture repairs. Compared to suture fixation of mesh, it allows for a 50% reduction in the time needed to complete the mesh insertion. This instrument should be included in every hernia repair when mesh is used.

The AMID HFD is distributed by direct representatives and distributors throughout the United States. A marketing campaign, “Putting Time On Your Side,” appears in advertisements in the September 2012 and November 2012 issues of Outpatient Surgery Magazine®. SafeStitch Medical will also be attending the American College of Surgeons Annual Clinical Congress beginning October 1, 2012 to demonstrate the AMID HFD, offer training on the Simplified Stapled Lichtenstein Procedure (SSLP™) and present an instructional video at the exhibit booth, #1031.

The AMID Hernia Fixation Device is used for both inguinal and ventral hernia surgeries. For inguinal hernia repair using the Lichtenstein method, the innovative design of the AMID HFD fixates mesh by delivering staples in a parallel plane to the femoral vessels, which may help avoid vascular injury. The AMID HFD allows for mesh manipulation, mesh fixation and skin closure.

About SafeStitch Medical, Inc.

Miami, Florida-based SafeStitch Medical, Inc. is a publicly traded medical device company founded by Charles J. Filipi M.D. and Jeffrey G. Spragens, in 2005, to develop a prototype for a minimally invasive obesity procedure. In the summer of 2006, Phillip Frost M.D., Chairman and CEO of OPKO Health, Inc. and Jane Hsiao Ph.D., Vice-Chairman and Chief Technical Officer of OPKO Health, Inc. became partners in SafeStitch Medical, Inc. and expanded SafeStitch’s mission 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 including mucosal excision. 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," "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: whether the AMID HFD will obtain committee approval to allow for physicians to purchase; whether the AMID HFD is gaining momentum since its introduction in April 2012; whether the AMID HFD has received positive feedback from physician surveys completed after operating room evaluations; whether the AMID HFD allows for faster and more effective mesh fixation, requires less retraction and allows for a 50% reduction in the time needed to complete mesh insertion; whether the AMID HFD may help avoid vascular injury. 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

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