Healthcare Industry News:  endoluminal intragastric surgery 

Devices

 News Release - January 8, 2007

EndoGastric Solutions, Inc. Completes Five Fully Transoral Redo-Obesity Procedures: Without Skin Incision - In As Little As 20 Minutes

REDMOND, Wash., Jan. 8 (HSMN NewsFeed) -- EndoGastric Solutions, Inc., the world leader in endoluminal intragastric surgery, announces the successful reduction of the stomach pouch size after gastric bypass for obesity, using StomaphyX(TM), a new endoluminal surgical device.

In December 2006, five StomaphyX(TM) pouch reduction procedures were successfully performed by Dr. Jacques Himpens and Professor Michel Cremer at Sint-Blasius Hospital in Dendermonde, Belgium. Immediately after the procedure, x-rays showed close to a 50% reduction in pouch size and a substantial change in pouch shape in all patients. All patients experienced the onset of satiety and a significant change in their eating patterns, reported that their stomachs felt similar to the four to five week period after the original surgery, and began to lose excess weight.

"For the first time, we have been able to achieve similar near term results as we would hope to achieve with a laparoscopic gastric redo-procedure but through a fully trans-oral procedure," said Dr. Jacques Himpens who has performed over 600 gastric redo-procedures and more than 6,000 bariatric procedures, making him one of the most experienced bariatric surgeons in the world.

"We demonstrated that this procedure is possible, less invasive, and so far after three weeks, effective," said Dr. Himpens. "All five of my patients have lost weight, significantly altered their eating habits, and have benefited from the incisionless aspects of this procedure. I also believe that the reconstructed pouches will hold for them in the near term."

"The StomaphyX procedure can be performed in as little as 15 to 20 minutes," continued Dr. Himpens. "Because the procedure is performed transorally, patients are able to return to their normal routines much faster than if they underwent open or laparoscopic surgery. I know that one patient was able to return to her job as a hairdresser the next day. This was especially important to her because she did not want to miss a single appointment during the busy holiday rush."

According to Himpens, failure to maintain adequate weight loss after gastric bypass has been reported to be as high as 25-30% as many procedures start to fail three years after surgery. In these cases, surgical redo- procedures are often required.

"This breakthrough procedure is important for the future of both bariatric surgery and gastroenterology since we are dealing with an extremely fragile patient population who often cannot undergo a second or third surgical procedure," said Professor Michel Cremer. "When these patients return for a follow up visit and have regained their weight, they are devastated from a psychological standpoint and, until now, they were faced with the prospect of yet another serious surgery or the risk of becoming morbidly obese again. StomaphyX has the potential to reach many of these patients and provide a minimally invasive alternative that carries far fewer risks than traditional approaches but with similar results to bariatric surgery."

"Revision bariatric procedures are difficult, time consuming and are associated with high complication rates," according to Dr. Kelvin Higa, President-Elect, American Society for Bariatric Surgery. With more than 170,000 bariatric procedures estimated to be performed in the US in 2007, the number of patients requiring a secondary operation will grow as well. "The need for a less invasive, safer, possibly endoluminal solution to this problem is of great benefit to our patients. This technology has the potential to develop into primary bariatric solutions as well," according to Dr. Higa.

"EndoGastric Solutions is extremely pleased to begin clinical experience on our second product, StomaphyX," said Thierry Thaure, CEO of EndoGastric Solutions. "Our mission is to become a full line provider of transoral surgical devices for pre-cancerous conditions, GERD and obesity. For many of our customers, this brings the same excitement as when surgical procedures evolved from open to laparoscopy because now major reconstructive procedures can be performed completely through natural orifices and without any incisions."

About EndoGastric Solutions, Inc.

EndoGastric Solutions(TM) is a pioneer in endoluminal procedures for the treatment of upper gastrointestinal diseases, including GERD and obesity. EGS's mission is to utilize the most current wisdom in gastroenterology and surgery to develop new trans-oral procedures and products to address the largest unmet needs in gastrointestinal diseases. EGS's initial solutions involve modifying current open surgical and/or laparoscopic approaches using transoral access. The company designs and manufactures single use instruments that will enable these incisionless solutions, and focuses on clinically based products for use by gastroenterologists and surgeons.

The StomaphyX device is not available for sale or use in the United States and is currently pending FDA 510(k) clearance. StomaphyX is CE marked and available in the European Union.

For more information about EndoGastric Solutions, Inc. and StomaphyX(TM) please visit:

http://www.endogastricsolutions.com

http://www.egseurope.eu


Source: EndoGastric Solutions

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