Healthcare Industry News:  EndoGastric Solutions 

Devices Gastroenterology Regulatory

 News Release - June 20, 2006

EndoGastric Solutions Launches the EsophyX(TM) Endoluminal Fundoplication Device in Europe

REDMOND, Wash., June 20 (HSMN NewsFeed) -- EndoGastric Solutions Inc. (EGS), a leader in reconstructive intragastric surgery, announced today that its EsophyX(TM) device is now approved for commercialization in the EU and is ready for limited commercial release to 40 leading European centers during 2006.

The technology created by EGS enables gastroenterologists and surgeons for the first time to perform true endoluminal fundoplication procedures for the treatment of GERD, completely through a trans-oral ("natural orifice") approach, without any incisions. What makes this procedure unique is that it is based on the proven surgical principles of antireflux surgery such as the Nissen Fundoplication, enabling complete reconstruction of the natural antireflux barrier.

Dr. Guy-Bernard Cadiere, Professor and Chief of Surgery at Centre Hospitalier Universitaire St-Pierre, the first surgeon to evaluate this new technology as part of EGS's clinical studies initially conducted at Hospital St. Pierre and Clinique du Parc Leopold - CHIREC in Belgium, stated today "The limited commercial release of the EsophyX product, represents a milestone for trans-oral incisionless surgical repair of the anti-reflux barrier and provides the first promising alternative to traditional laparoscopic fundoplication for the definitive treatment of GERD."

EGS has been testing the EsophyX device and improving the Endoluminal Fundoplication (ELF) procedure since June 2005. The six-month follow-up results using the first-generation EsophyX device in a phase 1 study have approached those obtained with more traditional laparoscopic Nissen fundoplications in terms of success at eliminating Proton Pump Inhibitor (PPI) drug dependence and protecting the esophagus from acid exposure (pH results).

The lead investigator, Professor Cadiere, states, "The preliminary results to date for EsophyX are very encouraging. Over 80% of patients have normal or near normal pH at six months post-ELF procedure despite discontinuing their GERD medications. Over 90% of patients show an improvement in quality of life and a reduction in GERD symptoms compared to before their ELF procedure and over 80% of patients remain off of PPI drugs at an average follow-up period of 10 months post-procedure. 70% of patients remain off any sort of GERD medication."

"If these results continue to hold up," Professor Cadiere continues, "we could easily imagine that up to 20% of all GERD patients worldwide could benefit from natural orifice surgery such as the EsophyX Procedure."

Thierry Thaure, President and Chief Executive Officer of EGS, said today, "We are extremely pleased with our progress at EndoGastric Solutions and believe that we are well on our way to being able to prove that it is not only possible but also easier to complete an endoluminal fundoplication procedure from inside the stomach. As the EsophyX product and ELF procedure mature, we intend to accomplish what the Laparoscopic Nissen failed to do, deliver a mainstream antireflux procedure to the general surgical and interventional gastrointestinal market."

About GERD

GERD is acid reflux with heartburn that is frequent and severe enough to impact daily life and damage the esophagus. Normally, after swallowing a valve between the esophagus and stomach opens to allow food to pass into the stomach, and then closes to prevent reflux of the food back into the esophagus. In GERD, this valve is weakened or absent, causing the acidic digestive juices from the stomach to flow back (or reflux) into the esophagus. This reflux is not only dangerous, because the esophagus is made of delicate tissue that cannot withstand the caustic, acidic contents of the stomach, but it is also painful, and "burns" the throat (and is therefore called "heartburn"). Reflux of these stomach contents can also lead to a precancerous condition called Barrett's esophagus and/or adenocarcinoma, a full-blown cancer that is very aggressive and deadly.

Drug Treatment of GERD

Current medical treatment of GERD includes drugs, such as H2 blockers and proton pump inhibitors, which neutralize or suppress the stomach acid and help relieve symptoms. However, these drugs are expensive, they don't work for everyone, and many people who do respond quit responding over time. Although over $13 billion are spent each year on proton pump inhibitors alone, these drugs do not correct the root cause of GERD (anatomic disintegration of the antireflux barrier) so symptoms return when the medication is stopped. More effective and permanent solutions are needed.

About Surgical Treatment of GERD

Surgical treatment of GERD by long, open incisions on the abdomen or by laparoscopy (usually five ports or small holes in the abdomen) has long been known to effectively treat GERD. However, this surgery is invasive, with lots of cutting both inside the patient around the stomach area, and on the abdominal skin. This surgery, generally called Nissen or laparoscopic fundoplication, also has issues. The effectiveness of the Nissen procedure is highly dependent on surgeon skill, since the procedure is complicated, and effectiveness can be only half as good with inexperienced surgeons. The Nissen can also cause problems if it is done too tight, and patients can experience "gas bloat syndrome" where they have cramps and pain and trapped gas. Other undesirable effects can include difficulty swallowing, painful swallowing and inability to burp or throw up. Despite these problems with the previous surgical approach (Nissen), the surgery is generally effective at reducing reflux by creating a valve at the base of the esophagus where it joins the stomach.

About Endoluminal Fundoplication (ELF) Procedures

The primary commercially available treatments for gastroesophageal reflux disease (GERD) in Europe were medications or surgery, until recently, when the ELF procedure, an additional option that mimics surgery but involves no abdominal or internal incisions has become available. The EsophyX device by EndoGastric Solutions (EGS), is used to perform an endoluminal fundoplication (ELF). The ELF procedure involves going through the mouth to deliver fasteners in the stomach that create a 3-5 cm thick flap of tissue in 270 degrees circumference at the base of the esophagus. This flap valve is what rests closed against the other side of the stomach at the junction of the stomach to the esophagus, to prevent stomach contents from refluxing back into the esophagus. Patients who have reflux disease generally have lost this flap valve and the junction of their esophagus to their stomach has stretched out and allows food to reflux or regurgitate back into the esophagus. These patients generally need an anatomical reconstruction to relieve their GERD symptoms. The ELF procedure, performed using the EsophyX device, mimics many of the principles of the laparoscopic fundoplication, including that EsophyX reduces hiatal hernia, restores the angle of His and creates a astroesophageal valve. However, EsophyX does not have the same issues with adverse effects that are seen with Nissen.

About EndoGastric Solutions

EndoGastric Solutions (EGS) is a pioneer in endoluminal procedures for the treatment of upper gastrointestinal diseases, including gastroesophageal reflux disease (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 trans-oral access. The company designs and manufactures single use instruments that will enable these incision-less solutions, and focuses on clinically based products for use by gastroenterologists and surgeons. EGS is a privately held corporation, located in Redmond, Washington with a European office and distribution center in Milan, Italy and a training office in Brussels, Belgium. Investors include MPM Capital, Advanced Technology Ventures, Foundation Medical Partners, Chicago Growth Partners and Oakwood Medical Investors.

Source: EndoGastric Solutions

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