Six-month results of the first-ever sham and placebo-controlled study of a transoral endoscopic procedure for GERD presented at American College of Gastroenterology (ACG) 2014 Annual Scientific Meeting

SAN MATEO, Calif. (Oct. 20, 2014)–EndoGastric Solutions (EGS) today announces six-month results from world’s first-ever randomized, sham- and placebo-controlled prospective clinical study of the TIF® procedure; the data demonstrates that the TIF procedure is more effective than twice daily proton pump inhibitor (PPI) drug at eliminating troublesome regurgitation in patients with chronic gastroesophageal reflux disease (GERD).

The data from the RESPECT (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) will be presented at the ACG 2014 Annual Scientific Meeting and Postgraduate Course in Philadelphia, PA during “Plenary Session 1: Esophagus” starting at 2:15 PM EST Tuesday, October 21, 2014 by Peter Kahrilas, M.D., Professor of Medicine-Gastroenterology, Northwestern University a co-principal investigator.

Significantly more patients who underwent the TIF procedure and then received an ongoing course of placebo medication, reported elimination of troublesome regurgitation after six months compared to patients randomized to the control arm, who underwent a sham procedure and continued to take double dose PPI (omeprazole) medical therapy.

In addition, the TIF procedure was associated with a decrease in all acid exposure parameters while patients in the control group had no detectable improvements in pH control. Patients in both groups were blinded to therapy during follow-up and were assessed at 2, 12 and 26 weeks. At the 6 month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure.

“Based on the robust, sham controlled trial design, we believe the TIF procedure is an option for appropriately selected GERD patients who suffer from troublesome regurgitation despite PPI therapy,” Dr. Kahrilas said. “The TIF procedure is best suited for patients with only a small or no detectible hiatal hernia.”

“Tens of thousands of long-term GERD sufferers fall into a treatment gap where they are no longer able to control their symptoms with lifestyle changes and medical therapy but aren’t prepared to undergo more invasive surgery,” said John Hunter, M.D., Mackenzie Professor & Chairman of Surgery, Oregon Health & Science University and co-principal investigators.

“The TIF procedure may address this treatment gap by offering patients a less invasive option to treat the underlying anatomical cause of their disease, improving their regurgitation symptoms, quality of life, and reducing esophageal exposure to acid,” concluded Hunter.

“The presentation of the six-month RESPECT data highlights our dedication to high-quality, controlled clinical research and represents a significant milestone for EGS and the entire field of advanced transoral procedural therapies,” said Skip Baldino, EGS President and CEO. “We would like to thank Dr. Kahrilas, Dr. Hunter and all of the other investigators for conducting this robust study.”

“Patients in this blinded sham-controlled study deserve special recognition for their willingness to enroll not knowing which treatment arm they were assigned to until 6 months after their treatment protocol began,” continued Baldino. “We express our deepest gratitude from EGS and the scientific community for their participation in this important study.”

Nine participating academic and community centers enrolled and treated 129 patients as part of the RESPECT study. The investigators, consisting of fifteen general surgeons and a gastroenterologist, will follow the patients for 12 months. Additional information about the RESPECT study can be found at www.clinicaltrials.gov.

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About GERD
Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects nearly 20 percent of the U.S. population. It is a chronic condition in which the gastroesophageal valve (GEV) allows gastric contents to reflux (wash backwards) into the esophagus, causing heartburn and possible injury to the esophageal lining. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Some patients may have mild or moderate symptoms of GERD, while others have more severe manifestations causing chronic heartburn, asthma, chronic cough, and hoarse voice or chest pain. Left untreated, GERD can develop into a pre-cancerous condition called Barrett’s esophagus, which is a precursor for esophageal cancer. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Proton pump inhibitor (PPI) medications are commonly used to treat GERD, but there are a variety of health complications associated with long-term dependency on PPIs, and more than 10 million Americans are refractory to PPI therapy and may opt for surgery.

About Transoral Incisionless Fundoplication (TIF® 2.0 procedure) for Reflux
The TIF 2.0 procedure enables an incisionless approach to fundoplication in which a device is inserted through the mouth, down the esophagus and into the upper portion of the stomach. This approach offers patients looking for an alternative to traditional surgery an effective treatment option to correct the underlying cause of GERD. Based on clinical studies, most patients stopped using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF 2.0 procedure. Additionally, clinical results have demonstrated that concomitant laparoscopic hiatal hernia repair (LHHR) immediately followed by TIF 2.0 procedure is safe and effective in patients requiring repair of both anatomical defects.

Over 25,000 TIF procedures have been performed worldwide. More than 140 peer-reviewed papers have consistently documented the sustained improved clinical outcomes and exemplary safety profile the TIF procedure provides to patients suffering from GERD. For more information, please visit www.GERDHelp.com.

About Reimbursement
With the support of clinical societies, commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF 2.0 procedure through recently expanded coverage policies. The TIF 2.0 procedure is a covered benefit for all Medicare beneficiaries across the country.

For the TIF 2.0 procedure, physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty. CPT is a registered trademark of the American Medical Association.

About EsophyX® Technology
The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids from refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope, and enables creation of a 3 cm, 270° esophagogastric fundoplication. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. The evolving technology, including the latest iteration EsophyX Z+, launched in 2017, enables surgeons and gastroenterologists to use a wide selection of endoscopes to treat the underlying anatomical cause of GERD.

Indications
The EsophyX device, with SerosaFuse® fasteners and accessories, is indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. It is indicated for the treatment of symptomatic chronic GERD in patients who require and respond to pharmacological therapy. The device is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia ≤ 2 cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2 cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2 cm or less.

About EndoGastric Solutions®
Based in Redmond, Washington, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of GERD. EGS has combined the most advanced concepts in gastroenterology and surgery to develop products and procedures to treat gastrointestinal diseases, including the TIF 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and LinkedIn: EndoGastric Solutions.

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Contact:
Ted Stephens
EndoGastric Solutions, Inc.
Phone: +1 513-312-9161
tstephens@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com