Positive six-month results were maintained a year after TIF procedure; all control patients crossed over to receive TIF procedure and achieved similar results to original treatment group
Data Presented at DDW® 2014

CHICAGO (May 5, 2014)—EndoGastric Solutions® (EGS), a leader in endoluminal reconstructive treatment for gastroesophageal reflux disease (GERD), today announced that new data show that a vast majority of patients with GERD who underwent the Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device continued to report complete elimination of all troublesome regurgitation and esophagitis for a full year after the procedure.

This new 12-month analysis of the prospective, randomized, multicenter clinical trial known as TEMPO also showed that all 21 patients in the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first six months of the trial crossed over to undergo the TIF procedure. This group achieved similar positive six-month results to the patients in the original treatment arm.

The new 12-month analysis was presented by principal investigator, Karim S. Trad, MD, as part of an American Gastroenterological Association (AGA) research forum earlier today at Digestive Disease Week® (DDW®) 2014 (Abstract #724), taking place here through May 6.

“This study confirms that in well-selected GERD patients with incomplete symptom control on high-dose PPI therapy, the TIF procedure is capable of dramatically and durably eliminating GERD symptoms, healing esophagitis and improving quality of life,” said Dr. Trad, a surgeon at George Washington University School of Medicine and Health Sciences who reported on the 12 months follow-up data at DDW. “This incisionless, endoluminal approach offers a subgroup of patients who are dissatisfied with PPIs a less invasive option than current surgical approaches, with minimal or no side-effects. We are planning to follow our study patients for up to three years.”

Seventy-seven percent of patients in original treatment arm (n-39) reported a global elimination of daily troublesome regurgitation and atypical symptoms 12 months following the TIF procedure. Esophagatis, or inflammation of the esophagus, remained healed in 100% of the patients in the original treatment arm.

At the end of the first six months of the study, only 5% (1/21) of patients in the control group who received maximum-dose PPI therapy reported global elimination of regurgitation and atypical symptoms; this proportion increased to 67% (14/21) six months after these patients crossed over and had the TIF procedure (P < 0.001). Additionally, 71% (15/21) of the cross-over patients were completely off PPIs six months following the TIF procedure.

“These results add to the growing body of Tier-1 clinical data supporting use of the TIF procedure as an important therapeutic option for many long-term GERD sufferers, particularly those who no longer respond to drug therapy, but aren’t prepared for the risk and recovery time of traditional open or laparoscopic surgery,” said Skip Baldino, President and CEO of EGS.

“The presentation of the one-year outcomes from this important study represents one of the most important clinical milestones for EGS and the entire endoluminal procedure category to date. This is just one of many presentations and publications we expect during 2014. I believe this evidence will have a substantial impact on the utilization of and reimbursement for endoluminal approaches for GERD – and is one of the key reasons why I wanted to join EGS at this time,” continued Baldino.

The primary outcome of TIF® versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial was elimination of daily troublesome regurgitation and atypical symptoms as evaluated by two validated instruments—Reflux Disease Questionnaire and Reflux Symptom Index; secondary outcomes included healing of esophagitis, normalization of esophageal acid exposure and PPI use in the TIF treated patients at 6 and 12 months.

This TEMPO data presented at the American Gastroenterological Association’s session GERD: Complications and Extraesophageal Presentations at the 2014 DDW® Annual Meeting in Chicago, Illinois include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices.

EndoGastric Solutions did not provide financial support for the following scientific sessions and did not influence the content in any way. However, research presented within these scientific sessions may have been supported by EndoGastric Solutions.

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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