12-Month RESPECT Data Presented At American College of Gastroenterology Finds EndoGastric Solutions, Inc.’s Transoral Incisionless Fundoplication (TIF®) Procedure Provides Sustained Relief Of Troublesome Regurgitation

Health Economic Data for TIF Procedure Also Highlighted

REDMOND, Wash.--(BUSINESS WIRE)--EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced updated one-year clinical data from the RESPECT (Randomized EsophyX® vs. Sham/Placebo Controlled Trial) study, the first-ever randomized, blinded, sham- and placebo-controlled study of the company’s Transoral Incisionless Fundoplication (TIF®) procedure. The RESPECT study, along with a second separate study of health economic data comparing reflux treatment methods including the TIF procedure, will be presented at the American College of Gastroenterology (ACG) 2015 Annual Scientific Meeting, October 16- 21, 2015 in Honolulu, Hawaii.

“Based on the improvements seen in these patients, we believe the TIF procedure is filling a treatment gap for patients who do not respond to PPI medications and want a less invasive procedure”

Eighty-seven patients were randomly assigned to the group that underwent the TIF procedure and then received an ongoing treatment of placebo medication. After more than 12 months, 72% reported elimination of troublesome regurgitation per Montreal consensus criteria.¹

The study also found that the mean DeMeester Score decreased from 33.6 to 23.9 at 6 months and to 24.7 at > 12 months post-TIF (p < 0.05).

Eight participating U.S. academic and community centers screened 696 patients of which 129 were enrolled into the RESPECT study: TIF/placebo n=87; SHAM/PPI n=42.

“The 12-month data from the RESPECT study further supports the TIF procedure as an effective treatment option to eliminate troublesome regurgitation and improves the quality of life for select chronic GERD patients,” said Peter Kahrilas, MD, Professor of Medicine-Gastroenterology, Northwestern University and co-principal investigator.

Both groups of patients enrolled in the RESPECT study, and their caregivers, were blinded to therapy during follow-up which occurred at two, 12 and 26 weeks. At the six-month follow-up, all patients were un-blinded and the sham control patients were given the opportunity to have a TIF procedure; 76% of sham/placebo group elected to crossover and receive a TIF procedure after un-blinding.

The RESPECT 12 month follow-up data will be displayed as a poster on Tuesday, October 20, 2015, 9:30 AM – 3:30 PM local time.

“Based on the improvements seen in these patients, we believe the TIF procedure is filling a treatment gap for patients who do not respond to PPI medications and want a less invasive procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions.

About Economic Data Study

Also being presented are results of a two-year study demonstrating the improved cost and healthcare utilization benefits of the TIF procedure in comparison to PPI medication and Nissen fundoplication.

In this study, the Optum healthcare database was utilized to determine overall resource utilization, which includes costs for hospitalizations, outpatient visits and PPI therapy. Of the 13,293 total patients included in the analysis, 10,486 patients were on high-dose PPI therapy, 2,734 underwent Nissen fundoplication, and 73 patients had the TIF procedure. At two years post-TIF procedure, median costs were comparable to those post-Nissen (TIF – $7,397, Nissen – $8,412) and healthcare utilization and total healthcare costs decreased compared to those associated with PPIs (TIF – $7,397, PPIs – $9,697).

“The TIF procedure is showing potential not only as a desirable GERD treatment, but as a cost-effective solution for patients,” said Lauren Gerson, MD, MSc, gastroenterologist at California Pacific Medical Center in San Francisco, CA. Dr. Gerson is the lead author of the study; this poster will also be on display Tuesday, October 20, 2015, 9:30 AM – 3:30 PM local time.

About GERD

Gastroesophageal reflux disease (GERD) 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. The stomach produces hydrochloric acid and other digestive enzymes after a meal to aid in the digestion of food. The cells that line the stomach are coated with a protective mucus that can withstand gastric contents, while the cells that line the esophagus lack the same protection.

GERD is the most common gastrointestinal-related diagnosis made by physicians during clinical visits in the U.S. It is estimated that pain and discomfort from acid reflux impacts over 80 million people at least once per month in the U.S. The standard recommendations for symptomatic GERD patients include lifestyle changes (e.g., diet, scheduled eating times, and sleeping positions) and escalating doses of prescription medications for prolonged periods of time. Long-term, maximum-dose usage of prescription medications has been linked to a variety of other health complications.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair another treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.

Over 17,000 TIF patients have been treated worldwide since EsophyX® device clearance ⁱⁿ 2007. More than 50 peer-review papers from over 40 centers have been published documenting consistent outcomes on over 800 unique study patients. For more information, visit www.GERDHelp.com.

About EsophyX® technology

The original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z in 2015. The technology has continued to evolve and is a clinically-backed tool for physician use in the treatment of GERD. The EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes–including low profile and larger high-definition models—to treat the underlying anatomical cause of GERD. The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope.

About EndoGastric Solutions®

Based in Redmond, WA, EndoGastric Solutions, Inc. (www.endogastricsolutions.com), is a medical device company focused on developing and commercializing innovative, evidence-based, incisionless surgical technology for the treatment of gastroesophageal reflux disease (GERD). EGS has combined the most advanced concepts in gastroenterology and surgery to develop the Transoral Incisionless Fundoplication (TIF®) procedure—a minimally invasive solution that addresses a significant unmet clinical need.

References

¹ Vakil N, Van zanten SV, Kahrilas P, Dent J, Jones R. The Montreal definition and classification of gastroesophageal reflux disease: a global evidence-based consensus. Am J Gastroenterol. 2006;101(8):1900-20.

Indications:

The EsophyX device with SerosaFuse fasteners is indicated for use in transoral tissue approximation, full thickness plication and ligation in the GI tract and is indicated for the treatment of symptomatic chronic gastroesophageal reflux disease in patients who require and respond to pharmacological therapy. It is also indicated to narrow the gastroesophageal junction and reduce hiatal hernia = 2cm in size in patients with symptomatic chronic gastroesophageal reflux disease.

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