Study Found 59% of Patients Undergoing TIF Procedure Had Remission of Gastroesophageal Reflux Disease Symptoms after Six Months

REDMOND, Washington; October 15, 2015 – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced findings published online by Alimentary Pharmacology and Therapeutics from a new double-blind, sham-controlled, multi-center European study, which further confirmed the efficacy of the company’s Transoral Incisionless Fundoplication (TIF ®) procedure as a viable alternative to proton pump inhibitors (PPIs) to control chronic symptoms of GERD.

Prior to the TIF procedure, patients were required to refrain from PPI consumption for at least 10 days. Of the randomized patients treated with the TIF procedure, 59% were determined to be in remission after six months compared to 9% of patients in the sham treatment arm (p < 0.0001).

The study also reported TIF procedure patients had improved acid reflux time (measurements of esophageal acid exposure) from 8.89 to 3.73 (p = 0.0002) compared to the sham-controlled group which had no changes in acid reflux time.

“It can now be concluded that Transoral Incisionless Fundoplication (TIF2) offers chronic GERD patients, being on long-term treatment with PPI, an effective therapeutic alternative,” stated Lars Lundell, MD, lead investigator of the study and Professor of Medicine at Karolinska University, Huddinge Hospital, Stockholm. “In fact, we can also conclude that the level of scientific proof of its efficacy and therapeutic gain surpasses anything that is available outside the area of traditional laparoscopic anti-reflux therapy.”

This is the second randomized study using a sham-controlled group that was conducted on a demographically balanced and diverse body of 44 patients between 18 and 80 years old. Originally, from 406 initial contacts, 121 patients were screened who suffered from persistent GERD symptoms and relied on daily administration of PPIs for relief for at least six months prior to enrollment.

The paper “Randomised clinical trial: transoral incisionless fundoplication vs. sham intervention to control chronic GERD” can be found here and a poster will be on display at United European Gastroenterology’s Week (UEGW) Conference in the Oesophageal, Gastric and Duodenal Disorders Section 1, October 26, 2015 09:00 to 17:00 local time at Fira de Barcelona – Gran Via Venue in Barcelona, Spain.

“This data is a new addition to the body of high quality TIF procedure evidence—it’s the fourth randomized controlled trial and second sham-controlled study,” said Skip Baldino, President and CEO of EGS. “This data aligns with RESPECT—our first sham-controlled study. In a recent New England Journal of Medicine editorial,1 the medical device industry was challenged to conduct more sham controlled trials in order to validate novel procedures and devices; Dr. Lundell’s study has also met this most rigorous scientific test.”

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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