EndoGastric Solutions Announces Publication of Meta-Analysis Further Validating TIF 2.0 procedure as an Appropriate Treatment Option for Refractory GERD Patients

TIF Procedure offers excellent short and long-term relief for the majority of chronic GERD patients.

REDMOND, Wash – EndoGastric® Solutions today announced the publication of a meta-analysis supporting the clinical utility of Transoral Incisionless Fundoplication (TIF®) 2.0 in the treatment of refractory gastroesophageal reflux disease (GERD). The TIF 2.0 procedure is a minimally invasive endoscopic option that enables anatomical correction of the gastric valve without incisions or complications associated with laparoscopic surgical fundoplication. The publication, Transoral Incisionless Fundoplication (TIF 2.0): A Meta-Analysis of Three Randomized, Controlled Clinical Trials, was published in the March/April issue of Chirurgia (Surgery).

This publication is a meta-analysis of three randomized clinical trials comprising of 223 patients with chronic long-term refractory GERD on optimized PPI therapy and is the first published Evidence Level Ia study comparing TIF 2.0 procedure with PPI therapy and sham endoscopy with or without PPI therapy. The analysis suggests that the TIF 2.0 is a durable, effective procedure that controls symptoms and allows patients to discontinue PPI use at rates similar to traditional surgical techniques with improved safety profile and fewer long-term side-effects.

“Given the potential side-effects associated with long-term PPI dependency and the known adverse events of traditional surgical options, validated treatment options are urgently needed to treat the 19 million daily reflux sufferers,” said Nirav Thosani, MD, MHA, Director of Advanced Endoscopy, Ertan Digestive Disease Center, Memorial Hermann Hospital, Texas Medical Center. “The TIF 2.0 procedure provides an alternative option for patients who want to eliminate or reduce medical therapy and do not want to undergo traditional surgery.

“We are extremely pleased to see a growing body of clinical data supporting both clinical and quality of life benefits associated with the TIF 2.0 procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “However, our excitement about this new analysis is tempered by our sadness for the loss of Dr. Lauren Gerson, lead author on the publication, who passed away last year. Dr. Gerson was a dedicated clinician and researcher, and we hope this final meta-analysis will serve as a testament to the numerous substantive contributions she made to advancing the care and outcomes of patients with gastrointestinal disorders.”

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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:
Amber Berman
EndoGastric Solutions, Inc.
ABerman@EndoGastricSolutions.com

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