SAGES Board of Governors reviewed and approved statement

REDMOND, Washington EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), is pleased to announce that based on clinical evidence, the Board of Governors of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) included a “strong recommendation” in favor of EsophyX® device used in Transoral Incisionless Fundoplication (TIF®) 2.0 procedure in their published “Clinical Spotlight Review: Endoluminal Treatments for Gastroesophageal Reflux Disease.”

SAGES “Strong Recommendation” EsophyX device TIF 2.0 Procedure“Based on existing evidence, TIF [2.0 procedure] can be performed with an acceptable safety risk in appropriately selected patients. The procedure leads to better control of GERD symptoms compared with PPI treatment…. Objective GERD measures improve similarly after TIF 2.0 [procedure] compared with PPI,” according to the report released by the organization.

“The publication of this Clinical Spotlight Review demonstrates SAGES’ interest in keeping current with evidence of less intrusive anti-reflux procedures that meet high thresholds of safety and efficacy as demonstrated through peer-reviewed publications,” says Skip Baldino, CEO, EndoGastric Solutions. “Clinical society reviews and updates of treatment guidelines are essential to providing guidance to members and payers for managing chronic diseases such as GERD.”

EGS will demonstrate the TIF procedure using the EsophyX Z device at SAGES Exhibit Hall booth #808 March 22-24, 2017 in Houston, TX.

In October 2016, Surgical Endoscopy, the official journal of SAGES, published online first three-year follow up data from TIF EsophyX vs Medical PPI Open Label (TEMPO), a prospective, randomized, multicenter clinical study, which demonstrated long-term control of chronic GERD after a TIF 2.0 procedure with the EsophyX® device. The study met its primary endpoint, with 83 percent of patients undergoing the TIF procedure experiencing elimination of regurgitation and all atypical GERD symptoms at three-years post-procedure. The open access paper is available at GERDHelp.com.

“In 2014, SAGES leadership played a pivotal role in an unprecedented unification with the gastroenterology societies—AGA, ACG, ASGE—to support the application for Category 1 CPT® code 43210 EGD: Esophagogastric Fundoplasty. Due to the collective societies’ efforts, the code went into effect January 1, 2016, and this has increased patient access to the TIF procedure as a treatment for their GERD symptoms,” continued Baldino.

In 2016, SAGES was also active in supporting a positive coverage decision from Health Care Service Corporation (HCSC) which is responsible for approximately 15 million members through its affiliates—Blue Cross Blue Shield of Illinois, Blue Cross Blue Shield of Montana, Blue Cross Blue Shield of New Mexico, Blue Cross Blue Shield of Oklahoma and Blue Cross Blue Shield of Texas.

To date, the TIF procedure has confirmed coverage with these Medicare Administrator Contractors: Palmetto GBA, LLC for over 4.4 million members in North Carolina, South Carolina, Virginia and West Virginia; Cahaba Government Benefit Administrators®, LLC for over three million members in Alabama, Georgia and Tennessee; CGS Administrators®, LLC which serves 2.4 million members in Kentucky and Ohio; and Novitas Solutions, Inc. which covers over nine million members in Arkansas, Colorado, Louisiana, Mississippi, New Mexico and Oklahoma.

About Current Procedural Terminology (CPT®)
CPT codes are a listing of descriptive terms and identifying codes for reporting medical services and procedures. The purpose of CPT is to provide a uniform language that accurately describes medical, surgical, and diagnostic services, and thereby serves as an effective means for reliable nationwide communication among physicians and other healthcare providers, patients and third parties. CPT is a registered trademark of the American Medical Association.

The Federal Register has posted coding and payment information specific to the CPT code, allowing patients to more easily receive access to treatment for GERD. Physicians and hospitals can reference CPT Code 43210 EGD esophagogastric fundoplasty and APC 5331 Complex GI Procedures for TIF® procedures.

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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