TEMPO 36 mo Long-term dataThree-year follow up data from the TEMPO randomized controlled trial supports evidence of TIF procedure as an effective, long-term treatment option for GERD

REDMOND, Washington – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced that Surgical Endoscopy has published positive three-year follow up data from TIF® EsophyX vs Medical PPI Open Label (TEMPO), a prospective, randomized, multicenter clinical study, demonstrating long-term control of chronic GERD after a Transoral Incisionless Fundoplication (TIF) procedure with the EsophyX® device.

The study evaluated the enduring effects of the TIF 2.0 procedure in 63 patients suffering from chronic GERD symptoms. Patients were randomly assigned to undergo the TIF procedure using the EsophyX device (n=40) or to receive high-dose proton-pump inhibitor (PPI) therapy (n=23). Six months after the start of the study, all patients from the PPI control group crossed over and received the TIF procedure.

The three-year results are the longest follow-up data from a randomized controlled clinical trial available. Overall, the study met the 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 study also met the secondary endpoints, with 70 percent of patients reporting discontinuation of PPI therapy and 87 percent of patients experiencing healing of reflux esophagitis at the 36-month follow-up.

“Our clinical data demonstrates the ability of the transoral incisionless fundoplication to sustain benefits up to three years’ post-procedure, providing physicians with an effective treatment option to improve long-term patient outcomes. The results of this study have confirmed that the endoscopic TIF 2.0 procedure is a durable alternative to PPIs and more invasive anti-reflux surgery operations,” said Karim Trad, MD, Clinical Professor of Surgery at George Washington University School of Medicine and principal investigator.

“We are pleased to have the three-year TEMPO data published in Surgical Endoscopy, adding to the existing clinical evidence that supports the TIF 2.0 procedure as a durable treatment option for patients who no longer benefit from PPI therapy and are seeking lasting relief from chronic GERD symptoms,” said Skip Baldino, President and CEO of EndoGastric Solutions. “This data offers even more support for our active work to establish positive insurance coverage policies and appropriate payment levels for the TIF procedure with providers and payers.”

With the support of leading gastroenterological and surgical clinical societies, top commercial health insurer, Health Care Service Corporation (HCSC), issued a medical coverage policy for the TIF procedure with the EsophyX® device, making the procedure available to the network’s approximate 15 million members of Blue Cross/Blue Shield of Illinois, Montana, New Mexico, Oklahoma and Texas. HCSC’s coverage policy went into effect July 15, 2016 and was based on multiple peer-reviewed, randomized controlled trial results that consistently demonstrate that the TIF procedure is a safe, effective and durable treatment option for chronic GERD.

Detailed results and durability data from the TEMPO trial were first published online on September 21, 2016 by Surgical Endoscopy the official publication of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and can be viewed here.

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 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 as of January 1, 2016.

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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