Longest follow-up data from randomized controlled trial available

2016 Boston SAGES logoREDMOND, Washington – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), today announced the presentation of three-year follow-up data from TEMPO, a prospective, randomized, multicenter clinical study. The data confirms long-term control of chronic GERD after a Transoral Incisionless Fundoplication (TIF®) procedure with the EsophyX® device. The study will be presented at the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) 2016 Annual meeting, taking place from March 16-19, 2016 in Boston, Massachusetts.

Sixty-three patients who suffered from troublesome chronic GERD symptoms were randomized to either undergo the TIF procedure (n=40) using the EsophyX device or take proton pump inhibitor (PPI) therapy (n=23); all patients in PPI control group crossed over and received TIF procedures six months after the start of the study.

At up to 36 months follow-up, 91% of patients reported elimination of troublesome regurgitation, 70% were able to completely stop PPI therapy, and reflux esophagitis healed in 87% of patients.

“Our data demonstrates that the benefits of transoral incisionless fundoplication are sustained up to three years following the procedure. Symptom control, reduction in acid exposure, healing of esophagitis, and cessation rates of PPIs are maintained over time, proving that the TIF procedure is a durable alternative to PPIs and more invasive anti-reflux operations” said Karim Trad, MD, Clinical Professor of Surgery at George Washington University School of Medicine and Health Sciences and principal investigator, who will present the data.

The data will be presented the SS08 Flexible Endoscopy session starting at 3:30 PM to 5:30 PM on Thursday, March 17, 2016 in Ballroom A moderated by Frederick L. Greene, MD and G. V. Rao, MS, MAMS.

EGS will also provide demonstrations of the EsophyX device for the TIF procedure at booth #416 in the SAGES exhibit hall from March 16-18.

“The ongoing, excellent results from this multi-center study represent another clinical milestone and add to the existing strong body of clinical evidence that support the TIF procedure as an excellent treatment option for patients who no longer benefit from PPIs and are seeking long-term relief from ongoing GERD symptoms,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Our thanks to Dr. Trad and the other investigators for their ongoing commitment to providing the GERD patients they serve with a full armamentarium of treatment options.”

In 2015 SAGES, in cooperation with the three primary GI societies—AGA, ACG, ASGE, jointly sponsored an application to the American Medical Association for a new Category I Current Procedural Terminology (CPT®) code. CPT 43210: EGD esophagogastric fundoplasty became effective January 1, 2016.

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 new 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