DDW 2016Product Theater Session to Provide Key Updates on Procedure Clinical Data and Reimbursement

REDMOND, Washington EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), announced today that the company will present new data on EGS’ Transoral Incisionless Fundoplication (TIF®) procedure at the Digestive Disease Week (DDW) 2016 annual meeting. The meeting is taking place from May 21 – 24, 2016 at the San Diego Convention Center in San Diego, California.

The new data on the TIF® Procedure with the EsophyX® device will include a meta-analysis poster presentation, “Efficacy of Transoral Incisionless Fundoplication for Gastroesophageal Reflux Disease.” The meta-analysis reviewed ten randomized, controlled and prospective cohort clinical trials to evaluate the overall efficacy of the TIF procedure for treating patients with GERD; poster will be presented by Lauren Gerson, MD, MSC, gastroenterologist at California Pacific Medical Center (CPMC) in San Francisco, and Karim S. Trad, MD, Clinical Professor of Surgery with The George Washington University School of Medicine & Health Sciences, on Sunday, May 22 from 12 p.m. to 2 p.m. PT in Hall C.

“The meta-analysis on the TIF procedure and the product theater session further demonstrates our commitment to providing physicians with the most current evidence on GERD therapeutic outcomes with the EsophyX device, to ensure they can make the optimal decisions for treating their patients,” said Skip Baldino, President and CEO of EndoGastric Solutions.

Sunday, May 22 from 1:15 p.m. to 2 p.m. PT at the DDW Exhibit Floor Product Theater there will be a series of presentations about the TIF procedure: patient selection criteria for optimal outcomes, level I and II clinical data, and payment and insurance coverage with the new CPT code 43210: EGD Esophagogastric Fundoplasty. Presenters are: Kyle A. Perry, MD, FACS, Associate Professor of Surgery and Co-Director of Research at the Center for Minimally Invasive Surgery at Ohio State University Wexner Medical Center, Reginald C.W. Bell, MD, FACS and founder of the SurgOne Foregut Institute, and Ashish Atreja, MD, MPH, Assistant Professor of Gastroenterology at Mount Sinai Hospital.

Also, Sunday, May 22 from 2:00 p.m. to 3:30 p.m. PT, Peter J. Kahrilas, MD, Professor of Medicine, Division of Gastroenterology and Hepatology, Northwestern University Feinberg School of Medicine will present “GERD Common but Challenging: Endoscopic and Surgical Therapies for GERD: Is There a Role?” at AGA’s Clinical Symposia session (Sp424).

EGS will demonstrate the full line of EsophyX® devices at booth #343 in the DDW exhibit hall.

About DDW
Digestive Disease Week® (DDW) is the largest international gathering of physicians, researchers and academics in the fields of gastroenterology, hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by the American Association for the Study of Liver Diseases (AASLD), the American Gastroenterological Association (AGA) Institute, the American Society for Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of the Alimentary Tract (SSAT), DDW takes place May 21-24, 2016, at the San Diego Convention Center, San Diego, CA. The meeting showcases more than 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology. More information can be found at www.ddw.org.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux
Performed without the need for external incisions through the skin, the TIF procedure offers patients who require an anatomical repair another treatment option to correct the underlying cause of GERD. Studies show that for up to three years after the TIF procedure esophageal inflammation (esophagitis) is eliminated and most patients are able to stop using daily PPI medications to control symptoms.

Over 17,000 TIF patients have been treated worldwide since EsophyX® device clearance in 2007. More than 60 peer-review papers from over 50 centers have been published documenting consistent outcomes on over 1,100 unique study patients. For more information, visit www.GERDHelp.com.

About EsophyX® technology
The original EsophyX device was cleared by the FDA in 2007. EGS launched the third generation EsophyX device, the EsophyX Z in 2015. The technology has continued to evolve and is a clinically-backed tool for physician use in the treatment of GERD. The EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes–including low profile and larger high-definition models—to treat the underlying anatomical cause of GERD. The EsophyX technology is used to reconstruct the gastroesophageal valve (GEV) and restore its function as a barrier, preventing stomach acids refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope.

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.

In 2015, four primary GI societies — SAGES, 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.

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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