— Leading Gastroenterology Experts Recommend Transoral Incisionless Fundoplication (TIF) for Select Patients with Gastroesophageal Reflux Disease (GERD) —

REDMOND, Wa.–(BUSINESS WIRE)–EndoGastric Solutions, Inc.® today announced that the American Gastroenterology Association retired their 2008 guidelines, Management of Gastroesophageal Reflux Disease and released a Clinical Practice Update (CPU), which includes the TIF 2.0 procedure as an effective endoscopic option for patients with troublesome regurgitation or heartburn who do not wish to undergo anti-reflux surgery, and who do not have severe reflux esophagitis. 1 Additionally, the TIF 2.0 procedure has been incorporated in the American College of Gastroenterology’s updated Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease for the same patient population.2

“The AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review is based on a thorough review of the clinical literature and extensive discussion of the available clinical data among experts in the field,” stated Kenneth J. Chang, MD, AGAF, MASGE, FACG, FJGES, Professor and Chief, Division of Gastroenterology and Hepatology, University of California, and Chair of EndoGastric Solutions, Inc. Medical Advisory Board. “The CPU is intended to provide practical advice to gastroenterologists who treat patients with GERD and to inform the greater public of best practices. The addition of the TIF procedure to this CPU expands the range of treatment options that gastroenterologists and surgeons can offer their patients as they strive to achieve optimal GERD outcomes.”

“Additional treatment options are needed for patients with documented GERD who do not have

satisfactory resolution of their symptoms or do not want to continue long term proton pump inhibitor therapy. The TIF procedure provides an excellent alternative for appropriately selected patients who are hesitant to undergo traditional, more invasive anti-reflux surgery,” said Phillip O. Katz, MD, MACG, Director of Motility Laboratories for the Division of Gastroenterology at Weill Cornell Medicine and lead author on the ACG publication. “The addition of the TIF procedure to the ACG guidelines offers GERD patients a new option to consider, with the potential to address their treatment needs and improve management of their reflux symptoms.”

Gastroesophageal reflux disease (GERD) is a common gastrointestinal disease that affects up to 28% of the U.S. population. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits, and accounts for approximately $15-20 billion per year of direct and indirect costs. 3 GERD 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. 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. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times, and sleeping positions). Medications, such as Proton pump inhibitors (PPI), are also commonly used to treat GERD. However, there are a variety of health complications associated with long-term dependency on PPIs, and more than thirty percent of patients are refractory to PPI therapy and may opt for surgery. Left untreated, GERD can lead to serious health risks, including esophagitis, esophageal stricture, Barrett’s esophagus, and esophageal cancer.

“EGS is committed to improving outcomes for patients with GERD,” said Skip Baldino, President and CEO of EndoGastric Solutions, Inc. “The inclusion of the TIF procedure in these updated documents from ACG and the AGA is an important addition to the treatment armamentarium of minimally invasive options that care providers can offer their patients suffering from GERD. We believe these updated recommendations will expand the use of the TIF procedure, allowing more patients to achieve satisfactory relief of GERD symptoms.”

References

  1. Yadlapati, R., Gyawali, C. P., Pandolfino, J. E., & CGIT GERD Consensus Conference Participants (2022). AGA Clinical Practice Update on the Personalized Approach to the Evaluation and Management of GERD: Expert Review. Clinical gastroenterology and hepatology: the official clinical practice journal of the American Gastroenterological Association, 20(5), 984994.e1. https://doi.org/10.1016/j.cgh.2022.01.025
  2. Katz, P. O., Dunbar, K. B., Schnoll-Sussman, F. H., Greer, K. B., Yadlapati, R., & Spechler, S. J. (2022). ACG Clinical Guideline for the Diagnosis and Management of Gastroesophageal Reflux Disease. The American journal of gastroenterology, 117(1), 2756. https://doi.org/10.14309/ajg.0000000000001538
  3. Gawron, A. J., French, D. D., Pandolfino, J. E., & Howden, C. W. (2014). Economic evaluations of gastroesophageal reflux disease medical management. PharmacoEconomics, 32(8), 745758. https://doi.org/10.1007/s40273-014-0164-8
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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