Amit Sohagia, MD received ACG’s Outstanding Poster Presenter Award for TIF 2.0 procedure poster

REDMOND, Wash. – EndoGastric^®Solutions today announced the presentation of three posters at the American College of Gastroenterology (ACG) 2018 Annual Scientific Meeting and Postgraduate Course, highlighting the safety and efficacy of Transoral Incisionless Fundoplication (TIF) 2.0 procedure in the treatment of gastroesophageal reflux disease (GERD). TIF 2.0 procedure is a minimally invasive and endoscopic intervention that enables anatomical correction of the gastric valve without incisions or attendant complications associated with laparoscopic surgical fundoplication. The  2018 annual meeting was held October 5 – 10 in Philadelphia, PA.

Amit Sohagia, MD, a gastroenterologist at Easton Hospital, received the ACG’s Outstanding Poster Presenter Award for an abstract titled “Transoral Incisionless Fundoplication: Effectiveness in Improving Typical and Atypical Symptoms of Gastroesophageal Reflux Disease Incompletely Controlled with Medical Therapy.”

“With the prevalence of GERD increasing worldwide, a growing number of patients are living with reflux symptoms that reduce their quality of life and increase their risk of cancer,” said Dr. Sohagia. “Patients refractory to medical therapy may benefit from surgical intervention, but traditional invasive procedures are associated with a variety of adverse events. The results of our study add to the robust foundation of data demonstrating that the TIF procedure improves quality of life in patients by effectively addressing both typical and atypical GERD symptoms.”

Dr. Sohagia presented the results of a prospective study conducted in 41 patients with long-standing history of GERD refractory to acid suppressant medications (proton pump inhibitors [PPIs] or histamine antagonists [H2 blockers]) who underwent the TIF procedure. The primary outcome was patient satisfaction as determined by pre- and post-TIF procedure GERD Health Related Quality of Life Questionnaires (GERD-HRQL) and Reflux Symptom Index (RSI) scores, along with the reduction in the use of PPIs or H2 blockers. At median follow up of nine months, significant improvements were reported for GERD-HRQL and RSI and for symptoms of heartburn, dysphagia and regurgitation (p= 0.0001 for all assessments except for dysphagia, which had a p value of 0.006). At short-term follow up, TIF procedure eliminated the need for PPI therapy in the majority of patients. Patients who initiated PPI or H2 blocker therapy after the TIF procedure also had significant improvements in pre- and post-TIF procedure scores on GERD-HRQL and RSI (p = 0.002 and 0.047, respectively).

The two other posters presented at ACG 2018 were:

• “Efficacy and Safety of Trans-Oral Incisionless Fundoplication Performed by Gastroenterologists,” which demonstrated that gastroenterologists trained in TIF procedure can safely perform the procedure in the endoscopy suite. This may save time and healthcare resources by reducing operating room (OR) use. The study also found that TIF procedure performed by gastroenterologists effectively improved HRQL in patients with symptomatic GERD. Presented by Ali Raza, MD¹, Marc Catalano, MD¹, Erik F. Rahimi, MD¹, Hani A Zamil, MD², Bijun S. Kannadath, MBBS, MS³, Julie Guider, MD¹, Reena V. Chokshi, MD⁴, Brooks D. Cash, MD, FACG¹, Todd Wilson, MD¹, Erik Wilson, MD¹, Nirav Thosani, MD²;¹University of Texas Health Science Center at Houston, Houston, TX; ²University of Texas Health Science Center at Houston / McGovern Medical School, Houston, TX; ³University of Arizona College of Medicine, Phoenix, AZ; ⁴UT Health – McGovern Medical School, Houston, TX
• “Transoral Incisionless Fundoplication in a Patient with Dysphagia from Peptic Stricture,” which showed that TIF procedure can be used to reduce esophageal acid exposure and prevent stricture recurrence in a patient with dysphagia due to recurrent peptic stricture. Presented by Zain Iqbal Memon, DO, David Dicaprio, DO, Patrick Okolo, MD; Northwell Health Lenox Hill Hospital, New York, NY.

“The data presented at ACG 2018 continues to demonstrate that TIF 2.0 procedure is a safe and effective approach to treating GERD in a variety of patient populations and can be performed in the operating room or the endoscopy suite,” said Skip Baldino, President and CEO of EndoGastric Solutions. “These results highlight the clinical benefits that the TIF 2.0 procedure provides to patients and the workflow flexibility that it affords physicians and care centers. We congratulate Dr. Sohagia on receiving the Outstanding Poster Presenter Award, and for his continued efforts to help the GERD patients he serves.”

About GERD
Gastroesophageal reflux disease (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. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are also instructed to take medications—proton pump inhibitors; unfortunately, patients frequently increase their dosage and, over time, become dependent on these medications to control their symptoms. In addition, a variety of other health complications are linked to long-term, maximum-dose dependency on these PPIs

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

A minimally invasive endoscopic treatment, performed without the need for external incisions through the skin, the TIF 2.0 procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stop using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF procedure, based on clinical studies.

There have been over 20,000 patients who have benefited from the TIF procedure worldwide since the EsophyX® device launched. In the past ten years, more than 60 centers have published over 80 peer-reviewed papers. These studies have consistently documented improved outcomes on more than 1,300 unique study patients. For more information, please visit www.GERDHelp.com.

About Reimbursement
Commercial and federal payer partnerships representing over 100 million lives have recognized the value of the TIF procedure through recent contract and coverage reimbursement expansions. EndoGastric Solutions has confirmed coverage for all Medicare enrollees through Medicare Administrative Contractors (MACs)—CGS, First Coast, NGS, Noridian, Novitas, Palmetto, WPS.

Annually, the Federal Register posts unadjusted average payments specific to the CPT® code for physicians and hospital Ambulatory Payment Codes (APC), allowing patients to receive access to treatment more easily for GERD. For the TIF procedure, physicians can reference CPT Code 43210 EGD esophagogastric fundoplasty and hospitals can reference APC 5362 Level 2 Laparoscopy Procedures. CPT is 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 refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.

Indications
The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are 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 ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less. 

About EndoGastric Solutions®
Based in Redmond, WA, 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 the Transoral Incisionless Fundoplication (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.

Contact:
Debbie Donovan
EndoGastric Solutions, Inc.
Phone: +1 408-621-0216
ddonovan@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com

NP02450-33A/-01K

Existing and New Investors Participated in Support of Rapid Commercialization

Redmond, Washington. – EndoGastric Solutions® (EGS), a leader in incisionless procedural therapy for gastroesophageal reflux disease (GERD), announced today that it has secured $30.5 million in new financing led by existing EGS investors Advanced Technology Ventures (ATV), Canaan Partners, Canepa Healthcare, Chicago Growth Partners, CRG, Radius Ventures, Sightline Partners, and several new healthcare investors excited about EGS’ commercial advances.

“EGS continues to lay the foundation for success having achieved a number of important commercial milestones in recent months,” said Mike Carusi, General Partner, Advanced Technology Ventures. “The company is very well positioned to continue the acceleration of its growth going forward. ATV and our fellow EGS co-investors are very excited about the company’s prospects to become the leading long-term solution in the treatment of GERD.”

EGS plans to supplement existing cash balances with these new proceeds to continue its commercial expansion of the TIF® procedure in support of its growing physician customer base, while continuing to invest in sustaining engineering to optimize gross margin.

“This round of funding will enable EGS to continue to expand commercial operations and provide the millions of patients suffering from GERD access to the TIF procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Recent publications demonstrating both durability and efficacy along with the FDA’s expanded labeling to include TIF procedures performed concomitantly with a hiatal hernia repair and the release of the third generation EsophyX Z+ device have positioned the company for rapid growth.  In addition, recent reclassification of outpatient payments now more accurately align with the true cost of the TIF procedure and will further the clinical adoption of this important treatment option.”

About GERD

Gastroesophageal reflux disease (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. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendation for patients with GERD is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are also instructed to take medications—proton pump inhibitors; unfortunately, patients frequently increase their dosage and, over time, become dependent on these medications to control their symptoms. In addition, a variety of other health complications are linked to long-term, maximum-dose dependency on these PPIs.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

A minimally invasive endoscopic treatment, performed without the need for external incisions through the skin, the TIF 2.0 procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stop using daily medications to control their symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF procedure, based on clinical studies.

There have been over 20,000 patients who have benefited from the TIF procedure worldwide since the EsophyX® device launched. In the past ten years, more than 60 centers have published over 80 peer-reviewed papers. These studies have consistently documented improved outcomes on more than 1,300 unique study patients. For more information, please visit www.GERDHelp.com.

About Reimbursement

Commercial and federal insurance providers, representing more than 100 million lives, have recognized the value of the TIF procedure through recently expanded contract and coverage reimbursement. EndoGastric Solutions has confirmed coverage for all Medicare enrollees through Medicare Administrative Contractors (MACs)—CGS, First Coast, NGS, Noridian, Novitas, Palmetto, WPS.

The Federal Register annually posts unadjusted average payments specific to the CPT® code for physicians and hospital Ambulatory Payment Codes (APC), allowing patients to receive access to treatment more easily for GERD. For the TIF procedure, physicians can reference CPT Code 43210 EGD esophagogastric fundoplasty and hospitals can reference APC 5362 Level 2 Laparoscopy Procedures. 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. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include lower profile and larger, high-definition models.

Indications

The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are 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 ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less.

About EndoGastric Solutions®

Based in Redmond, WA, 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 the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and Google+: GERDHelp, LinkedIn: EndoGastric Solutions.

#  #  #

Contact:
Debbie Donovan
EndoGastric Solutions, Inc.
Phone: +1 408-621-0216
ddonovan@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com

NP02450-29A/-01K

TIF 2.0 Procedure improves symptoms and esophagitis while reducing acid exposure and decreasing risk associated with long-term proton pump inhibitor use for POEM patients

REDMOND, Wash – EndoGastric^® Solutions today announced the publication of new clinical data demonstrating the safety and efficacy of the Transoral Incisionless Fundoplication (TIF^®) 2.0 procedure in patients with achalasia who have undergone Peroral Endoscopic Myotomy (POEM). The TIF 2.0 procedure is a minimally invasive procedure that enables physicians to perform an endoscopic gastric fundoplication.

This study, titled, “Transoral Incisionless Fundoplication for reflux after peroral endoscopic myotomy: a crucial addition to our arsenal” appeared in the May issue of Endoscopy International Open (PDF Link)

Achalasia is a gastroesophageal disorder that causes patients to have difficulty swallowing. Patients may also experience chest pain and regurgitation of food and liquids. The POEM procedure is effective in more than 90% of achalasia patients, but the reduction in lower esophageal sphincter pressure that addresses achalasia symptoms can give rise to increased acid exposure and gastroesophageal reflux disease (GERD) which is associated with an increased prevalence of Barrett’s Esophagus and esophageal cancer.

Many patients often require long-term therapy with proton pump inhibitors (PPI) to address their GERD symptoms following the POEM procedure; however long-term PPI use is associated with several negative side-effects which include increased risk of developing depression, dementia, chronic kidney disease, gastrointestinal infections and vitamin and mineral deficiencies.

“POEM is now clearly established as an effective therapy for achalasia, but it may lead to increased esophageal acid exposure which can be associated with significant long-term health effects,” said Amy Tyberg, MD, Associate Director of Endoscopy at Rutgers Robert Wood Johnson Medical School, Rutgers, New Brunswick, NJ. “There is a robust and growing data set supporting the TIF 2.0 procedure as a durable and safe approach to treating chronic GERD, and the results of this study demonstrate that it can also provide clinical benefit as a minimally invasive intervention following POEM. These findings are an important advance in the care of achalasia patients who are status post POEM, some of whom trade in symptoms of dysphagia for symptoms of GERD.”

Tyberg continued, “In a recently published meta-analysis, Repici et al. concluded that for achalasia patients, performing myomectomy (laparoscopically or endoscopically) and then a staged antireflux procedure to control GERD symptoms may increase efficacy when treating this challenging condition.”[1]

This study, the first case series evaluating the role of the TIF procedure in the management of GERD post-POEM, was conducted in five consecutive patients 18 years of age or older who underwent POEM and subsequent TIF procedures at a single center between December 2014 and June 2017. The average time between POEM and TIF procedures was 13.5 months (range 4 – 27 months).

Patients enrolled in the study had achieved complete or partial relief of their GERD symptoms with PPIs. Three patients entered the study with esophagitis. The TIF procedure was performed with the EsophyX® Z model device. The primary outcome was discontinuation of PPI use and healing of esophagitis in those patients in which this condition was present at the time of the TIF procedure. At mean follow up of 27 months (range 5 – 34 months) key study findings include:

• Technical success of the TIF procedure was achieved in all five patients.
• Complete discontinuation of PPI use was achieved in all five patients (100%).
• The three patients with esophagitis saw resolution of inflammation three months following the TIF procedure.
• There were no adverse events.

“These findings support the TIF 2.0 procedure with the EsophyX device as an effective and safe treatment in patients who develop GERD following POEM,” said Skip Baldino, President and CEO of EndoGastric Solutions. “We hope that these results will encourage physicians to consider this approach as they treat post-POEM achalasia patients.”

About GERD

Gastroesophageal reflux disease (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. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendations for GERD patients is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are instructed to take medications—proton pump inhibitors; unfortunately, it is a common practice to increase medication doses and, over time, become dependent on these medications to control symptoms. A variety of other health complications are linked to the long-term, maximum-dose dependency on PPIs.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

A minimally invasive endoscopic treatment, performed without the need for external incisions through the skin, the TIF 2.0 procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stopped using daily medications to control symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF procedure based on studies.

There have been more than 20,000 TIF patients treated worldwide since the EsophyX® device launched. In the past ten years, over 60 centers published more than 80 peer-reviewed papers. These studies document consistent outcomes on over 1,300 unique study patients. For more information, visit www.GERDHelp.com.

About Reimbursement

Commercial and federal insurance providers, representing over 100 million lives, have recognized the value of the TIF procedure through recently expanded contract and coverage reimbursement. EndoGastric Solutions has confirmed coverage for all Medicare enrollees through Medicare Administrative Contractors (MACs)—CGS, First Coast, NGS, Noridian, Novitas, Palmetto, WPS.

Annually, the Federal Register posts unadjusted average payments specific to the CPT® code for physicians and hospital Ambulatory Payment Codes (APC), allowing patients to receive access to treatment more easily for GERD. For the TIF procedure, physicians can reference CPT Code 43210 EGD esophagogastric fundoplasty and hospitals can reference APC 5362 Level 2 Laparoscopy Procedures. CPT is 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 refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.

Indications

The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are 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 ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less. 

About EndoGastric Solutions®

Based in Redmond, WA, 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 the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and Google+: GERDHelp, LinkedIn: EndoGastric Solutions.

#  #  #

Contact:
Debbie Donovan
EndoGastric Solutions, Inc.
Phone: +1 408-621-0216
ddonovan@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com

[1] Repici A, et Al., Send to Gastrointest Endosc. 2018 Apr;87(4):934-943.e18. doi: 10.1016/j.gie.2017.10.022.

NP02450-32a/-01J

TIF 2.0 procedure provides improved quality of life and elimination of daily PPI use for up to 10 years in patients with symptomatic GERD;
TIF 2.0 procedure combined with laparoscopic hiatal hernia repair is a safe and effective option for patients with severe GERD and hiatal hernia

REDMOND, Wash – EndoGastric^® Solutions today announced the presentation of two clinical abstracts highlighting the efficacy of Transoral Incisionless Fundoplication (TIF®) 2.0 procedure for gastroesophageal reflux disease (GERD). The TIF 2.0 procedure is a minimally invasive procedure that enables physicians to perform an endoscopic gastric fundoplication. One abstract reports follow-up data to 10-year post-TIF 2.0 procedure and the other reports results of TIF 2.0 procedure immediately following laparoscopic hiatal hernia repair in patients with GERD. The abstracts are being displayed as posters on Saturday, June 2 at Digestive Disease Week (DDW) 2018 taking place in Washington, DC June 2-5.

Study Results

Transoral Incisionless Fundoplication with EsophyX (TIF 2.0) For Gastro-Esophageal Reflux Disease: Three- To Ten-Year Outcomes in A Prospective Observational Single-Center Study
Presented by: Professor Pier Alberto Testoni – San Raffaele Hospital, Milano, Italy
Session Number: 5230; Abstract Number: Sa1950

In this single-center study, TIF 2.0 procedure was performed using EsophyX® device in a series of 50 consecutive patients with symptomatic GERD responsive to PPIs. For the 3- to 10- year post-TIF period patients underwent annual assessment using the GERD-HRQL questionnaire and recording of PPI usage and results were compared with pre-TIF baseline values. Key study findings include:

• Over the 10-year follow-up the mean GERD-HRQL score was significantly reduced compared with the pre-TIF score (46±19) but appeared substantially unchanged between 2 and 10 years post-TIF procedure.
  • The percentages of patients who stopped or halved their PPI therapy 3, 5, 7 and 10 years after TIF procedure were 84.4%, 73.5%, 83.3%, and 91.7%, respectively; this rate remained substantially stable and similar to that at 2 years (87.8%).
  • TIF 2.0 procedure using the EsophyX device achieved a significant GERD-HRQL score improvement compared to baseline and lasting elimination of daily dependence on PPI in about 73-91% of patients for up to 10 years.

Efficacy of Combined Transoral Incisionless Fundoplication and Laparoscopic Hiatal Hernia Repair
Presented by: Dr. Viktor E. Eysselein – Harbor UCLA Medical Foundation, California, USA
Session Number: 5230; Abstract Number: Sa1932

This study evaluated TIF 2.0 procedures performed immediately after laparoscopic hiatal hernia repair in GERD patients with hiatal hernia greater than 2 cm and concluded the procedure is safe and an effective therapeutic option for patients with severe GERD and large hiatal hernia. Between June 2015 and September 2017, 27 patients with chronic GERD symptoms refractory to double-dose PPI and with a Hill Grade greater than 2, underwent the concomitant procedure. Patients were evaluated for indication, PPI use, pre- and post-procedure symptoms, patient satisfaction and complications 1-29 months post procedure (median follow-up was 11 months). Key study findings include:

• Daily PPI use was eliminated in 85% (23/27) of patients.
• At post-procedure follow-up, 96% (26/27) of patients reported satisfaction with concomitant procedure set.
• Specific GERD symptom prevalence improvements after treatment were noted: heartburn 70% to 26%; regurgitation 63% to 11%; cough 26% to 15% and hoarse voice 11% to 3%.
• There were no postoperative complications, and no dysphagia or gas-bloating symptoms were reported.

“These results underscore the clinical benefits the TIF 2.0 procedure can provide to a broad array of GERD patients,” said Dr. Peter Janu, Director of the Ascension NE WI Reflux Center of Excellence. “The improvements in health-related quality of life scores and elimination of daily proton pump inhibitor therapy (PPIs) use for up to 10-years suggests that the TIF 2.0 procedure is a viable and important treatment option for patients who do not want to undergo traditional more invasive surgical procedures or are intolerant to PPIs. Additionally, while the TIF 2.0 procedure has been shown to be effective in GERD patients with hiatal hernia less than two centimeters, this new data continues to reinforce that in combination with laparoscopic hiatal hernia repair, it’s also a safe and effective option for patients with a larger hiatal hernia.

“Dr. Testoni’s 10-year follow-up data adds to the durability evidence supporting the clinical utility of the TIF 2.0 procedure,” said Skip Baldino, President and CEO of EndoGastric Solutions. “Consistent with the FDA’s expanded label of the EsophyX device in June 2017, Dr Eysselein’s data further confirm that concomitant laparoscopic repair is safe and effective treatment options for the millions of patients with a larger hiatal hernia.

DDW Product Theater

EndoGastric Solutions is also sponsoring a symposium at DDW 2018 titled “Shaping the Future of GERD Management: Updates on the TIF 2.0 Procedure with EsophyX Device” from 1:15 p.m. EDT to 2:00 p.m. EDT on Sunday, June 3, in the DDW Product Theater. During the symposium, faculty will present the clinical utility of the TIF 2.0 procedure, including its concomitant use following hiatal hernia repair. Faculty members are:

• Kenneth J. Chang, M.D., Executive Director of the H.H. Chao Comprehensive Digestive Disease Center and Chief of the Division of Gastroenterology & Hepatology, Department of Medicine, UC Irvine School of Medicine
• Barham K. Abu Dayyeh, M.D., M.P.H., Gastroenterologist at the Mayo Clinic
• Peter G. Janu, M.D., Director of the Ascension Reflux Center of Excellence

About GERD

Gastroesophageal reflux disease (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. In the United States (U.S.), GERD is the most common gastrointestinal-related diagnosis physicians make during clinical visits. Pain and discomfort from acid reflux impact more than 80 million Americans at least once a month according to estimates. The first treatment recommendations for GERD patients is to make lifestyle changes (e.g., diet, scheduled eating times and sleeping positions). Patients are instructed to take medications—proton pump inhibitors; unfortunately, it is a common practice to increase medication doses and, over time, become dependent on these medications to control symptoms. A variety of other health complications are linked to the long-term, maximum-dose dependency on PPIs.

About Transoral Incisionless Fundoplication (TIF®) procedure for reflux

A minimally invasive endoscopic treatment, performed without the need for external incisions through the skin, the TIF 2.0 procedure offers patients who require an anatomical repair an effective treatment option to correct the underlying cause of GERD. Most patients stopped using daily medications to control symptoms and had their esophageal inflammation (esophagitis) eliminated up to five years after the TIF procedure based on studies.

There have been more than 20,000 TIF patients treated worldwide since the EsophyX® device launched. In the past ten years, over 60 centers published more than 80 peer-reviewed papers. These studies document consistent outcomes on over 1,300 unique study patients. For more information, visit www.GERDHelp.com.

About Reimbursement

Commercial and federal insurance providers, representing over 100 million lives, have recognized the value of the TIF procedure through recently expanded contract and coverage reimbursement. EndoGastric Solutions has confirmed coverage for all Medicare enrollees through Medicare Administrative Contractors (MACs)—CGS, First Coast, NGS, Noridian, Novitas, Palmetto, WPS.

Annually, the Federal Register posts unadjusted average payments specific to the CPT® code for physicians and hospital Ambulatory Payment Codes (APC), allowing patients to receive access to treatment more easily for GERD. For the TIF procedure, physicians can reference CPT Code 43210 EGD esophagogastric fundoplasty and hospitals can reference APC 5362 Level 2 Laparoscopy Procedures. CPT is 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 refluxing back into the esophagus. The device is inserted through the patient’s mouth with direct visual guidance from an endoscope. The U.S. Food and Drug Administration cleared the original EsophyX device in 2007. EndoGastric Solutions® launched the third generation EsophyX device, the EsophyX Z model, in 2015. The evolving EsophyX technology now enables surgeons and gastroenterologists to use a wider selection of endoscopes to treat the underlying anatomical cause of GERD. These options include low profile and larger high-definition models.

Indications

The EsophyX device with SerosaFuse® fasteners and accessories are indicated for use in transoral tissue approximation, full thickness plication and ligation in the gastrointestinal tract. They are 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 ≤ 2cm in size in patients with symptomatic chronic GERD. Patients with hiatal hernias larger than 2cm may be included, when a laparoscopic hiatal hernia repair reduces the hernia to 2cm or less. 

About EndoGastric Solutions®

Based in Redmond, WA, 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 the Transoral Incisionless Fundoplication (TIF®) 2.0 procedure—a minimally invasive solution that addresses a significant unmet clinical need. Join the conversation on Twitter: @GERDHelp Facebook: GERDHelp and Google+: GERDHelp, LinkedIn: EndoGastric Solutions.

#  #  #

Contact:
Debbie Donovan
EndoGastric Solutions, Inc.
Phone: +1 408-621-0216
ddonovan@endogastricsolutions.com

Erich Sandoval
Lazar Partners
Phone: +1 917-497-2867
esandoval@lazarpartners.com

NP02450-31A/-01J