March 05, 2015 5:40 PM ET

Healthcare Equipment and Supplies

Company Overview of EndoGastric Solutions, Inc.

Company Overview

EndoGastric Solutions, Inc. is a medical device company that develops, markets, and sells natural orifice surgical products and procedures in the field of gastroenterology, including gastroesophageal reflux disease and other gastrointestinal disorders. It offers EsophyX, a device for transoral incision less fundoplication that is used to reconstruct the gastroesophageal valve. The company also offers SerosaFuse Fasteners that are used in conjunction with EsophyX device to be deployed in a range of tissue thicknesses to accommodate esophagogastric or gastrogastric tissue plications. It offers its products in the United States. EndoGastric Solutions, Inc. was formerly known as EsophyX, Inc. an...

1900 O'Farrell Street

Suite 325

San Mateo, CA 94403

United States

Founded in 2002





Key Executives for EndoGastric Solutions, Inc.

Chief Executive Officer, President and Director
Age: 53
Director of Finance and Controller
Senior Director of Clinical & Medical Affairs and Medical Science Liaison
Senior Director of US Sales
General Manager of Redmond Operations
Compensation as of Fiscal Year 2014.

EndoGastric Solutions, Inc. Key Developments

EndoGastric Solutions Advances EsophyX Platform with the Launch of EsophyX 2 HD Device

EndoGastric Solutions announced the launch of the EsophyX 2 HD (high definition), the latest-generation of the company’s EsophyX platform. The new system allows surgeons and gastroenterologists to use a wider selection of endoscopes–including larger high-definition versions—when performing Transoral Incisionless Fundoplication (TIF) procedures to treat the underlying anatomical causes of GERD. The new device, which received 501(k) clearance from the U.S. Food and Drug Administration in September, is available in the U.S and is the second product iteration in the past 18 months. The new model of EsophyX 2 HD accommodates HD endoscopes while retaining the functionality, features and many dimensions of the EsophyX 2 Plus device. The company engineers increased the endoscope channel diameter of EsophyX 2 HD to accommodate a broad range of commercially available endoscopes and it is compatible with the existing 6.5 mm and 7.5 mm SerosaFuse Implantable Fastener cartridges.

EndoGastric Solutions Announces Publication of US Registry Data on Gastroesophageal Reflux Disease

EndoGastric Solutions(R) (EGS) announced publication of US registry data showing that long-term gastroesophageal reflux disease (GERD) sufferers who underwent an incisionless procedure maintained symptom relief without the need to take proton pump inhibitor medicines for two years. Data from the EndoGastric Solutions(R) (EGS) Transoral Incisionless Fundoplication (TIF(R)) registry show that outcomes from the procedure observed at six and 12 months remained stable across a range of evaluation methodologies at 24-month follow-up. The TIF procedure reconstructs the gastroesophageal valve which has been found to be the primary cause of GERD. Patient quality of life scores, measured using a series of validated questionnaires, improved and were sustained compared to baseline at 6-, 12-, and 24-month follow-up intervals (p=<0.001). The data show that quality-of-life scores remained the same over time, suggesting durability of outcomes from 6 months post procedure to 24-month follow-up. The results were published in the November issue of the journal American Surgeon in a study designed to assess the impact of the TIF procedure on patients with chronic GERD at 6-, 12- 24- and 36 month follow-up points. The publication reports results following TIF procedures in 127 consecutive patients prospectively enrolled in the registry and treated at 14 U.S. centers, including 13 general surgery practices and one gastroenterology practice.

EndoGastric Solutions Announces Publication of Study Demonstrating Benefits of TIF Procedure in Controlling GERD Symptoms

EndoGastric Solutions announced publication of one-year results of the TEMPO randomized, crossover trial, which found that the Transoral Incisionless Fundoplication (TIF(R)) procedure achieved sustained elimination of all GERD symptoms and healing of esophagitis. In the patients randomized to the TIF treatment group (n=39), 93% achieved elimination of troublesome regurgitation; 77% achieved global elimination of all atypical symptoms and regurgitation. Reflux esophagitis was healed in all 19 patients who presented with the erosive disease on PPI therapy before the TIF procedure. 97% of patients were off daily PPI therapy. All esophageal pH parameters were significantly reduced at 12-month follow-up, compared to baseline. In the crossover (control) group (n=21), after six months of high-dose PPI therapy twice daily, only 5% (1/21) of patients reported global elimination of regurgitation and atypical symptoms; this proportion significantly increased to 65% (13/20) six months after these patients crossed over and had the TIF procedure. Additionally, 80% of the cross-over patients were off daily PPIs six months following the TIF procedure.

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