July 28, 2014 4:38 AM ET

Healthcare Equipment and Supplies

Company Overview of EndoGastric Solutions, Inc.

Company Overview

EndoGastric Solutions, Inc., a medical device company, develops natural orifice surgical products and procedures for the treatment of gastrointestinal diseases. Its products include EsophyX and SerosaFuse fasteners that are used for reconstructive gastrointestinal procedures through transoral approach. EndoGastric Solutions, Inc. was formerly known as EsophyX, Inc. and changed its name to EndoGastric Solutions, Inc. in 2005. The company was founded in 2002 and is headquartered in San Mateo, California.

1900 O'Farrell Street

Suite 325

San Mateo, CA 94403

United States

Founded in 2002

Phone:

650-578-5100

Fax:

650-578-5101

Key Executives for EndoGastric Solutions, Inc.

Chief Executive Officer and President
Age: 53
Senior Vice President of Operations
Vice President of International Sales - Americas
Vice President and Medical Director
Compensation as of Fiscal Year 2014.

EndoGastric Solutions, Inc. Key Developments

EndoGastric Solutions Names Skip Baldino as President and CEO

EndoGastric Solutions announced that industry veteran Skip Baldino has been named President and CEO. Baldino brings nearly three decades of healthcare experience to EGS, including four years as President, Americas for Given Imaging. Baldino served as a divisional Vice President for Abbott Laboratories for eight years.

EndoGastric Solutions Announces 12-Month Tempo Study Data Confirms TIF Procedure Dramatically Eliminates GERD Symptoms in Majority of Patients

EndoGastric Solutions(R) announced that new data show that a vast majority of patients with GERD who underwent the Transoral Incisionless Fundoplication (TIF(R)) procedure with the EsophyX(R) device continued to report complete elimination of all troublesome regurgitation and esophagitis for a full year after the procedure. This new 12-month analysis of the prospective, randomized, multicenter clinical trial known as TEMPO also showed that all 21 patients in the original control arm who had received maximum-dose proton pump inhibitor (PPI) therapy for the first six months of the trial crossed over to undergo the TIF procedure. This group achieved similar positive six-month results to the patients in the original treatment arm. The new 12-month analysis was presented by principal investigator, Karim S. Trad, MD, as part of an American Gastroenterological Association (AGA) research forum earlier on May 5, 2014 at Digestive Disease Week(R) (DDW(R)) 2014 (Abstract #724), taking place through May 6, 2014. 77% of patients in original treatment arm (n-39) reported a global elimination of daily troublesome regurgitation and atypical symptoms 12 months following the TIF procedure. Esophagatis, or inflammation of the esophagus, remained healed in 100% of the patients in the original treatment arm. At the end of the first six months of the study, only 5% (1/21) of patients in the control group who received maximum-dose PPI therapy reported global elimination of regurgitation and atypical symptoms; this proportion increased to 67% (14/21) six months after these patients crossed over and had the TIF procedure (P < 0.001). Additionally, 71% (15/21) of the cross-over patients were completely off PPIs six months following the TIF procedure. The primary outcome of TIF(R) versus Medical PPI Management of Refractory GERD symptoms (TEMPO) trial was elimination of daily troublesome regurgitation and atypical symptoms as evaluated by two validated instruments--Reflux Disease Questionnaire and Reflux Symptom Index; secondary outcomes included healing of esophagitis, normalization of esophageal acid exposure and PPI use in the TIF treated patients at 6 and 12 months. This TEMPO data presented at the American Gastroenterological Association's session GERD: Complications and Extraesophageal Presentations at the 2014 DDW(R) Annual Meeting in Chicago, Illinois include results from 63 patients treated at seven U.S. centers, including three gastroenterology practices and four general surgery practices.

EndoGastric Solutions Announces Publication of 6-Month Data from Randomized Controlled Trial Indicating TIF(R) Procedure's Superior Reflux Symptom Control Compared to Proton Pump Inhibitor Therapy

EndoGastric Solutions, Inc. announced publication of data from its first level-1, randomized, controlled trial directly comparing outcomes from the Transoral Incisionless Fundoplication (TIF(R)) procedure to maximum-dose proton-pump inhibitor therapy (PPI)--the TEMPO trial. The initial findings showed the TIF procedure was more effective than maximum daily dose PPIs at reducing a wide range of typical and atypical GERD symptoms and in healing of reflux esophagitis while achieving similar normalization rates of distal esophageal acid exposure. In the TEMPO trial, 97% of patients reported elimination of regurgitation versus 50% in the PPI arm; troublesome heartburn was eliminated in 90% of TIF patients versus 13% of PPI patients. The TIF procedure was better than PPIs in controlling atypical symptoms as indicated by a significant improvement in RSI score (from 23 on PPIs before TIF to 3 off PPIs at 6-month follow-up); in the PPI group the same score fell insignificantly from 23 to 21 on maximum daily-dose of PPIs. Patients were evaluated using subjective and objective measures including: GERD-HRQL, RSI and RDQ questionnaires, upper endoscopy exams and 48-hr pH monitoring to determine acid levels in the esophagus over two days. Both groups achieved similar normalization of distal esophageal acid exposure (54% of patients in the TIF group and 52% of patients in the PPI group). There was no difference between treatment groups in the clinical characterizations of the disease at baseline. The TEMPO trial was designed to assess the safety and efficacy of the Transoral Incisionless Fundoplication procedure as compared with high-dose PPI therapy to treat symptoms associated with chronic GERD. Patients will continue in the study until they have completed 3-year follow-up.

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