EndoGastric Solutions, Inc. (EGS), a company out of San Mateo, CA, has been on our radar since 2007, when it developed the EsophyX device, the first of a kind transoral fundoplication technology for patients with long term GERD. We caught up with Mr. Skip Baldino, President & Chief Executive Officer of the company to check on the latest.
Gene Ostrovsky, Medgadget: The latest prospective 2-year outcome data of transoral incisionless fundoplications (TIF) in 127 patients demonstrate stable positive results (see Am Surg. 2014 Nov;80(11):1093-105). Tell me more about the data collected so far to support EndoGastric Solutions’ transoral incisionless fundoplication procedure (TIF) for acid reflux. What have been the most notable outcomes?
Skip Baldino: As a company, we’ve had over 50 published peer-reviewed studies of the TIF procedure — EGS’ transoral endoscopic procedure for GERD– in medical journals and more have been presented at top medical meetings for surgeons and gastroenterologists. We’re especially pleased with the six-month results of the first-ever sham and placebo-controlled study of the TIF procedure , which was officially published in the Gastroenterology journal this month. The data demonstrates that the TIF procedure is more effective than a twice-daily proton pump inhibitor drug at eliminating troublesome regurgitation in patients with chronic gastroesophageal reflux disease (GERD), which is an enormous milestone in this disease.
Medgadget: What’s the cause for this?
Skip: It is estimated that pain and discomfort from acid reflux impacts 30-60 million people in the U.S. each month, and that an estimated 8 million of these patients continue to have symptoms despite daily PPI therapy. Therefore, we’ve been spending the last ten years developing and refining our EsophyX platform product and rigorously studying our transoral incisionless fundoplication (TIF) procedure to help fill this enormous treatment gap.
Medgadget: Ok, so can you explain the procedure, kind of step-by-step.
Skip: The TIF procedure is completely incisionless and is performed through the mouth under general anesthetic. Until recently, there has been no available and clinically validated treatment like ours to address the underlying anatomical cause of the disease other than invasive surgery. During the procedure, a specially trained surgeon or GI sends a scope down into the esophagus and stomach to essentially recreate the barrier to reflux. This corrects the root cause of GERD- an anatomic defect at the gastroesophageal valve (GEV).
Ultimately, we’re treating a mechanical problem, GERD, with a mechanical solution, the TIF procedure, rather than PPIs, a chemical solution.
Medgadget: Is the procedure complicated to perform?
Skip: Physicians who are trained and do the procedure very well will tell you that they’re very comfortable with performing the procedure. We’ve also been consistently listening to physician users of our EsophyX system to gather their feedback about how to improve the product, and we continue to refine proper procedural techniques in addition to generating a growing body of clinical data We actually just launched in December our next generation EsophyX2 ® HD device, which allows surgeons and gastroenterologists to use a wider selection of endoscopes—including larger HD versions— when performing TIF procedures.
Medgadget: What are the costs, benefits or price and how does that play out?
Skip: That’s a great question. We’re looking at independent, health economic data from a national payer group in order support our belief that the TIF procedure is cost effective in the short term and long term. We’re working with a number of physicians and experts in the industry to mine the data, so we’re hoping to have those results sometime in this year. We also have had ample data showing the benefits from the procedure, which has already been performed in over 16,000 patients. Seven different surgeon and GI journals published eight studies on the TIF procedure in 2014 alone – all with positive safety and efficacy results.
Medgadget: Ok, so overall you’d say it’s highly competitive if you take account of all these other things other than just simply the outcome?
Skip: Yes, absolutely. Based on our significant collection of data, we truly believe that the TIF procedure presents a compelling option for patients seeking relief from GERD symptoms.
Medgadget: Excellent – do you have any closing thoughts?
Skip: Yes, thank you for your time. We look forward to the rest of 2015 and continuing to present clear and compelling clinical evidence that supports the TIF procedure as a viable, much-needed treatment option to enhance the quality of life of millions of GERD suffers.
Medgadget: Finally, we recently heard news that Barack Obama has been diagnosed with GERD. What are your thoughts, do you recommend the President gets the TIF procedure for GERD?
Skip: I’m not going to make any recommendation. His physician would need to recommend what is best for him and his specific situation.
Medgadget: Thanks for speaking with us, and we’d like to hear more once you have more data come out. You said you have a new device coming out, so we’d love to hear about that as that becomes available. So please keep us informed of that.
Skip: Thanks again.
Link: EndoGastric Solutions…
