Mayo, Texas Medtech Firm to Conduct Trial for Minimally Invasive Weight-Loss Surgery
A medtech company co-founded by a prominent former Mayo Clinic gastroenterologist is launching a new clinical trial to assess the effectiveness of an emerging, minimally invasive surgical procedure for weight loss.
Apollo Endosurgery Inc. (Nasdaq: APEN), based in Austin, Texas, revealed in a U.S. Securities Exchange Commission filing last week it has entered in a clinical trial agreement with Mayo to measure the efficacy of the endoscopic sleeve gastrectomy (ESG) procedure.
The company says it will be the first randomized, multi-center controlled trial to assess the long-term effectiveness of the procedure, which is being touted by its backers as a potential game-changer in the battle against the U.S. obesity epidemic.
Apollo was founded in 2006 by a group of gastroenterologists seeking to revolutionize the way stomach surgery is used to achieve weight loss in obese patients. Its current focus is moving the state of the art toward minimally invasive endoscopic procedures, such as with its OverStich system.
Using OverStitch, doctors can shrink the stomach by 80 percent, reshaping it into a smaller “sleeve” the width of a banana by utilizing a snake-like endoscope containing a camera and a mechanized suturing apparatus which is inserted through the mouth.
It is envisioned as an attractive alternative for patients who don’t qualify for or object to highly invasive bariatric surgery, such as gastric bypass procedures. Only one percent of patients who qualify for such surgeries actually undergo them due to limited access, aversion to the procedure and the cost. In comparison, ESG costs only one-third as much as a traditional gastrectomy while also being minimally invasive.
One of Apollo’s co-founders and stockholders is Dr. Christopher Gostout, the founder and former director of Mayo’s Developmental Endoscopy Unit, which helped pioneer novel gastroenterological interventions such as ESG. Gostout retired from his Mayo post at the end of last year following more than 30 years at the clinic, and was named as Apollo’s chief medical officer shortly thereafter.
Another Mayo-Apollo connection is Dr. Barham Abu Dayyeh, an associate professor at the Mayo Medical School and a consultant for the clinic’s gastroenterology and hepatology division. His research into using endoscopes for bariatric surgery has received financial support from Apollo, as well as a career development and innovation award from the Mayo Department of Medicine.
An earlier clinical trial at Mayo headed by Dr. Abu Dayyah found that one year after undergoing an ESG, a cohort of 25 moderately obese patients had lost a mean of 56 percent of their excess weight — comparable to weight loss with traditional bariatric surgery—while experiencing only a few temporary adverse events.
Despite its promise, ESG has been slow to catch on with many endoscopists due to the belief that it requires time-consuming training and has a slow learning curve, according to recent medical literature.
The new two-year clinical trial, meanwhile, seeks to further establish the procedure’s credentials as a viable alternative to traditional anti-obesity surgeries. Dubbed MERIT-Trial (or Multi-center ESG Randomized Interventional Trial), it is set to get underway in the fourth quarter of 2017.
The trial is expected to enroll 200 patients (80 treatment and 120 control), stratified into three groups: obesity, obesity with hypertension, obesity with diabetes. All treatment participants will undergo ESG, receive a repeat upper endoscopy at around one year to evaluate and continued follow-up for another year.
Control participants, meanwhile, will follow a low-calorie, healthy lifestyle intervention for 12 months and then may be eligible for crossover to receive the ESG.
Among its primary endpoints will be at least 25 percent average excess weight loss measured at 12 months after ESG compared to the control group.
The new trial is being undertaken after Apollo raised $36 million in a secondary stock offering completed in July. The company’s biggest shareholder is PTV Healthcare Capital, an Austin-based late-stage venture and expansion capital firm.