Apollo Endosurgery, Inc. (NASDAQ:APEN) Files An 8-K Other Events
Item 8.01Other Events.

On October27, 2017, Apollo Endosurgery, Inc. (the “Company”) entered into a Clinical Trial Agreement with Mayo Clinic to undertake the MERIT-Trial (Multi-center ESG Randomized Interventional Trial), the first, prospective randomized multi-center controlled trial evaluating the efficacy of the endoscopic sleeve gastrectomy (“ESG”) procedure in producing significant and medically-relevant long-term weight loss and improvement of obesity associated co-morbidities. This investigator-sponsored clinical study is expected to commence in the fourth quarter of 2017.

ESG is an endoscopic minimally invasive weight loss procedure based on full-thickness endoscopic suturing using Apollo’s OverStitch™ device. In the ESG procedure, full-thickness endoscopic suturing is used to reduce the stomach volume by 80% through a series of endolumenally placed full-thickness sutures through the gastric wall in order to create a restrictive endoscopic sleeve.

The MERIT-Trial will be conducted at up to eight sites in the United States. The trial’s purpose is to evaluate the long-term safety and efficacy of ESG compared to efficacy endpoints set forth in a consensus statement of the American Society of Gastrointestinal Endoscopy (ASGE) and the American Society of Metabolic Bariatric Surgery (ASMBS) and its impact on obesity related co-morbidities in patients with obesity and body mass index (BMI) between 30 – 45 kg/m².

The trial is expected to enroll two hundred patients (80 treatment / 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 52 weeks +/- 4 weeks to evaluate and continued follow-up for twelve additional months. Control participants will follow a low-calorie, healthy life>

The trial will have two levels: 1) the randomized study phase with primary outcomes for both treatment and control participants evaluated at twelve months, and 2) the crossover, non-randomized study phase with outcomes for a) the initial treatment participants at 24 months after their ESG, and b) the control cross-over participants evaluated at twelve months after their ESG.

Primary endpoints will be at least 25% average excess weight loss (EWL) measured at 12 months after ESG and at least 15% more EWL in the treatment participants compared to the control participants at 12 months, or, 15% more EWL in patients crossed over to ESG in the non-randomized phase of the trial compared to EWL in the twelve months prior to cross over. The trial’s safety endpoint is defined as a less than 5% serious adverse events rate.

About Apollo Endosurgery, Inc. (NASDAQ:APEN)

Apollo Endosurgery, Inc., formerly Lpath, Inc., is a medical device company. The Company is focused on less invasive therapies for the treatment of obesity, as well as other gastrointestinal disorders. The Company’s device-based therapies are an alternative to invasive surgical procedures. The Company offers products in over 80 countries. The Company’s products include ORBERA, LAP-BAND and OverStitch. The Company’s product, ORBERA, is a gastric balloon. The ORBERA Intragastric Balloon System is a weight loss aid for adults suffering from obesity. The LAP-BAND System is a minimally invasive procedure that offers weight loss. The LAP-BAND System is indicated for weight reduction for patients with obesity. The OverStitch Endoscopic Suturing System enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures through a flexible endoscope. OverStitch offers solutions for defects in both the upper and lower gastrointestinal tract.