The first patient in the Post-Approval Study Evaluating the Long-Term Safety and Effectiveness of ORBERA® was enrolled earlier this month in New Orleans, Louisiana, by the site’s lead investigator, bariatric surgeon Dr. Rachel Moore.

"ORBERA®’s post-approval clinical study exemplifies Apollo’s commitment to offering safe and effective weight loss solutions to patients and their physicians in the United States," Dr. Moore said.

"The resulting data will help clinicians worldwide improve the treatment of obesity with a proven, minimally invasive option."

The post-approval study is a prospective, multicenter, open-label study designed to demonstrate the safety and effectiveness of ORBERA® as an adjunct to weight reduction for obese adults (22 years of age and older) with a Body Mass Index (BMI) of = 30 kg/m2 and BMI = 40 kg/m2. The study will involve approximately 255 subjects at up to 20 U.S. sites.

The U.S. pivotal ORBERA® clinical trial first announced in May of 2015 was a multicenter, prospective, randomized, non-blinded comparative study where a total of 255 patients suffering from obesity with a BMI between 30 and 40 were randomized to treatment or control in a 1:1 ratio.

The treatment group (125 patients) underwent placement of the ORBERA® balloon followed by removal after six months. They concurrently participated in a 12-month behavioral modification program.

The control group (130 patients) participated in the 12-month behavioral modification program alone. For patients in the treatment group, the device was removed at month six, with regular office visits continuing through one year.

Detailed findings from the trial include:

At month six, the ORBERA® group achieved a mean of 38.4 percent Excess Weight Loss (EWL).

Mean Total Body Weight Loss (TBWL) at six months was 10.2 percent for the treatment group compared to 3.3 percent TBWL for the control group.

The ORBERA® group lost 3.1 times as much weight as the control group at six months.

The ORBERA® group also lost significantly more weight than the control group over the course of the study, and was able to maintain significant weight loss through month 12, six months after removal of the device.

"Clinical confidence in medical devices comes from clinical evidence. Since ORBERA®’s inception, there have been over 230 peer-reviewed ORBERA® publications around the globe reporting on data of over 8,000 patients," said Todd Newton, Chief Executive Officer of Apollo Endosurgery.

"Retrospective and pivotal studies show, time and again, that ORBERA® is safe and effective, and helps patients lose the weight and also keep the weight off even after the device is removed. We believe the U.S. post-approval study will add to this unmatched dataset."

ORBERA® is an incision-less, non-surgical weight loss solution designed for adult patients suffering from obesity, who are not appropriate for or considering invasive surgery, but for whom diet and exercise or pharmaceutical interventions have not worked.
In a non-surgical (endoscopic) procedure, the thin and deflated ORBERA® balloon is placed into the stomach.

It is then filled with saline until it’s about the size of a grapefruit. The procedure typically takes about 20 to 30 minutes and the patient can generally go home the same day. At six months, through another non-surgical procedure, the ORBERA® balloon is deflated and then removed.

Once the balloon is in place, the patient receives an individually tailored support program through the ORBERA® Managed Weight Loss System team of experts to help keep them motivated, coordinate their program and help them work through weight loss barriers to meet their long-term weight loss goals.

Coaching takes place over 12 months, even though the balloon is removed after six months. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.

The U.S. Food and Drug Administration (FDA) approved the ORBERA® Intragastric Balloon in August 2015.

It is the market-leading gastric balloon worldwide, and for more than 20 years, the global medical community has been using intragastric balloons from the makers of ORBERA® to help thousands of people lose weight. More than 220,000 ORBERA® balloons have been distributed worldwide in over 80 countries.