Apollo Endosurgery Announces CE Mark Approval for the ORBERA365™ Managed Weight Loss System, Expanding the Indwell Period from 6 Months to 12 Months with the Gastric Balloon Category Leader

AUSTIN, Texas–(BUSINESS WIRE)–Apollo Endosurgery, Inc. (“Apollo”) (NASDAQ:APEN), a global leader in less invasive medical devices for bariatric and gastrointestinal procedures, today announced CE (Conformité Européene) Mark approval for the ORBERA365 Managed Weight Loss System.

The ORBERA365 Managed Weight Loss System doubles the indwell period of the #1 intragastric balloon in the world from 6 months to a 12 month treatment period. The approval enables Apollo to market and sell the ORBERA365 Weight Loss Balloon in European Union and the European Economic Area member countries. The Company expects ORBERA365 to be commercially available starting in the fourth quarter of 2017.

“I’ve been using ORBERA since 1999 and have helped thousands of patients lose weight with my ORBERA program. Now with ORBERA365 patients will have the possibility of getting better weight loss results because in my experience the longer the treatment the more weight patients tend to lose. Actually, using ORBERA365 our patients will now have twice as long to change their eating behaviors and ensure long lasting results,” said Professor Alfredo Genco, Sapienza University, Rome, Italy.

“The CE Mark approval of ORBERA365 has been a significant accomplishment for Apollo and involved a comprehensive review of clinical and non-clinical data by a regulatory body in a market with deep understanding and experience with intragastric balloon therapy. Obtaining CE Mark approval now for ORBERA365 is a strong testimony of the relevance and significance of more than a decade of the ORBERA system’s safety and efficacy data as supported by more than 277,000 distributed implants and 230 published peer-reviewed papers,” said Todd Newton, CEO of Apollo Endosurgery.

About ORBERA365™

ORBERA365 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 ORBERA365 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 minutes and the patient can generally go home a few hours later. After up to twelve months, through another non-surgical procedure, the ORBERA365 balloon is deflated and then removed.

Once the balloon is in place, the patient works with their physician and their staff in a formal lifestyle modification program to meet their long-term weight loss goals. Coaching takes place over 12 months while the balloon is in place. The program is designed to help the patient develop sustainable, healthy habits that will help keep weight off over time.

For additional information regarding ORBERA365, please visit www.orbera.com/uk-ireland/.

For full safety information please visit www.orbera.com/uk-ireland/dfu.

For more information regarding weight loss surgery or non-surgical weight loss options in Los Angeles, please visit www.lapbandla.com.

Adjustable Gastric Banding From Another Perspective

Adjustable Gastric Banding (AGB) is a misunderstood weight loss surgical procedure that has helped thousands of patients suffering from obesity for 24 years. Most bariatric surgical procedures such as the lap-band, require multiple interventions (beginning with least invasive to more invasive) during a patient’s life, just like other chronic diseases. While the article in JAMA suggests that subsequent surgical interventions post AGB are costly, a group of concerned bariatric surgeons disagree.

The JAMA article reported that among 18.5% of patients underwent about 4 (and some as many as 12) additional interventions post Adjustable Gastric Banding. AGB patients usually undergo either one or two additional operation, therefore the bariatric surgeons wonder about the reasons behind the questionable data. It could be one or more of the following reasons: (1) assignment of inaccurate International Classification of Diseases, Ninth Revision codes during subsequent hospitalizations for patients who were initially coded as an AGB patient; (2) inclusion of procedures to address post-stapling complications in patients who had their bands removed and were subsequently converted to a stapling procedure; (3) performance of multiple operative interventions on AGB patients by surgeons who have no familiarity with the gastric band and its aftercare; and (4) inadvertent billing for up to 12 surgical procedures when indeed such procedures were never performed.

Bariatric surgeons admit that subsequent procedures on AGB patients are costly. However, since AGB is one of the safest and most effective bariatric interventions, it should be reimbursed by Medicare and other insurance plans. It is regretful that the public has been misrepresented with inaccurate data and misguided by the deceptive article reported by JAMA. However, the bariatric surgeons are thankful for the chance to provide their second opinion in General Surgery News.

The most popular Adjustable Gastric Banding procedure in the world is the lap-band procedure. It is one of few procedures that had been proven to be very effective and safe as a weight loss surgery. Choosing the right obesity treatment is a serious task and should not be taken lightly. If you happen to be a Los Angeles or Southern California resident who needs to speak with a weight loss physician regarding their weight loss problem and obesity treatment options, please visit LapBandLA.com.

References: A Second Opinion on Gastric Banding retrieved from http://www.generalsurgerynews.com/Opinions-and-Letters/Article/07-17/A-Second-Opinion-on-Gastric-Banding/41843/ses=ogst?enl=true