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ORBERA™ Receives FDA Approval | Official Announcement, Illustrations and Animations



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Apollo Endosurgery, Inc. Announces FDA Approval of the ORBERATM Intragastric Balloon, a Non-Surgical Solution to Assist Patients in Weight Loss

  • 3.1 times the weight loss than diet and exercise alone
  • Safe and effective weight loss solution with over 220,000 placements worldwide

Austin, TX (August 6, 2015) -- Apollo Endosurgery, Inc., a leader in minimally invasive endoscopic surgical products for bariatric and gastrointestinal procedures, today announced that the U.S. food and Drug Administration (FDA) has approved the ORBERA™ Intragastric Balloon to assist adult patients suffering from obesity – with a body mass index (BMI) of 30 to 40 – in losing and maintaining weight.

The ORBERA™ balloon is part of the ORBERATM Managed Weight Loss System, a comprehensive, non-surgical two-part program that includes a balloon filling space in a patient’s stomach to reinforce proper Portion Control. Data on ORBERA™ collected in the U.S. clinical trial has shown that the average person lost 3.1 times the weight as compared with diet and exercise alone within six months.

“While new to the United States, ORBERA™ is a weight loss device with more than 220,000 balloons distributed in over 80 countries and approximately 230 published papers documenting its clinical results,” said Todd Newton, Chief Executive Officer of Apollo Endosurgery. “ORBERA™ is a proven, innovative and non-surgical solution to help fight the obesity epidemic and treat patients before their disease progresses and requires more invasive treatments. With the FDA approval of ORBERA™, Apollo can now offer this safe and effective solution to patients and their physicians in the United States.”

“For many, the weight loss journey leaves patients with little support or options other than diet and exercise and traditional surgery. The approval of ORBERA™ fills this gap in available treatments and is an exciting development for healthcare professionals who are committed to providing patients with less invasive options that can assist them in reaching their long-term weight loss goals,” said Christine Ren-Fielding, M.D., a New York-based bariatric surgeon. “ORBERA™ gives us a new weight loss option to help address what has become a critical health issue in the United States.”

Introducing ORBERATM

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 done under a mild sedative, 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 done under a mild sedative, the ORBERA™ balloon is deflated and then removed.

Once the balloon is in place, the patient receives an individually tailored support program through the ORBERATM Managed Weight Loss System team of experts – which may include a dietician, psychologist and exercise physiologist – 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.

ORBERA™ Pivotal Study Results

In the U.S. pivotal ORBERA™ clinical trial, a multicenter, prospective, randomized, non-blinded comparative study, 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 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 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.

A total of 125 patients were randomized to the treatment group and 130 patients were randomized to the control group.

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.

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.

For additional information regarding ORBERA™, please visit Orbera.com.

For full safety information please visit orbera.com/dfu, talk with your doctor, or call Apollo Customer Support at 1-855-MYORBERA

About Apollo Endosurgery, Inc. Apollo Endosurgery, Inc. is revolutionizing the treatment of obesity and other gastrointestinal disorders by developing less invasive solutions for a whole new group of patients not seeking treatment today. Apollo is a global innovator pushing boundaries to bring new technologies and innovative products to markets in over 80 countries today. In particular, Apollo’s bariatric products fill the gap between non-surgical weight loss solutions and invasive surgeries, allowing physicians to do more for those patients who require more than drug therapy and dietary advice. For more information regarding Apollo Endosurgery, go to: www.apolloendo.com.

Media Contact: Jennifer Cook (p) 512.279.5158 jen.cook@apolloendo.com

ORBERA™ Patient Animation:

ORBERA™ Procedure Illustrations:

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ORBERA™ Product Images:

Retouched Orbera-10 - inflated and deflated - smaller.jpg

Retouched Orbera-10 - inflated and deflated.jpg

Obesity Backgrounder Fact Sheet

OBESITY: A CHRONIC DISEASE

  • Obesity affects more than 78.6 million U.S. adults and is one of the leading causes of preventable death in the U.S. 6,1
  • As of 2010, more than 1 in 3 U.S. adults are obese.7
  • Overall, U.S. obesity rates have stayed steady since 2003; however, they’ve more than doubled since 1980 and remain alarmingly high—the highest among all of the high-income countries in the world.9 If trends in U.S. obesity continue, it is estimated that by 2030, roughly half of all men and women will be obese.9
  • It is one of the most pervasive chronic diseases and increases the risk of health problems such as heart disease, diabetes and high blood pressure.1,2

BY DEFINITION

  • Overweight and obese are terms used to describe ranges of weight that are greater than what is generally considered healthy.3
  • The most widely used measurement for obesity is Body Mass Index (BMI). The BMI approximates body mass using a mathematical ratio of weight and height [(weight in kg ÷ height in meters2) or (weight in pounds ÷ height in inches2 x 703)].
    • A BMI between 18.5 and 24.9 is considered healthy for an adult.3

    • A BMI between 25 and 29.9 is considered overweight for an adult.3

    • A BMI of 30 or higher is considered obese for an adult.3

    • A BMI between 30 and 40 is considered lower BMI.

    • It’s important to note that BMI measurements in body-builders and athletes may not be accurate determinants of obesity because the BMI does not distinguish between muscle and fat.

LOWER BMI

  • Lower BMI is used to describe the range of weight that falls within a BMI of 30 – 40.
  • While on the low end of the obesity spectrum, a person with a “lower BMI” still falls within the range of obesity and is therefore at increased risk for health problems.
  • To date, individuals with lower BMI have had limited weight loss options outside of diet and exercise as most surgical weight loss interventions, like bariatric surgery, require a BMI of at least 40.

CAUSES

  • Obesity is generally caused when the intake of calories is higher than the amount that is burned through exercise and activity.11
  • Obesity is also influenced by a variety of behavioral, environmental and genetic factors, which can include: unhealthy diet, inactivity, lack of sleep, pregnancy, medications, medical problems, and metabolism.4,11

CONSEQUENCES & QUALITY OF LIFE

  • Obesity can increase the risk of more than 30 chronic health conditions, including: type 2 diabetes, high cholesterol, hypertension, heart disease, sleep apnea, gastroesophageal reflux disease (GERD), asthma and other respiratory conditions, and numerous cancers.1
  • Obesity can also significantly impact an individual’s quality of life in areas such as: depression, social isolation, sexual problems, shame and guilt, and lower work achievement.10

ECONOMIC IMPACT

  • Obesity has a direct impact on the U.S. healthcare system.4
    • In 2008, an estimated $147 billion was spent in medical costs for obesity.4 If obesity trends continue, it’s estimated that related medical costs could rise an additional $43 to $66 billion each year in the U.S. by 2030.5

Sources:

1. http://www.obesity.org/resources-for/what-is-obesity.htm

2. http://www.mayoclinic.org/diseases-conditions/obesity/basics/definition/con-20014834

3. http://www.cdc.gov/obesity/adult/defining.html

4. http://www.cdc.gov/obesity/adult/causes/index.html

5. http://obesitycampaign.org/obesity_facts.asp

6. http://www.cdc.gov/obesity/data/adult.html

7. http://win.niddk.nih.gov/statistics/

8. http://emedicine.medscape.com/article/123702-overview

9. http://www.hsph.harvard.edu/obesity-prevention-source/obesity-trends/obesity-rates-worldwide/

10. http://www.mayoclinic.org/diseases-conditions/obesity/basics/complications/con-20014834

11. http://www.mayoclinic.org/diseases-conditions/obesity/basics/causes/con-20014834

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