KING OF PRUSSIA, Pa., June 14, 2016 /PRNewswire/ -- Aspire Bariatrics, Inc., announced today that the US Food & Drug Administration (FDA) has approved the AspireAssist® System, an endoscopic alternative to weight loss surgery for people with moderate to severe obesity. The AspireAssist procedure is indicated for adults with a BMI of 35 to 55 who have not succeeded with more conservative therapies.
"With less than 1% of the 25 million Americans with BMIs over 35, availing themselves of bariatric surgery each year, there is clearly a need for a non-surgical weight loss procedure that is effective, safe, and reversible. AspireAssist therapy satisfies this need and additionally offers a lower cost solution to the healthcare system," said Christopher Thompson, MD, Associate Professor of Medicine at Harvard Medical School and the Director of Therapeutic Endoscopy at Brigham and Women's Hospital.
The AspireAssist provides a novel approach to obesity treatment through portion control. It is intended for long-term duration of use, and is to be used in conjunction with diet and exercise counselling and medical monitoring. The device is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient's internal anatomy.
The AspireAssist was evaluated in the PATHWAY study, a 171-subject, multicenter trial in the US, and the results will be presented in San Diego in May at Digestive Disease Week, the largest annual international meeting of gastroenterologists and gastrointestinal surgeons. In a previous randomized US clinical study with the AspireAssist, patients lost an average of 46 pounds in the first year.
"Patients with AspireAssist therapy have the opportunity not only to lose a significant amount of weight in a safe and controlled manner, but also to develop a healthier life style through more mindful eating habits," said Louis Aronne, MD, FACP, the Sanford I. Weill Professor of Metabolic Research at Weill-Cornell Medicine and a co-Principal Investigator of the PATHWAY study.
"We are very happy to be able now to offer this life-changing therapy in the US to patients with obesity; many of whom felt, until now, that there were few viable solutions for them," said Katherine Crothall, PhD, President & CEO of Aspire Bariatrics.
About Aspire Bariatrics, Inc.
Aspire is a committed to providing safe and effective treatments for obesity to patients worldwide, with excellent customer service, education, and continued innovation. www.aspirebariatrics.com.
Statements in this press release that are not historical facts are forward-looking statements and are subject to risks, assumptions and uncertainties that could cause actual future events or results to differ materially from such statements. Any such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact for Investors and Media
Kathy Crothall, PhD
President and CEO
SOURCE Aspire Bariatrics, Inc.