KING OF PRUSSIA, Pa., July 28, 2015 /PRNewswire/ -- Aspire Bariatrics, Inc., announced today that it has submitted to the Food & Drug Administration (FDA) a Pre-Market Approval (PMA) application of its lead product the AspireAssist® Aspiration Therapy System, an endoscopic alternative to weight loss surgery.
The AspireAssist is the first endoscopically-placed device to meet its primary endpoints in a US randomized, controlled pivotal trial for weight loss for people with body mass index (BMI) of 35-55 kg/m2. The PMA submission included one-year data from the PATHWAY study, a randomized, controlled pivotal trial of 171 subjects at ten leading medical centers across the USA, including Brigham and Women's Hospital, the Mayo Clinic, Northwestern University, Washington University, and Weil Cornell Medical Center.
"With more than 25 million Americans with BMIs over 35, many of whom do not want, or qualify for, bariatric surgery, our submission of the PMA application is an important milestone towards the Company's mission to provide a safe and effective weight loss solution to this vastly underserved market," said Kathy Crothall, Chief Executive Officer and President. "Based on our excellent weight loss results and safety profile, we are encouraged by the potential of this device to revolutionize obesity treatment of patients in the US, and outside the US, in the near future."
The AspireAssist provides a novel approach to obesity treatment through portion control and intake modulation. The device is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient's internal anatomy.
About Aspire Bariatrics, Inc.
Aspire is a committed to providing safe and effective treatments for obesity to patients worldwide, with excellent customer service and 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, Ph.D.
President and CEO
SOURCE Aspire Bariatrics