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Aspire submits PMA application

Aspire Bariatrics submits PMA application of AspireAssist

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

Aspire Bariatrics has submitted to the 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 randomised, controlled pivotal trial for weight loss for people with BMI35-55.  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 revolutionise obesity treatment of patients in the US, and outside the US, in the near future."

AspireAssist

The AspireAssist is a first in class chronic weight loss treatment which is designed to reduce caloric absorption while gradually changing eating habits. The device does not alter the patient's gastrointestinal anatomy, is minimally invasive, and is reversible. 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.

The AspireAssist provides the patient with a method for achieving effective ‘portion control’ of food intake at the level of the stomach, which lowers the threshold for successful weight loss and facilitates lifestyle behaviour change for long-term weight management. The AspireAssist system consists of a low-profile implantable gastrostomy tube and a siphon system. Patients drain the contents of their stomachs after a meal, reducing caloric absorption by approximately 30%.

The AspireAssist is given in conjunction with lifestyle therapy, in which patients are taught portion control, careful chewing, and other healthy lifestyle habits.

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