Aspire Bariatrics Announces Completion Of Enrollment & Device Implantation In Pivotal US Trial
KING OF PRUSSIA, Pa., July 8, 2014 /PRNewswire/ -- Aspire Bariatrics, Inc., a company that develops and markets novel medical devices to treat obesity, today announced that it has completed enrollment and device implantation in the company's PATHWAY pivotal trial for obesity as of June 18. A total of 171 patients have been enrolled at 10 clinical sites in the United States. The PATHWAY trial is a randomized, controlled, pivotal study testing the effectiveness and safety of the AspireAssist® Aspiration Therapy System in the treatment of obesity in patients with initial body mass index from 35.0-55.0 kg/m2. 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 easily reversible.
The Company also announced the initiation of post-market studies in Italy, United Kingdom, Austria, and Germany, in addition to ongoing post-market studies in Sweden, Czech Republic, and Spain. The AspireAssist received CE Mark in December 2011.
"The Aspire approach to obesity is exciting for many reasons. Its safety profile, low cost, and focus on modifying eating habits are all compelling. We are very pleased with how easily the study has progressed and are currently busy with monitoring subject progress," stated Christopher Thompson, a co-Principal Investigator of the PATHWAY trial and Director of Therapeutic Endoscopy at Brigham & Women's Hospital.
"Obesity is a worldwide problem approaching epidemic proportions," said Louis Aronne, MD, FACP, the Sanford I. Weill Professor of Metabolic Research at Weill-Cornell Medical College and a co-Principal Investigator of the Pathway study. "With less than 1 percent of patients who meet the eligibility requirements for bariatric surgery actually electing to undergo bariatric surgery, there is clearly a need for alternative approaches that are safer, less invasive, reversible, less intrusive on patients' daily life, affordable to the healthcare system and patients, and suitable for long-term therapy. The AspireAssist may help to address this unmet need. Having reached the milestone of completion of enrollment for this pivotal study, we are now one step closer to that goal."
About the AspireAssist® Aspiration Therapy System
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 behavior 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.
About the Pathway Pivotal Trial
The Pathway Pivotal Trial is a randomized, controlled, multicenter pivotal clinical trial in 171 patients at 10 sites testing the effectiveness and safety of AspireAssist. Participants in the study were randomized in a 2:1 allocation to treatment or control groups. The treatment group receives both Aspiration Therapy and Lifestyle Therapy, while the control group receives Lifestyle Therapy alone.
Institutions involved in the trial include Boston University Medical Center, Brigham & Women's Hospital, Cornell University, Howard University, the Mayo Clinic, Northwestern University, St. Mary Medical Center, University of Pennsylvania, the Veterans Affairs San Diego Healthcare System, and Washington University.
The Company anticipates filing its application for premarket approval of the AspireAssist to the Food and Drug Administration in or about June 2015.
About Aspire Bariatrics, Inc.
Aspire, a leading maker of minimally-invasive medical devices for weight-loss, is dedicated to helping obese patients to lose weight in a safe and controlled manner and to develop a healthier lifestyle through product innovation, patient education, and customer support. For more information on Aspire, visit www.aspirebariatrics.com or call Aspire Bariatrics, Inc. at 610-590-1577.
The AspireAssist is not approved for sale in the US, but is available for sale in Europe and New Zealand.
Statements in this press release or made by management from time to time regarding Aspire Bariatrics, Inc. 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.
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SOURCE Aspire Bariatrics, Inc.