KING OF PRUSSIA, Pa., Jan. 05, 2017 (GLOBE NEWSWIRE) -- Aspire Bariatrics, Inc., a commercial-stage medical-device company with a novel device for the treatment of obesity, announced today that the two-year results of a 25-patient observational study of the Company’s AspireAssist® were published in the December issue of the peer-reviewed journal, BioMed Central Obesity.
The results of the study showed that AspireAssist provided comparable weight loss at two-years to bariatric surgery, with excellent safety and minimal side effects. In addition, the improvement in HbA1C of patients with type 2 diabetes was notable. After completing two years of therapy, patients achieved 61.5% mean excess weight loss (52.9 pounds). Patients were assessed for quality of life and showed significant improvement compared to baseline.
The study was a single-center, observational, one-year study, conducted at Blekinge County Hospital in Karlskrona, Sweden, a non-investigational setting. Patients were consecutively recruited after advertisement in a local newspaper. Inclusion criteria were Body Mass Index (BMI) over 35 and age from 25 to 65 years. Exclusion criteria were myocardial infarction during the prior three months, known malignancy, chronic liver or kidney disease, prior upper GI tract surgery, substance abuse, eating disorders, and mental retardation. Patients were not screened for motivation and had the option of continuing the study after the first year.
“With only 1% of patients with morbid obesity opting for bariatric surgery in any one year, there is a clear need for a safe, effective, and long-term alternative. The AspireAssist data is compelling and I look forward to offering this therapy to my patients,” said Nancy Bohannon, MD, FACP, FACE, an endocrinologist in San Francisco, California, with affiliation with California Pacific Medical Center.
The AspireAssist, an endoscopic alternative to weight loss surgery, is indicated for adults with a BMI of 35 to 55. The device is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient’s internal anatomy. The AspireAssist received premarket approval from the Food & Drug Administration in June 2016, and is now available commercially in the US, Europe, Australia, and New Zealand.
“Publication of this study is important as it demonstrates significant and durable weight-loss in patients with morbid obesity in a community-setting. This publication, in conjunction with other publications in peer-reviewed journals, goes a long way towards Aspire developing the body of evidence for widespread insurance coverage,” said Katherine Crothall, PhD, President & CEO of Aspire Bariatrics.
The full text publication can be accessed at: http://link.springer.com/article/10.1186/s40608-016-0134-0/fulltext.html
About Aspire Bariatrics, Inc.
Aspire Bariatrics is a commercial-stage medical device company with a minimally-invasive, endoscopic device, the AspireAssist®, to treat obesity. In June 2016, the Company received premarket approval (PMA) from the FDA. AspireAssist Therapy is an alternative to bariatric surgery, providing comparable weight loss, but with far better safety, complete reversibility, and at a significantly lower cost than bariatric surgery. The therapy provides a holistic approach to patient development of improved eating behaviors, reflected in significant improvement in quality of life and high satisfaction with the therapy. 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.