KING OF PRUSSIA, Pa., Dec. 6, 2016 /PRNewswire/ -- Aspire Bariatrics, Inc., announced today that the results of the PATHWAY study of AspireAssist®, a 171-subject, multicenter randomized control trial in the US, was published today in the American Journal of Gastroenterology. The AspireAssist, an endoscopic alternative to weight loss surgery, is indicated for adults with a BMI of 35 to 55. 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.
"The PATHWAY study showed that AspireAssist procedure is a viable alternative to bariatric surgery for patients with Class II or Class III obesity, with both significant weight loss and excellent safety. Side effects such as nausea and vomiting are rare, and, notably, the treatment group showed improvement in eating habits, with better food choices and more thorough chewing. This is partly due to the procedure mandating follow-up with the healthcare team for ongoing use, or the device shuts off," said Christopher Thompson, MD, Associate Professor of Medicine at Harvard Medical School, Director of Therapeutic Endoscopy at Brigham and Women's Hospital, and co-Principal Investigator of the PATHWAY Study.
The AspireAssist is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient's internal anatomy. After 52-weeks of therapy, patients lost 37% of their excess weight, on average. Although the study was not sized to show significant improvement in cardiometabolic parameters, clinically significant improvement in the treatment group was seen in HbA1C (-0.36% relative to 5.7% baseline, P <0.0001), triglycerides (?9.9%, P =0.02), and high-density lipoprotein cholesterol (+8.1%, P =0.0001), at week 52 compared with baseline. There was no evidence of patients in the treatment group developing adverse eating behaviors.
"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.
"With less than 1% of the 29 million Americans with BMIs over 35 availing themselves of bariatric surgery each year, there is a significant unmet 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. Publication of the PATHWAY results should help facilitate insurance coverage," said Katherine Crothall, PhD, President & CEO of Aspire Bariatrics.
The full text publication can be accessed at: http://www.nature.com/ajg/journal/vaop/ncurrent/full/ajg2016500a.html
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 MediaKathy Crothall, PhDPresident and CEO(610) [email protected]
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"The PATHWAY study showed that AspireAssist procedure is a viable alternative to bariatric surgery for patients with Class II or Class III obesity, with both significant weight loss and excellent safety. Side effects such as nausea and vomiting are rare, and, notably, the treatment group showed improvement in eating habits, with better food choices and more thorough chewing. This is partly due to the procedure mandating follow-up with the healthcare team for ongoing use, or the device shuts off," said Christopher Thompson, MD, Associate Professor of Medicine at Harvard Medical School, Director of Therapeutic Endoscopy at Brigham and Women's Hospital, and co-Principal Investigator of the PATHWAY Study.
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The AspireAssist is implanted in a 15-minute outpatient procedure, is fully reversible, and does not alter the patient's internal anatomy. After 52-weeks of therapy, patients lost 37% of their excess weight, on average. Although the study was not sized to show significant improvement in cardiometabolic parameters, clinically significant improvement in the treatment group was seen in HbA1C (-0.36% relative to 5.7% baseline, P <0.0001), triglycerides (?9.9%, P =0.02), and high-density lipoprotein cholesterol (+8.1%, P =0.0001), at week 52 compared with baseline. There was no evidence of patients in the treatment group developing adverse eating behaviors.
"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.
"With less than 1% of the 29 million Americans with BMIs over 35 availing themselves of bariatric surgery each year, there is a significant unmet 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. Publication of the PATHWAY results should help facilitate insurance coverage," said Katherine Crothall, PhD, President & CEO of Aspire Bariatrics.
The full text publication can be accessed at: http://www.nature.com/ajg/journal/vaop/ncurrent/full/ajg2016500a.html
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 MediaKathy Crothall, PhDPresident and CEO(610) [email protected]
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/aspireassist-pivotal-trial-results-published-in-the-american-journal-of-gastroenterology-300373853.html
SOURCE Aspire Bariatrics, Inc.
