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Press Release

AspireAssist® Demonstrates Significant Weight Loss through Four Years with Strong Safety Profile


Posted on: 05 Feb 18

KING OF PRUSSIA, Pa., Feb. 05, 2018 (GLOBE NEWSWIRE) -- Aspire Bariatrics, Inc., a commercial-stage medical device company, announced today the publication of 201-patient, multi-center post-market European registry study in the peer-reviewed Obesity Surgery Journal. The post market study was designed to evaluate long-term safety and efficacy of aspiration therapy (AT) in a clinical setting in five European clinics.

The published results demonstrate with statistical significance that aspiration therapy with the AspireAssist® System is a safe, effective, and durable weight loss therapy in people with Class II and Class III obesity in a clinical setting. Significant findings from the trial include:
             

  • Mean percent total weight loss at 1, 2, 3 and 4 years respectively of 18.2%, 19.8%, 21.3%, and 19.2%
  • Clinically significant reductions in glycated HbA1C, triglycerides and blood pressure
  • For participants with diabetes, an HbA1C decrease of 1% from 7.8% at baseline to 6.8% at one year
  • Results as effective and safe in a community setting as in the research setting, with AspireAssist proving to be a viable, lower cost, alternative therapy to bariatric surgery
  • No statistical difference in efficacy or safety for heavier patients (BMI >50kg/m2) vs patients with BMI 35-50 kg/m2; or for older patients (age >55) vs patients younger than 55

“We are pleased with the publication of these data which continue to demonstrate that Aspiration Therapy with the AspireAssist System is a safe, durable, and effective weight management therapy for people with Class II and Class III obesity,” said Kathy Crothall, PhD, President & CEO of Aspire Bariatrics. “Importantly, the ability to perform AspireAssist on an outpatient basis with a low incidence of costly, serious complications and an excellent safety profile suggest that AspireAssist could serve as a lower cost alternative to bariatric surgery.”

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.

About the AspireAssist
Approved by the FDA in 2016, the AspireAssist offers an alternative therapy for patients with BMI 35 to 55 who decline bariatric surgery, or are not candidates for surgery. The AspireAssist works through a dual mechanism of action, serving as a tool to help patients learn slow and mindful eating, while preventing about 30% of calories from being absorbed by the body. The device is placed in a simple 15-minute PEG procedure, and offers excellent weight loss with an exceptionally low incidence of complications.

Contact for Investors and Media
Kathy Crothall, PhD
President and CEO
(610) 590-1568
kathy.crothall@aspirebariatrics.com

GlobeNewswire
globenewswire.com

Last updated on: 06/02/2018

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