Information for Physicians

Aspire Bariatrics, Inc. regrets to inform you that we are winding down all operations at the Company and, as a result, are withdrawing our FDA premarket approval (PMA) for the AspireAssist, effective April 8, 2022. Unfortunately, COVID-19 and its reemergence have wreaked havoc with our plans and we can no longer afford to continue operations at the Company. In accordance with federal law, AspireAssist supplies may no longer be distributed in interstate commerce once we withdraw our PMA, effective April 8, 2022.

Please note that our withdrawal of our PMA is entirely the result of economic factors, not the result of safety or effectiveness issues associated with or reported with the product. Indeed, the safety and effectiveness profile of the AspireAssist, as has been found in the field, is consistent with the safety and effectiveness profile as reported in our Clinician Guide and as reported in the literature.

Please read the full Letter to Physicians here:

Additional Resources for Clinicians:

 

Contact Information for Clinicians:

Kathy Crothall, CEO: kathy.crothall@aspirebariatrics.com

Audrey Finkelstein, EVP Sales & Marketing: audrey.finkelstein@aspirebariatrics.com