The U.S. Patent and Trademark Office (USPTO) has issued a utility patent (#8661586) to Amenity Health, Inc. for its MedCline reflux relief system. The patent applies to the unique features of MedCline, as well as its method of positioning, which specifies sleeping on an incline and in a lateral side position. This issuance makes Medcline™ the only patented, on demand sleep positioning system available on the market today that combines these two strategies known to be effective at relieving nighttime acid reflux (GERD).
This patent comes on the heels of a successful independent clinical study conducted by The Medical University of South Carolina showing that when compared to a traditional bed wedge, those sleeping on Medcline™ experienced an 87% reduction in esophageal acid exposure when sleeping on the left side. Tests also showed a 38% reduction in nighttime acid reflux episodes. Finally, MedCline was also found to be 2x as comfortable.
MedCline is currently being utilized in another clinical study with Cleveland Clinic. This study aims to quantify health-related quality of life improvements when sleeping on MedCline, as well as accessing patients’ ability to decrease medication usage over time.
The utility patent, clinical trial results from The Medical University of South Carolina, as well as the forthcoming results from Cleveland Clinic puts MedCline in the unique position to offer acid reflux (GERD) patients a much needed treatment alternative to taking prescription and OTC medications, as well as invasive surgical procedures.
MedCline is a Class I Medical Device listed with the FDA and cleared for patient use. The system also meets the requirements of Section 125 of the IRS Guidelines to be classified as a FSA/HSA-approved medical expenditure. In some cases, insurance companies may cover MedCline (using HCPCS code E0190) though individuals need to contact their insurance companies directly to determine coverage.