Apollo Endosurgery, Inc. announced the marketing authorization of the Apollo ESGTM, Apollo ESG SxTM, Apollo REVISETM and Apollo REVISE SxTM Systems through the U.S. Food and Drug Administration's (FDA) De Novo Classification process, a rigorous pre-market review pathway for low-to moderate-risk devices without a predicate. These are the first and only devices authorized by the FDA for endoscopic sleeve gastroplasty (ESG) and endoscopic bariatric revision. ESG is an incisionless procedure that utilizes an endoscopic suturing system to reduce the volume of a person's stomach and delay emptying of the stomach, resulting in clinically meaningful, durable weight loss.

In a randomized controlled trial, the ESG procedure demonstrated safety and effectiveness with durability out to two years. The results from this trial add to a larger body of evidence reporting outcomes in over 10,000 patients receiving ESG. ESG can be performed as a same-day procedure without incisions or scars, and patients typically return to work within a few days.

Bariatric revision procedures are the fastest growing segment of the bariatric surgery market. Studies have shown that after ten years, patients who underwent gastric bypass have regained an average of 20-30% of the weight they initially lost. Transoral outlet reduction (TORe) is an endoscopic procedure performed to revise a previous gastric bypass and like ESG, can be performed as a same-day procedure without incisions or scars.