Apollo Endosurgery's New Obesity Endoscopic Systems Receive FDA Nod

Apollo Endosurgery Inc (NASDAQ:APEN) announced the marketing authorization of the Apollo ESG, Apollo ESG Sx, Apollo REVISE, and Apollo REVISE Sx Systems through the FDA De Novo Classification process.
The process is a premarket 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 Apollo ESG and Apollo ESG Sx Systems are intended to be used by trained gastroenterologists or surgeons to facilitate weight loss in adults with Body Mass Index between 30-50 kg/m2 who have not been able to lose weight or maintain weight loss through more conservative measures.
The Apollo REVISE and Apollo REVISE Sx Systems are intended to be used to revise a previous bariatric procedure.
Price Action: APEN shares are up 12.10% at $4.76 during the market session on the last check Wednesday.