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.

See more from Benzinga

• Pluristem Posts Mixed Results From Study Of Muscle Regeneration After Hip Fracture Surgery

• Why TherapeuticsMD Shares Are Sinking Today?

Don't miss real-time alerts on your stocks - join Benzinga Pro for free! Try the tool that will help you invest smarter, faster, and better.

© 2022 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.