- 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.
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