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FDA granted the applicant 510(k) clearance for the aprevo Cervical ACDF System on November 15, 2024, with separate indications for the aprevo Cervical ACDF system and the aprevo Cervical ACDF-X system (with and without CAM)

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A 12-week randomized trial demonstrated: Average weight loss of 2.6 kg in AOD-9604 group (1 mg/day) versus 0.8 kg in placebo group Preferential reduction in abdominal and visceral fat deposits No adverse effects on carbohydrate metabolism or insulin sensitivity Non-dose-dependent effects, with higher doses (10 mg/day) producing less weight loss than lower doses However, a subsequent 24-week Phase III trial with 502 subjects incorporating intensive diet and exercise showed no statistically significant weight loss compared to placebo, leading to development termination in 2007

Analyst 143 , 23902396 (2018)