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(1) Alternative Pathway Device Pass-Through Applications As discussed in the CY 2026 OPPS/ASC proposed rule, we received four device pass-through applications by the March 2025 quarterly application deadline for devices that have received Breakthrough Device designation from FDA and FDA marketing authorization for the indication for which they have a Breakthrough Device designation and, therefore were eligible to apply under the alternative pathway

The REDEFINE Phase 3 program directly addressed this, showing CagriSema achieved 20.4% weight loss versus lesser results with semaglutide alone, cagrilintide alone, and placebo

AOD-9604s selective action on fat metabolism rather than overall growth hormone function makes it a unique peptide

Further structural refinement of the growth hormone C-terminal fragment produced AOD-9604, a compound generating a distinct research trajectory within GH-derived peptide pharmacology