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It was authorized for marketing in the United States in 2023 following its designation as a Breakthrough Device by the US Food and Drug Administration and remains the only clinically validated, non-pharmaceutical treatment available for patients with RLS

In vitro follicular activation and stem cell therapy as a novel treatment strategies in diminished ovarian reserve and primary ovarian insufficiency

But, since the procedure requires injecting, the person might feel pain and irritation around the area of venipuncture

When a compound is being proposed for wide access through compoundingwithout the manufacturing controls and labeling requirements of an FDA-approved productthat absence is hard to paper over