News and Announcements
Analytica’s PeriCoach Sexual Health Indication Clarification from USFDA
- Published August 02, 2016 12:37PM UTC
- Publisher Wholesale Investor
- Categories Company Updates
29th July 2016, ASX Announcement
Analytica Ltd (ASX: ALT), manufacturer of the PeriCoach® system, is pleased to announce that it has received clarification from the US Food and Drug Administration regarding additional marketing claims for improved sexual function in women from strengthening their pelvic floors using the PeriCoach system.
Following recent discussions regarding the over-the-counter clearance for PeriCoach system in the US, the USFDA has confirmed that the PeriCoach may be marketed for sexual function under “general Wellness” claims. This allows the product to state, for example, that “Strengthening of the pelvic floor muscles can also potentially improve sexual sensation or satisfaction and orgasm potential in some women.” This clarification provides a level of certainty when communicating the benefits of the PeriCoach with clinicians and members of the public.
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