Our first project is the support of the company Thoreme and its founder Maxime Labrit, inventor of the Andro-switch ring. According to the European Medical Device Regulation (EU 2017/745), Andro-switch, as a contraceptive medical device, falls under class IIb, which corresponds to a fairly high degree of danger (from the least dangerous to the most dangerous: I, IIa, IIb and III).
To make Andro-switch available throughout Europe, it is necessary to obtain the CE mark attesting to its compliance with the European Regulation.
To obtain the CE mark, the safety and performance of Andro-switch must be demonstrated through a clinical study adapted to the requirements of the Regulation.
August 2022 - Partnership with CIC-IT Bordeaux
Feb. 2023 - Funding: Male Contraception Initiative ($300K) and an American philanthropist ($30K)
Feb. 2024 - Funding by the Conseil régional de Nouvelle-Aquitaine (€50K).
To launch the clinical study, Andro-switch rings must be produced in compliance with the Medical Device Quality standard (ISO 13485:2016).
Once the standardized production unit has been set up, the new-generation Andro-switch can be produced and validated by the French health authorities to begin the study.
The clinical investigation of Andro-switch began in February 2024 and comprises several phases: product testing, safety testing and performance testing.
The design of the safety test is currently under development.
The clinical safety trial will start in winter 2024-2025.
For this trial, a panel of around 30 men will be monitored in their use of Andro-switch for 18 months in the Paris region.
Following the clinical study, a final audit by a notified body will authorize market access for the Andro-switch medical device, based on its compliance with ISO 13485:2016.
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