The project

Accompanying Andro-switch

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.

Certification course

August 2022 - today
Search for partners and funding
Planning the certification process

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).

Oct. 2023 - today
Andro-switch production compliance

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.

2024 - 2026
Clinical investigation

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.

Jan. 2027
Market access

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.

Financing
The certification of a medical device implies important costs due to the research time and the multiple skills it requires. To overcome these obstacles, our team implements a financing strategy with each entrepreneur it accompanies, by favoring public and and participatory financing. By joining us, our members also choose to finance the development of the male contraception.
Clinical development
Entrelac.coop guarantees the safety of users and the performance of each medical device that it accompanies to the market by establishing a clinical development strategy and managing each step of the clinical studies. By mobilizing the scientific community, we promote research in the field of reproductive health.
male contraceptive cooperative incubator
Market access
Each step forward is valuable for the development of male and testicular contraception, so we can offer each entrepreneur support from A to Z in his project: development plan, industrial compliance of the product, marketing strategy.
Entrelac.coop is the springboard for innovation for a more equitable and accessible contraception.

You are developing a solution for a more equitable contraception? contact us!