What we have shown, and what we have not shown yet.
A medical device earns trust step by step. Here we separate what has been demonstrated from what is being tested, and from what is designed but not yet proven. With the setting of each result.
Every claim, with its setting.
Lab, tissue model, animal or women. A result in the lab is not yet a result in women, so we say which is which.
The valve is watertight
A closed valve does not let sperm pass.
Materials tolerated by tube tissue
No toxicity or inflammation in fallopian tube organoids grown from human stem cells.
No safety concerns after 28 days
The implant stayed in place despite the natural contractions of the rabbit's tube, which are stronger than in humans. Rabbit tubes are too small for the valve itself, so the valve was not tested there.
A first view inside the human tube
With our own 1.2 mm endoscope, in women undergoing a hysterectomy.
Placement and compatibility in women
In women scheduled for a hysterectomy, with Máxima MC.
Coatings and removal
Studies in fallopian tube tissue grown in the lab.
Contraceptive effect
To be demonstrated in clinical studies.
Reversal after long-term use
Built into the design. To be demonstrated in clinical studies.
ISO 13485 quality system
Certified since 2023, the standard for medical device quality management.
Patents in Europe and the US
Three patent families: the system, the valve and its mode switch.
From here to approval.
The plan was developed in 2023 with Bevinced, a contract research organisation for medical devices, and follows FDA guidance for this type of device. The first stages may change as studies in the US are prepared.
Valve, materials and placement tested in the lab, in tissue models and in animals.
Placement studied in women already scheduled for a hysterectomy.
At least 50 women, at several centres.
500 to 1,000 women, in Europe and the US.
FDA approval targeted for 2031, market introduction in 2032.
| Stage | What | Women | Timing |
|---|---|---|---|
| Endoscope usability | The endoscope in the tube, in women already scheduled for a hysterectomy. | 2 × 2 | 2026 |
| First placement | Choice ONE placed before a planned hysterectomy, with study of the removed tissue. Some women also go through removal. | 29 planned | About 1 year |
| Pilot study | Multi-centre, with confirmation that the tubes are closed at 3 months, and follow-up of at least 1 year. | At least 50 | About 1 year |
| Pivotal study | For CE marking and FDA approval. Pregnancy and safety as endpoints, follow-up up to 5 years. | 500 to 1,000 | About 2.5 years |
| After approval | Registry of long-term use. | About 2,000 | 5 years or more |
Frequently asked.
Is Choice available?
No. Choice is an investigational device and has not been approved for use. It can only become available after clinical studies and regulatory approval.
Can I take part in a study?
Studies are organised through our clinical partners and follow medical-ethical review. We will share how to register interest once studies open to participants.
How is Choice different from earlier tubal implants such as Essure?
Earlier implants were designed for permanent sterilisation, were placed without seeing inside the tube and could not be removed without surgery. Choice is designed from the start to be switchable and removable, is placed under direct vision, is about 15 mm long and uses a single metal. These are design choices: their effect still has to be demonstrated in clinical studies.
Does Choice protect against sexually transmitted infections?
No. Only the full separation that a condom provides prevents STI infections. Choice is not designed to protect against STIs, so a condom is still needed for that.