Roadmap
Preparing for First-in-Human Trials on prostate cancer patients
Roadmap to commercialization
Pre-clinical studies
Clinical trial preparation (CRO) & authorizations
Magnetosomes production & formulation
> Magnetosomes (DM1) regulatory biocompatibility
Ultrasound heating probe fabrication
> Ultrasound heating probe (DM2) regulatory biocompatibility
Preparation of clinical study
> CRO and authorizations
Clinical study phase
Clinical trial preparation, authorization & realization
Pilot & pivotal study
> Determine efficacy & safety of the treatment on humans
Preparation & validation of CE marketing
Discussion with regulatory authorities and notified bodies
Regulatory affairs all along
2030 onward Commercialization
Regulatory Access
To reach CE marking,
- we have classified our medical devices as class III for magnetosomes and class IIb for the ultrasound heating module;
- we have been working with a notified body;
- we have been following the EU Regulatory framework that is adequate for our medical devices.
Following CE marking, we intend to ask the FDA for the authorisation to start commercialization of our treatment in the United-States.