Implantation in the USA:Funding to secure FDA approval

Call to the FTM community!

Dear patients and surgeons of the United States:

This callout is not an advertisement for ZSI products in the US. It’s a plea to help us obtain FDA approval in the United States, so that one day we’ll be able to exhibit and implant our products there.

ZSI, a dynamic and innovative family company founded in Switzerland, has dedicated a large portion of its financial resources to research into and development of FTM implants. Another large portion of ZSI’s budget is dedicated to the continuous development of implants for biological men.

The US market is very attractive for ZSI. However, given the small number of FTM implantations taking place worldwide compared to the number done for biological males, the cost of obtaining FDA certification to enter the US market is more than ZSI can afford to pay.

We invest large sums of money in research and development, which is our passion, but unfortunately we cannot do the same for the registration of products.

We are seeking, in the transsexual network, organizations that can help us cover the costs of obtaining FDA certification in the United States. We’re available to meet to find solutions to this problem.

 

ZSI is the only European manufacturer of artificial urinary sphincters and of malleable and inflatable penile implants, as solutions for male urological problems (incontinence), sexual complications (Erectile Dysfunction), and gender identity procedures (prostheses for trans men and women).

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