Pivotal trial

But we want to finish enrolling the balance of our patients.

for the US Pivotal Study, which we're now running.

We're in the midst of that study, and our team is right now opening new clinical and old clinical sites for clinical study in the US to speed up the enrollment, which we hope to finish by the end of the year.

When I say enrollment, it means an identified clinical site, a hospital or a clinic, A doctor who specializes in research and doing those things with a team around him.

Not only screening and choosing the patients because they need to qualify, it's an FDA monitored and mandated study, but also including doing the procedure.

So by the end of the year, we'll finish the required number of patients by FDA to do our clinical pivotal study, which is the ultimate study in order to get permission to market in the U.S. Another thing that we're doing is working quite actively on commercialization.

We have approval in Europe.

So we are permitted already to market and sell in Europe.