A key goal for the first Vasalgel studies, in addition to demonstrating the contraceptive’s safety and effectiveness, was to establish its reversibility. Vasalgel was reversible after a year in rabbits, but as we’ve reported, reversibility has so far been elusive in large-animal studies.
We suspect we simply haven’t found a suitable large-animal model; for example the baboon vas deferens is smaller and more fragile than that of the human. We’re cautiously optimistic that everything will be much easier in human trials, because the human vas is larger and sturdier. And we’re hard at work trying some other things too. But in the meantime, the first clinical trial will be designed to include just men who aren’t counting on reversibility, while we sort out those issues.
Thousands of people would like to be in the first trial, but there are only a few spots. And the researcher will have to pick local men who are the best candidates and want vasectomy anyway. So we’re trying to keep everybody’s focus on the ultimate prize: getting Vasalgel to market, with availability to ALL. If trials go well, then the sky’s the limit: we’ll seek approvals to bring Vasalgel to market, starting in the U.S., E.U., and Canada… and expanding from there.