AltaSeal®
is an investigational Class III medical device and it has not been approved for
commercial use in any jurisdiction.
AltaSeal has undergone a rigorous design and pre-clinical testing process. First-in-Woman clinical trials has been
undertaken at three European sites to test safety and effectiveness, under
appropriate Ethics Committee and regulatory approval. To date, 84 women have
been relying on AltaSeal for an average of five years with no pregnancies and an
excellent safety record.
AltaScience
is now building on the results from the First-in-Woman trials to make design enhancements
and to prepare for a pivotal trial, subject
to approval of an FDA Investigational Device Exemption.
