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.
THIS DEVICE IS NOT YET FOR SALE IN THE UNITED STATES
– IT IS AN INVESTIGATIONAL DEVICE LIMITED BY FEDERAL (OR UNITED STATES) LAW TO INVESTIGATIONAL USE.