Tissium Receives Investigational Device Exemption for Vascular Sealant

The FDA has approved Tissium’s investigational device exemption request for a vascular sealant it is developing.

The sealant, which is designed to quickly achieve hemostasis and prevent post-operative bleeding after peripheral vascular surgeries, is now cleared for a U.S. clinical trial.

Tissium CEO Christophe Bancel said the approval represents "a key milestone” for the investigational device but did not say when the company plans to start its trial.