Bio-Tissue can proceed with a phase 2 study investigating morselized cryopreserved amniotic membrane and cryopreserved umbilical cord following clearance from the FDA, according to a press release.
TTBT01 is being studied to support regenerative healing in dry eye disease. Because it is a section 351 biologic investigational new drug, TTBT01 will undergo a strict FDA preapproval process involving two randomized phase 3 clinical trials demonstrating safety and efficacy, the release said.
“Our leadership team determined early on that going after a regenerative therapy based on natural human
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