TissueTech Receives U.S. Food and Drug Administration Clearance to Proceed with Clinical Study using Investigational New Drug TTBT01

Share this article
Share this article
MIAMI, March 1, 2021 /PRNewswire/ -- Bio-Tissue, Inc., a TissueTech, Inc. company and pioneer in the clinical application of human birth tissue-based products, announced today that its parent company TissueTech had received clearance from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2 study using morselized Cryopreserved Amniotic Membrane (CAM) and Cryopreserved Umbilical Cord (CUC) Investigational New Drug (IND) TTBT01. This clearance represents another milestone as the company works to achieve FDA approval for its graft and morselized human birth tissue products as biologics for important clinical indications.
Already a leader in ocular clinical research and regenerative medicine, Bio-Tissue is now pioneering a pipeline in ocular biologics, as illustrated by the pursuit of morselized human birth tissue product TTBT01 to support regenerative healing in patients with persistent corneal epithelial defect – commonly referred to as dry eye disease.  As a 351 biologic IND, TTBT01 will be subject to a stringent FDA pre-approval process that includes two randomized Phase 3 clinical trials to demonstrate safety and efficacy.

Related Keywords

Miami , Florida , United States , Amy Tseng , Amniox Medical Inc , Linkedin , Twitter , Tissuetech Inc , Drug Administration , Tissue Inc , Public Health Service , Tissuetech Co , Facebook , Cryopreserved Amniotic Membrane , Cryopreserved Umbilical Cord , Investigational New Drug , Public Health Service Act , Biologics License Application , Tissuetech Co Founder , Chief Executive Officer , Ocular Surface Optimization , Mechanical Dry Eye , Physician Portal , Amniox Medical , Refractive Surgery , Bio Tissue , Inc , மியாமி , புளோரிடா , ஒன்றுபட்டது மாநிலங்களில் , ஆமி ட்செங் , சென்டர் , ட்விட்டர் , திசு இன்க் , பொது ஆரோக்கியம் சேவை , முகநூல் , பொது ஆரோக்கியம் சேவை நாடகம் , உயிரியல் உரிமம் விண்ணப்பம் , தலைமை நிர்வாகி அதிகாரி , கண் மேற்பரப்பு தேர்வுமுறை , இயந்திர உலர்ந்த கண் , மருத்துவர் போர்டல் , ஒளிவிலகல் அறுவை சிகிச்சை , உயிர் திசு , இன்க் ,