TissueTech Receives U.S. Food and Drug Administration Clearance to Proceed with Clinical Study using Investigational New Drug 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.
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.
"We have been diligent in building an infrastructure to develop products as biologics under Section 351 of the Public Health Service Act and pursuing the Biologics License Application (BLA) regulatory pathway for several years now," said TissueTech Co-Founder, President and Chief Executive Officer, Amy Tseng. "Our leadership team determined early on that going after a regenerative therapy based on natural human birth tissue to achieve Ocular Surface Optimization (OSO) would be the right thing to do – affording the company the opportunity to give physicians optimal treatment options to manage common dry eye problems effectively."
Bio-Tissue's commercially available product, PROKERA is well recognized as part of the algorithm in achieving ocular surface optimization, by reducing ocular surface disorder severity and improving dry eye classification from severe frequent/constant to mild and/or episodic.1 PROKERA was cleared by the FDA in 2003 as a 510(k) medical device and contains the only amniotic membrane designated by the FDA that has anti-inflammatory, anti-scarring, and anti-angiogenic properties for the ocular surface.
About Bio-Tissue, Inc.
Bio-Tissue, Inc., a TissueTech, Inc. company, is the market leader in the clinical application of CAM-based products for the treatment of diseases and disorders of the ocular surface. Established in 1997, Bio-Tissue serves an unmet need for better surgical and therapeutic alternatives for helping eye care professionals manage ocular surface conditions, such as keratitis, recurrent corneal erosions, conjunctivochalasis (Mechanical Dry Eye or MDE), pterygium, and severe dry eye. Connect with Bio-Tissue on our Physician Portal (for healthcare professionals only), Website, Facebook, LinkedIn, and Twitter, or through your local sales professional.
About TissueTech, Inc.
TissueTech, Inc., the parent company of Bio-Tissue, Inc. and Amniox Medical, Inc., is a scientific and market leader in the field of regenerative medicine. TissueTech manufactures a broad range of ocular, surgical, wound care, and soft tissue products that are marketed under these subsidiaries. Clinicians have performed more than 600,000 human implants with the company's products and published more than 380 peer-reviewed studies supporting its products and platform technology. TissueTech is committed to an unwavering integrity culture that places our patients' safety and clinical outcomes above all else. Learn more at tissuetech.com.
1. Journal of Cataract & Refractive Surgery: May 2019 - Volume 45 - Issue 5 - p 669-684 doi: 10.1016/j.jcrs.2019.03.023
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SOURCE Bio-Tissue, Inc.
