Bio-Tissue is the pioneer of the birth tissue industry, said CTO Scheffer Tseng. Biotissue is cryopreserved, and boasts anti-inflammation, anti-scarring, anti-angiogenesis, and promotion of wound healing. Bio-Tissue has created several products based off this technology, including AmnioGraft, UCGuard, Prokera, Prokera Plus, and Prokera Clear.
The Prokera line has reimbursement and each product has its own CPT code. “A single placement of Prokera in dry eye accelerates the recovery of normal cornea and the effects last more than three months,” Dr. Tseng points out. It is the “first and only” therapy directed at restoring/regenerating the corneal nerve. In 97 eyes (84 patients) with moderate-to-severe dry eye, placement with Prokera for about five days resulted in a notable improvement of dry eye symptoms in 88% (n=74 patients).
Bio-Tissue plans to submit an IND for topical Regenesol (to treat persistent corneal epithelial defects); the twice daily treatment should begin Phase II studies during Q2 2018. The company is also working on platform technology (HC-HA/PTX3), designed to orchestrate regenerative healing. The platform is currently in a Phase II study (readout is not expected until mid-2018) for prevention of proliferative vitreoretinopathy.