Bio-Tissue® Expands PROKERA® Product Line with PROKERA® Clear

PROKERA is the only FDA-cleared medical device that reduces inflammation and promotes healing

MIAMI, Fla., March 3, 2016 – Bio-Tissue®, Inc., the industry leader in regenerative tissue therapies and ocular hygiene products for lid margin and ocular surface diseases, today announced the introduction of PROKERA® Clear, the newest addition to the Company’s PROKERA biologic corneal bandage product line. PROKERA is the only FDA-cleared therapeutic medical device that reduces inflammation and promotes healing.

“PROKERA Clear goes beyond simply hydration of the eye for temporary relief to rejuvenate and heal the cornea, which is key for patients to find true relief in order to have a better quality of life,” said Tom Daniells, Chief Commercial Officer, Bio-Tissue. “Additionally, it’s ideal for those patients with the need to maintain their vision during treatment, and like the entire PROKERA product line, PROKERA Clear reduces inflammation, prevents haze and scarring, and expedites healing.”

“We have been using PROKERA for many years now and are very much looking forward to the addition of PROKERA Clear to our toolbox,” said Douglas K. Devries, OD. There is a definite need for certain patients that require the maintenance of their vision during treatment, such as patients that need to return to work or patients with only one eye. Bio-Tissue is responding to an important need in the market with the addition of PROKERA Clear.”

For the millions of Americans suffering from symptoms of chronic ocular surface disease, traditional treatments typically provide only temporary relief and fail to heal the ocular surface, primarily because they don’t tackle the corneal damage that may be causing the symptoms. New PROKERA Clear heals the cornea and maintains visual acuity with the central Clear-View™ Aperture. PROKERA Clear is ideal for ambulatory, chronic ocular surface disease, corneal-involved dry eye patients, and post-LASIK/PRK patients.

The PROKERA line of products (PROKERA® Clear, PROKERA® SLIM, PROKERA®, and PROKERA® PLUS) contains amniotic membrane tissue that has natural therapeutic actions that help damaged eyes heal faster. The tissue is processed using the Company’s proprietary CryoTek® method that preserves the heavy chain hyaluronic acid/pentraxtrin 3 (HC-HA/PTX3) biologic signaling matrix, which is essential for anti-inflammatory and anti-scarring effects while facilitating the healing process. PROKERA® products support faster and more effective healing of the cornea with less discomfort, scarring and inflammation, leading to clear corneas and improved clinical outcomes. PROKERA is safe and effective; has no risk of IOP spikes or delayed healing; and improves vision by restoring the ocular surface without scarring.

The PROKERA line of products (PROKERA® Clear, PROKERA® SLIM, PROKERA®, and PROKERA® PLUS) contains amniotic membrane tissue that has natural therapeutic actions that help damaged eyes heal faster. The tissue is processed using the Company’s proprietary CryoTek® method that preserves the heavy chain hyaluronic acid/pentraxtrin 3 (HC-HA/PTX3) biologic signaling matrix, which is essential for anti-inflammatory and anti-scarring effects while facilitating the healing process. PROKERA® products support faster and more effective healing of the cornea with less discomfort, scarring and inflammation, leading to clear corneas and improved clinical outcomes. PROKERA is safe and effective; has no risk of IOP spikes or delayed healing; and improves vision by restoring the ocular surface without scarring.

About Bio-Tissue
Bio-Tissue, Inc., is a subsidiary of TissueTech, a privately held biotechnology company that develops innovative wound healing and hygiene solutions for the prevention and treatment of ocular surface diseases and disorders. Bio-Tissue provides a comprehensive line of cryopreserved amniotic membrane ocular wound healing products, including AmnioGraft®, a biologic ocular transplantation graft; AmnioGuard®, a biologic glaucoma shunt tube graft; and the PROKERA® family of biologic corneal bandage devices. These products incorporate human amniotic membrane processed with the Company’s proprietary CryoTek® method proven to preserve the biological properties of amniotic membrane and umbilical cord tissue essential for anti-inflammatory and anti-scarring effects compared with the dehydration method that drastically alters the structural and biological integrity of this tissue.1 Bio-Tissue also developed and markets the Cliradex® line of products, a natural lid, lash and facial cleanser with 4-Terpineol, the active component of tea tree oil (TTO), for the management of symptoms in ocular diseases such as blepharitis, demodex, and rosacea. For more information, visit www.biotissue.com.

1 Marissa Cooke, Ek Kia Tan, Christian Mandrycky, Hua He, Julie O'Connell, Scheffer C.G. Tseng, Comparison of Cryopreserved Amniotic Membrane and Umbilical Cord Tissue with Dehydrated Amniotic Membrane/Chorion Tissue, The Journal of Wound Care, October 2014, Vol. 23, No. 10.