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PUBLIC RELEASE DATE:
8-Jan-2013

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Contact: Karen Richardson
krchrdsn@wakehealth.edu
336-716-4453
Wake Forest Baptist Medical Center
@wakehealth

New company applies regenerative medicine to corneal transplantation

WINSTON-SALEM, N.C. - Jan. 8, 2013 - Ocular Systems, Inc. (OSI), Wake Forest Baptist Medical Center and the North Carolina Eye Bank have formed a new company based on a promising new technology aimed at engineering replacement corneas in the lab for transplantation.

"The global need for corneal tissue for transplantation far exceeds the supply," said Dean Vavra, director of the North Carolina Eye Bank. "We are excited to be part of this innovative approach to sight restoration that has the potential to increase the availability of corneal tissue."

The new approach, not yet tested in patients, involves isolating cells from "banked" donor corneas to grow replacement corneal tissue in the lab. The advantage is that cells from a single donor could potentially benefit multiple patients with impaired vision.

The company, formed by OSI, the sponsor and initial funder of the project, Wake Forest Baptist Medical Center, whose Institute for Regenerative Medicine is conducting the research, and the North Carolina Eye Bank, is an example of the type of collaboration that is a strategic goal of the Piedmont Triad Research Park (PTRP). Also assisting with funding was the N.C. Biotechnology Center through a Collaborative Funding Grant.

The goal of the startup company, known as HCEC, LLC (Human Cultured Endothelial Cells), is to advance the technology to the next level, which includes conducting the additional studies needed to apply to the U.S. Food and Drug Administration to begin studies in human patients. This is expected to take several years.

"Today's announcement is the culmination of more than four years of planning and research," said OSI CEO Jerry Barker, who is the new company's managing partner. "We believe this innovative initiative has the potential to change the face of corneal transplantation. The formation of HCEC, LLC will enable the team to expedite research and development efforts and move toward commercialization at a much faster pace."

The cornea is the transparent dome at the front of the eye that helps with focus. The cells that line the inside of the cornea, known as corneal endothelial cells (CECs), pump fluid out of the cornea. If these cells become diseased or damaged, vision is blurred. Because CECs cannot repair themselves, the standard treatment is to replace the cornea or cells with tissue from a cadaveric donor.

The current surgical technique is to replace a patient's damaged CECs with a very thin layer of tissue containing cells from a cadaveric donor cornea. The new cells pump fluid out of the cornea, restoring corneal clarity. With the advent of this procedure, there has been increased demand for donor tissue with healthy CECs. The goal of the new partnership is use regenerative medicine technology to meet this increased demand.

"The technique of bioengineering replacement tissues using cells and scaffolds can theoretically be applied to almost any tissue in the body," said Anthony Atala, M.D., director of the Wake Forest Institute for Regenerative Medicine. "We are delighted to be OSI's academic partner in this project."

"It is exciting that a collaboration based in the Piedmont Triad research Park, right her in Winston-Salem, has the potential to create products that can bring benefits to patients throughout the world," said Eric Tomlinson D.Sc., Ph.D., PTRP president and Chief Innovation Officer at Wake Forest Baptist. "This project is an example of the innovation that can be sparked in a research-park environment."

Shay Soker, Ph.D., professor of regenerative medicine at Wake Forest Baptist, is the lead scientist for the project. Other team members are Tracy Criswell, Ph.D., instructor of regenerative medicine; Ocular Systems Inc. scientists Jin San Choi, Ph.D., and Belinda Wagner, Ph.D.; and Wake Forest Baptist Department of Ophthalmology physicians Craig Greven, M.D., chair, Matthew Giegengack, M.D., assistant professor, and Keith Walter, M.D., associate professor.

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Editor's Note: Wake Forest Baptist Medical Center and Keith Walter, M.D. receive royalties from OSI from sales of the EndoSerter® device, and Dr. Walter serves on OSI's Medical Advisory Board and provides consulting for OSI.

Media Contacts:

Ocular Systems Inc.: Cathy Hasel, chasel@ocularsystemsinc.com; 336-784-4603
Wake Forest Baptist: Karen Richardson, krchrdsn@wakehealth.edu, (336) 716-4453 or Main Number (336) 716-4587.

About Ocular Systems, Inc.

Ocular Systems, Inc. is located in the Piedmont Triad Research Park, in Winston-Salem, NC. OSI was the first company dedicated to the processing of human corneal tissue for endothelial replacement surgeries. Founded in 2004, OSI is an FDA-registered human tissue establishment and is also an ISO 13485 registered device manufacturer. OSI manufacturers the EndoSerter® and EndoSaver® corneal endothelium delivery devices used to deliver corneal endothelial allografts into the eye during a specialized transplant procedure. OSI is committed to delivering to physicians innovative solutions to help patients improve their vision.

About the Wake Forest Institute for Regenerative Medicine

The Wake Forest Institute for Regenerative Medicine is dedicated to the discovery, development and clinical translation of regenerative medicine technologies. Institute scientists were the first in the world to engineer a replacement organ in the laboratory that was successfully implanted in patients. The institute has used biomaterials alone, cell therapies, and engineered tissues and organs to treatment patients with injury or disease. The Institute is based at Wake Forest Baptist Medical Center, a fully integrated academic medical center located in Winston-Salem, N.C. The institution comprises the medical education and research components of Wake Forest School of Medicine, the integrated clinical structure and consumer brand Wake Forest Baptist Health, which includes North Carolina Baptist Hospital and Brenner Children's Hospital, the commercialization of research discoveries through the Piedmont Triad Research Park, as well as a network of affiliated community-based hospitals, physician practices, outpatient services and other medical facilities.

About the North Carolina Eye Bank

For over 60 years, the mission of The North Carolina Eye Bank (NCEB) is to recover, process and distribute ocular tissue for the restoration of sight through corneal transplantation and related medical therapy and research. Each year, NCEB, a 501(c)3 not-for-profit organization provides corneas for over 3,000 transplants, with additional tissue being provided for research and training. To accomplish its mission, NCEB is committed to educating the public and medical communities about the need for eye and tissue donors; ensuring that the wishes of donors and donor families are carried out to the greatest extent possible; maintaining procedures to maximize quality of tissue distributed; and working cooperatively with ophthalmologists and other professional clients to ensure optimal results for the recipient.



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