Ocular Systems, Inc., Wake Forest Baptist Medical Center and the North Carolina Eye Bank have announced the formation of a new company based on new technology for engineering replacement corneas for transplantation.

Funding for the new company, known as HCEC, LLC (Human Cultured Endothelial Cells), came in part from a Collaborative Funding Grant from the North Carolina Biotechnology Center.

“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, on Tuesday. “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.”

A New Approach to Improving Vision

The new approach to cornea transplantation involves isolating cells from traditional donor corneas and using them to grow replacement corneal tissue in the lab.

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.

Current surgical techniques involve replacing 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 to 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.”

Company to Help Meet Global Need

Though it has not yet been tested in patients, the technology could potentially benefit multiple patients suffering from impaired vision since it uses just a few cells from donor corneas, whereas traditional corneal transplantation requires an entire cornea to help a single patient.

“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.”

OSI initially funded and is the sponsor of the project while Wake Forest Baptist Medical Center’s Institute for Regenerative Medicine is conducting the research. The partnership between these two companies and the North Caroline Eye Bank is the type of collaborative effort that fits in with the strategic goal of the Piedmont Triad Research Park.

“It is exciting that a collaboration based in the Piedmont Triad research Park, right here 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 Medical Center. “This project is an example of the innovation that can be sparked in a research-park environment.”

The company aims to advance their 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, which is expected to take several years.

About Ocular Systems, Inc.

Ocular Systems, Inc. is located in Winston-Salem’s Piedmont Triad Research Park. OSI was the first company dedicated to the processing of human corneal tissue for endothelial replacement surgeries. Founded in 2004, the company is an FDA-registered human tissue establishment. 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.

(C) NC Biotech Center