WINSTON-SALEM, N.C. – Ocular Systems Inc. is working to bring medical innovation to an eye surgery that has not changed all that much in 100 years.
CEO Jerry Barker founded OSI to prepare corneal tissue for transplant, saving doctors time spent doing that prep work themselves. Last year, OSI received U.S. marketing clearance for its first product, a medical device to assist doctors in these transplant surgeries.
Now Barker wants to address the constant need for new corneas. He believes regenerative medicine can help.
Winston-Salem-based OSI is raising $3 million to finance its research, the first time that the company — completely self-funded to date — has sought outside money. Barker said that although OSI could sustain its research efforts on its own, the company needs the financing to accelerate its work.
OSI is working with the Wake Forest Institute for Regenerative Medicine. Beyond that, Barker is keeping specifics under wraps for now. But he says an initial $3 million will finance R&D on the regenerative medicine technology. The company will need a second tranche, the total amount to be determined largely by what the U.S. Food and Drug Administration requires for clinical testing of this new regenerative medicine technology.
The first corneal transplant is attributed to Austrian surgeon Eduard Zirm in 1905. While better suturing methods have improved Zirm’s procedure, Barker said that a penetrating keratoplasty surgery today is essentially the same — donor corneal tissue replaces the cornea and is attached by sutures. The technique works but has limitations. The cornea does not have blood supply to heal the tissue. That means that the bond of the transplanted tissue does not get stronger after the surgery and the transplanted cornea can be knocked loose.
In the last decade, a newer type of corneal transplant surgery developed called endothelial keratoplasty, or EK. This surgery removes only the innermost diseased tissue of the cornea and leaves more of the healthy tissue intact. It uses a small incision to transplant the tissue and does not require sutures. The challenge for EK surgeries is that the transplanted cornea can be damaged by forceps surgeons use to fold the tissue, force it through an incision between 5 millimeters and 6 millimeters in size, and then unfold the tissue. Although Barker founded OSI in 2004 for the purpose of preparing corneal tissue for doctors, his company soon found itself working on a way to improve the surgery.
Wake Forest ophthalmologist Keith Walter was looking for a better way to do EK surgeries in 2004 and he had an idea to do it. He collaborated with OSI to develop a medical device to handle, insert and unfold the tissue. The device needs a smaller incision – just 4 millimeters — which poses less of a risk of injuring the patient or damaging the transplant tissue. The EndoSerter received a CE Mark in 2010 and FDA 510(k) clearance last year. Watch the EndoSerter in action in this OSI video:
The Eye Bank Association of America says that 46,196 corneal transplants were performed in the United States in 2011. Nearly half of them were EK procedures. Barker says OSI is now researching regenerative medicine because the company must look ahead to the next innovation for these surgeries. Many cornea donors are elderly; their corneas can be damaged or are otherwise unsuitable for transplant. But Barker envisions a way of making the most of the healthy donor tissue that is available.
“Instead of one cornea going to one patient, why couldn’t those cells go to treat multiple patients,” he asked.
Corneal transplant surgery techniques stayed much the same for its first 100 years. OSI aims to use regenerative medicine to transform the surgery for the next century.