Chris Pulling, CEO, MicroOptx
Chris Pulling, CEO of MicroOptx, is looking forward to human trials beginning late summer or early fall on the implant that the medical device company is developing that it says can cure glaucoma.
Pulling said nonclinical and animal tests show the company's device, implanted through the eye's surface, halts the progression of glaucoma, which can cause blindness.
The device, which houses nano-engineered flow channels to shunt fluid from inside the eye to reduce pressure that damages the optic nerve, is the thickness of about 1½ human hairs, Pulling said.
It represents a cure "in the sense that we can halt the progression to blindness from glaucoma, where all other therapies only slow the progression to blindness in the hope of preserving at least some sight through the end of life," Pulling said.
MicroOptx is optimistic it can raise the $30 million it needs to complete clinical trials and the federal approval process.
Pulling founded the company in 2014 with Roy Martin, his partner in a contract medical research organization that they previously sold; Dr. J. David Brown, among the state's leading glaucoma surgeons and the device's inventor; and finance partner Keith Bares.
MicroOptx, which will conduct its first human study in the Twin Cities, has been working with a Food and Drug Administration program designed to accelerate device innovation.
Trials will continue for at least five years, Pulling said, with an FDA submission and market approval expected in 2019.
Q: Would the device help people who have begun to lose vision to glaucoma?
A: We do not know how to regain vision that has already been lost, but recent research suggests that significantly lowering pressure may be restorative for some people.
Q: What challenges do you face in getting the device to market?
A: The bigger issue is a perception issue and overcoming biases in the medical community that arise from historically failed or disappointing glaucoma therapies with different modes of action. The way to overcome that is with our clinical data that we'll be collecting over the next couple of years, proving that we've effectively solved all of those historical issues.
Q: What potential do you see for the device?
A: A lot of third-world countries have high rates of glaucoma and have no treatments available. This device, with a one-minute implant procedure, easy follow-up care and its potential effectiveness, if we can get this to patients who need it, I feel like this is Nobel Prize-winning for Dr. Brown, the inventor. It's that big.