The Albuquerque company, which launched in 2008 with advanced diagnostic software developed at the University of New Mexico, expects to begin its first clinical study next year for U.S. Food and Drug Administration approval of its technology. The company achieved government certification for its retinal-screening system in Mexico this year, and it is now using it to screen thousands of diabetic patients in Monterrey in partnership with the Mexican chain of diabetes service offices Clinicas del Azúcar.
“We’re making a lot of progress,” VisionQuest founder and CEO Peter Soliz said. “We’ve started generating revenues from commercial operations in Mexico, and we’re pushing forward with the steps needed for FDA clearance.”
The company is a veteran of Technology Ventures Corp.’s annual Deal Stream Summit, where it presented to investors on three occasions, including fall 2015. Its new $1.5 million grant from the National Institutes of Health, which it received in September, puts VisionQuest halfway toward the $3 million fundraising goal it set at TVC last year.
The company has actually raised about $16 million in NIH and Small Business Innovation Research grants over the past eight years, about $5 million of which it used to develop its software system.
The company created two software technologies: one to make sure retinal images are up to the quality standards needed for analysis and another to rapidly screen those images to determine whether a patient shows signs of eye damage from diabetes and needs to be seen by an ophthalmologist.
“Our patented technology detects specific features in the retina to identify which ones have retinal disease that can lead to blindness,” said Simon Barriga, VisionQuest president and chief research scientist. “The objective is to screen out the patients who don’t need to see an ophthalmologist, which accounts for about 80 percent of diabetics, and rapidly identify the 20 percent who have developed advanced stages of disease and require intervention.”
That rapid screening process is critical, given the pandemic expansion of diabetes worldwide, with about 29 million diabetics in the U.S. and about 485 million globally.
“They all should be examined every year, because retinal disease is now the leading cause of blindness in the working-age population,” Barriga said. “But there’s not enough doctors to do the exams in the U.S. or elsewhere. Our technology can provide greater access to retinal exams for those who need it.”
The company has incorporated its image-quality assurance software in handheld commercial retinal cameras so that even amateur photographers in clinics will know if the images they’re taking are adequate for analysis.
“Many clinics have inexperienced photographers who don’t know a good image from a bad one, so our software tells them if the picture is good enough before the patient leaves,” Soliz said.
Separately, the company is developing technology to screen diabetes patients for peripheral neuropathy in feet. That’s a condition in which a person loses sensation because of damage to the nerves, which can lead to undetected sores or infections because the patient can’t feel them, and it often progresses to the point at which amputation is necessary.
VisionQuest’s software will measure sense deterioration with infrared imaging based on how well a patient regains feeling in his or her feet after a cold patch is applied to the skin.
“Temperature recovery is different in patients with and without the disease, because the nerve ends are compromised,” Barriga said. “We can detect the disease early this way. That’s important, because many patients go to the doctor when they already have problems with foot ulcers, but you want to catch it before that point.”
The company recently received a $1.5 million grant to further develop that technology. It will launch a clinical study with 400 patients next year at the UNM Health Sciences Center.
Other technologies under development include software to diagnose retinopathy in infants born prematurely that can lead to blindness if untreated, and software to identify malarial retinopathy, which can indicate cerebral malaria. That disease kills about 500,000 children in Africa every year.
But the retinal screening system for diabetics is the most advanced technology, constituting the company’s core product. The company sought Mexican regulatory approval for commercial deployment first because certification is easier to achieve there and in other countries than it is in the U.S.
Through its partnership with Clinicas del Azúcar, VisionQuest’s system has been used to screen about 7,000 diabetes patients this year. It will examine about 10,000 more next year, said Gilberto Zamora, VisionQuest’s director of clinical operations.
The system has proved 100 percent accurate in identifying patients with potential eye damage who need to see an ophthalmologist, Zamora said. And it’s cut the eye-care workload at the Mexican clinics by 50 percent, allowing the staff to see a lot more patients.
In the U.S., the company’s new NIH grant will allow it to take the first big steps toward FDA approval of its technology. It’s now working to standardize its software technology for easy commercial use.
Next year, VisionQuest will launch a clinical study with 600 patients in up to 10 medical centers nationwide. The results will be submitted to the FDA in 2018.
The company still needs about $1.5 million more to carry it through the FDA approval process and to begin marketing its technology in the U.S. But VisionQuest is now a lot closer to commercialization, Soliz said.
The company employs 15 people at a 2,500-square-foot facility at 2501 Yale SE near the Albuquerque International Sunport.