FDA Signs Off on Sales of Wicab’s BrainPort Device to Help Blind “See”

Xconomy Wisconsin — 

After more than five years of clinical evaluations and regulatory review, the FDA has given Wicab the green light to begin selling its “BrainPort” device in the U.S.—a product that helps blind people “see” through electronic impulses on their tongues.

Middleton, WI-based Wicab’s device involves a small video camera mounted to sunglasses that are connected via an electrical cord to a square-shaped, lollipop-like mouthpiece with a grid of 400 electrodes. The video feed is translated into digital signals expressed by the electrodes as light electronic pulses on the tongue. White pixels from the camera are translated into strong pulses, gray pixels feel slightly weaker, and black pixels result in no stimulation; the device can also reverse that so that darker images trigger the stimulation and lighter ones do not.

The sensation, which feels similar to “Pop Rocks” candy, is meant to evoke in the mind a picture “painted on the tongue with tiny bubbles,” the company says—a much more sophisticated version of the children’s game where you interpret words traced by fingers on your back.

The battery-powered device is intended for use with a cane or guide dog and, with training and experience, is meant to help blind people determine the “location, position, size, and shape of objects, and to determine if objects are moving or stationary,” the FDA said in a press release.

The FDA cleared the device for sale in the U.S. based on a 74-person clinical trial that was funded by Google. In the yearlong study, 69 percent of participants successfully used BrainPort to recognize objects, which was the study’s primary goal, Wicab said. Some study participants also successfully used the device to identify words and complete mobility tasks. The FDA said that some subjects “reported burning, stinging, or metallic taste associated with” the device, but there were no serious side effects from using it.

Wicab submitted an application for FDA clearance in August 2013, but didn’t receive the sale approval until last week. Part of the reason for the lengthy wait was that Wicab’s device was being evaluated under the de novo review process, which is for medical devices that are of “low to moderate risk,” but are not substantially similar to devices already on the market.

The FDA clearance is “very rewarding because we spent five years-plus in terms of not only the FDA process for review, but also designing and then conducting the clinical study,” Wicab CEO Robert Beckman said in a phone interview.

But now the really hard part begins for Wicab. Its device costs $10,000, so securing reimbursement from insurers will be crucial to sales growth. The high cost of the device has been one of the sales challenges in Canada and Europe, where the BrainPort was previously approved for sale.

The company intends to apply for insurance reimbursement with the Centers for Medicare & Medicaid Services in January, when the federal agency begins its annual review process, Beckman said.

The company intends to start its U.S. sales push on a small scale by partnering with nonprofit advocacy and training groups for the blind in New York and Chicago. Wicab will lead BrainPort demonstrations and training workshops with those organizations, which company leaders hope will lead to sales, Beckman said.

Wicab also said it intends to form partnerships with philanthropic groups that might purchase the devices and donate them to users who can’t afford the BrainPort.

Wicab, which has snagged around $26 million in grants and venture capital over the past decade, plans to raise more funds to help boost sales and marketing, Beckman said.

The next target for the company is selling its product in China, a strategy aided by Haiyin Capital, a Chinese venture capital firm that invested $3 million in Wicab last year. The market opportunity is larger overseas—about 5 million people are “profoundly” blind in China, according to Wicab’s research, as compared with more than 1 million blind people in the U.S., according to federal data.

“No doubt we’re more than a year away before we’re able to commercialize the device in China,” Beckman said. “But we intend to pursue that.”

The good news for Wicab is the Chinese approval process will likely be shorter and less expensive than in the U.S. Wicab will need to conduct another clinical study, but it will likely be a smaller one than the U.S. trial; and the government review should be quicker, Beckman said.