Wicab’s Wearable Vision Device Nears U.S. Market, Thanks to Google

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a black sheet hung on the wall, and Malarsie had to figure out whether the ruler was pointing horizontally or vertically, based on the pattern of the electrical pulses on his tongue as he moved his head around. He felt “this weird tingly sensation,” but it was “not really uncomfortable,” Malarsie says. He could immediately tell which direction the ruler was being held. “I could—I use the word ‘see,’ it’s not sight—I could feel how she was moving this thing, can imagine what it would look like,” he says.

Other exercises included discerning big letters put up on the wall and looking around the room to determine where the windows were, Malarsie says.

“He just really started to explore the room on his own,” Arnoldussen says. “That demo was purely Mike’s doing. I facilitated the trial, but what was the most exciting, was just how intuitive he was.”

For Malarsie, it was the closest thing to sight he’d experienced since an IED buried in a Kandahar road exploded in front of him several months earlier, instantly killing two soldiers and blowing him off a bridge into the river below. Shrapnel hit him in the face, destroying his left eye and tearing his right retina. “From the second it went off, it was pitch black,” Malarsie says.

His memory of the immediate aftermath is “a bit murky.” But he knows that a fellow soldier and a medic pulled him out of the water, then the pair advanced into the nearby village, enemy gunfire raining down on them, to recover the body of the soldier who stepped on the IED, Malarsie says.

In the hospital afterward, Malarsie’s father delivered the news: His two rescuers didn’t make it back alive. All told, four men died and six were wounded that day, he says.

“It was right then that I knew I didn’t have any right to feel sorry for myself to let being blind hold me back,” Malarsie says. “I wouldn’t be alive if it wasn’t for what they did. I decided right then to live my life in a way that would make them happy, proud of me.”

Retired Staff Sergeant Mike Malarsie with his guide dog, Xxon. Photo courtesy of Mike Malarsie.

Retired Staff Sergeant Mike Malarsie with his guide dog, Xxon. Photo courtesy of Mike Malarsie.

Malarsie, 27, who later rose to the rank of staff sergeant, retired from the military in 2013. These days, he travels the country giving speeches about his experiences, writes a blog reviewing technology for blind people, and consults for a guide dog company. He has a wife and three children and sounds upbeat about the future.

The meeting at Google five years ago was one of the moments that made him excited about potential technological advances, as he listened to Google employees spit-balling ideas for improving the BrainPort device. “That was kind of the first time I thought, ‘You know what, with this kind of stuff happening right now, unless I die early, there’s no way I’m going to die without being able to see,’” Malarsie says. “At some point in my life, I’m going to look back and tell my grandkids, ‘Back when I was blind, I used to walk around like this.’ Blindness will be a thing of the past.”

That’s still far from reality, but new technologies that hold promise for the visually impaired are starting to move from research labs into the hands of consumers. California-based Second Sight Medical Products (NASDAQ: EYES) and French company Pixium Vision developed retinal implant systems for people blinded by retinitis pigmentosa. The technology takes images from a video camera attached to glasses and translates them into digital signals expressed as electrical pulses by electrodes in the eye implants. The optic nerve then delivers this information to the brain, which perceives patterns of light—again, not returning full sight, but still providing more stimuli to interpret surroundings than without the device.

One of the challenges is these technologies have high price tags. Second Sight’s product has a base cost of more than $100,000, but the company has secured reimbursement from some insurers, including Medicare in certain situations.

BrainPort’s device costs $10,000, which partly explains why sales have been hard to come by in Europe and Canada. The company intends to conduct additional demonstration studies aimed at securing reimbursement from insurers in Europe, Canada, and the U.S., if the FDA clears the device for sale, Beckman says.

Wicab will try to raise at least $3 million more to fund the additional studies, Beckman says. The company will also try to break into the Chinese market, aided by Haiyin Capital, a Chinese venture capital firm that invested $3 million in Wicab last year.

Beckman doesn’t know when he’ll get an answer from the FDA—Wicab submitted its approval request in August 2013. The process has “taken a lot longer” than he imagined, which he partly blames on caution by the agency as it evaluates the new technology.

Beckman says the study of 75 subjects found that the electrical stimulation on the tongue was safe. Eighteen people dropped out of the study for various reasons, but the majority of those who completed the one-year assessment successfully used BrainPort to identify objects, locate and identify signs while navigating a hallway, and read words on a computer screen. The company intends to market BrainPort as a device that, after some training, can assist blind people with “orientation, mobility, and object recognition,” but is not a replacement for other aids like the white cane and guide dogs, Beckman says.

If the FDA gives BrainPort the green light, the company would still have its work cut out to convince insurers to cover the device, and to continue advancing the technology and simplifying the design to make it more practical. But FDA clearance would still mark a significant step in Wicab’s journey to market.

Malarsie’s experience with BrainPort during a six-month trial in 2011 gives a taste of how the device might help more users in the future. He trained to the point where he could use it to … Next Page »

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