Two factors define the Wicab story: First - sometimes a failure to get FDA approval can be the trigger to re-think product usage. Second - when Money sources - this the Army and Google - support that rethink, something very important - and life-changing - for potentially millions can occur.
Date: Feb 09, 2015 Author: Jeff Engel Source: xConomy (
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Paul Bach-y-Rita believed technology could help blind people to, in a way, "see" the world around them by substituting touch for sight. After 17 years and nearly $26 million in total funding, the late scientist's company, Wicab, is closer than ever to turning his idea into reality.
Wicab has gotten some international attention in the past decade for its "BrainPort" device that converts video signals to electronic pulses that are felt on the tongue. But what isn't widely known is that the company had been on the brink of failure - and that it took refocusing on the vision problem, plus some help from the U.S. military and tech giant Google, to right the ship.
The Middleton, WI, company is now seeking regulatory approval in the U.S. In pilot tests, Wicab's device has helped blind people navigate sidewalks without a guide dog or cane, aided a blind rock climber to more confidently pursue his passion, and helped blind children in China learn to recognize Mandarin characters and play games of darts.
The technology is based on decades of research by Bach-y-Rita, who pioneered the field of "neuroplasticity," the idea that the brain can reorganize itself and that senses can substitute for one another - in this case, the tongue's dense group of receptors delivering information to the brain that would normally arrive via the optic nerve. Bach-y-Rita and his team showed that the brain can be trained to interpret this sensory data and, although it wouldn't perfectly replicate vision, it could help the blind to better perceive their surroundings.
"Paul famously said we see with our brains and not with our eyes," Wicab CEO Robert Beckman says. "The eyes are sensors. If the sensor is damaged or not working, you can provide an alternate sensor to provide the information to the person's brain."
The BrainPort device mounts a small video camera 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. The tongue is an ideal choice for the contact point partly because it's chock full of nerve endings and is constantly coated in saliva, all the better for conducting the electronic pulses. 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 one interprets words traced by fingers on their back.
Wicab BrainPort V100
Bach-y-Rita, a former University of Wisconsin-Madison researcher, died in 2006 from lung cancer. But his company continued his work, and is now closer to commercializing the BrainPort device in the U.S., after getting approval to sell the product in Europe and Canada in 2013. Wicab is getting ready to publish positive results from a small clinical trial testing the technology, and it awaits U.S. Food & Drug Administration clearance to sell the medical device here, Beckman says.
Wicab's story is an example of the twists and turns a medical startup can take as it tries to make the sometimes-perilous leap from the research lab to a successful business. A decade ago, the company had a different focus. Between 2005 and 2006, it had convinced investors to pump more than $10.5 million into commercializing its experimental technology primarily for the purposes of helping people with balance problems. At the time, the company combined the electrode-equipped mouthpiece with an accelerometer, which can tell when something tilts. The device would emit soft pulses of electric current that formed a pattern on the person's tongue. If the person stayed upright, the pattern would remain in the middle of the tongue, but it would shift if the person started to tip over. The technology was thought to help people with chronic balance issues, perhaps through damaged inner ears or a stroke, to train themselves to maintain balance, Beckman says.
Wicab poured money into a clinical trial to test its theory. The device indeed showed it could help people improve their balance, but those in the control group who used a sham device also improved their balance via the series of exercises completed as part of the study, Beckman says.
The clinical trial had failed, and Wicab was running low on capital and forced to lay off a chunk of its staff, which had been in the 20s. "To be quite honest, I thought we were dead in the water," Beckman recalls.
But Wicab stayed afloat thanks to two things. First, it shifted its focus toward applying the technology to help the blind, Beckman says.
Second, it won funding in 2010 from two high-profile sources to pursue its new plan. One was the U.S. Department of Defense, which awarded Wicab a $3.2 million grant to see if the technology could help soldiers blinded by improvised explosive devices in Iraq and Afghanistan. The other source was Google, which gave Wicab $2.5 million to fund the 75-person study, but didn't take an equity stake in the company, Beckman says.
The Google funding was serendipitous for Wicab. A U.S. Air Force general and a Silicon Valley venture capitalist heard about the BrainPort device and arranged a demonstration at Google's headquarters in California. The pair wanted to help Mike Malarsie, an Air Force senior airman who was recently blinded by an IED in Afghanistan.
Malarsie tried out the BrainPort after a quick tutorial by neuroscientist Aimee Arnoldussen, who at the time was leading Wicab's clinical research. Among the spectators were a few Google employees, including Eric Schmidt, Google's executive chairman and former CEO, Arnoldussen says. Google later decided to back further BrainPort research partly because "they witnessed somebody benefiting from the technology and wanted to make a difference for people who are blind," Beckman says.
Malarsie says he was confused at first by the concept of the device. "You're going to put this thing on your tongue and it's kind of going to draw what you're looking at. When they said it, it made absolutely no sense," he says.
But he quickly got the hang of the BrainPort, Arnoldussen says. In one of the tests, she held a ruler against 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 walk down the sidewalk without his guide dog or a cane. "It was a liberating experience to walk somewhere outside without my hands outstretched in front of me, without a cane. It's something I haven't done since losing my sight. It was pretty awesome."
In addition to navigation, BrainPort was useful for discerning where people were located in a room. There would be too much stimuli for it to be useful in a crowd of people, Malarsie says, but he could use it to chase his children around the house and "see" where they were going, for example. "It kind of helps with a sense of inclusion," he says. "So, just to have a sense of where people are sitting, how many people are around - that's extremely helpful."
Although Wicab has made the device less bulky over time, Malarsie says it could be improved if it used a smaller camera that wasn't so noticeable, and also was higher resolution; if it didn't have any wires; and if it didn't require the user to hold the lollipop device in the mouth and take it out with their hand to talk. He didn't mind that strangers stared at him while wearing the contraption because it was useful to him, but he knows some blind people wouldn't want to wear the device in its current form. "They already stand out; they don't want to stand out more," he says.
Beckman says Wicab is aware of these inconveniences and is working to tweak the design and continue improving the technology.
Wicab intends to eliminate the handheld device that controls the intensity of the electronic pulses and the camera zoom, instead placing those controls on the glasses. That would free up one of the user's hands, which would be useful because a cane or a guide dog leash might occupy the other hand, Beckman says.
The company considered converting the lollipop device into a retainer that would sit on the roof of the mouth, and the person would lift the tongue and touch it to feel the electrical stimulation. But focus groups raised concerns about the possibility of misplacing the retainer, so the company intends to keep the lollipop device tethered to the glasses, Beckman says.
Beckman acknowledges that the current version of BrainPort looks "somewhat strange," and he recognizes that blind people "are still very much aware of aesthetics." But people's reactions can change after they get used to seeing new gadgets. "The first time I saw somebody with a Bluetooth in their ear, I thought that was really odd," Beckman says. "I believe that wearable technology, including glasses, are going to continue to be developed. As that happens, our technology will fit right in."
A next frontier for Wicab is partnering with software developers to integrate mobile apps with BrainPort, which would open up new possibilities for more advanced and complementary features, Beckman says. "We need to couple the capability we have - which is to interpret simple information, or the big picture, I would call it - with the Internet, which has the ability already to decipher and interpret complex information."
One of the early ideas is that a blind person could tell the mobile app she is seeking, say, a bus stop. The app could look online to find the next bus's estimated time of arrival, while also helping steer the user to the bus stop. The app could have access to the BrainPort's video feed and could communicate to the user - perhaps audibly, or through a signal on the tongue, or through bone conduction, a la Google Glass - that the bus stop is within view.
Beckman equates it to the technology that will enable driverless cars to stay within lanes and identify the signals of traffic lights.
"A lot has developed in computer vision, face recognition, contextual understanding of surroundings, the idea of tapping into cloud resources, that didn't exist" several years ago, says Arnoldussen, who left Wicab in 2012 but still consults for the company. Once BrainPort can integrate those types of technologies, she adds, "I think the impact will be quite strong."
Simplifying the logistics of operating the device and combining it with mobile apps are the key to making BrainPort a more practical technology right "out of the box," Beckman says. "I think the device, as it is, is useful and will meet with some success. But I think where we're headed is in a direction that will greatly expand the number of people that want to purchase the technology."
