A Canadian startup company is developing a wireless shoe insert that will help people with diabetes manage peripheral nerve damage and hopefully prevent amputations that often stem from diabetic foot ulcers.
Orpyx Medical Technologies, based in Calgary, Alberta, will soon be seeking regulatory approval in the U.S. and Canada to sell SurroSense Rx, an insole that that collects data of where wearers are putting pressure on their feet. The sensor wirelessly transmits data, following the ANT+ standard, to a wristwatch-type display or to a smartphone, alerting users that they might be putting too much pressure on their heels and risking numb feet that can lead to ulcers.
"Many cases [of diabetic peripheral neuropathy] are because people have no idea of the pressure they're putting on their feet," Amanda Hehr, VP of marketing at Orpyx, tells MobiHealthNews.
According to the company, more than 60 percent of diabetic patients will suffer from foot numbness, and the inability to feel pain is a leading cause of ulceration and eventually amputation. Prevention can reduce the risk of amputation by as much as 85 percent, Orpyx says in its marketing material.
Hehr says SurroSense Rx, should go on sale by November as a Class I medical device, pending, of course, clearance from the FDA in the U.S. and from Health Canada north of the border.
Orpyx, which was co-founded and is headed by Dr. Breanne Everett, a resident in plastic and reconstructive surgery at the University of Calgary, also is working on a product called SurroGait Rx, which pairs the shoe insert with a sensor worn on the back. The insole wirelessly sends pressure information to the back sensor, which transposes sensation to the back that a numb foot cannot feel, based on the concept of neuroplasticity.
The idea, according to Hehr, is for users to learn to "feel" their feet via their backs and eventually train their brains to recognize signs of diabetic peripheral neuropathy. Orpyx will start clinical trials on SurroGait Rx early next year in hopes of bringing the product to market by 2014.
Everett explained the technology – along with the "democratization of data" in healthcare and innovation in medicine – at TEDxYYC, a TED-affiliated event held in Calgary on May 25. Watch a video of that presentation here.