RxFunction (Eden Prairie, Minn.) today announced the market launch of Walkasins, its wearable, lower-limb sensory neuroprosthesis designed to improve balance and gait in patients with sensory peripheral neuropathy.
The announcement came at the American Physical Therapy Association NEXT 2019 Conference in Chicago.
RxFunction said it will initially offer Walkasins within the Veterans Administration, which has a large number of veterans with peripheral neuropathy. Walkasins have two components – a leg unit and a foot pad. The insoles measure the user’s foot pressure and give immediate gentle and tactile sensory cues so that they can control balance and stability, according to the company.
The company recently released the results of a randomized cross-over study of 31 male veterans aged 56-84 who lack sensation in their feet. Most had fallen within the previous six months. At the end of two treatment sessions, 16 of the men had improved their functional gait assessment score to normal fall-risk status. The study also found that the sensory balance information provided by Walkasins more than doubled the likelihood of improving clinically measurable balance. The study was conducted in collaboration with the Center for Veterans Research and Education under a grant from the National Institute of Health (NIH). Results were published recently in the journal PLOS One.
“The completion of product development and the move to market launch and production is an exciting and historic moment for our company,” RxFunction CEO Tom Morizio said in a news release. “This marks the culmination of building the organization, hiring and training sales and operational staff, launching our walk2Wellness long-term clinical trial and publishing results of an earlier clinical trial in PLOS ONE. We will first offer Walkasins within the Veterans Administration, which has a large number of veterans with peripheral neuropathy who may benefit from our product.
“With the Walkasins market launch, RxFunction is poised to play a leadership role in development of innovative wearable technology for those with this disabling neuromuscular disorder,” Morizio stated.
“I am incredibly pleased to see the technology that we’ve been researching and developing for many years reach completion and move into production,” added Lars Oddsson, co-inventor of Walkasins and co-founder of RxFunction. “This brings us one step closer to helping people suffering with peripheral neuropathy.”
Morizio also said that the walk2Wellness long-term clinical trial soon will be expanded with two additional sites. The walk2Wellness study, designed to determine the effectiveness of Walkasins on peripheral neuropathy patients with a high risk of falling, began in late 2018 at three U.S. medical centers: Veterans Administration Medical Center in Minneapolis; Fairview Health Services in Minneapolis; and Baylor College of Medicine in Houston, Texas. The study will evaluate Walkasins’ impact on approximately 125 patients for up to one year. More information about study site locations, enrollment status, and requirements can be found at ClinicalTrials.gov.