Providence-based Afferent Corp. announced that research involving its technology
in treating nerve dysfunction stemming from diabetes will be published in the
clinical journal Diabetes Care.
Jason D. Harry, the company’s president and CEO, said the journal’s prestige helps to further Afferent’s journey toward putting out a product.
“I think this brings us a lot closer to market,” said Harry. “We can’t come close to the technical development without first getting proof of principle on the clinical end.”
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He added that the study was done in collaboration with Harvard University with “leading researchers in the field of diabetes,” which is another factor that lends a sense of integrity to the project.
The pilot study included 20 subjects with moderate to severe nerve damage in their feet classified as peripheral neuropathy.
Harry said these individuals have a much higher threshold for sensation than a normal person does due to decreased blood flow caused by diabetes.
The subjects were outfitted with modified Teva sandals in which the soles contained a prototype of Afferent’s product. The gel insoles, which are imbedded with coils that generate tiny electrical currents, predispose the damaged nerves to take in the stimulation and react.
“If you imagine nerves as a trigger of a gun, it’s kind of like pushing the trigger most of the way and then leaving the finger only one-sixteenths of an inch further to go,” he said. “Our technology fills in the space below the threshold.”
According to Harry, the technology made it, on average, 10 percent to 20 percent easier for subjects to feel the sensation, depending on which of the two types of tests were administered.
He said the Afferent insoles aim at cutting the incidence of foot ulcers in diabetes patients.
“The ulcer is difficult to heal and they often become infected,” he said, adding that ulcers turn to gangrene which leads to amputations that increasingly become more severe.
The cost of dealing with health-related issues involving loss of protective sensation, or LOPS, is $4 billion.
Dr. Aristidis Veves, director of the Joslin-Beth Israel Deaconess Foot Center in Boston and Afferent collaborator, said the findings of the research are significant.
“Although further clinical testing is required, this result is an advance toward what may prove to be an important new therapy,” he said.
Harry says the company is about 18 months to 24 months from developing a product to put out to market.
James Collins, a Boston University engineer and faculty member, conducted tests and developed much of the underlying research and technology. A previous study about the Afferent insoles was published in the British medical journal Lancet.
Research in that study focussed using the technology to improve balance in older subjects. The National Center for Injury Prevention said Americans 65 and older fall at least once a year and a 1994 study found the cost of fall-related injuries is $20.2 billion.
The company is also using its technology for products to help stroke patients.
Afferent, formerly Sensory Technologies Inc., was formed in 2000 and received $2.8 million in financing, including about $1.1 million from the National Institutes of Health and $1.3 million in equity investment.
The diabetes research was funded through a phase 1, $100,000 grant through
the National Institutes of Health.












