IEEE Robotics & Automation Magazine - March 2016 - 14

insole. The electrodes are made with
the standard microfabrication process
from biocompatible materials; they are
compliant and flexible at the same
time, enabling long-term implantation within the residual nerves. This
was a longtime
bottleneck and
The IEEE Robotics and
object of extensive research,
Automation Society
but we reached
Entrepreneurship
the optimized
design using acStart-up Competition
curate computAward is boosting our
er modeling
conviction even more. and long-term
animal studies,
resulting in a
human proof-of-concept. The implantable neurostimulator is in bidirectional
telemetry communication with the external controller, the brain of the system,
which is dedicated to linking the sensorized insole on the one side and the
implanted device on the other. SENSY
induces several benefits to disabled

IEEE ROBOTICS & AUTOMATION MAGAZINE

Implantable
Stimulator

Neural Electrodes

External
Controller

Sensorized
Insole
(a)

(b)

Figure 1. The working principle of SENSY: the restoration of sensory information to the user
during walking is obtained by the transmission of the sensor readout to the residual nerves by
means of neural stimulation with intraneural electrodes. (a) Stance phase and (b) swing phase.

people: restoration of their complete
physiological sensory functionality, diminution of phantom limb pain, ability to
feel the artificial limb as part of their
own body and psychological amelioration, among others.
During the technology-development
phase, we were still not sure how patients would respond. The clear benefits
indication came in 2013 during our first

march 2016

tests with a hand amputee, who underwent the implantation of four intraneural electrodes over four weeks. By using
a prosthesis equipped with the sensoryfeedback-restoring device, the subject
was able to control the force exerted
with the prosthesis and recognize the
stiffness and shape of objects. Moreover,
the subject had a decrease in phantom
limb pain and, most importantly, perceived the prosthesis as a part of his own
body. Incredibly positive and emotional
feedback from the patient triggered our
inspiration and enthusiasm to go forward and construct the device for use in
lower-limb amputees, which is our target population.
Although we successfully solved several technological pitfalls, U.S. Food and
Drug Administration approval, Conformité Européenne (CE) certifications,
and market entry are big challenges that
have to be faced by any start-up in the
health-care space, with substantial funding of the company being today's priority. Our venture is a synergistic effort
converging expertise from microtechnologies, algorithms, electronics, and
clinical trials, with great dedication and
belief in the social benefit of what we are
doing. The IEEE Robotics and Automation Society Entrepreneurship Start-Up
Competition Award is boosting our
conviction even more.
We strongly believe in and are working hard toward a tomorrow in which
amputations will be treated similarly to
laser operation for the eyes, making the
world a better place in which to live.

Table of Contents for the Digital Edition of IEEE Robotics & Automation Magazine - March 2016