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Breakthrough Device Designation for EIT Health Headstart winner: SensArs Neuroprosthetics

SensArs Neuroprosthetics Sàrl. has received Breakthrough Device Designation by the US Food and Drug Administration (FDA) for its SENSY System.

6.9-10% of the world population is affected by chronic neuropathic pain. Drugs are often not effective in the treatment, which could be replaced with neuromodulation, however, the currently available neuromodulation therapies only have partial effectiveness, along with partial patient satisfaction, as well as worsening long-term benefits. Thus, SensArs offers a solution by inserting a patented implantable electrode inside the nerve, allowing the physiological activation of the nerve fibres that elicit natural and pleasant movement and touch sensations. By doing so, neuropathic pain can be eliminated.

The company´s first application, SENSY is a unique worldwide device to restore sensory feedback to leg amputees through their prostheses. The system is built up of a novel implantable stimulator that allows access to fascicles inside the nerve, which enable a highly selective stimulation. The device is able to retrieve naturalistic sensations of the limb with pinpoint selectivity thanks to its external sensors, hence, offering optimal coverage and mitigation of painful areas.

The winner of the EIT Health Headstart award 2018 and finalist in the 2018 edition of European Health Catapult, SensArs Neuroprosthetics and its CEO Francesco Petrini, have earlier also featured in MIT´s list of European Innovators Under 35, and according to François Jouen, Director of Studies and Senior Researcher at the Ecole Pratique des Hautes Etudes, SENSY “proposes a very innovative approach to restoring the processing of sensory information for people with amputations.” 

This great achievement of receiving the Breakthrough Device Designation is a huge step towards SensArs’ mission of bringing their therapy to millions suffering from chronic peripheral neuropathic pain and/or movement disabilities due to sensory loss.

Francesco Petrini, PhD., CEO of SensArs, commented:

“We are thrilled to have received the Breakthrough Designation, as it further confirms the novelty of our technology putting us at the forefront of peripheral neurostimulation. Our breakthrough approach for interfacing with the nerve will allow high selectivity enabling the patient to regain the natural sensation of the limb like no other technology before. Furthermore, this designation is especially attractive due to the quicker path to Medicare reimbursement coverage we anticipate under the MCIT(Medicare Coverage of Innovative Technology), following FDA market authorization.”