Device for treating gait deficit caused by multiple sclerosis receives FDA marketing authorization

Cambridge Consultants, part of Capgemini, and Helius Medical Technologies, Inc. (NASDAQ:HSDT), have confirmed that a groundbreaking device they developed for short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) has received marketing authorization from the U.S. Food and Drug Administration (FDA).

Cambridge Consultants worked with Helius to develop its breakthrough technology to treat patients suffering from neurological disease. The device, known as the Portable Neuromodulation Stimulator (PoNS™), is the first commercial product from Helius and is designed to deliver potentially life-changing therapy via the tongue.

MS is a chronic, degenerative and debilitating disease estimated to affect approximately one million patients in the United States. MS patients can have restriction of mobility, balance, and gait, and can struggle to stand or walk on their own. There has been a lack of access to effective solutions until now.

The PoNS device, developed for Helius by Cambridge Consultants, is a non-invasive, body-worn medical device that delivers controlled neurostimulation to two cranial nerves, via the tongue. It is the first and only tongue-delivered neuromodulation therapy. When used in conjunction with physical therapy, PoNS Treatment is believed to enhance a patient’s neuroplasticity – the brain’s ability to restructure or relearn new functions. Enhanced neuroplasticity improves a patient’s ability to learn, train, and rehabilitate. Patients in the United States suffering from gait deficit due to mild-to-moderate symptoms from MS can benefit from PoNS Treatment, which has the potential to improve, or even restore, their ability to walk.

The PoNS device is the result of complex systems engineering and technological innovation, while the science behind how the device stimulates the tongue is unique. Sophisticated electronics, firmware and software are integrated – via intricate mechanical design – in an ergonomic form factor. The body-worn, interactive controller, designed for user-centric patient and clinician workflow, is coupled with a mouthpiece electrode system that delivers precise neurostimulation during therapeutic exercise. A clinician interface with cloud-based data management software provides clinicians with a digital ecosystem to enable efficient patient care. 

Cambridge Consultants works with ambitious and visionary companies seeking to disrupt the status quo. In the medical technology space, the company has a long track record of developing breakthrough medical devices, technologies and services for pharmaceutical, life sciences, surgical, and acute care applications.

Cambridge Consultants has provided Helius with design and development services for the past four years, delivering world-class systems and expertise for the PoNS device. Our multidisciplinary expertise spans electronics, software, mechanics, design for manufacturing, industrial design and human factors. The Cambridge Consultants team worked closely with Helius, and its manufacturing partner, from system design through to verification, transfer to manufacturing, and new product introduction. 

Rahul Sathe, Head of Medical Innovation, Cambridge Consultants, said: “The development collaboration between Helius and Cambridge Consultants has been built on commercial vision, clinical science, product innovation, and technology expertise. These are the ingredients enabling us to create world-changing innovation and products that transform our clients’ businesses. We congratulate Helius on their milestone achievement to deliver life-changing therapy to significantly underserved MS patients.”

Dane Andreeff, Interim President and Chief Executive Officer of Helius, added: “The PoNS device is now the first, and only, medical device cleared in the U.S. for this indication. This milestone represents the most important achievement of our organization. I would like to take this opportunity to thank Cambridge Consultants for their contributions. Their team successfully delivered the unique combination of disciplines and expertise required to complete our project. The result of these efforts, our PoNS device, has the potential to significantly improve the ability of MS patients to walk and as a result may enhance their safety and quality of life.”