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.
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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.”
Cambridge Consultants develops breakthrough products, creates and licenses intellectual property, and provides business consultancy in technology-critical issues for clients worldwide. For more than 60 years, the company has been helping its clients turn business opportunities into commercial successes, whether they are launching first-to-market products, entering new markets or expanding existing markets through the introduction of new technologies. With a team of more than 900 staff, including engineers, scientists, mathematicians and designers, in offices in Cambridge (UK), Boston (USA), Tokyo and Singapore, Cambridge Consultants offers solutions across a diverse range of industries including medical and life science, industrial and energy, consumer and retail, and communications and infrastructure. For more information, visit: www.cambridgeconsultants.com
Cambridge Consultants is part of Capgemini Invent, the innovation, consulting and transformation brand of the Capgemini Group. Capgemini Invent helps CxOs envision and build what’s next for their organisations. Located in more than 30 offices and 25 creative studios around the world, its 7,000+ strong team combines strategy, technology, data science and creative design with deep industry expertise and insights, to develop new digital solutions and business models of the future.
Capgemini Invent is an integral part of Capgemini, a global leader in partnering with companies to transform and manage their business by harnessing the power of technology. The Group is guided everyday by its purpose of unleashing human energy through technology for an inclusive and sustainable future. It is a responsible and diverse organisation of 270,000 team members in nearly 50 countries. With its strong 50 year heritage and deep industry expertise, Capgemini is trusted by its clients to address the entire breadth of their business needs, from strategy and design to operations, fueled by the fast evolving and innovative world of cloud, data, AI, connectivity, software, digital engineering and platforms. The Group reported in 2020 global revenues of €16 billion.
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About Helius Medical Technologies, Inc.
Helius Medical Technologies is a neurotech company focused on neurological wellness. The Company’s purpose is to develop, license and acquire unique and non-invasive platform technologies that amplify the brain’s ability to heal itself. The Company’s first commercial product is the Portable Neuromodulation Stimulator (PoNSTM). For more information, visit www.heliusmedical.com.
About the PoNS Device and PoNS Treatment
The Portable Neuromodulation Stimulator (PoNS™) is an innovative non-surgical medical device, inclusive of a controller and mouthpiece, which delivers mild electrical stimulation to the surface of the tongue to provide treatment of gait deficit and is indicated for use in the United States as a short-term treatment of gait deficit due to mild-to-moderate symptoms from multiple sclerosis (MS) and is to be used as an adjunct to a supervised therapeutic exercise program in patients 22 years of age and over by prescription only. The PoNS device is authorized for sale in Canada as a class II, non-implantable, medical device intended as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS, and chronic balance deficit due to mild to moderate traumatic brain injury (mmTBI) and is to be used in conjunction with physical therapy. The PoNS device is an investigational medical device in the European Union (“EU”) and Australia (“AUS”). It is currently under premarket review by the AUS Therapeutic Goods Administration.
- multiple sclerosis