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.”
Notes to editors
캠브리지 컨설턴트(Cambridge Consultants)는 혁신적인 제품을 개발하고, 지적 재산권을 창출 및 라이선스하며, 전 세계 고객을 대상으로 기술 중심 문제를 해결하는 비즈니스 컨설팅 서비스를 제공합니다. 캠브리지 컨설턴트는 60년 이상 기업고객이 신기술을 도입하여 업계 최초로 제품을 출시하거나, 새로운 시장에 진출하거나, 기존 시장을 확장하거나, 사업기회를 상업적 성공으로 전환하도록 지원해 왔다. 엔지니어, 과학자, 수학자 및 디자이너를 포함한 900명 이상의 인원이 캠브리지(영국), 보스턴(미국), 도쿄(동경), 싱가포르(싱가포르)의 연구소에서 의료 기술, 산업 및 소비자 제품, 디지털 보건, 에너지 및 무선 통신 등 다양한 업종에 걸친 솔루션을 제공합니다.더 많은 정보를 원하시면, www.cambridgeconsultants.com를 방문하세요.
케임브리지 컨설턴트(Cambridge Consultants)는 캡제미니 그룹의 혁신 컨설팅 브랜드인 캡제미니 인벤트 (Capgemini Invent)의 소속입니다. 캡제미니 인벤트는 CxO가 조직의 미래를 계획하고 구축할 수 있도록 지원합니다. 30개 이상의 오피스와 25개 이상의 창의적인 연구소를 보유하고 있습니다. 캡제미니 인벤트의 7,000 여개의 팀들은 창의적인 설계, 깊은 산업 전문 지식과 통찰력을 바탕으로 미래의 새로운 디지털 솔루션 및 비즈니스 모델을 개발합니다.
캡제미니 인벤트는 그룹의 핵심적인 부문으로, 기술력을 바탕으로 고객사의 비즈니스를 혁신하고 관리하는 데 있어 기업과 협력하는 글로벌 리더입니다. 캡제미니 그룹은한 포용적이고 지속 가능한 미래를 위하기술을 통해 인간의 에너지를 촉발하려는 목적에 따라 매일 발전됩니다. 거의 50 개국에서 270,000 명의 팀원으로 구성된 책임감 있고 다양한 조직입니다. 우수한 50 년 전통과 깊은 산업 전문성을 갖춘 캡제미니는 빠르게 진화하고 혁신적인 클라우드, 데이터, AI, 커넥티비티 소프트웨어, 디지털 엔지니어링 및 플랫폼에 힘입어 전략 및 설계에서 운영에 이르기까지 비즈니스의 전체 폭을 해결할 수 있도록 고객사로부터 신뢰를 받고 있습니다. 캡제미니 그룹은 2020 년 글로벌 매출이 160 억 유로라고 보고했습니다.
원하는 미래 얻기 | www.capgemini.com
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