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.

We design disruptive technology to revolutionize diagnosis and treatment.

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

ケンブリッジコンサルタンツは、画期的な製品開発、知的所有権の創出や供与、技術的な難題に対するビジネスコンサルティングを、世界中のお客様に向けて行っています。市場初となる製品の立ち上げや新規市場参入、新技術導入による既存市場の拡大など、お客様がビジネスチャンスを成功へと変えるお手伝いを60年以上にわたり継続してきました。英国ケンブリッジ、米国ボストン、東京、シンガポールに、エンジニアや科学者、数学者やデザイナーを含む900名以上のスタッフを擁し、医療機器、ライフサイエンス、産業機械、エネルギー、消費財、流通、通信、インフラストラクチャなど、多様な分野におけるソリューションを提供しています。詳細はwww.cambridgeconsultants.comをご参照ください。

ケンブリッジコンサルタンツは、デジタルイノベーション、コンサルティング、トランスフォーメーションを統合したグローバル・ビジネス・ライン、「キャップジェミニ・インベント」の一員です。キャップジェミニ・インベントは、経営責任者たちの構想、次の一手の策定支援を行います。世界中の30のオフィスと25のクリエイティブ・スタジオにある7,000以上の強力なチームで構成され、戦略、技術、データサイエンス、クリエイティブ設計領域において、市場をリードする専門家集団を組織します。

キャップジェミニ・インベントは、テクノロジーの力を活用して企業ビジネスの変革・管理を支援するパートナーシップにおけるグローバルリーダーである、キャップジェミニの一部門です。キャップジェミニ・グループは、テクノロジーを通して人々が持つエネルギーを解き放つことで、包摂的で持続可能な未来を目指し、日々まい進しています。世界約50ケ国の27万人に及ぶチームメンバーから成る、極めて多様的で責任感の強い組織です。キャップジェミニは、50年にわたって積み上げてきた経験と実績そして豊かな専門知識を活かし、クラウド、データ、AI、コネクティビティ、ソフトウェア、デジタルエンジニアリング、プラットフォームなど、急速に進化するイノベーティブなテクノロジーを原動力として、戦略から設計、オペレーションに至るまで、お客様の幅広いビジネスニーズすべてに対応して、お客様から厚い信頼をいただいています。グループ全体の2020年度の売上は、160億ユーロです。

Get the Future You Want – 望む未来を手に入れよう | 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.

  • PoNS
  • multiple sclerosis
  • Helius
  • Neuromodulation
  • neurostimulation

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