Inclusion of the top neurorehabilitation centers REHABOLOGYM, Neurology Center of New England, and MGH Institute of Health Professions completes site participation enrollment for the U.S. registrational program in stroke

顶级神经康复中心REHABOLOGYM、新英格兰神经病学中心和MGH卫生专业研究所的加入完成了美国中风登记项目的现场参与登记

In Canada, an additional study on the use of Portable Neuromodulation Stimulator (PoNS®) Therapy to treat stroke has started to support Canadian reimbursement and U.S. approval for stroke

在加拿大，关于使用便携式神经调节刺激器（PoNS®）治疗中风的另一项研究已开始支持加拿大报销和美国批准中风

NEWTOWN, Pa., June 17, 2024 (GLOBE NEWSWIRE) -- Helius Medical Technologies, Inc. (Nasdaq:HSDT) (“Helius” or the “Company”), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, today announced the completion of site participation enrollment for its stroke registrational program in the U.S.

宾夕法尼亚州纽顿，2024年6月17日（环球通讯社）--Helius Medical Technologies，Inc.（纳斯达克：HSDT）（“Helius”或“公司”），一家专注于为平衡和步态缺陷提供新型治疗性神经调节方法的神经科技公司，今天宣布完成其在美国的中风登记项目的现场参与登记。

with the addition of REHABOLOGYM, Neurology Center of New England (NCNE), and MGH Institute of Health Professions (MGH-IHP). The stroke registrational program, which also includes Brooks Rehabilitation and Shepherd Center, is designed to establish the effects of cranial-nerve non-invasive neuromodulation (“CN-NINM”), delivered using PoNS Therapy®, on gait and dynamic balance in chronic stroke survivors..

随着REHABOLOGYM，新英格兰神经病学中心（NCNE）和MGH卫生专业研究所（MGH-IHP）的加入。中风登记计划还包括布鲁克斯康复和牧羊人中心，旨在确定使用PoNS Therapy®提供的颅神经非侵入性神经调节（“CN-NINM”）对慢性中风幸存者步态和动态平衡的影响。。

Under the direction of Avrielle Rykman Peltz, M.A., OTR/L and Dr. Jay Lombard, D.O., REHABOLOGYM has already enrolled six subjects and expects to reach at least ten patients by early July. NCNE and MGH-IHP joined the study in May and June, respectively, and both sites will begin enrollment in July. Brooks Rehabilitation started enrollment in April with three participants to date while Shepherd Center enrolled two participants in May and expects to add two more by the end of June.

在医学硕士AvrielleRykman-Peltz，OTR/L和D.O.Jay Lombard博士的指导下，REHABOLOGYM已经招收了六名受试者，预计到7月初将至少招收十名患者。NCNE和MGH-IHP分别于5月和6月加入该研究，两个网站将于7月开始注册。布鲁克斯康复中心于4月开始招生，迄今已有三名参与者，而牧羊人中心于5月招收了两名参与者，预计到6月底还会增加两名参与者。

Helius anticipates enrolling at least thirty patients into the open label study, across all sites, by the end of the third quarter..

。。

“PoNS Therapy has demonstrated the ability to generate neuroplasticity, essentially rewiring parts of the brain to significantly and meaningfully improve gait and balance in chronic stroke survivors. With the addition of REHABOLOGYM, NCNE, and MGH-IHP, we now have five of the top neurorehabilitation centers in the U.S.

“脑桥疗法已证明具有产生神经可塑性的能力，基本上可以重新连接大脑的某些部分，以显着和有意义地改善慢性中风幸存者的步态和平衡。随着REHABOLOGYM，NCNE和MGH-IHP的加入，我们现在拥有五个美国顶尖的神经康复中心。

participating in our stroke registrational program, which will significantly bolster our FDA submission when we submit for regulatory approval in 2025,” said Dr. Antonella Favit-Van Pelt, Helius’ Chief Medical Officer..

参加我们的中风登记计划，当我们在2025年提交监管部门批准时，这将大大支持我们向FDA提交的申请，”Helius首席医疗官Antonella Favit Van Pelt博士说。。

“Having spearheaded several research studies on stroke funded by premier public and private medical establishments, Dr. Lombard and I see great potential for PoNS to assist with stroke recovery and are thrilled to partner with Helius on this groundbreaking, multi-center research trial. REHABOLOGYM’s goal is to accelerate the advancement of cutting-edge technologies, especially when they can pair with therapeutic interventions to deliver long-lasting improvements for people affected by neurological conditions and injuries.

“Lombard博士和我领导了几项由顶级公共和私人医疗机构资助的中风研究，他们认为脑桥在帮助中风康复方面具有巨大潜力，并很高兴与Helius合作进行这项开创性的多中心研究试验。REHABOLOGYM的目标是加速尖端技术的进步，特别是当它们可以与治疗干预相结合时，可以为受神经系统疾病和伤害的人提供持久的改善。

PoNS Therapy perfectly aligns with our mission, and we believe that together we can help bring new, validated therapies to the neurologically impaired,” said Avrielle Rykman Peltz, M.A., OTR/L, Co-Founder & Chief Operating Officer of REHABOLOGYM..

脑桥疗法与我们的使命完美契合，我们相信，通过共同努力，我们可以为神经系统受损者带来新的、经过验证的疗法，”REHABOLOGYM联合创始人兼首席运营官Avrielle Rykman Peltz，M.A.，OTR/L说道。。

“Leading research suggests that the brain has significant plasticity, with the ability to establish new pathways after various types of brain injuries including stroke. With the only portable and readily accessible therapy that has the potential to generate neuroplasticity, Helius is leading the way in applying technological breakthroughs at the bedside,” stated Dr.

“领先的研究表明，大脑具有显着的可塑性，能够在包括中风在内的各种类型的脑损伤后建立新的通路。凭借唯一具有产生神经可塑性潜力的便携式和易于获得的疗法，Helius在床边应用技术突破方面处于领先地位，”Dr。

Jay Lombard, D.O., co-investigator at REHABOLOGYM..

Jay Lombard，D.O.，REHABOLOGYM的联合调查员。。

The registrational program was established in part based on real-world evidence from Canada, where PoNS is already authorized for treatment of stroke. To support national reimbursement in Canada, Helius has begun an additional study on the use of PoNS Therapy to treat stroke, with the goal of enrolling 60 subjects by the end of 2024 at three centers of excellence for stroke rehabilitation.

注册计划部分基于加拿大的真实证据建立，加拿大已经授权脑桥治疗中风。为了支持加拿大的国家报销，Helius开始了一项关于使用脑桥疗法治疗中风的额外研究，目标是到2024年底在三个中风康复卓越中心招募60名受试者。

The study led by Dr. Murielle Grangeon, PhD, Adm., Founder and General Manager, at Neuro-Concept Rehabilitation Center, with the participation of Neuphysio and Synaptic Health, has already received approval by the Institutional Review Boards (IRB). The sites will begin patient enrollment by the end of the month and the results from this study will be part of the data package submission to obtain FDA authorization for stroke in the United States..

这项由神经概念康复中心创始人兼总经理Murielle Grangeon博士领导的研究，在Neuphysio和Synaptic Health的参与下，已获得机构审查委员会（IRB）的批准。。。

About REHABOLOGYM

关于REHABOLOGYM

REHABOLOGYM is a neuro-robotic rehabilitation center utilizing state of the art technologies and comprehensive methodologies for neurological occupational therapy (OT), physical therapy (PT), speech therapy (ST/SLP) and certified personal training (CPT). For more information visit www.rehabologym.com..

REHABOLOGYM是一家神经机器人康复中心，利用最先进的技术和综合方法进行神经职业治疗（OT），物理治疗（PT），言语治疗（ST/SLP）和认证个人培训（CPT）。有关更多信息，请访问www.rehabologym.com。。

About Neurology Center of New England

关于新英格兰神经病学中心

The Neurology Center of New England is a comprehensive neurological care center devoted to the diagnosis, care and management of patients with neurological diseases and syndromes. NCNE manages patients with conditions such as Multiple Sclerosis, migraine and other headache syndromes, Parkinson’s disease, neuropathy, seizure disorders and epilepsy, dementia and memory disorders, numbness, and spasticity/dystonia.

新英格兰神经病学中心是一家综合性神经护理中心，致力于神经疾病和综合征患者的诊断，护理和管理。NCNE管理患有多发性硬化症，偏头痛和其他头痛综合征，帕金森氏病，神经病，癫痫发作和癫痫，痴呆和记忆障碍，麻木和痉挛/肌张力障碍等疾病的患者。

For more information visit www.myneurodr.com..

有关更多信息，请访问www.myneurodr.com。。

About MGH Institute of Health Professions

关于MGH卫生职业研究所

The MGH Institute of Health Professions is a private university focused on the health sciences and located in Boston, Massachusetts. It was founded by Massachusetts General Hospital in 1977 and is accredited by the New England Commission of Higher Education. For more information visit www.mghihp.edu..

MGH健康专业研究所是一所私立大学，位于马萨诸塞州波士顿，专注于健康科学。它由马萨诸塞州总医院于1977年成立，并得到新英格兰高等教育委员会的认可。有关更多信息，请访问www.mghihp.edu。。

About Neuro-Concept Rehabilitation Center

The Neuro-Concept center for neurological rehabilitation and adapted physical conditioning integrates into clinical practice the latest technologies and the advanced expertise of therapists to meet the needs of pediatric, adult and geriatric neurological clients. Based on evidence and neuroplasticity concept, Neuro-Concept has been applying best practices in the rehabilitation of individuals living with a neurological condition.

神经康复和适应性身体调节的神经概念中心将最新技术和治疗师的先进专业知识融入临床实践，以满足儿科，成人和老年神经科客户的需求。基于证据和神经可塑性概念，Neuro concept一直在应用最佳实践来康复患有神经系统疾病的个体。

By offering intensive rehabilitation programs to improve recovery and functional independence in daily life, Neuro-Concept is dedicated to putting patient need first. For more information visit www.neuro-concept.ca..

通过提供强化康复计划来改善日常生活中的康复和功能独立性，Neuro Concept致力于将患者需求放在首位。有关更多信息，请访问www.neuro-concept.ca。。

About Neuphysio

关于Neuphyso

Neuphysio is a private rehabilitation company that provides physiotherapy services to persons in London, ON and surrounding areas. Neuphysio offers clinic, in-home and community-based therapy to persons living with injury or disease. With a focus on neurological rehabilitation, vestibular rehabilitation and gait and balance training, the staff at Neuphysio offer world class service and quality of care.

Neuphyso是一家私人康复公司，为伦敦、安大略省和周边地区的人提供物理治疗服务。。Neuphysio的员工专注于神经康复、前庭康复以及步态和平衡训练，提供世界一流的服务和护理质量。

Client centered goals are functionally based and aimed at improving mobility, stability and quality of life. For more information visit www.neuphysio.com..

以客户为中心的目标以功能为基础，旨在提高移动性、稳定性和生活质量。有关更多信息，请访问www.neuphyso.com。。

About Synaptic Health

关于突触健康

Synaptic provides a comprehensive range of neurorehabilitation services designed to optimize recovery and enhance quality of life. From physiotherapy and occupational therapy to employing cutting-edge rehabilitation methods and technology, Synaptic’s team strives to deliver the highest standard of therapy and is committed to delivering personalized rehab services tailored to the meet the unique needs of each individual.

Synaptic提供全面的神经康复服务，旨在优化康复并提高生活质量。从物理治疗和职业治疗到采用尖端康复方法和技术，Synaptic的团队致力于提供最高标准的治疗，并致力于提供个性化的康复服务，以满足每个人的独特需求。

Synaptic extends support to individuals of all ages facing neurological injuries, conditions, and symptoms, regardless of their stage of recovery or whether they have received a formal diagnosis. For more information visit www.synaptichealth.ca..

Synaptic为面临神经损伤，疾病和症状的所有年龄段的个体提供支持，无论其恢复阶段或是否已接受正式诊断。有关更多信息，请访问www.synaptichealth.ca。。

About Helius Medical Technologies, Inc.

关于Helius Medical Technologies，Inc。

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using an orally applied technology platform that amplifies the brain’s ability to engage physiologic compensatory mechanisms and promote neuroplasticity, improving the lives of people dealing with neurologic diseases.

Helius Medical Technologies是医疗器械领域的领先神经技术公司，专注于神经缺陷，使用口服应用技术平台，增强大脑参与生理补偿机制和促进神经可塑性的能力，改善神经系统疾病患者的生活。

The Company’s first commercial product is the Portable Neuromodulation Stimulator. For more information about the PoNS® or Helius Medical Technologies, visit www.heliusmedical.com..

该公司的第一个商业产品是便携式神经调节刺激器。有关PoNS®或Helius Medical Technologies的更多信息，请访问www.heliusmedical.com。。

About the PoNS Device and PoNS Therapy

The Portable Neuromodulation Stimulator (PoNS) is an innovative, non-implantable, orally applied therapy that delivers neurostimulation through a mouthpiece connected to a controller and it’s used, primarily at home, with physical rehabilitation exercise, to improve balance and gait. The PoNS device, which delivers mild electrical impulses to the tongue, 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..

便携式神经调节刺激器（PoNS）是一种创新的，不可植入的口服应用疗法，通过连接到控制器的喉舌提供神经刺激，主要在家中用于身体康复锻炼，以改善平衡和步态。PoNS装置可向舌头提供轻微的电脉冲，在美国用于短期治疗多发性硬化症（“MS”）轻度至中度症状引起的步态缺陷，并仅通过处方作为22岁及以上患者监督治疗运动计划的辅助手段。。

PoNS has shown effectiveness in treating gait or balance and a significant reduction in the risk of falling in stroke patients in Canada, where it received authorization for sale in three indications: (i) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from stroke and is to be used in conjunction with physical therapy; (ii) for use as a short-term treatment (14 weeks) of chronic balance deficit due to mild-to-moderate traumatic brain injury (“mmTBI”) and is to be used in conjunction with physical therapy; and (iii) for use as a short-term treatment (14 weeks) of gait deficit due to mild and moderate symptoms from MS and is to be used in conjunction with physical therapy.

PoNS已显示出治疗步态或平衡的有效性，并显着降低了加拿大中风患者跌倒的风险，它在三个适应症中获得了销售授权：（i）用作短期治疗（14周）由于中风的轻度和中度症状导致的步态缺陷，并将与物理治疗结合使用；；（iii）由于MS的轻度和中度症状而用作步态缺陷的短期治疗（14周），并与物理治疗结合使用。

PoNS is also authorized for sale in Australia for short term use by healthcare professionals as an adjunct to a therapeutic exercise program to improve balance and gait. For more information visit www.ponstherapy.com..

PoNS还被授权在澳大利亚销售，供医疗保健专业人员短期使用，作为改善平衡和步态的治疗性锻炼计划的辅助手段。有关更多信息，请访问www.ponstherapy.com。。

Cautionary Disclaimer Statement

警示性免责声明

Certain statements in this news release are not based on historical facts and constitute forward-looking statements or forward-looking information within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and Canadian securities laws. All statements other than statements of historical fact included in this news release are forward-looking statements that involve risks and uncertainties.

本新闻稿中的某些陈述并非基于历史事实，而是构成《1995年美国私人证券诉讼改革法案》和加拿大证券法所指的前瞻性陈述或前瞻性信息。本新闻稿中除历史事实声明外的所有声明均为前瞻性声明，涉及风险和不确定性。

Forward-looking statements are often identified by terms such as “believe,” “expect,” “continue,” “will,” “goal,” “aim” and similar expressions. Such forward-looking statements include, among others, statements regarding the functions and results of the stroke registrational program and the additional Canadian stroke study, including the timing of enrollment, future regulatory submissions by the Company as well as future decisions and approvals from applicable regulatory entities in the U.S.

前瞻性陈述通常由“相信”、“期望”、“继续”、“意志”、“目标”、“目标”等术语和类似表达来识别。此类前瞻性声明包括关于中风登记计划和加拿大额外中风研究的功能和结果的声明，包括登记时间，公司未来的监管提交以及美国适用监管实体的未来决定和批准。

and Canada, and the uses and effectiveness of PoNS and PoNS Therapy..

和加拿大，以及脑桥和脑桥疗法的用途和有效性。。

There can be no assurance that such statements will prove to be accurate and actual results and future events could differ materially from those expressed or implied by such statements. Important factors that could cause actual results to differ materially from the Company’s expectations include uncertainties associated with the Company’s capital requirements to achieve its business objectives, availability of funds, the Company’s ability to find additional sources of funding, manufacturing, labor shortage and supply chain risks, including risks related to manufacturing delays, the Company’s ability to obtain national Medicare insurance coverage and negotiate reimbursement with other third-party payers, the Company’s ability to continue to build internal commercial infrastructure, secure state distribution licenses, market awareness of the PoNS device, future clinical trials and the clinical development process, the product development process and the FDA regulatory submission review and approval process, other development activities, ongoing government regulation, and other risks detailed from time to time in the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2023, and its other filings with the United States Securities and Exchange Commission and the Canadian securities regulators, which can be obtained from either at www.sec.gov or www.sedar.com..

无法保证这些陈述将被证明是准确的，实际结果和未来事件可能与这些陈述所表达或暗示的内容有重大差异。可能导致实际结果与公司预期产生重大差异的重要因素包括与公司实现业务目标的资本要求相关的不确定性、资金的可用性、公司寻找额外资金来源的能力、制造、劳动力短缺和供应链风险，包括与制造延误有关的风险、公司获得国家医疗保险覆盖范围和与其他第三方付款人谈判报销的能力、公司继续建设内部商业基础设施的能力、安全的国家分销许可证、PoNS设备的市场意识、未来的临床试验和临床开发过程、产品开发过程和FDA监管提交审查和批准过程、其他开发活动、正在进行的政府监管以及其他风险不时出现在“风险因素”中公司截至2023年12月31日的年度报表10-K中的一节，以及其向美国证券交易委员会和加拿大证券监管机构提交的其他文件，可从www.sec.gov或www.sedar.com获得。。

The reader is cautioned not to place undue reliance on any forward-looking statement. The forward-looking statements contained in this news release are made as of the date of this news release and the Company assumes no obligation to update any forward-looking statement or to update the reasons why actual results could differ from such statements except to the extent required by law..

提醒读者不要过度依赖任何前瞻性陈述。本新闻稿中包含的前瞻性声明是在本新闻稿发布之日做出的，公司没有义务更新任何前瞻性声明，也没有义务更新实际结果可能与此类声明不同的原因，除非法律要求。。

Investor Relations Contact

Lisa M. Wilson, In-Site Communications, Inc.

Lisa M.Wilson，现场通信公司。

T: 212-452-2793

T： 212-452-2793

E: lwilson@insitecony.com

Elwilson@insitecony.com