Shepherd Center’s Dr. Deborah Backus to Showcase Final Results of PoNSTEP Study, Providing New Insight into Maximizing Impact of Neuromodulation to Improve Gait in People with MS

Shepherd中心的Deborah Backus博士将展示PoNSTEP研究的最终结果，为最大化神经调节对改善多发性硬化症患者步态的影响提供新的见解。

NEWTOWN, Pa., May 20, 2025 (GLOBE NEWSWIRE) --

宾夕法尼亚州纽顿，2025年5月20日（环球新闻社）--

Helius Medical Technologies

赫利厄斯医疗科技公司

, Inc. (NASDAQ: HSDT), a neurotech company focused on delivering a novel therapeutic neuromodulation approach for balance and gait deficits, announced it will highlight the results of a new study confirming the therapeutic regimen and sustained efficacy of its

公司（纳斯达克股票代码：HSDT），一家专注于为平衡和步态障碍提供新型治疗性神经调节方法的神经科技公司，宣布将重点介绍一项新研究的结果，该研究证实了其治疗方案和持续有效性。

Portable Neuromodulation Stimulator

便携式神经调节刺激器

(PoNS

（PoNS

®

®

) device for people with multiple sclerosis (MS) at the 2025 Consortium of Multiple Sclerosis Centers (CMSC) Annual Meeting. The event runs from May 28-31 at the Phoenix Convention Center in Phoenix.

) 用于多发性硬化症 (MS) 患者的设备，将在 2025 年多发性硬化症中心联盟 (CMSC) 年度会议上展示。该活动将于 5 月 28 日至 31 日在凤凰城的凤凰城会议中心举行。

Deborah Backus, PT, Ph.D., FACRM – Vice President of Research and Innovation at Atlanta’s

Deborah Backus，物理治疗师，博士，FACRM会员——亚特兰大研究与创新副总裁

Shepherd Center

谢泼德中心

, one of six sites that conducted the

，六个站点之一进行了

PoNS Therapeutic Experience Program

PoNS治疗体验计划

(PoNSTEP) study – will present the full study results for the first time at a platform presentation session on Thursday, May 29, from 3:20-3:40 p.m. Attendees can learn more about PoNSTEP from Helius Chief Medical Officer Antonella Favit-Van Pelt, M.D., Ph.D., who will meet attendees at booth 600 to answer questions and discuss the study outcomes in more detail..

(PoNSTEP) 研究 —— 将于周四，5月29日下午3点20分至3点40分的平台演讲环节首次公布完整的研究结果。与会者可以了解更多关于 PoNSTEP 的信息，Helius 首席医学官 Antonella Favit-Van Pelt 医学博士将在600号展位与参会者见面，回答问题并详细讨论研究结果。

“Those of us familiar with PoNS have seen how it enables some people with MS to walk better. But PoNSTEP data provide the first clinical evidence that there’s a statistically significant relationship between adherence to PoNS Therapy and the degree of improvement – and that the improvement can be sustained,” Dr.

“我们中熟悉 PoNS 的人已经看到它如何使一些多发性硬化症患者更好地行走。但 PoNSTEP 数据提供了第一个临床证据，证明坚持 PoNS 治疗与改善程度之间存在统计学上的显著关系——而且这种改善可以持续，”博士表示。

Backus said. “These results affirm the potential of PoNS Therapy to drive real, measurable gain in better mobility for people with MS. For a population that has long faced limited treatment options for gait deficits, this represents an important step forward.”.

巴库斯说：“这些结果证实了 PoNS 疗法在改善多发性硬化症患者的行动能力方面具有推动实际、可衡量的收益的潜力。对于长期以来面临步态缺陷治疗选择有限的群体来说，这是一个重要的进步。”

PoNSTEP was a three-phase, real-world therapeutic experience study designed to assess the impact of adherence on gait deficit and long-term outcomes. Participants began with two weeks of supervised in-clinic therapy, followed by 12 weeks of combined clinic and at-home use, and concluded with a six-month follow-up period to evaluate the durability of their improvements..

PoNSTEP 是一项分为三个阶段的真实世界治疗体验研究，旨在评估依从性对步态缺陷和长期结果的影响。参与者首先进行了为期两周的诊所内监督治疗，随后是 12 周的诊所与家庭结合使用，最后通过六个月的随访期来评估其改善的持久性。

PoNSTEP’s key finding is that stronger adherence to PoNS Therapyä, which combines non-invasive cranial nerve translingual neuro-stimulation (TLNS) with specific physical exercises, results in better therapeutic outcomes. The most-adherent participants maintained superior gait improvement from the end of the study’s supervised therapy phase through its unsupervised therapy phase, achieving a gain of over 6 points in their Dynamic Gait Index (DGI) scores – a key clinical measurement of walking function and balance – over the first 14 weeks of the trial.

PoNSTEP 的关键发现是，更强地依从 PoNS Therapyä（该疗法结合了非侵入性颅神经舌下神经刺激 (TLNS) 和特定的物理锻炼）会带来更好的治疗效果。依从性最高的参与者在研究的监督治疗阶段结束后的无监督治疗阶段仍保持了更优的步态改善，在试验的前 14 周内，其动态步态指数 (DGI) 评分提高了 6 分以上。DGI 是衡量行走功能和平衡的关键临床指标。

PoNSTEP data also show gait improvement levels are durable, sustained at 6 months post-treatment..

PoNSTEP 数据还显示，步态改善水平是持久的，在治疗后 6 个月仍然保持。

Highly adherent patients—using the device for at least 85% of the recommended 100–120 minutes per day during Phase 2—improved their Dynamic Gait Index (DGI) scores by more than 6 points. Those with moderate adherence (around 70%) showed a smaller, yet meaningful, improvement of 5 points total. These results demonstrate a linear relationship between adherence and gait improvement outcomes.

高依从性患者——在第二阶段每天使用设备至少达到推荐的100至120分钟的85%以上——其动态步态指数（DGI）得分提高了6分以上。而中等依从性（约70%）的患者则表现出较小但有意义的进步，总分为5分。这些结果表明依从性与步态改善结果之间存在线性关系。

In addition, more than 95% of participants who were evaluated 6 months later maintained their level of improvement..

此外，超过 95% 的参与者在 6 个月后进行评估时仍保持其改善水平。

“PoNSTEP is the latest in a series of important milestones for PoNS and I’m delighted to join Dr. Backus in sharing PoNSTEP full study results with the broader MS community,” said Dr. Favit-Van Pelt.

“PoNSTEP 是 PoNS 系列重要里程碑中的最新成果，我非常高兴能与 Backus 博士一起向更广泛的 MS 社区分享 PoNSTEP 的完整研究结果，”Favit-Van Pelt 博士说道。

The study provides further evidence of the power of neuromodulation and neuroplasticity in rehabilitating the neural network and confirms the benefit of 14 weeks of PoNS therapy as a meaningful therapeutic option for people with MS and gait deficit. Access to PoNS therapy is provided by insurance through the U.S.

该研究进一步证明了神经调节和神经可塑性在修复神经网络方面的力量，并确认了为期14周的PoNS治疗作为多发性硬化症（MS）和步态障碍患者的一种有意义的治疗选择的益处。美国的保险可提供PoNS治疗的使用权限。

Department of Veterans Affairs and U.S. Department of Defense, with several commercial healthcare providers already starting to reimburse the device out of network..

美国退伍军人事务部和美国国防部，一些商业医疗保健供应商已经开始对网络外的设备进行报销。

About PoNS Therapeutic Experience Program (PoNSTEP)

关于PoNS治疗体验计划（PoNSTEP）

The Therapeutic Experience Program (“TEP”) is a Helius-sponsored, open-label, observational, interventional multi-center outcome research study designed to assess adherence to on-label PoNS therapy for improvement in gait deficits for patients with multiple sclerosis (“MS”) in a real-world clinical setting.

治疗体验计划（“TEP”）是一项由Helius赞助的开放标签、观察性、干预性的多中心结果研究，旨在评估在真实临床环境中，多发性硬化症（“MS”）患者对按标签使用的PoNS治疗在改善步态缺陷方面的依从性。

The study aims to understand better the relationship between adherence to on label (100-120 minute per day) PoNS Therapy, which combines the PoNS device with physical therapy, and the therapeutic outcome on gait deficit improvement over 14 weeks of study treatment, as measured by changes in the Dynamic Gait Index (DGI) scores.

本研究旨在更好地理解在为期14周的研究治疗中，每天按照标签规定时间（100-120分钟）坚持使用PoNS设备结合物理疗法的PoNS治疗方案，与通过动态步态指数（DGI）评分变化衡量的步态缺陷改善之间的关系。

PoNS therapy is applied in a supervised clinical setting for the first two weeks (Phase 1) and, independently, at home for the remaining 12 weeks (Phase 2). The study also includes a six-month no-treatment follow-up phase aimed at establishing the durability of the therapeutic effect (Phase 3)..

PoNS疗法在前两周（第一阶段）在有监督的临床环境中进行，随后的12周（第二阶段）患者可在家独立进行。研究还包括一个为期六个月的无治疗随访阶段，旨在评估治疗效果的持久性（第三阶段）。

The primary endpoint of the study is maintenance of gait improvement from the end of supervised therapy (Phase 1) to the end of unsupervised therapy (Phase 2) in relation to the subject’s adherence to PoNS therapy. The secondary endpoints are, among others, maintenance of improvement of gait and balance deficit over a 6-month timeframe and clinical global impression of change..

该研究的主要终点是与受试者对PoNS治疗的依从性相关的从监督治疗结束（第一阶段）到非监督治疗结束（第二阶段）步态改善的维持情况。次要终点包括在六个月时间范围内步态和平衡缺陷改善的维持情况以及临床整体印象变化等。

The study was performed at six Centers of Excellence across the United States, including Neurology Center of New England in Foxboro (MA), the Shepherd Center in Atlanta (GA), Montefiore Medical Center (“Montefiore”) in NY (NY), Oregon Health & Science University (“OHSU”) in Portland (OR), MGH Institute of Health Professions in Boston (MA), NYU Langone Health in NY (NY), and recruited 43 MS participants with gait deficit..

该研究在美国的六个卓越中心进行，包括马萨诸塞州福克斯伯勒的新英格兰神经病学中心、佐治亚州亚特兰大的谢泼德中心、纽约州纽约的蒙特菲奥里医疗中心（“蒙特菲奥里”）、俄勒冈州波特兰的俄勒冈健康与科学大学（“OHSU”）、马萨诸塞州波士顿的麻省总医院健康职业学院、纽约州纽约的纽约大学朗格尼健康中心，并招募了43名步态缺陷的多发性硬化症参与者。

About the PoNS Device and PoNS Therapy

关于PoNS设备和PoNS疗法

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 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、非植入式的、通过口腔施加的治疗设备，它通过连接到控制器的口腔件提供神经刺激，主要用于家庭环境，结合物理康复训练，以改善平衡和步态。PoNS 设备通过向舌头传递温和的电脉冲，在美国被指定用于短期治疗因多发性硬化症（MS）轻至中度症状导致的步态缺陷，并且仅可通过处方使用，适用于22岁及以上的患者，作为监督下治疗性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在加拿大已被证明对治疗中风患者的步态或平衡障碍有效，并显著降低了跌倒的风险，该设备已获准在三种适应症中销售：(i) 用于短期治疗（14周）由轻度和中度中风症状引起的步态缺陷，并需结合物理治疗使用；(ii) 用于短期治疗（14周）由轻度至中度创伤性脑损伤（“mmTBI”）引起的慢性平衡障碍，并需结合物理治疗使用；以及(iii) 用于短期治疗（14周）由多发性硬化症（MS）引起的轻度和中度步态缺陷，并需结合物理治疗使用。

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 .

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，作为治疗性运动计划的辅助工具，以改善平衡和步态。欲了解更多信息，请访问。

www.ponstherapy.com

www.ponstherapy.com

.

。

About Helius Medical Technologies, Inc.

关于赫利俄斯医疗科技公司

Helius Medical Technologies is a leading neurotech company in the medical device field focused on neurologic deficits using 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是一家领先的神经科技公司，专注于医疗设备领域，利用口腔应用技术平台来放大大脑参与生理补偿机制的能力，促进神经可塑性，从而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.

公司的第一个商业产品是便携式神经调节刺激器。有关 PoNS 的更多信息。

®

®

or Helius Medical Technologies, visit

或访问赫利奥斯医疗技术公司，

www.heliusmedical.com

www.heliusmedical.com

.

。

Cautionary Disclaimer Statement

警告声明

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，而是构成美国1995年《私人证券诉讼改革法案》和加拿大证券法意义上的前瞻性陈述或前瞻性信息。本新闻稿中包含的所有非历史事实的陈述均为涉及风险和不确定性的前瞻性陈述。

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 future presentation and uses of the PoNSTEP study results and the uses and effectiveness of PoNS and PoNS Therapy..

前瞻性陈述通常通过诸如“相信”、“期望”、“继续”、“将”、“目标”、“宗旨”等类似表述加以识别。此类前瞻性陈述包括但不限于关于PoNSTEP研究结果的未来展示及其用途，以及PoNS和PoNS疗法的用途和有效性的声明。

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 to obtain a reimbursement code, 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..

无法保证这些陈述的准确性，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存在重大差异。导致实际结果与公司预期产生重大差异的重要因素包括：与公司实现其业务目标所需资本要求相关的不确定性、资金的可用性、公司寻找额外融资来源的能力、制造、劳动力短缺和供应链风险（包括与制造延迟相关的风险）、公司获得国家医疗保险覆盖和报销代码的能力、公司继续建设内部商业基础设施的能力、获取州分销许可证、市场对PoNS设备的认知、未来的临床试验及临床开发过程、产品开发过程以及FDA监管提交审查和批准流程、其他开发活动、持续的政府监管，以及其他风险。这些风险不时详细列于公司截至2023年12月31日年度的Form 10-K年报中“风险因素”部分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中，可从www.sec.gov或www.sedar.com获取。

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..

读者应注意不要过分依赖任何前瞻性声明。本新闻稿中的前瞻性声明是截至本新闻稿发布之日作出的，公司不承担更新任何前瞻性声明或更新实际结果可能与该等声明不同的原因的义务，除非法律要求。

Investor Relations Contact

投资者关系联系人

Philip Trip Taylor

菲利普·特里普·泰勒

Gilmartin Group

吉尔马丁集团

investorrelations@heliusmedical.com

投资者关系@heliusmedical.com