--PoNS Therapeutic Experience Program (PoNSTEP) study demonstrates durable long-term beneficial effects of PoNS Therapy on gait deficit improvement in people with Multiple Sclerosis--

--脑桥治疗经验计划（PoNSTEP）研究表明，脑桥治疗对多发性硬化症患者步态缺陷的改善具有持久的长期有益作用--

--Statistically significant findings in DGI (Dynamic Gait Index) during Phase 1 and Phase 2 among the 38 subjects

--38名受试者在第一阶段和第二阶段的DGI（动态步态指数）有统计学意义的发现

who completed the treatment protocol

谁完成了治疗方案

showing a total mean improvement of 5.00 (4.1 to 5.9, p<0.001) at week 14--

第14周总平均改善5.00（4.1至5.9，p<0.001）--

NEWTOWN, Pa., Jan. 22, 2025 (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 positive results from the PoNS Therapeutic Experience Program, or PoNSTEP, study for people with multiple sclerosis (MS)..

宾夕法尼亚州纽敦，2025年1月22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，今天宣布了针对多发性硬化症（MS）患者的脑桥治疗体验计划（PoNSTEP）研究的积极成果。。

“The results from this study validate existing evidence of the efficacy of PoNS across clinical data and real-world utilization of the therapy by demonstrating durability of effect as further evidence of its long-term therapeutic benefits,” stated Antonella Favit-Van Pelt, M.D., Ph.D., Helius’ Chief Medical Officer.

“这项研究的结果通过证明效果的持久性作为其长期治疗益处的进一步证据，验证了脑桥在临床数据和治疗的实际应用中的有效性的现有证据，”Helius的首席医疗官Antonella Favit Van Pelt医学博士说。

“The PoNSTEP study marks an important stepstone in further understanding the role of neuromodulation and, consequently, neuroplasticity in gait function rehabilitation. PoNS Therapy’s neuromodulation effect on brain mechanisms of motor control is likely to enhance neuroplasticity and contribute to maintain PoNS therapeutic effect on gait deficit in people with MS.”.

。

The recently completed study, provides the first clinical evidence of a positive relationship between adherence to using the PoNS device with targeted physical exercise (PoNS Therapy) and improvement of gait deficit, along with establishing the long-term therapeutic effect of PoNS Therapy at six months post-treatment in people with MS.

最近完成的这项研究提供了第一个临床证据，证明坚持使用脑桥装置进行有针对性的体育锻炼（脑桥疗法）与改善步态缺陷之间存在正相关关系，同时确定了脑桥疗法在MS患者治疗后6个月的长期治疗效果。

This observation is in line with maintenance of effect’s evidence from other clinical trials in people with balance deficits due to traumatic brain injury..

这一观察结果与维持其他临床试验对创伤性脑损伤导致平衡缺陷患者的影响证据一致。。

The study involved 43 patients with gait deficit due to mild-to-moderate MS, who received 14 weeks of physical rehabilitation with PoNS Therapy. The therapy included 2 weeks in the clinic (Phase 1) and 12 weeks at home (Phase 2), followed by a 6-month post-treatment observation (Phase 3). Of the 41 patients who started, 38 completed the study, and 29 were evaluated at 6 months.

这项研究涉及43名轻度至中度MS患者的步态缺陷，他们接受了14周的脑桥治疗身体康复。治疗包括在诊所2周（第1阶段）和在家12周（第2阶段），然后进行6个月的治疗后观察（第3阶段）。在开始的41名患者中，38名完成了研究，29名在6个月时进行了评估。

Patients with a 30% or greater decline in functional improvement were eligible for an additional 12 weeks of therapy. The primary outcome measure was the DGI, with changes evaluated using statistical tests and correlation analyses to assess adherence and DGI improvements..

功能改善下降30%或更大的患者有资格再接受12周的治疗。主要结局指标是DGI，使用统计检验和相关性分析评估变化，以评估依从性和DGI改进。。

PoNSTEP Results

PoNSTEP结果

There were statistically significant findings in DGI during Phase 1 and Phase 2 among the 38 subjects who completed the treatment protocol for a total mean improvement of 5.00 (4.1 to 5.9, p<0.001) at week 14.

在完成治疗方案的38名受试者中，第1阶段和第2阶段的DGI有统计学意义的发现，第14周的总平均改善率为5.00（4.1至5.9，p<0.001）。

In Phase 2, average therapy adherence 71% and gait improvement was linearly associated with adherence (r=0.345; p=0.034), while, in Phase 1 adherence, was 89.5% and, consequently, not associated with improvement.

在第二阶段，平均治疗依从性为71%，步态改善与依从性呈线性相关（r=0.345；p=0.034），而在第一阶段依从性为89.5%，因此与改善无关。

In addition to mean 2.5 points improvement in DGI achieved in Phase 1, Phase 2, participants with ≥85% adherence improved mean 3.7 points [1.8 SD]; those with <85% adherence improved mean 2.0 points [1.8 SD], and the difference was statistically significant [p=.0.008].

除了在第一阶段第二阶段实现的DGI平均提高2.5分外，依从性≥85%的参与者平均提高了3.7分[1.8 SD]；那些依从性低于85%的患者平均提高了2.0分[1.8 SD]，差异有统计学意义[p=0.008]。

28 of 41 (70.7%) participants who completed the 14-wk therapy were reassessed at 6-months and only 1 of 28 showed ≥ 30% decline in DGI (95% exact binomial CI: 0.09% to 18.4%).

完成14周治疗的41名参与者中有28名（70.7%）在6个月时进行了重新评估，28名参与者中只有1名显示DGI下降≥30%（95%精确二项式CI:0.09%至18.4%）。

Mean decline (%) in DGI was -4.1 (95% CI -9.4% to 1.1%; range -35.7% to 25.0%) with the 95% CI’s lower bound showing statistically reliable evidence that the true mean decline was no more than -9.4% (p=0.12).

DGI的平均下降（%）为-4.1（95%CI为-9.4%〜1.1%；范围为-35.7%〜25.0%），95%CI的下限显示统计学上可靠的证据表明真实的平均下降不超过-9.4%（p=0.12）。

“We are pleased to report the PoNSTEP study results corroborate the known evidence of PoNS Therapy’s efficacy in improving gait deficit due to MS,” stated Dane Andreeff, Helius’ President and Chief Executive Officer. “Like many therapeutics, treatment compliance is key to achieving incremental and lasting therapeutic beneficial effects with PoNS Therapy.

Helius总裁兼首席执行官Dane Andreeff表示：“我们很高兴报告PoNSTEP研究结果证实了PoNS疗法在改善MS引起的步态缺陷方面有效的已知证据。”。“像许多疗法一样，治疗依从性是通过脑桥疗法实现增量和持久治疗有益效果的关键。

This important study provides convincing evidence of the role of neuroplasticity for a durable gait function improvement in MS. We thank all the investigators and patients involved in the study and we look forward to sharing the data to increase awareness on PoNS Therapy at upcoming scientific conferences.”.

这项重要的研究提供了令人信服的证据，证明了神经可塑性对MS持续步态功能改善的作用。我们感谢所有参与研究的研究人员和患者，我们期待在即将举行的科学会议上分享数据，以提高对脑桥治疗的认识。”。

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.

治疗经验计划（“TEP”）是一项由Helius赞助的开放标签观察性介入性多中心结果研究，旨在评估在现实世界中多发性硬化症（“MS”）患者步态缺陷的标签上脑桥治疗依从性。

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.

该研究旨在更好地了解将PoNS装置与物理治疗相结合的标签上（每天100-120分钟）PoNS治疗与14周研究治疗中步态缺陷改善的治疗结果之间的关系，如通过动态步态指数（DGI）评分的变化来衡量的。

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 durability of therapeutic effect (Phase 3)..

脑桥治疗在前两周（第1阶段）在有监督的临床环境中应用，其余12周（第2阶段）在家中独立应用。该研究还包括为期六个月的无治疗随访阶段，旨在建立治疗效果的持久性（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 6-m timeframe and clinical global impression of change..

该研究的主要终点是维持步态改善，从监督治疗结束（第1阶段）到无监督治疗结束（第2阶段），与受试者坚持脑桥治疗有关。次要终点包括在6米的时间范围内维持步态改善和平衡缺陷以及临床整体变化印象。。

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 (GE), 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..

这项研究是在美国六个卓越中心进行的，包括位于福克斯博罗（MA）的新英格兰神经病学中心，亚特兰大（GE）的牧羊人中心，纽约（NY）的蒙特菲奥医学中心（“蒙特菲奥”），波特兰（OR）的俄勒冈州健康与科学大学（“OHSU”），波士顿（MA）的MGH健康专业研究所，纽约（NY）的纽约大学朗格尼健康中心，并招募了43名步态缺陷的MS参与者。。

About the PoNS Device and PoNS Therapy

关于脑桥装置和脑桥治疗

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，非植入式的口服应用疗法，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.

；（ii）用作轻度至中度创伤性脑损伤（“mmTBI”）引起的慢性平衡缺陷的短期治疗（14周），并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.  .

。有关更多信息，请访问www.ponstherapy.com。

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 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，专注于使用口服应用技术平台治疗神经缺陷，该平台可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.

该公司的第一个商业产品是便携式神经调节刺激器。有关脑桥的更多信息。

®

®

or Helius Medical Technologies, visit

或Helius Medical Technologies，访问

www.heliusmedical.com.

www.heliusmedical.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 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PoNSTEP研究结果的未来介绍和使用以及PoNS和PoNS治疗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存在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获得报销代码的能力、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不时详细说明的风险“风险因素”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

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

investorrelations@heliusmedical.com