First non-invasive, orally applied neuromodulation device FDA-cleared for stroke rehabilitation, expanding access for the more than 7 million Americans living with stroke-related gait disability

首款获美国食品药品监督管理局（FDA）批准用于卒中康复的非侵入性、口服式神经调节设备，为超过700万患有卒中相关步态障碍的美国人扩大了治疗可及性

Clearance

清关

expands PoNS indication beyond existing

将 PoNS 的适应症扩展至现有范围之外

Multiple Sclerosis

多发性硬化症

approval

批准

VALENCIA, Calif.

加利福尼亚州瓦伦西亚

,

，

June 29, 2026

2026年6月29日

/PRNewswire/ -- Bioness Medical, Inc. ('Bioness', or the 'Company'), a global leader in functional electrical stimulation (FES) and advanced rehabilitation technologies, today announced that the Company's PoNS

/美通社/ -- 功能性电刺激（FES）和先进康复技术领域的全球领导者 Bioness Medical, Inc.（“Bioness”或“公司”）今日宣布，公司的 PoNS

®

®

(Portable Neuromodulation Stimulator) System has received FDA 510(k) clearance for the treatment of dynamic gait deficit due to chronic stroke symptoms. This clearance is supported by the Stroke Registrational Program (SRP), a three-study, 159-patient program at 10 centers of excellence in the U.S.

（便携式神经调节刺激器）系统已获得美国食品药品监督管理局（FDA）510(k)许可，用于治疗因慢性卒中症状导致的动态步态缺陷。该许可得到了卒中注册研究项目（SRP）的支持，该项目是一项涵盖10家美国卓越医疗中心、共159名患者的三项研究计划。

and Canada, which demonstrated a sustained, statistically significant, and clinically meaningful improvement in dynamic gait deficit versus physical therapy (PT) alone, with a favorable safety profile, across all studies..

以及在加拿大，所有研究均显示，与单纯物理治疗（PT）相比，动态步态缺陷获得了持续、具有统计学显著性且具有临床意义的改善，且安全性良好。

The PoNS System expands the Company's L300 Go and H200 Wireless FES technology platform to include a unique non-invasive neuromodulation of the central nervous system, delivered via the tongue, by leveraging stimulation of selective cranial nerve pathways to promote neuroplasticity and functional recovery..

PoNS系统将公司的L300 Go和H200无线功能性电刺激（FES）技术平台扩展至包含一种独特的中枢神经系统非侵入性神经调控功能，该功能通过舌部递送，利用对选择性颅神经通路的刺激来促进神经可塑性和功能恢复。

'The evidence from the registrational program demonstrate the superiority of active PoNS Therapy® as compared to physical therapy alone, when applied in standard routine clinical settings for stroke rehabilitation,' said Antonella Favit-Van Pelt, M.D., Ph.D., Bioness' Chief Medical Officer. 'The totality of data in chronic stroke survivors with gait deficits confirms the broader evidence of PoNS therapeutic effect in improving walking disability by transitioning the outcome of physical therapy alone to a clinically meaningful effect with a 45.5% increased response rate to PoNS treatment as compared to PT alone.'.

Bioness首席医疗官Antonella Favit-Van Pelt医学博士、哲学博士表示：“注册研究项目的证据表明，在常规临床环境中应用于卒中康复时，主动PoNS Therapy®优于单纯物理治疗。”“对于伴有步态缺陷的慢性卒中幸存者，全部数据证实了PoNS在改善行走障碍方面的更广泛疗效证据，即将单纯物理治疗的结果转化为具有临床意义的效果，与单纯物理治疗相比，PoNS治疗的应答率提高了45.5%。”

About PoNS SRP

关于 PoNS SRP

PoNS efficacy and safety was clinically established from three clinical trials across 10 sites and 159 enrolled chronic stroke survivors with gait deficit due to stroke. The studies were structured to assess the effectiveness and safety of the PoNS device in conjunction with routine physical rehabilitation therapy as compared to PT alone, over a 12-week treatment period.

PoNS 的疗效和安全性已在三项临床试验中得到临床验证，这些试验涉及10个研究中心，共纳入159名因卒中导致步态障碍的慢性卒中幸存者。研究设计旨在评估在为期12周的治疗期内，与单独进行物理治疗（PT）相比，PoNS设备联合常规康复物理治疗的疗效和安全性。

Participants were also followed for 12 weeks after completion of treatment to assess durability of treatment effect. Primary efficacy endpoints for gait by the Functional Gait Assessment (FGA) and balance by Berg Balance Scale (BBS), as well as key secondary endpoints including risk of falling (determined by FGA <23) and durability of effect (established at <30% reduction of FGA improvement 12 weeks after completion of study treatment) were analyzed, across the two pivotal studies, using a propensity score design methodology adjusted for multiplicity control.

在治疗完成后，对参与者进行了为期12周的随访，以评估治疗效果的持久性。采用倾向评分设计方法并校正多重性，对两项关键研究中的主要疗效终点（通过功能性步态评估[FGA]衡量的步态和通过Berg平衡量表[BBS]衡量的平衡能力）以及关键次要终点（包括跌倒风险[由FGA<23确定]和效果持久性[定义为研究治疗完成后12周时FGA改善幅度降低<30%]）进行了分析。

Study success was achieved by demonstrating superiority, using the Hochberg method, for either primary endpoint, which, then, allowed for analysis of the key secondary endpoints with the same methodology..

通过使用Hochberg方法证明在任一主要终点上的优效性，研究取得成功，从而允许采用相同的方法对关键次要终点进行分析。

SRP Study Results

SRP研究结果

Overall, the primary endpoint was met and statistically significant for gait deficit (FGA). The primary analysis of the pooled pivotal randomized controlled and single-arm studies demonstrated that treatment with active PoNS plus PT led to a statistically significant and clinically meaningful adjusted mean change in FGA of 5.37 points (95% CI: 4.23 to 6.52) at Week 12 as compared to a non clinically meaningful change of 3.31 points (95% CI 1.96 to 4.76) in the control group (sham PoNS plus PT) in the primary per-protocol dataset.

总体而言，主要终点得以实现，且步态缺陷（FGA）的改善具有统计学显著性。对汇总的关键性随机对照研究和单臂研究进行的主要分析表明，在主要符合方案集（per-protocol dataset）中，与对照组（假性PoNS加物理治疗）相比，活性PoNS联合物理治疗（PT）在第12周时使FGA的调整后均值变化达到5.37分（95% CI：4.23至6.52），该变化具有统计学显著性和临床意义；而对照组的FGA变化为3.37分（95% CI：1.96至4.76），不具有临床意义。

The treatment group difference by propensity adjustment was 2.06 (95% CI 0.29 to 3.84) with a 2-sided p-value of 0.0233 that met the Hochberg requirement for multiplicity (< 0.025). 45% more subjects treated with active PoNS responded to treatment using a 6-point FGA increase threshold (56.1% vs 11.1%) and at least 30% more using a ≥4-point or ≥5-point improvement threshold (63.1% vs 33.3% and 58.5% vs 33.3%, respectively).

经倾向评分调整后，治疗组间的差异为2.06（95%置信区间：0.29至3.84），双侧p值为0.0233，满足Hochberg多重性校正要求（<0.025）。采用6分面部残疾指数（FGA）增加作为应答阈值时，接受活性PoNS治疗的受试者中应答率高出45%（56.1% vs 11.1%）；采用≥4分或≥5分改善作为应答阈值时，应答率分别至少高出30%（分别为63.1% vs 33.3%和58.5% vs 33.3%）。

Maintenance of active PoNS therapeutic effect achieved at Week 12 was also demonstrated, with a mean percentage reduction in FGA ranging between -4.71% and -4.97% and with 89.7% (95% CI 81.8% to 97.5%) of subjects meeting the durability performance goal. Improvement from baseline to Week 12 was also demonstrated for BBS in the active PoNS group although it did not reach between-group statistically significant separation.

还证实了在第12周时实现的主动PoNS治疗效果得以维持，FGA的平均百分比减少幅度介于-4.71%至-4.97%之间，且89.7%（95%置信区间为81.8%至97.5%）的受试者达到了耐久性性能目标。尽管未达到组间统计学显著差异，但主动PoNS组的BBS从基线到第12周也显示出改善。

Similarly, risk of falling was resolved in 17.4% of subjects in the active PoNS group as compared to 8.9% in the control subjects, albeit not statistically significant. Treatment with PoNS was confirmed to be safe and well-tolerated with no incidence of treatment-related SAEs, across the SRP trials and existing RWE data, and adverse events (ranging between 0.0% and 14.8%) that were unrelated to the PoNS devi.

同样，主动PoNS组受试者的跌倒风险缓解率为17.4%，而对照组为8.9%，尽管这一差异无统计学意义。在SRP试验和现有真实世界证据（RWE）数据中，PoNS治疗被证实安全且耐受性良好，未发生与治疗相关的严重不良事件（SAEs），且不良事件（发生率介于0.0%至14.8%之间）均与PoNS设备无关。

'This FDA clearance is a major step forward for stroke rehabilitation and for the millions of patients suffering from stroke-related walking difficulties,' said Todd Cushman, CEO of Bioness. 'PoNS is a non-invasive, prescription-based therapy that uses the brain's natural ability to rewire itself to help patients walk better and regain their independence.

Bioness 首席执行官 Todd Cushman 表示：“此次获得美国食品药品监督管理局（FDA）的许可，是中风康复领域以及为数百万受中风相关行走困难困扰的患者迈出的重要一步。PoNS 是一种非侵入性、需处方使用的疗法，它利用大脑自我重塑的天然能力，帮助患者改善行走功能并重获独立生活能力。”

Built for home use, PoNS is easy to use, accessible, and affordable — and with Medicare coverage, it gives healthcare providers a dependable treatment option to help their patients regain functional mobility.'.

PoNS专为家庭使用设计，具有易用、便捷和实惠的特点。在医疗保险覆盖下，它为医疗保健提供者提供了一种可靠的治疗方案，帮助患者恢复功能性活动能力。

For current multiple sclerosis (MS) users, the perception on PoNS effectiveness and the feedback on its therapeutic value has been consistently positive. Leveraging deep, well-established relationships in the rehabilitation and neurology fields, our seamless conversations on the benefit of Bioness Medical technologies will continue..

对于当前的多发性硬化症（MS）患者而言，他们对PoNS疗效的认知及其治疗价值的反馈始终积极正面。凭借在康复和神经病学领域深厚且稳固的关系网络，我们将继续就Bioness Medical技术所带来的益处开展顺畅的沟通与交流。

About PoNS

关于PoNS

PoNS® is a non-invasive, non-implantable, orally applied prescription medical device that delivers gentle neurostimulation through a mouthpiece placed on the tongue, used at home in conjunction with a physical rehabilitation exercise program. By stimulating branches of the trigeminal and facial cranial nerves, PoNS activates direct connections to the brainstem, promoting neuroplasticity mechanisms that facilitate the development of new neural networks to compensate for impaired corticospinal pathways, delivering reliable, durable improvements in walking function..

PoNS®是一种非侵入性、非植入式、经口腔使用的处方医疗器械，通过放置在舌头上的咬合装置提供温和的神经刺激，可在家中配合物理康复锻炼计划使用。通过刺激三叉神经和面颅神经的分支，PoNS激活与脑干的直接连接，促进神经可塑性机制，帮助发展新的神经网络以补偿受损的皮质脊髓通路，从而带来可靠且持久的步行功能改善。

Multiple Sclerosis:

多发性硬化症：

The PoNS device 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.

PoNS 设备在美国被批准用于短期治疗由多发性硬化症（MS）轻度至中度症状引起的步态缺陷，且必须作为监督下的治疗性运动计划的辅助手段，仅限处方用于22岁及以上的患者。

Chronic Stroke:

慢性卒中：

The PoNS device is indicated for use as a treatment of dynamic gait deficit due to chronic symptoms from stroke 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.

PoNS 设备适用于治疗因脑卒中慢性症状导致的动态步态缺陷，须作为监督下治疗性运动计划的辅助手段，仅限凭处方用于22岁及以上患者。

About Bioness Medical

关于Bioness医疗

Bioness Medical is a leading provider of advanced rehabilitation technologies designed to restore mobility, function, and independence. Its portfolio spans functional electrical stimulation, robotic gait training, and neuromodulation, supporting clinicians and healthcare systems worldwide with evidence-based solutions..

Bioness Medical 是先进康复技术的领先供应商，致力于帮助患者恢复行动能力、功能及独立性。其产品组合涵盖功能性电刺激、机器人步态训练和神经调控，为全球临床医生和医疗保健系统提供基于循证医学的解决方案。

SOURCE Bioness Medical, Inc.

来源：Bioness Medical, Inc.

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