ONWARD Medical N.V., the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries (SCI) and other movement disabilities, today announced that it has received 510(k) clearance to expand the ARC-EX System indication for home use in the US..

ONWARD Medical N.V. 是一家领先的神经技术公司，致力于开发恢复脊髓损伤（SCI）患者及其他运动障碍患者的运动、功能和独立性的疗法，该公司今日宣布已获得510(k)许可，将扩大ARC-EX系统在美国的家庭使用适应症。

The US Food and Drug Administration (FDA) has cleared the ARC-EX System for use in conjunction with functional task practice in the clinic and take-home exercises in the home to improve hand strength and sensation in adults with chronic, non-progressive neurological deficits resulting from an incomplete SCI (C2-C8 inclusive).

美国食品药品监督管理局（FDA）已批准ARC-EX系统用于临床功能性任务练习，以及在家中进行的带回家练习，以改善因不完全脊髓损伤（C2-C8，包括在内）导致的慢性、非进展性神经功能缺损成人的手部力量和感觉。

The ARC-EX System is non-invasive and delivers programmed, transcutaneous electrical spinal cord stimulation. It is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients as needed..

ARC-EX系统为非侵入性，提供程序化的经皮电脊髓刺激。该系统旨在由康复专业人士在医疗中心操作，并由患者或在需要时协助患者的人员在家中使用。

“Today’s authorization expanding the ARC-EX System indication for home use greatly enlarges the US market opportunity and is a defining milestone for the spinal cord injury community,” said Dave Marver, CEO of ONWARD Medical. “People living with SCI will now be able to benefit from use of the ARC-EX System in the comfort and convenience of their own homes.”.

“今天授权扩大ARC-EX系统在家庭使用的适应症，极大地扩展了美国市场的机会，并且是脊髓损伤社区的一个决定性里程碑，”ONWARD医疗公司的首席执行官戴夫·马弗说。“脊髓损伤患者现在将能够在自己家的舒适和便利环境中受益于ARC-EX系统的使用。”

“I’m excited to see this innovative SCI rehabilitation technology now available for home use,” said Dr. Candy Tefertiller, PT, DPT, PhD, NCS, Executive Director of Research and Evaluation at Craig Hospital in Denver, Colorado. “For people with limited mobility who navigate daily logistical challenges, having the option to use this therapy at home can make a meaningful difference.

“我很高兴看到这种创新的脊髓损伤康复技术现在可以在家中使用，”科罗拉多州丹佛市克雷格医院研究与评估执行主任坎迪·特费蒂勒博士（Candy Tefertiller，物理治疗师、物理治疗博士、哲学博士、神经临床专科认证专家）表示。“对于行动能力有限且每天面临各种实际挑战的人来说，能够在家中使用这种疗法可能会带来重要的改变。”

Integrating in-clinic and at-home therapy may help support and maintain improvements in hand strength and sensation, contributing positively to overall quality of life.”.

结合诊所内和家庭疗法可能有助于支持和维持手部力量和感觉的改善，从而积极提升整体生活质量。

“Today’s FDA clearance marks an important next step toward expanding multiple avenues of care — and ultimately cures — for people living with spinal cord injury and paralysis,” said Marco Baptista, Ph.D., Chief Scientific Officer of the Christopher & Dana Reeve Foundation. “By enabling therapy to be delivered at home, this milestone broadens access to technologies that may meaningfully improve health and quality of life, including addressing the secondary complications of SCI.

“今天FDA的批准标志着在扩大脊髓损伤和瘫痪患者的多种治疗途径——最终是治愈方法上迈出了重要的下一步，”Christopher & Dana Reeve基金会首席科学官Marco Baptista博士说道。“通过使治疗能够在家中进行，这一里程碑拓宽了获取可能显著改善健康和生活质量的技术的机会，包括解决脊髓损伤的继发性并发症。”

For more than 40 years, the Reeve Foundation and our community have invested boldly in high-risk, high-reward science, pairing funding and leadership with the lived experience of those living with SCI and those who care for them. Today’s achievement demonstrates that we are now seeing breakthroughs once thought impossible.”.

四十多年来，里夫基金会和我们的社区大胆投资于高风险、高回报的科学，将资金和领导力与脊髓损伤患者及其护理人员的生活经验相结合。今天的成就表明，我们正在见证曾经被认为不可能实现的突破。"

ARC-EX Therapy is supported by a unique body of clinical evidence. Results of the Up-LIFT pivotal study, published in Nature Medicine, showed that 90% of participants improved strength or function, 87% reported improvement in quality of life, and benefits were observed up to 34 years post-injury. Study participants also reported less spasm frequency, improved sleep quality, and improved upper body sensation and sense of touch.

ARC-EX疗法得到了独特的临床证据支持。发表在《自然医学》上的Up-LIFT关键研究结果显示，90%的参与者增强了力量或功能，87%的参与者报告生活质量有所改善，且损伤后长达34年仍能观察到益处。研究参与者还报告了痉挛频率减少、睡眠质量提高以及上半身感觉和触觉的改善。

The investigator-sponsored Pathfinder2 Study, published in Neuromodulation: Technology at the Neural Interface, demonstrated that ARC-EX Therapy, combined with activity-based rehabilitation, delivered significant functional improvements and continued gains over one year with no plateau in therapeutic benefit.

研究者发起的Pathfinder2研究发表在《神经调节：神经接口技术》上，研究表明，ARC-EX疗法结合基于活动的康复治疗，在一年内带来了显著的功能改善，并且治疗效果持续增强，没有出现平台期。

Most recently, results of the LIFT Home Study, published in Neurology: Clinical Practice, showed that continued use of ARC-EX Therapy at home is effective in maintaining and extending gains achieved in the clinic..

最近，发表在《神经学：临床实践》上的LIFT家庭研究结果表明，在家中持续使用ARC-EX疗法对于保持和扩大在诊所取得的成效是有效的。

Commercially available for less than one year, the ARC-EX System is now accessible in more than 60 clinics across the US. ARC-EX was named one of TIME magazine’s Best Inventions and was recognized among Fast Company’s 2025 World Changing Ideas for its potential to transform lives.

商用时间不到一年，ARC-EX 系统现已在美国 60 多家诊所投入使用。ARC-EX 被《时代》杂志评为最佳发明之一，并因其改变生活的潜力入选《快公司》2025 年改变世界创意榜单。

About ONWARD Medical

关于ONWARD Medical

ONWARD Medical is the leading neurotechnology company pioneering therapies to restore movement, function, and independence in people with spinal cord injuries and other movement disabilities. Building on decades of scientific discovery, preclinical research, and clinical studies conducted at leading hospitals, rehabilitation clinics, and neuroscience laboratories, the Company developed ARC Therapy.

ONWARD Medical是一家领先的神经技术公司，开创了恢复脊髓损伤和其他运动障碍患者的运动、功能和独立性的疗法。基于在顶尖医院、康复诊所和神经科学实验室进行的数十年科学发现、临床前研究和临床试验，该公司开发了ARC疗法。

It has subsequently been awarded 10 Breakthrough Device Designations from the FDA. The Company’s ARC-EX® System is cleared for commercial sale in the US and Europe. The Company is also developing an investigational implantable system called ARC-IM®, designed to address several unmet needs including blood pressure instability after spinal cord injury.

此后，它已获得美国食品药品监督管理局（FDA）授予的10项突破性器械认定。该公司的ARC-EX®系统已获准在美国和欧洲进行商业销售。该公司还在开发一种名为ARC-IM®的植入式研究系统，旨在解决多种未满足的需求，包括脊髓损伤后的血压不稳定问题。

It can also be paired with a brain-computer interface (BCI) and artificial intelligence (AI) to restore thought-driven movement..

它还可以与脑机接口 (BCI) 和人工智能 (AI) 相结合，以恢复由思维驱动的运动。

Headquartered in the Netherlands, the Company has a Science and Engineering Center in Switzerland and a US office in Boston, Massachusetts. The Company is listed on Euronext Paris, Brussels, and Amsterdam (ticker: ONWD) and its US ADRs can be traded on OTCQX (ticker: ONWRY). For more information, please visit ONWD.com..

公司总部位于荷兰，在瑞士设有科学与工程中心，并在美国马萨诸塞州波士顿设有办公室。公司于巴黎泛欧交易所、布鲁塞尔和阿姆斯特丹上市（股票代码：ONWD），其美国存托凭证（ADR）可在OTCQX交易（股票代码：ONWRY）。欲了解更多信息，请访问ONWD.com。

To stay informed about ONWARD’s research studies, technologies, and the availability of therapies in your area, please complete this webform.

要随时了解 ONWARD 的研究、技术和您所在地区的疗法可用性，请填写此网络表单。

For Media Inquiries:

媒体查询：

Sébastien Cros, VP Communications

塞巴斯蒂安·克罗斯，副总裁通讯部

[email protected]

电子邮件地址

For Investor Inquiries:

投资者查询：

[email protected]

电子邮件地址

Forward-Looking Statements

前瞻性声明

Certain statements, beliefs, and opinions in this press release are forward-looking, which reflect the Company’s or, as appropriate, the Company directors’ current expectations and projections about future events. By their nature, forward-looking statements involve several risks, uncertainties, and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements.

本新闻稿中的某些陈述、信念和意见属于前瞻性陈述，反映了公司或适当时公司董事对未来的事件的当前预期和预测。就其性质而言，前瞻性陈述涉及若干可能导致实际结果或事件与前瞻性陈述所表达或暗示的内容存在重大差异的风险、不确定性和假设。

These risks, uncertainties, and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, delays in regulatory approvals, changes in demand, competition, and technology, can cause actual events, performance, or results to differ significantly from any anticipated development.

这些风险、不确定性和假设可能对本文所述计划和事件的结果及财务影响产生不利影响。众多因素，包括但不限于监管审批延迟、需求变化、竞争和技术变革，可能导致实际事件、表现或结果与任何预期发展存在显著差异。

Forward-looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions, or circumstances on which these forward-looking statements are based.

本新闻稿中包含的关于过去趋势或活动的前瞻性陈述不应被视为表示这些趋势或活动将在未来继续。因此，公司明确声明不承担任何义务或承诺，因任何预期变化或任何事件、条件、假设或这些前瞻性陈述所依据的情况发生变化而发布对这些前瞻性陈述的任何更新或修订。

Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such person’s officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments.

公司及其顾问、代表、任何子公司或其任何人员、董事或雇员，均不保证这些前瞻性陈述所依据的假设无误，也不对本新闻稿中包含的前瞻性陈述的未来准确性或预测发展的实际发生承担任何责任。

You should not place undue r.

您不应施加不适当的约束。

Trademarks: ONWARD, ARC-EX, ARC-IM, ARC-BCI, and the stylized O-Logo are proprietary and registered trademarks of ONWARD Medical. Unauthorized use is strictly prohibited.

商标：ONWARD、ARC-EX、ARC-IM、ARC-BCI 以及风格化的 O-Logo 是 ONWARD Medical 的专有注册商标。未经许可严禁使用。

ARC-EX Indication for Use (US): The ARC-EX System is intended to deliver programmed, transcutaneous electrical spinal cord stimulation in conjunction with functional task practice in the clinic and with take-home exercises in the home to improve hand sensation and strength in individuals between 18 and 75 years old that present with a chronic, nonprogressive neurological deficits resulting from an incomplete spinal cord injury (C2-C8 inclusive).

ARC-EX 使用适应症（美国）：ARC-EX 系统旨在通过经皮电刺激脊髓的方式，结合临床中的功能性任务练习以及家庭中的带回家练习，改善 18 至 75 岁因不完全性脊髓损伤（C2-C8 包括在内）导致的慢性、非进行性神经功能缺损患者的双手感觉和力量。

The ARC-EX System is intended to be operated in medical centers by rehabilitation professionals and at home by patients and persons providing assistance to patients, as needed..

ARC-EX系统旨在由康复专业人士在医疗中心操作，并根据需要由患者和在家为患者提供帮助的人员使用。

Other Investigational Products: All other ONWARD Medical devices and therapies including ARC-IM and ARC-BCI are investigational and not available for commercial use.

其他研究性产品：所有其他ONWARD医疗设备和疗法，包括ARC-IM和ARC-BCI，均为研究性产品，不适用于商业用途。

Source: globenewswire.com

来源：globenewswire.com