ONWARD Medical N.V. (Euronext: ONWD), the medical technology company creating innovative spinal cord stimulation therapies to restore movement, function, and independence in people with spinal cord injury (SCI), today announces it has been awarded Breakthrough Device Designation (BDD) by the US Food and Drug Administration (FDA) for the ARC-BCI System, which uses brain-computer interface (BCI) technology in conjunction with its ARC-IM® Therapy to restore thought-driven lower limb mobility after spinal cord injury (SCI).

Forward Medical N.V.（泛欧交易所：ONWD），一家创造创新脊髓刺激疗法以恢复脊髓损伤（SCI）患者运动，功能和独立性的医疗技术公司，今天宣布它已被美国食品和药物管理局（FDA）授予突破性设备称号（BDD）用于ARC-BCI系统，该系统使用脑机接口（BCI）技术及其ARC-IM®疗法来恢复脊髓损伤（SCI）后思维驱动的下肢活动能力。

This BDD is supported by clinical data from two feasibility studies.  This is the tenth FDA BDD awarded to ONWARD Medical. The designation is reserved for novel, cutting-edge therapies addressing an unmet need and provides many potential regulatory and reimbursement advantages. This latest award gives ONWARD Medical priority FDA review, the opportunity to interact with FDA experts throughout the pre-market regulatory review phase, and the potential to seek additional reimbursement for its ARC-BCI System.  “Brain-computer interface technology unlocks the transformative potential to enhance ARC-IM with thought-driven control of movement after paralysis,” said ONWARD Medical CEO Dave Marver.

该BDD得到了两项可行性研究的临床数据的支持。这是第十个FDA BDD授予Forward Medical。该名称保留用于解决未满足需求的新型尖端疗法，并提供许多潜在的监管和报销优势。这一最新奖项为FDA提供了医疗优先审查，在整个上市前监管审查阶段有机会与FDA专家互动，并有可能为其ARC-BCI系统寻求额外报销。Forward Medical首席执行官戴夫·马弗（DaveMarver）说：“脑机接口技术释放了通过思维驱动的瘫痪后运动控制来增强ARC-IM的变革潜力。”

“We look forward to learning more about the potential for this combination of ARC Therapy™ and a BCI to help people with spinal cord injury live more independently. We are also grateful to the FDA for recognizing our innovations and their potential to help people with profound unmet needs.”  An implanted BCI records brain activity, capturing signals that indicate a person’s intention to move.

“我们期待着更多地了解ARC Therapy™和BCI结合的潜力，以帮助脊髓损伤患者更独立地生活。我们也感谢FDA认可我们的创新及其帮助严重未满足需求的人的潜力。”植入的BCI记录大脑活动，捕捉指示一个人移动意图的信号。

The ARC-BCI System then uses artificial intelligence (AI) to decode those signals and translate them into specific i.

然后，ARC-BCI系统使用人工智能（AI）对这些信号进行解码，并将其转换为特定的i。