ONWARD Medical Secures Grant for Innovative Stroke Therapy Research

Grant Awarded to ONWARD Medical for Groundbreaking Stroke Research

ONWARD Medical N.V. (Euronext: ONWD), a pioneering medical technology firm, has recently announced its receipt of a prestigious grant from the European Innovation Council. This funding aims to support the first clinical trials that evaluate the effectiveness of the investigational ARC-BCI Therapy in restoring upper limb movement after subcortical stroke. This innovative therapy utilizes brain-computer interface (BCI) and artificial intelligence (AI), showcasing a transformative approach to rehabilitation for stroke survivors.

Exploring New Frontiers in Stroke Recovery

Approximately 15 million people worldwide suffer a stroke annually, leading to severe life-altering consequences. The impact is particularly profound for those unable to reclaim basic movements post-stroke. With this new grant, ONWARD Medical is intensifying its focus on restoring thought-driven movement abilities through the ARC-BCI Therapy. This initiative reflects the company's commitment to expanding its impact beyond spinal cord injuries, enticing hopes for stroke patients and their families.

Comments from Leadership

CEO Dave Marver emphasized the breakthrough nature of this grant, stating, "While helping people with spinal cord injury remains our North Star, this grant underscores the potential for our breakthrough therapies to impact people with other movement disabilities, such as stroke." His comments signify the dual focus ONWARD Medical has: advancing treatments for spinal cord injuries while innovating for broader neurological rehabilitation.

Details of the Grant and Funding Usage

This generous grant, totaling EUR 6 million over five years, will enable ONWARD Medical to develop the capabilities necessary to program and control two investigational ARC-IM implanted neurostimulators simultaneously. The funds will also be directed towards enhancing the ARC-IM Lead, critical for targeting the cervical spinal cord, an area crucial for upper extremity functioning. Along with support from the Swiss State Secretariat for Education, Research, and Innovation (SERI), ONWARD's commitment to restoring movement post-stroke is gaining substantial momentum.

Current Research and Trial Participants

To date, three participants have benefited from the implantation of the ARC-BCI Therapy, marking a significant milestone in clinical research. In 2021, the first human trial aimed at improving lower limb mobility using this therapy commenced, with promising results documented recently. Moreover, trials are in place to investigate the restoration of upper extremity function in individuals with spinal cord injuries, showcasing ONWARD Medical’s dedication to a multi-dimensional recovery approach.

The Technology Behind ARC-BCI Therapy

The innovative ONWARD ARC-BCI System integrates the WIMAGINE BCI with the investigational ARC-IM Therapy, forming what is termed a DigitalBridge™. This system is designed to create seamless communication pathways between the brain and the body using wireless technology. The ARC-BCI Therapy utilizes AI to decode brain signals, transforming thoughts into movements, thereby enabling users to regain preferences in maneuverability.

Significance of the FDA Breakthrough Device Designation

In a significant endorsement of its potential, the US FDA granted Breakthrough Device Designation to the ARC-BCI System early in 2024. This recognition emphasizes the therapy’s innovative capabilities, marking it as one of only ten such devices acknowledged by the FDA within the ONWARD Medical portfolio. Such accolades reinforce the enthusiasm and expected success associated with these breakthrough technologies.

About ONWARD Medical and Its Forward-Moving Mission

ONWARD Medical is determined to create therapies aimed at restoring movement and independence for individuals affected by spinal cord injuries and other movement disabilities. By leveraging over a decade of dedicated scientific research and collaboration, the company has developed the ARC Therapy platform, securing ten Breakthrough Device Designations from the FDA.

Headquartered in Eindhoven, Netherlands, ONWARD Medical has research and development operations in Switzerland and active commercial strategies in the United States. The firm is committed to regulatory submissions in both the US and Europe, significantly for the ARC-EX System, aiming to revolutionize mobility options and improve quality of life for countless individuals.

Frequently Asked Questions

What is the purpose of the grant awarded to ONWARD Medical?

The grant aims to support clinical trials for the ARC-BCI Therapy, which focuses on restoring movement in stroke patients through brain-computer interfaces.

How does the ARC-BCI Therapy work?

The ARC-BCI Therapy utilizes AI and brain-computer interface technology to decode brain signals, allowing individuals to restore their thought-driven movements.

What are the potential benefits of ARC-BCI Therapy?

This therapy has the potential to significantly improve mobility and quality of life for individuals recovering from strokes and other movement disabilities.

Where is ONWARD Medical located?

ONWARD Medical is headquartered in Eindhoven, the Netherlands, with additional research centers in Switzerland and operational offices in the United States.

How can I contact ONWARD Medical for media inquiries?

For media inquiries, please contact Aditi Roy, VP Communications, at media@onwd.com.

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