ONWARD Medical Achieves Fifth Successful Brain-Computer Interface Implant

Analysis reveals significant industry trends and economic implications

Release Date

2025-05-21

Category

Clinical Trial Event

Reference

Source

Breakthrough Clinical Results

ONWARD Medical announced the successful implantation of its investigational ARC-BCI® Therapy in two additional individuals with spinal cord injury, bringing the total to five. This BCI system, paired with the ARC-IM® System, creates the ONWARD DigitalBridge™, enabling thought-driven movement. The procedures were performed at CHUV in Lausanne, Switzerland, under the direction of Dr. Jocelyne Bloch. Detailed results are expected in a peer-reviewed publication. The ARC-BCI System received Breakthrough Device Designation from the FDA in February 2024. This advancement builds on ONWARD's leadership in developing BCI-enabled movement solutions for individuals with spinal cord injury, recently highlighted on CBS 60 Minutes.

Key Highlights

  • Fifth successful implantation of ONWARD's investigational ARC-BCI® Therapy.
  • ARC-BCI System, paired with ARC-IM®, creates a wireless brain-body connection (ONWARD DigitalBridge™).
  • Procedures performed at CHUV in Lausanne, Switzerland.
  • Detailed results to be published in a peer-reviewed scientific publication.

Incidence and Prevalence

Global Burden of SCI:

The global burden of spinal cord injury (SCI) remains substantial, with varying estimates across different studies and years. Here's a summary of the latest available data from PubMed:

Key Observations:

It's important to note that these estimates vary due to differences in methodologies, data sources, and the years covered. Continued research and standardized reporting are crucial for a more precise understanding of the global SCI burden and for developing effective prevention and treatment strategies.

Unmet Needs and Target Populations in Spinal Cord Injury Research (Based on PubMed Publications from 2020-2023)

Spinal cord injury (SCI) research has identified several key unmet needs and target populations, reflecting the complex and multifaceted nature of this condition. These needs span across the continuum of care, from acute management to long-term rehabilitation and community reintegration. The following key areas and populations have been highlighted in recent PubMed publications:

1. Effective Neuroprotective and Neuroregenerative Therapies:

  • A significant unmet need remains the development of effective treatments to limit secondary injury and promote regeneration after SCI. While preclinical studies have shown promise for various interventions (e.g., cell-based therapies, biomaterials, neuromodulation), translation to clinical success has been limited. This highlights the need for more robust preclinical models and improved clinical trial designs.
  • There is a particular need for therapies that address the chronic phase of SCI, including strategies to overcome the inhibitory environment of the glial scar and promote axonal regeneration and functional recovery.
  • Combinatorial approaches, targeting multiple pathophysiological mechanisms simultaneously, are increasingly recognized as essential for maximizing therapeutic efficacy.

2. Addressing Health Inequalities and Disparities:

  • Research has consistently shown that people with SCI experience health inequalities related to income, access to care, and social determinants of health. Lower-income individuals and those in low- and middle-income countries face greater challenges in accessing appropriate healthcare services and experience higher rates of unmet needs.
  • Studies have highlighted the need for interventions to address unmet healthcare needs, particularly related to the cost of care, transportation, and service availability.
  • Older adults with SCI represent a growing population with specific unmet needs related to age-related comorbidities, long-term care, and the interaction between aging and SCI.

3. Improving Long-Term Health and Well-being:

  • Beyond functional recovery, research emphasizes the importance of addressing the broader health and well-being of people with SCI. This includes managing chronic pain, promoting physical activity and participation, addressing mental health concerns (e.g., depression, anxiety), and supporting community reintegration.
  • There is a need for more research on the psychosocial impact of SCI and the development of interventions to support individuals, families, and caregivers.
  • Employment and work integration are important priorities for people with SCI, and research has identified unmet needs related to vocational rehabilitation, workplace accessibility, and employer support.

4. Optimizing Rehabilitation and Supportive Care:

  • Research highlights the need for comprehensive and individualized rehabilitation programs that address the specific needs of each person with SCI. This includes access to specialized SCI rehabilitation centers, advanced technologies (e.g., robotics, neuromodulation), and ongoing support in the community.
  • There is a need for better strategies to address unmet rehabilitation needs in the chronic phase of SCI, as these needs can significantly impact long-term outcomes and quality of life.
  • Supportive care services, including management of secondary health conditions (e.g., pressure ulcers, urinary tract infections), are essential for optimizing health and well-being.

5. Enhancing Clinical Trial Design and Methodology:

  • A recurring theme in recent research is the need for improved clinical trial design in SCI. This includes developing more sensitive outcome measures, incorporating patient-reported outcomes, and addressing the heterogeneity of the SCI population.
  • There is a need for larger, multi-center clinical trials to evaluate the efficacy of promising interventions and translate preclinical findings into clinical practice.
  • Standardized reporting of epidemiological data and clinical trial results is essential for building a robust evidence base and informing clinical practice guidelines.

By addressing these unmet needs and focusing on the specific needs of target populations, SCI research can contribute to improving the lives of individuals with SCI and reducing the burden of this condition on individuals, families, and society.

Drug used in other indications

ARC Therapy, also known as ARC-BCI Therapy and utilizing the ARC-IM System, is primarily known for its trials and application in cervical spinal cord injury (cSCI). While the provided text focuses heavily on SCI, it mentions that spinal cord stimulation (SCS), a broader category under which ARC Therapy falls, is being investigated for a wider range of applications. The text specifically states:

  • SCS is being applied more broadly as a possible therapy for a range of indications, including neurological, cardiac, and gastrointestinal disorders.
  • Almost 20% of SCS trials pertain to conditions other than chronic pain syndromes.
  • International guidelines recommend spinal cord stimulation to treat refractory angina; other indications, such as congestive heart failure, are being investigated.
  • Spinal cord stimulation has been used to treat chronic pain for several years.
  • SCS also improves cancer-related pain, although research on this issue is scarce.
  • Non-pain-related indications for SCS are movement disorders, spasticity, and sequelae of spinal cord injury.

While the provided text doesn't explicitly detail which of these broader SCS applications ARC Therapy is specifically being trialled for beyond cSCI, it strongly suggests the possibility. It's important to distinguish between general SCS and ARC Therapy. ARC Therapy is a specific type of SCS that involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. Therefore, while SCS has broader applications, ARC Therapy's specific focus on the cervical spinal cord might limit its applicability to some of the conditions listed above.

The text does not provide specific intervention models for ARC Therapy outside of cSCI. However, it does mention various intervention models for general SCS, which could potentially inform future ARC Therapy trials:

  • Different stimulation parameters: Burst stimulation, high-frequency stimulation, tonic stimulation.
  • Combination with other therapies: SCS can be combined with physical therapy, rehabilitation protocols, exoskeletons, and other molecular therapies.
  • Targeting different neural targets: Dorsal root ganglion stimulation (DRGS) as an alternative or in combination with standard SCS.

To determine the precise indications and intervention models for ARC Therapy beyond cSCI, further research and consultation of clinical trial registries (e.g., ClinicalTrials.gov) would be necessary.

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