NIH Investment Fuels VA Innovation: COSMIIC Implant System to be Applied for Walking Recovery After Spinal Cord Injury

A joint collaboration between Case Western Reserve University, the MetroHealth System, and the Advanced Platform Technology (APT) Center and Cleveland Functional Electrical Stimulation (FES) Center at the VA Northeast Ohio Healthcare System (VANEOHS) is launching the first customization of the existing COSMIIC (Cleveland Open Source Modular Implant Innovators Community) System—a fully implantable neurotechnology platform made available to researchers and startups as “open source” through NIH funding.

Nathan Makowski PhD, a researcher in the MetroHealth Center for Rehabilitation Research, is spearheading this groundbreaking work at the VANEOHS. With a new four-year, $3.9 million Department of Defense (DoD) award through the Spinal Cord Injury Research Program, Dr. Makowski’s team is conducting a first-in-human study of the COSMIIC System for a new use—enabling standing and walking in people with incomplete spinal cord injury (iSCI). Referencing an existing Investigational Device Exemption (IDE) for the COSMIIC System—originally for another medical indication—the team’s access to an open source IDE reduced the testing and novel documentation required to implement the technology in people with iSCI for walking. The team has secured IDE approval to use the device for an early feasibility study in humans. Achieving this IDE with open documentation demonstrates how fundamental regulatory resources can be shared and how federally funded open source neurotechnology can benefit researchers and Veterans and non-Veterans.

A New Concept for Neurotech Development Supported by SPARC Program Funding

The COSMIIC System itself was established by an investment from the NIH SPARC Program into open source platforms designed to accelerate innovation in bioelectronic medicine. The open source framework offers a new pathway for biomedical researchers to translate work into clinical applications faster by eliminating costs and barriers associated with proprietary technologies.

“This DoD funded project at the VA would not be possible without the foundational NIH investment in open source human-grade implantable devices,” said Dr. Makowski. “We are now seeing the potential for scalable, modular technology supported by public funding to directly benefit Americans living with disability.” This milestone not only represents the first new use of the COSMIIC System in humans, but is also a model of interagency synergy— NIH investment in fundamental technology is being advanced by VA investigators and Department of Defense funding to meet clinical needs. By combining public funding with open innovation, this effort opens new possibilities for restoring independence to those living with disability.

About COSMIIC

COSMIIC (Cleveland Open Source Modular Implant Innovators Community) is an initiative established through major funding from the National Institutes of Health (NIH) Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program via a three-year, $12.5M grant starting September 2022, expanding on technology originally developed at Case Western Reserve University supported by the National Institute of Biomedical Imaging and Bioengineering and National Institute of Neurological Disorders and Stroke.

COSMIIC enables researchers to prototype, adapt, and translate implantable systems more efficiently by providing a human-ready, regulatory-informed foundation. The platform supports a wide range of applications, from preclinical testing to early feasibility studies. COSMIIC is a collaborative community of engineers, scientists, and clinicians started in Cleveland, including teams from the APT Center and Cleveland FES Center at the VA Northeast Ohio Healthcare System, Case Western Reserve University, the University of Michigan, University of California Los Angeles, and The MetroHealth System. COSMIIC is growing internationally and looking to collaborate with interested researchers and startups.

About the Functional Electrical Stimulation Center

The Cleveland FES Center is a neuromodulation and neurostimulation research consortium of six nationally recognized institutions: VA Northeast Ohio Healthcare System, Syracuse VA Medical Center, The MetroHealth System, Case Western Reserve University, University Hospitals of Cleveland, and the Cleveland Clinic Neurological Institute. The Cleveland FES Center is at the forefront of academic and clinical research to further the advancement of neural technology; thereby accelerating the translation of innovation into clinical practice and improving the quality of life for people with neural disorders and their families. Visit FEScenter.org to learn more.

About the VA Northeast Ohio Healthcare System

Focusing on treating the whole Veteran through health promotion and disease prevention, VA Northeast Ohio Healthcare System provides comprehensive, seamless health care and social services for more than 135,000 Veterans across Northeast Ohio. With 17 locations of care, including 12 outpatient clinics, two community resource and referral centers, a psychosocial rehabilitation and recovery center, a chronic dialysis center, and an outpatient surgery center, VA Northeast Ohio Healthcare System’s quality services are easily accessible to Veterans in 21 counties. VA Northeast Ohio Healthcare System also contributes to the future of medicine through education, training, and research programs. For more information about programs and services offered by VA Northeast Ohio Healthcare System, visit www.cleveland.va.gov or follow us on Facebook, Instagram or X @ClevelandVAMC.

About MetroHealth System

Founded in 1837, MetroHealth is leading the way to a healthier you and a healthier community through service, teaching, discovery, and teamwork. Cuyahoga County’s public, safety-net hospital system, MetroHealth meets people where they are, providing care through five hospitals, four emergency departments and more than 20 health centers. Each day, our nearly 9,000 employees focus on providing our community with equitable healthcare — through patient-focused research, access to care, and support services — that seeks to eradicate health disparities rooted in systematic barriers. For more information, visit metrohealth.org. 

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