Cleveland’s COSMIIC grows out of a research program that has developed implantable devices since the 1960s, including the first spinal cord stimulator implanted in Cleveland in 1967. Today, it is an open-source community making the Networked Neuroprosthesis available to researchers and startups pursuing neuromodulation studies, from animal work to early human research.
FDA Early Feasibility Study Investigational Device Exemption (IDE)
Compliance program
NIH SPARC Program
Compliance program
FDAIDE
Quality certification
Synapse Biomedical IncFounded in 2002, Oberlin-based Synapse Biomedical develops and manufactures neurostimulation medical devices that help patients breathe and recover movement. Its FDA-approved NeuRx Diaphragm Pacing System supports diaphragm conditioning for people with spinal cord injuries and ALS, while the company’s TransAeris system is designed to address ventilator-induced diaphragm dysfunction. Synapse says its NeuRx products are manufactured in Ohio at an ISO 13485-certified facility and have been used to treat more than 2,000 patients.OBERLIN, OH
Neuronoff, IncCleveland-based Neuronoff develops and manufactures the investigational Injectrode, a needle-delivered neuromodulation device designed to make chronic-pain treatment less invasive than conventional implanted stimulators. Its system is placed through an 18-gauge needle, powered externally through the skin, and designed for straightforward removal; the company has completed its first-in-human LIFE study and reports Technology Readiness Level 7 for lower-back pain applications. Neuronoff manufactures in Cleveland under ISO 13485 and MDSAP-certified quality systems, while researching applications beyond pain care.CLEVELAND, OH
Auxano MedicalBorn from 1980s NASA ion-bombardment research at Case Western Reserve University, Brecksville-based Auxano Medical develops orthopedic implants designed to improve bone integration. Founded by biomaterials researcher Dr. George Picha, the company builds its products around a patented pillared surface morphology and applies it to procedures including midfoot fusion and flatfoot correction. Its research record includes 14 issued U.S. and international patents, two peer-reviewed publications, and a team with more than 75 years of combined orthopedic experience.BRECKSVILLE, OH
Threshold NeuroDiagnosticsThreshold NeuroDiagnostics makes the Medusa Electrode, an FDA-registered Class II device that adapts neuromodulation leads to universal EEG connectors so clinicians and researchers can record neural signals with standard neurophysiology equipment. Founded around the hands-on expertise of Geoffrey Allott, the company draws on more than 16 years connecting to neuromodulation electrodes and experience with over 400 human-subject procedures. Its work also supports research into brain and spinal stimulation, including biomarker access and neural-network mapping.