Development Projects
CLINICAL TRIAL
The COSMIIC System’s implantable modular approach has resulted in a multi-center clinical trial scheduled to start later in 2023, aiming to test and validate the sensing and control algorithms embedded in the COSMIIC platform to deliver Hand-Grasp functionality to spinal cord injured individuals. This system is a full-featured neuro-device that has already achieved use in human studies under an Early Feasibility Study Investigational Device Exemption from the Food and Drug Administration (FDA) for application in spinal cord injury patients. Regulatory documents, test procedures, test results, and interaction with the FDA in order to obtain IDE approval will be made available to researchers as part of COSMIIC’s open source commitment. This information should help academic researchers to successfully navigate the IDE process when they apply to the FDA with their own unique clinical applications using the COSMIIC System.
UPCOMING MODULES AND DEVICES
New implantable remote modules and an external wireless link will substantially broaden the tools available for human research in bioelectronics, neuromodulation, and neuroprosthetics.
Many implantable bioelectronic systems require a high channel count throughput for electrical stimulation or recording of biopotential signals. Our current high channel recording and stimulating module design relies on an eight-contact linear connector, which can be stacked to achieve higher channel counts. However, this physically limits available channels. Instead, we are developing a modular 16-channel connection to be incorporated into a fully-networked module, allowing for multiple HIVE modules within a single system.
HIVE High Density Interconnects with Variable Electronics |
|
The remote modules of the COSMIIC System platform are sized to fit in the torso, legs, and arms of an average-sized adult, but they are too large to be placed in the hands, feet, or directly on organs. The SWARM Module is designed to address this limitation, and consists of a module adaptable to a variety of sensors with placement based on clinical need and targeted function. Potential applications could measure foot and hand movement; support feedback control for gait, balance, hand positioning and object manipulation; or form part of an implanted system regulating autonomic function in the heart, lungs, stomach, or other organs.
SWARM Sensor Withdrawn from A Remote Module |
|
The therapeutic effect of Kilohertz frequency alternating current (KHFAC) is complex and multimodal, often resulting in suboptimal results due to improperly tuned waveform parameters. But the ability to use electrical waveforms to both up-regulate and down-regulate the nervous system creates the possibility of COSMIIC users operating with greater autonomy, accuracy and control over their own physiological parameters. Additionally, adding an electrical nerve block to a system that already has electrical stimulation will allow researchers to incorporate reversible electrical nerve block via KHFAC into their research in a practical, effective, and safe manner.
NECTAR |
|
We are developing an external wireless link that facilitates communication between the implanted COSMIIC Power Module and external sensors utilizing common wired (USB, I2C, SPI, CAN) and wireless (WiFi, ZigBee, ANT) protocols. This innovation will enable researchers to make use of off-the-shelf technology or purpose-built systems to act as inputs/outputs to the implanted COSMIIC System – lowering costs and risks while enhancing function.
WING Wireless Interoperable Neuroprosthesis Gear |
|
Applications
Heart/Vascular
Myocardial Infarction
Atrial Arrhythmias
Congestive Heart Failure
Angina
VT Storms
Hypertension
Bowel/Gastric
Incontinence
Spinal Cord Injury
Pelvic Organ Prolapse
Endocrine
Diabetes
Obesity
Retina
Retinitis Pigmentosa
Macular Degeneration
Sexual Function
Menopause
Spinal Cord Injury
Diabetes
Hypertension
Skeletomuscular
Spinal Cord Injury
Stroke
Cerebral Palsy
Brain
Spinal Cord Injury
Spinal Cord
Dorsal Root Ganglia
Pain