A notorious battlefield injury which has affected millions of American operators for over a century is Traumatic Brain Injury (TBI). Currently, no treatment exists for TBI, and no medical device or drug is used to directly treat TBI, leaving millions with lifelong disabilities which significantly impact the lives of American veterans. A crucial reason for this capability gap is that much of the brain tissue damage resulting from TBI manifests within 30 minutes following blast, which has presented significant challenges to medical researchers seeking to develop strategies to mitigate the development of brain damage in chaotic, low-resource and information-sparse environments. WetWareâs solution derives its technology from the directed, purposeful application of decades of focused scientific research to the problem of TBI. Of few potential treatments, Transcranial Magnetic Stimulation (TMS) has been FDA-approved to halt disease mechanisms that are known to occur in TBI. Specifically, malignant waves of damaging neural activity cause degenerative brain injury with rapid deterioration immediately following injury. To mitigate this disease process, transcranial magnetic fields disrupt the damaging waves, preventing neuronal degeneration. TMS presents little to no health risk to uninjured patients, and is currently used in clinical trials to stop refractory seizures in patients. WetWare has engineered a medical device system to deliver TMS in austere environments, called the IRONCROWN system. The IRONCROWN system is compact, lightweight, rugged, and purposefully built to integrate into soldier and medic-based protection. The system can be integrated into all current helmet architectures in use in the DoD through an attachable helmet liner. IRONCROWN is equipped with a blast gauge capable of registering blast overpressure, and upon identifying blast, applies a 40-second treatment paradigm to mitigate brain cell damage. The solution has the potential to rapidly treat and stabilize operators suffering from TBI on the battlefield. To implement this technology, WetWare has developed a commercialization strategy for its proprietary technology based on the needs of both defense and civilian markets. With the assistance of the University of Rochester, WetWare has built a milestone-based process for successfully gaining FDA approval to market and sell the IRONCROWN System in a Phase II SBIR. In the proposed Phase I plan of work, customer discovery will play a crucial role in determining the role of the IRONCROWN system in context of the current TBI treatment pipeline, and will then be leveraged into rapid development of TBI-mitigating hardware through dialogue with eventual defense end users. The results will serve as the basis for a pursuant SBIR Phase II proposal, in which the ruggedized system will be shown to be safe and efficacious for the hyperactue treatment of Traumatic Brain Injury with the goal of saving the lives of American operators
