IRONCROWN: A Novel Medical Device for the Prehospital Diagnosis and Treatment of Traumatic Brain Injury

Blast-related Traumatic Brain Injury (TBI) has plagued American servicemen since World War I. More than a century later, there remains no direct treatment for TBI, leaving at-risk populations vulnerable to life-long neurological damage and disability. WetWare BioSystems, in partnership with BlackBox Biometrics, has developed the revolutionary helmet-borne IRONCROWN medical device system, which is capable of detecting and treating TBI resulting from IED-like blast exposure. Upon detection of an injurious blast, impact, or acceleration, the system administers a phased array of magnetic fields to decouple deleterious disease mechanisms which cause progressive neurological deterioration from the physical consequences of blast wave exposure, effectively preventing the manifestation of delayed neurotrauma. IRONCROWN uses a well-studied, previously FDA-approved neurostimulation technology called Transcranial Magnetic Stimulation, which has been demonstrated in animal models to mitigate brain injury resulting from ischemic and traumatic insults, all the while presenting less than a .02% chance of side effects. Under this Phase I effort, WetWare will partner with the industry leader in blast sensing, BlackBox Biometrics, to manufacture and test the integrated system in the setting of free-field blast to demonstrate the feasibility of the system for eventual implementation as an FDA-approved treatment for blast-related TBI. Anticipated Benefits/Potential Commercial Applications of the Research or Development: The anticipated benefits of this research and development effort are to establish the viability of the IRONCROWN system for use in operational environments as an effective method to treat blast TBI. If successful, the Phase I effort will result in a significant base of technical data for iterative prototyping, allowing for subsequent clinical testing to definitively demonstrate the efficacy of IRONCROWN in alleviating blast-induced neurotrauma. The resulting data will pave the way for deployment in training settings, where a clinical trial will generate the key data required for submission to the FDA’s De Novo review process for final regulatory approval of IRONCROWN as a treatment for blast TBI. If successful, this research and development effort will generate the first known treatment for TBI. The United States spends roughly $86 billion dollars annually for the treatment of TBI, and faced with the 70 million new TBIs which occur worldwide each year, there exists a vast market need and a clear potential to create the TBI treatment market through sales to defense customers, hospital systems, law enforcement agencies, EMS agencies, and home users seeking to protect themselves and their constituency against the risks posed by TBI.