Company
Portfolio Data
Back to Company SearchWetWare BioSystems LLC
UEI: VNMNENDXFJ29
Number of Employees: 5
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
SBIR/STTR Involvement
Year of first award: 2021
2
Phase I Awards
0
Phase II Awards
N/A
Conversion Rate
$299,972
Phase I Dollars
$0
Phase II Dollars
$299,972
Total Awarded
Awards
IRONCROWN: A Novel Medical Device for the Rapid and Noninvasive Detection, Diagnosis, and Treatment of Blast-Related Traumatic Brain Injury
Amount: $49,996 Topic: AF203-CSO1
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. WetWare’s 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.
Tagged as:
SBIR
Phase I
2021
DOW
USAF
IRONCROWN: A Novel Medical Device for the Prehospital Diagnosis and Treatment of Traumatic Brain Injury
Amount: $249,976 Topic: DHA211-002
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.
Tagged as:
SBIR
Phase I
2021
DOW
DHA