Critical Innovations is currently developing multiple medical devices toward regulatory clearance. The company focuses on task-shifting evidence-based interventions to earlier echelons of care and more general specialty levels, to simplify management and allow for rapid provision in emergency and combat environments. To date, the company has worked under more than 20 different Department of Defense awards from all three military branches charged with medical technology development (i.e. U.S. Army, Air Force, and Navy), including such agencies as the Air Force Medical Support Agency; Army Medical Research and Development Command; Defense Health Agency; and, Office of Naval Research. Contract types have included Small Business Innovation Research (SBIR), Joint Warfighter, and Other Transactional Authority. As a prime contractor, Critical Innovations currently has a 100% transition rate from Phase I to Phase II, as well as Phase II to Phase III, for all eligible SBIR programs.
BurRapid™ Intracranial Access Platform
Critical Innovations is developing this patented technology through Defense Health Agency (DHA) Phase IIE SBIR funding and Phase III funding via MTEC. BurRapid™ is a paradigm-shifting medical device that immediately advances state-of-the-art Traumatic Brain Injury (TBI) care while providing a platform for future integration of additional devices and advanced technologies. BurRapid™ seeks to make emergent neurosurgical procedures (e.g. extra-axial hematoma drainage, invasive ICP monitoring, ventriculostomy) easier to perform, while allowing task shifting to a wider range of medical providers in addition to neurosurgeons. As demonstrated in an ACURO-approved large animal model of epidural hemorrhage, the simplified system will be able to stabilize TBI casualties by preventing and mitigating secondary brain injury from bleeding and increased intracranial pressure (ICP). Although such surgical procedures are well-established and evidence-based interventions for moderate-to-severe TBI, they were previously only available from a neurosurgeon in a controlled hospital environment. The streamlined, ruggedized, portable, and field-deployable BurRapid™ system allows these life-saving surgical techniques to be task-shifted to earlier echelons of care.
Donaldson Decompression Needle™
The Defense Health Agency (DHA) is funding this patented technology through a Phase II SBIR program. The Donaldson Decompression Needle™ is a universal, automated needle decompression device tailored to the battlefield environment that addresses the critical need of tension pneumothorax, a major cause of potentially preventable combat death. It is portable, lightweight, self-contained, requires no power, and can be used by a wide range of providers including EMT-Basic and lower (e.g. Combat Casualty Care, Buddy Aid). The device is a paradigm shift in the treatment of tension pneumothorax. By automating the process, it mitigates the risk of iatrogenic injury to vital organs (e.g. heart, major vessels, lung) and ensures that the needle always reaches the pleural cavity. This new technology can even be used on a healthy lung with minimal side effects. This means it can be used bilaterally in practice, for any patient at risk for tension pneumothorax, as well as outside the traditional needle decompression "safe zones" (i.e. 2nd midclavicular and 4-5th midaxillary), to allow for easy site selection throughout most of the thorax. The minimally-invasive device rapidly results in the treatment of this life-threatening process, while additionally being easy to secure to the chest for optimized patient transport.
Fast Onset Abdominal Management™ (F.O.A.M.™)
Recipient of the MTEC 2020 Prototype of the Year Award, this program is funded by the U.S. Army Medical Materiel Development Activity (USAMMDA), a subordinate command of the U.S. Army Medical Research and Development Command, through an Other Transaction Agreement with Military Technology Enterprise Consortium (MTEC). Critical Innovations is developing this innovative life-saving technology to control intra-abdominal hemorrhage in the out-of-hospital, forward surgical, and prolonged field care environments. A recent review of U.S. battlefield deaths demonstrated that around 90% of all injury mortality occurred pre-medical facility, with the vast majority of potentially survivable deaths due to non-compressible abdominopelvic hemorrhage. American military experts have declared this “a clear and persistent gap in medical treatment capability that has been present for the entire history of warfare.” Severe intra-abdominal bleeding currently requires operative treatment by trained surgeons, while the patented F.O.A.M.™ technology task-shifts to allow earlier abdominal hemostasis by a wider range of providers. The product is an easily transportable medical device that can be used by non-surgeon providers within the battle area, before or during medical evacuation. F.O.A.M.™ is field-adapted for long shelf life, resorbable by the body with minimal risk for complications, and easily removable if needed for subsequent surgery. This program has been an unconditional success to date, having met or exceeded all program deliverables, received Breakthrough Device Designation from the FDA, delivered very encouraging porcine survival data under two separate ACURO-approved studies, and received several additional allocations of funds from USAMMDA.
PleuraPath™ Thoracostomy System
Critical Innovations is developing this exciting, patent-pending technology through Defense Health Agency (DHA) Phase IIE SBIR funding and the FY18 Joint Warfighter Medical Research Program (Phase III SBIR Funding). Thoracic trauma is one of the principal causes of combat deaths, as well as a significant cause of mortality among civilians. Tube thoracostomy (the placement of a chest tube into the pleural space) is the definitive treatment for the majority of severe chest injuries, as acknowledged in U.S. Tactical Combat Casualty Care guidelines. The PleuraPath™ Thoracostomy System eliminates many of the problems with traditional tube thoracostomy, while preventing and treating retained hemothorax. The device allows easy adjustment and/or replacement of chest tubes after the initial insertion procedure, which traditionally required fully repeating the initial sterile procedure. A correctly placed chest tube enables optimal evacuation of air and fluid from the pleural cavity, obviating the need for subsequent surgery and leading to shorter intensive care unit and hospital stays. The device is additionally optimized for placement outside of the operating room, where maintaining a large sterile field is difficult (e.g. battlefield, emergency department, intensive care unit). It also has additional attachments for patient transport and performing video-assisted thoracoscopic surgery (VATS) type procedures at the bedside.
Succor™ Combat Foam for Large Burn Wounds
Under Defense Health Agency (DHA) Direct to Phase II SBIR funding, Critical Innovations is currently developing this innovative, self-setting hydrogel that is an ideal dressing for burns, while additionally preventing and treating wound infections that make up a significant cause of morbidity and mortality among U.S. uniformed personnel. Although personal protective equipment and trauma care have improved combat survival, burns and other injuries in the deployed environment continue to be at high risk for infection, including with multi-drug resistant bacteria. Succor™ fills a known need for infection prevention and treatment of large-size wounds, starting at the point-of-injury. The new product is field-adapted with long shelf-life and temperature tolerance; rapidly conforms to wound surfaces; reduces wound pain; intrinsically prevents bacterial adhesion and biofilm formation; inhibits resistance mechanisms in multidrug-resistant bacteria; delivers a wide range of antibiotic coverage; prevents dressing adhesion; is easily washed away; and, uses components already FDA-approved for multiple applications.
- CAUTION -
All medical technologies listed on this page are INVESTIGATIONAL and NOT AVAILABLE FOR COMMERCIAL SALE. These statements have NOT been evaluated by the Food and Drug Administration and these technologies are NOT currently approved for human use.
CD010 Rev.H 10-22-2021