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.
In addition to developing its own medical devices, Critical Innovations assists other companies in developing their technologies and intellectual property targeted toward the combat and emergency environments. This can include the full cycle of medical technology planning, analysis, design, implementation, testing, and deployment. Critical Innovations' value-added expertise includes the provision of clinical subject matter expert feedback, assistance with securing non-dilutional funding, and various business development activities (e.g. transition and commercialization, market analysis, reimbursement analysis, cost analysis).
Nanostasis™ Intravenous Agent for Traumatic Hemorrhage Control
Under Army SBIR Phase II funding, Critical Innovations is assisting subcontractor Cayuga Biotech in developing their traumatic hemorrhage treatment technology. Nanostasis™ is a novel systemic therapy for out-of-hospital management of combat-associated, non-compressible traumatic hemorrhage starting at the point-of-injury through en route care and beyond. Its novel platelet-like nanoparticles are an ideal intravenous treatment to halt hemorrhage in the far forward combat environment. The final product will not only have innovative hemorrhage-stopping properties, but also be easily transportable (e.g. small volume, no special storage requirements, shelf-stable for long periods under environmental extremes) and easily administered in the operational environment with a straightforward plan for practical combat deployment.
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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.J 2021-11-09