SBIR-STTR Award

The Defense Health Agency seeks to develop a novel wearable wound infection treatment delivery device capable of delivering treatment for the prevention of infection in a prolonged care setting. Critical Innovations, KARA & Associates, and consultants Loren Miller, MD, MPH, Captain David Tanen, MD, FAAEM, FACMT (USN, Ret.), and former Commander Denise Whitfield, MD, FACET (USN), have formed a team of experts to address this important need. During Phase I, our objectives will be to further advance the innovative Rx-Shooter product. This will include: 1) On-boarding program requirements, goals, and schedule; 2) Developing a proof-of-concept Rx-Shooter prototype that addresses applicable treatment requirements; 3) Performing benchtop testing on the Rx-Shooter to demonstrate feasibility; 4) Maintaining and compiling all regulatory compliance requirements while preparing for upcoming regulatory hurdles.

The Defense Health Agency seeks to develop a novel wearable wound infection treatment delivery device capable of delivering treatment for the prevention of infection in a prolonged care setting. Critical Innovations, NDA Partners, IOTAI, and consultants Loren Miller, MD, MPH, Gary Fong, PharmD, BCPS, BCIDP, Captain David Tanen, MD, FAAEM, FACMT (USN, Ret.), and former Commander Denise Whitfield, MD, FACET (USN), have formed a team of experts to address this important need. During Phase II, our objectives will be to further advance the innovative Rx-Shooter product. This will include: 1) Production of a refined prototype using an agile engineering approach; 2) Development of a manufacture-ready device; 3) Performance of additional studies to demonstrate product stability and efficacy; 4) Performance of a pilot Rx-Shooter study in a live-animal model; and 5) Maintenance of all regulatory compliance requirements while preparing for upcoming regulatory and transition hurdles.