CRITICAL INNOVATIONS LLC — Department of Defense SBIR Phase II: DHP16-011
CRITICAL INNOVATIONS LLC — SBIR Phase II award from Department of Defense.
Phase II SBIR prototype / development signal
- Phase II is where Department of Defense funds deeper R&D after feasibility. Incumbents with Phase II history are serious competitors on adjacent topics.
- Use this award as past-performance context and to map customer organizations for STRATFI/TACFI-style transition planning.
- Obligated amount $1,100,000 is consistent with substantial Phase II-scale effort; compare to related awards from the same agency.
- Topic code DHP16-011 links this award to a solicitation family — search the same topic stem for incumbents and recompete timing.
- Amount
- $1,100,000
- Agency
- Department of Defense · Defense Health Program
- Program / Phase
- SBIR · Phase II
- Topic
- DHP16-011
- Solicitation
- 16.1
- NAICS
- —
- Place of performance
- CA
- Period
- 2022-06-14 → 2024-10-12
Description
The Defense Health Agency seeks to develop a novel device that can replace or work with existing large bore (>28 French) chest tubes to help evacuate or prevent accumulation of blood in the chest space after chest trauma or chest surgery. Critical Innovations, KARA & Associates, BioSurg, and consultants 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 this second Phase II, our objectives will be to further advance the innovative PleuraPath device. This will include: 1) On-boarding of program-specific requirements, goals, and schedule; 2) Production of cGMP production-equivalent device lot for use in GLP large-animal testing; 3) Performance of an FDA-requested GLP study to evaluate PleuraPath™ in a live, large-animal model; 4) Preparation of regulatory submission materials and maintenance of compliance toward a regulatory submission.