SBIR/STTR Research Award
PleuraPath Thoracostomy System
Award amount
$1,100,000Program and phase
SBIR · Phase IIAward year
2022Award details
- Awarding agency
- Department of Defense
- Branch
- Defense Health Agency
- Recipient company
- CRITICAL INNOVATIONS LLC
- Proposal award date
- 2022-06-14
- Contract end date
- 2024-10-12
- UEI
- Q611FJPN1AK5
- Solicitation number
- 16.1
- Topic code
- DHP16-011
Research abstract
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.
Technology keywords
Not reported
Other awards by this recipient
Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.
- Aid-Tex Wearable e-Textile System for Control of Junctional and Extremity
- Succor Combat Foam for Open Traumatic Brain Injury
- Succor Combat Foam for Large Burn Wounds
- Aid-Tex Wearable e-Textile System for Control of Junctional and Extremity Hemorrhage
- Donaldson Decompression Needle for Automated Treatment of Tension Pneumothorax
Awards with the same topic code
Verified by an exact topic code match. This is not a text-similarity match.
- AgiTube (now CLR): Further Studies to Refine Device Use for the Management of Hemothorax and other Pleural Collections
- Steerable Check Tube and Portable Suction/Infusion Machine for the Prevention of Retained Hemothorax after Injury
- Devices to Prevent and Treat Retained Hemothorax after Chest Injury
- AgiTube: A Device for Preventing Retained Hemothorax
- Devices to Prevent and Treat Retained Hemothorax after Chest Injury
Research funding history
25 SBIR/STTR records share this UEI (2016–2025). Reported award amounts total $19,081,745. Reported amounts are not federal obligations.
Phases: Phase II, Phase I, Phase II – Direct to Phase II
Agencies: Department of Defense