Research and development contract - proposal JW220021 - contract proposal title - evaluating the safety and ease of use of counterflow hemostatic gauze for extreme cold environments

Active Definitive Contract Awarded Last action

Contract number
HT942523C0095
Awardee
Awarding agency
Obligated
$6,485,297

Award facts

Opportunity
  • W81XWH22SJWMR Solicitation number
Contract value 100% obligated
$6,485,297.00 Current and potential, with all options
Completion date 94% complete
Current and potential, with all options
Contracting staff
Set-aside
No set-aside
Competition
Full and Open Competition · 1 offer Basic Research
Pricing
Cost No Fee
Place of performance
Milwaukee, WI 53201, USA

Award details come from SAM.gov/FPDS.

Transactions

Action Obligated Date
Change Order P00004 · Name change and dodaac transfer $0
Change Order P00003 $0
Change Order P00002 · Proposal joint warfighter 20021 - contract $0
Supplemental Agreement for work within scope P00001 · Proposal joint warfighter 220021 - contract $1,985,297
Original award $4,500,000

About this award

The Defense Health Agency awarded a $6.485 million definitive contract to Versiti Blood Health, Inc. on September 25, 2023, for research and development to evaluate the safety and ease of use of counterflow hemostatic gauze for extreme cold environments, with ultimate completion on December 24, 2026.

The contract carries cost-plus-no-fee pricing and was issued without set-aside. Place of performance is Milwaukee, WI.

The research program encompasses protocol approvals, efficacy testing of counterflow gauze compared to combat gauze and standard gauze with intravenous tranexamic acid (TXA) in a swine hemorrhage model at extreme cold (-10 degrees Celsius), development of analytical and bioanalytical methods for thrombin and TXA assessment, FDA regulatory submissions including Investigational Device Exemption and Investigational New Drug applications, establishment of Good Manufacturing Practice manufacturing processes, and production of pilot batches up to 2,400 units for preclinical and safety testing. Major subcontractors include ST Michael's Hospital for in vivo efficacy studies in extreme cold environments and Comotion Drug Delivery Systems Inc. for analytical method development, regulatory submissions, and GMP manufacturing scale-up with equipment upgrades and barium thread integration processes.

Subawards

Subcontractor Amount Awarded
ST Michael's Hospital PROPOSAL JOINT WARFIGHTER 220021 - CONTRACT Major Task 0.1 Obtain protocol approvals from ACURO/USAMRMC. Milestone #0.1 Approvals obtained. Objective 1.… $699,941
Comotion Drug Delivery Systems Inc. PROPOSAL JOINT WARFIGHTER 220021 - CONTRACT Major Task 2.1: Generate analytical and bioanalytical methods for thrombin and TXA assessment. Subtask 2.1.1:… $899,989
Comotion Drug Delivery Systems Inc. PROPOSAL JOINT WARFIGHTER 220021 - CONTRACT Major Task 2.1: Generate analytical and bioanalytical methods for thrombin and TXA assessment. Subtask 2.1.1:Develop… $1,800,000

Quick answers

Who was awarded contract HT942523C0095?

HT942523C0095 was awarded to Versiti Blood Health, Inc. by Defense Health Agency (Department of Defense) on September 25, 2023.

How much is contract HT942523C0095 worth?

The government has obligated $6,485,297 on HT942523C0095.

Was contract HT942523C0095 competed?

The extent of competition for HT942523C0095 was full and open competition. The government received 1 offer.

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