U.S. Military & Navy HBOC Research
Key dates, amounts and original documents behind the Army trauma program and the Naval Medical Research Center’s RESUS collaboration with Biopure on Hemopure (HBOC-201).
The record in six facts
Dated milestones
Each entry names what the source documents. Statements of intent remain labelled as plans.
Army clinical context.A Defense news report described testing at Brooke Army Medical Center and the military problem of blood storage and positioning near casualties.
Defense archive ↗Congressional testimony.Carl W. Rausch presented Biopure’s oxygen-therapeutics rationale, including storage and emergency logistics. These were his historical statements.
Prepared testimony ↗Pre-9/11 research requirement.House Report 107-194 described a need for a room-temperature-stable oxygen carrier for combat casualties and recommended $7.0m in additional research funding.
House report ↗Disaster readiness testimony.Rausch discussed locally stockpiled oxygen-carrying support before donated blood could be processed after a crisis.
House hearing ↗Army grant.Biopure reported a $908,900 Army award for a proposed controlled Phase II trial in trauma patients.
2002 annual report ↗Navy RESUS agreement.NMRC and Biopure formalized CRADA NCRADA-NMRC-03-1497, “Restore Effective SUrvival in Shock.” Daniel Freilich was the Navy principal investigator.
CRADA and amendments ↗FDA clinical hold.The proposed NMRC RESUS trial could not start under its submitted protocol; Biopure reported the hold and later FDA concerns about the product’s risk-benefit profile.
FY2005 Form 10-K ↗Conditional defense supply term.CRADA Amendment #3 contemplated a written NMRC request for 1,500 HBOC-201 units for military units totaling at least 10,000 personnel. Biopure’s estimated total cost was capped at $650 per unit. This provision does not establish that the units were bought or fielded.
Amendment #3 ↗Modified formulations.Biopure reported that the Navy agreed to buy Hemopure and seven modifications for preclinical testing. This describes a research purchase, not a field-use approval.
FY2007 Form 10-K ↗Three proposed protocols.Biopure said the Navy expected to submit revised RESUS, military Op RESUS and a phase 1b nitric-oxide-donor safety study to FDA. RESUS was still described as on clinical hold.
Form 8-K ↗
Funding: what each number means
A recommendation, an awarded grant and a company-reported appropriation describe different events. They should not be added together.
+$7.0m for oxygen-therapeutics research
House Report 107-194 recommended this increase for room-temperature-stable oxygen therapeutics. The report itself does not establish a payment to Biopure.
Open House report ↗$908,900 research grant
Biopure’s annual report described an Army award for a controlled trauma-trial plan. It is a company disclosure, not evidence that the proposed study was completed.
Open SEC archive ↗At cost, no more than $650 per unit
Amendment #3 set a ceiling on estimated manufacturing, regulatory, administrative and distribution costs for a possible 1,500-unit HBOC-201 supply upon a written NMRC request. This is a contract term, not the documented price of the Navy’s later preclinical purchases or proof of delivery.
Open CRADA Amendment #3 ↗$22.5m to DoD in total
Biopure reported that Congress had appropriated $16m to the Navy and $6.5m to the Army for Hemopure trauma development. This is not a statement that Biopure received $22.5m.
Open FY2005 Form 10-K ↗Hemopure + seven modified formulations
The Navy agreed to buy material for testing; the filing described expected proceeds, not a clinical purchase or operational supply.
Open FY2007 Form 10-K ↗Primary document index
Direct links to government archives, SEC-filed agreements and contemporary filings. Company records are identified as company disclosures.
NMRC–Biopure RESUS CRADA
Agreement number NCRADA-NMRC-03-1497; objectives, research responsibilities and amendments.
Read signed record ↗House Report 107-194
Military need and $7.0m committee recommendation predating 11 September 2001.
Read report ↗FY2005 Form 10-K
DoD appropriations reported by Biopure and description of the 2005 FDA clinical hold.
Read filing ↗21 November 2008 Form 8-K
Revised RESUS, planned Op RESUS and proposed nitric-oxide-donor study, with clinical-hold status.
Read filing ↗How to read this history
These records document research needs, funding decisions, contractual collaboration, preclinical work and proposed protocols for a specific historical product. They do not establish current FDA marketing approval, clinical efficacy, routine military deployment or the performance of a future BHOC formulation. Historical “blood substitute” wording is retained only where it names the original source.