At the Biotechnology Summit: Putting a Human Face on Biotechnology, Carl W. Rausch, Chairman and CEO of Biopure Corporation, delivered prepared testimony titled Oxygen Therapeutics as Alternatives to Red Blood Cells.

Official status

Joint Economic Committee of the U.S. Congress

Date: September 29, 1999. Place: Room SH-216, Hart Senate Office Building, Washington, D.C. Record: 106th Congress, first session, S. Hrg. 106-677. The testimony is part of the official congressional hearing record.

Read Carl Rausch's testimony ↗Open the complete congressional record PDF ↗Official hearing agenda ↗

The status matters. This was not a company brochure or an industry conference presentation. Oxygen therapeutics entered a national policy discussion about biotechnology, healthcare infrastructure and economic policy.

It is equally important to say what that status does not mean. Congressional testimony is not congressional endorsement, an FDA conclusion or independent proof of every company claim. It is a primary historical record of what Biopure proposed, which problems it identified and what it believed its technology could solve in 1999.

The problem was never blood alone

Rausch described a new class of biopharmaceuticals called oxygen therapeutics. The term “blood substitute” appeared in the testimony, but the central idea was more specific: support the oxygen-delivery function normally provided by red blood cells when donor blood is unavailable, delayed, incompatible or operationally difficult to use.

Blood is a biological system.Oxygen delivery is a physiological function.

BHOC did not yet exist under its present name, and Precision Oxygen Therapeutics had not yet been defined as today's broader framework. But the central problem was already stated publicly before Congress: how can oxygen-carrying capacity reach tissues at the place and time it is needed when red blood cells cannot provide that function?

This is one historical foundation of the line that now connects oxygen therapeutics, the Biological Hemoglobin Oxygen Carrier, or BHOC, and Precision Oxygen Therapeutics.

What Rausch told Congress

The 1999 argument was built around four connected limitations of the donor-blood system:

AvailabilityRegional shortages were recurring, and a national shortfall was being projected.
Storage and logisticsRed cells had a limited storage period and required collection, testing, matching, storage and distribution.
Compatibility and biological riskDonor blood remained linked to blood-group matching, transfusion reactions and known or emerging infectious agents.
Total system costThe unit price did not capture testing, transport, readiness, administration, wastage and complication costs.

Biopure's proposed response was a purified, chemically modified bovine hemoglobin product. In the testimony, the company described its product as compatible with all blood types, stable for two years at room temperature, able to transport oxygen immediately after administration and manufactured through a validated purification process intended to remove infectious agents.

Historical claim boundaryThese were Biopure's product-specific statements in 1999. They should not be generalized to every HBOC and are not present-day performance claims for BHOC.

The numbers entered into the record

12M+blood units donated annually in the United States, with as many as 4 million transfusion recipients, according to the testimony.
300,000 to 550,000the projected red-cell shortage range described by Rausch for the following year.
35 to 42 daysthe red-cell storage period contrasted with Biopure's claimed two-year room-temperature shelf life.
$14,000additional hospitalization cost per affected patient associated with serious bacterial infection in a study cited by Rausch.
Almost $1M/dayBiopure's stated understanding of the cost of maintaining military blood readiness during Operation Desert Storm, while most blood held in readiness went unused.
$300Mcapital Biopure reported raising from its 1984 inception to develop the technology and products.

Rausch also described a compassionate-use case involving a 21-year-old woman whose red-cell volume reportedly fell below 4 percent. The testimony states that Hemopure was administered over eight days as support until the hemolytic process could be controlled.

These figures are historical statements reproduced from the testimony. They are not current burden estimates, and several originated from studies or company accounts cited by the witness.

What happened after 1999

1998Oxyglobin became the first FDA-approved oxygen therapeutic for veterinary use.
1999European authorization followed, and oxygen therapeutics entered the U.S. congressional hearing record.
2001South Africa granted marketing authorization for Hemopure in acutely anemic adult surgical patients, for eliminating, reducing or delaying allogeneic red-cell transfusion.
2002Biopure reported more than 20 clinical trials, 806 Hemopure recipients, more than 115,000 Oxyglobin units sold and a manufacturing scale-up pathway.

Biopure reported validated annual manufacturing capacity of approximately 75,000 Hemopure units, installed equipment intended to support expansion toward 100,000 units and plans for a facility designed around 500,000 units annually.

This was real translational progress from molecule to process, manufacturing, regulation and clinical use. It was not an uninterrupted success.

Cell-free hemoglobin is not equivalent to hemoglobin enclosed within a red blood cell. Programs across the heterogeneous HBOC field produced disappointing results and safety concerns. Later evidence syntheses identified cardiovascular safety signals and intensified scrutiny of vascular response, product design, dose, indication and clinical-trial interpretation. Biopure also encountered serious regulatory, financial and corporate difficulties.

The honest historical lessonCarrying oxygen is only the beginning. The carrier must interact with physiology safely, predictably and measurably. The achievement should not be erased, and the problems should not be hidden.

From a product claim to Precision Oxygen Therapeutics

The scientific question is now more precise than it was in 1999.

Hemoglobin concentration is not the same as oxygen delivery. Oxygen content in the circulation is not the same as oxygen reaching and being used by tissue. Cardiac output, microvascular distribution, diffusion, oxygen extraction, tissue demand and cellular utilization all matter.

Precision Oxygen Therapeutics is the broader translational framework concerned with the measurement, regulation and therapeutic support of oxygen delivery according to physiological demand, independent of whether donor blood is available or transfusion is otherwise feasible.

WHEREWhere is oxygen needed?
WHENWhen is additional oxygen delivery required?
HOW MUCHHow much oxygen support is required?
CONTROLHow can that support be controlled and continuously evaluated?

BHOC is a platform within this framework. It is not a claim to replace every biological function of blood. It is a hemoglobin-mediated approach to supporting oxygen-delivery function. Product-specific safety, vascular behavior, microcirculatory performance and clinical outcomes require direct evidence.

The next platform standard

The technology cannot advance through terminology alone. It needs exactly measurable and characterizable material, reproducible processes and a manufacturing architecture that can scale without losing control of identity, purity, function or quality.

The BHOC development direction links that scalable manufacturing objective to a practical clinical and economic unit: the BHOC treatment procedure with cartridge. The objective is not simply to manufacture more material. It is to produce the same controlled material through the same defined process and deliver it through a standardized procedure.

Development statusThis is a platform and engineering objective. It is not a claim of an approved or commercially validated BHOC system. The required number of cartridges per procedure and a commercial price have not been defined.

Did the original problem disappear?

Current evidence says no.

More than 400 U.S. ground EMS agencies now carry blood products, yet the Prehospital Blood Transfusion Coalition reported in June 2026 that this represented fewer than 3 percent of eligible agencies. In a separate analysis of NHS Blood and Transplant data, available whole-blood collection capacity increased by 7.6 percent between 2022/23 and 2025/26, while successful donations decreased by 3.4 percent.

These are different datasets from different systems and cannot be directly compared with the 1999 projections. But they show that capacity on paper still does not guarantee blood at the point of need.

In 1999, almost $1 million per day was presented to Congress as the cost of maintaining military blood readiness during Desert Storm.

More than a quarter-century later, have the costs fallen, or have they multiplied? Has access expanded by the same factor? Has our ability to deliver the right oxygen, to the right tissue, at the right time improved proportionally?No comment.

Sources and evidence boundaries

  1. Joint Economic Committee, U.S. Congress. Prepared Testimony of Carl Rausch: Oxygen Therapeutics as Alternatives to Red Blood Cells, September 29, 1999.
  2. Joint Economic Committee, U.S. Congress. Biotechnology Summit hearing agenda, September 29, 1999.
  3. U.S. Government Printing Office. Biotechnology Summit: Putting a Human Face on Biotechnology, S. Hrg. 106-677.
  4. BHOC Scientific Evidence Platform. Biopure: Standing on the Shoulders of Giants.
  5. BHOC Scientific Evidence Platform. Prehospital and EMS evidence landscape.
  6. BHOC Scientific Evidence Platform. Blood Collection Capacity Does Not Equal Available Blood.
Evidence boundary: Historical product, efficacy, safety and economic statements are attributed to the 1999 witness or contemporaneous company reports. They do not establish current BHOC performance. BHOC and Precision Oxygen Therapeutics are presented as scientific and technology-development concepts. Product-specific claims require direct analytical, preclinical, clinical and regulatory evidence.