Military and civilian medicine share an urgent challenge: how to protect vital organs from oxygen deprivation in the field while patients await definitive treatment, thereby preventing patient death and disability. This interagency briefing will bring together government stakeholders to review the development of an oxygen delivery biotherapeutic designed to release oxygen in severely hypoxic tissues and its relevance to warfighter and civilian patient populations. Using data from federally-funded preclinical case studies, Omniox will demonstrate the broad applicability for an oxygen delivery therapeutic in multiple critical care indications, such as hemorrhagic shock, stroke, and respiratory distress.

Development of any therapeutic requires credible biomedical evidence and a coordinated development pathway from laboratory findings through manufacturing, regulatory evaluation, and clinical testing. This discussion will cover nonclinical evidence, development readiness, manufacturing considerations, and the remaining work needed to establish safety and effectiveness in patient populations. Attendees will have an opportunity to consider how this work may align with their organizations’ medical research interests and operational needs, as well as provide a forum for mission-aligned DoW and NIH officials to discuss potential research sponsorship, funding sources and follow-up technical engagement for the next development stage. The discussion will also examine Other Transaction Authority (OTA) and SBIR Phase III mechanisms and collaborative federal research pathways already in place that can support biomedical development, subject to agency authority and program fit.

Executive Orders (EO) and other directives

• EO 14265 Modernizing Defense Acquisitions and Spurring Innovation in the Defense Industrial Base directing the defense acquisition enterprise to accelerate capability delivery through greater use of commercial solutions, Other Transactions Authority (OTA), Rapid Capabilities Office policies, and streamlined acquisition pathways, where appropriate and consistent with law.
• EO 14336 Ensuring American Pharmaceutical Supply Chain Resilience by Filling the Strategic Active Pharmaceutical Ingredients Reserve 
• EO 14293 Sec. 3. Streamlining Review of Domestic Pharmaceutical Manufacturing by the Food and Drug Administration
• National Defense Authorization Act for Fiscal Year 2026 and 2027

Attendees will learn:

• The impact of oxygen deprivation in critical care indications such as hemorrhagic shock and stroke
• How participation in development of innovative oxygen delivery therapeutics can save warfighter and civilian lives
• How to connect OMX’s nonclinical evidence and development path to agency priorities and policy directives

Recommended attending personnel

• DoW combat and warfighter trauma support personnel
• Military and civilian agency research and development personnel
• Biological Technologies Office program personnel
• Scientific program officers and translational research personnel
• Manufacturing-readiness specialists supporting biomedical development
• Contracting officers and procurement specialists

Briefing Preparation Materials

• Primer, OMX technology: https://www.omniox.com/technology.html
• Select current and previous grants supporting OMX development: https://www.usaspending.gov/search?hash=38f142c461954df438d74e942503eafc

Access and accessibility

Important: This briefing uses a Zoom-based communication connection via your network. This briefing will be accessible via phone if you are unable to connect online, and recorded versions will be distributed with closed captions for the hearing impaired. We will provide login instructions upon registration. Transcription will be provided for deaf and hard of hearing attendees.

Agency Panelist Participation

GovBrief encourages participation from agency officials for this briefing. If you or one of your colleagues would like to contribute or serve as a panelist, please contact support@govbrief.us or call 888-818-8726. GovBrief provides complimentary access for all government presenters, and all briefing materials are provided at no charge.

Disclaimer

This briefing is hosted by an HHS/NIH and DoW grant awardee. While this session contains case studies of grant-funded activities, this event is not affiliated with or endorsed by any federal agency and is provided to the audience for informational purposes only and is not medical advice. All participation in this briefing is voluntary, and any engagement by government personnel is not an indication of endorsement of, or commitment to purchase from, any vendor. OMX is an investigational therapeutic currently in preclinical development. It has not been approved by the U.S. Food and Drug Administration or any other regulatory agency for any use.