DARPA SBIR DPA26BZ06-DV029: ICU-in-a-Box, Autonomous Extracorporeal Multiple-Organ Support Therapies
Quick Answer
DPA26BZ06-DV029 is a DARPA SBIR Direct to Phase II topic under the DoW 2026 SBIR Broad Agency Announcement, Release 6. DARPA wants a single, portable, battery-operated extracorporeal life support device that runs itself: one cannula into a central vein, and from that single access point the machine provides lung support, cardiovascular support, fluid resuscitation, and optionally electrolyte management and medication delivery, autonomously, for days, in a place where no critical care physician exists. The award is $1,500,000 over 24 months with a $500,000 option over 6 months. The topic opens September 23, 2026 and closes October 21, 2026 through the Defense SBIR/STTR Innovation Portal.
The clinical logic is stated plainly. Severe hemorrhage is the number one cause of preventable combat deaths, followed by airway compromise. Following initial trauma, sepsis and multiple-organ failure predominate. Point of injury care has gotten much better, so more casualties survive the first hour, but in large-scale combat operations and in remote Special Operations settings, access to definitive medical care may not be available for days. More survivors plus fewer evacuation opportunities equals a population of casualties who need ICU-level organ support in a place that has none.
There is one scoping sentence that decides whether your idea fits. Approaches that only enable a user or users to interact with and control multiple different systems, meaning system of systems solutions, are not in scope. The goal is a single, portable device delivering all the desired clinical interventions through a single intravenous cannula. If your concept is an integrated cart of best-in-class modules with a unifying controller, this topic is not for you.
Topic At a Glance
Topic number: DPA26BZ06-DV029
Title: ICU-in-a-Box: Autonomous Extracorporeal Multiple-Organ Support Therapies
Agency: Defense Advanced Research Projects Agency (DARPA)
Solicitation: DoW 2026 Small Business Innovation Research Broad Agency Announcement, Release 6, DARPA Proposal Submission Instructions
Program type: Direct to Phase II (DP2). This topic solicits Direct to Phase II proposals only
Technical volume format: White Paper and Slide Deck. The white paper shall not exceed 20 pages and the slide deck shall not exceed 15 slides
Base award: $1,500,000
Base period of performance: 24 months
Option: $500,000 over 6 months, for a pre-clinical pilot study
Component Technology Priority Area: Biotechnology
Projected CMMC level requirement: Level 1
Export control status: no topic-level ITAR or EAR restriction paragraph appears on this topic
Central architectural constraint: a single portable device, one patient-inserted cannula, preferably no larger than 15Fr (5mm), into the internal jugular or femoral vein
Explicitly out of scope: system of systems solutions, and autonomous cannulation or decision support for cannulation
Testing basis: large animal model testing, with IACUC and ACURO regulatory timelines built into the milestone schedule
Technical and Business Assistance: up to $25,000 per Phase II project, in addition to the cost ceiling
Topic Q&A: DSIP Topic Q&A is not available for DARPA topics. Technical questions go to SBIR_BAA@darpa.mil by October 14, 2026
Topic open date: September 23, 2026
Proposal deadline: October 21, 2026. DARPA will not accept late proposals
Submission portal: DSIP at dodsbirsttr.mil
Keywords: autonomous systems, life support systems, resuscitation, trauma, shock, casualties, ARDS, multiple organ failure
The Feasibility Bar, Which Is the First Thing to Check
This is a Direct to Phase II topic and DARPA is unusually numeric about what you must already have. Proposers must provide data demonstrating that the following has been achieved to be considered for award: a prototype, portable, battery operated extracorporeal system that can do four things.
One. Achieve at least 2 L/min of blood flow and lung support, meaning both oxygenation and ventilation.
Two. Deliver at least 75 mL/min oxygen.
Three. Exchange at least 40 mL/min carbon dioxide.
Four. At least one of the following three closed-loop algorithms.
An algorithm that maintains oxygenation and ventilation within specified ranges for SpO2 and EtCO2 by adjusting combinations of blood flow, sweep gas, and FiO2.
An algorithm that maintains mean arterial pressure within a specified range using at least one vasopressor and, as needed, fluid resuscitation, preferably blood and alternatively crystalloid.
An algorithm that controls blood flow, ultrafiltration, and monitoring of an extracorporeal renal replacement or blood purification system for removing potassium.
Read the fourth requirement carefully
The first three are hardware performance numbers. The fourth is the one that eliminates most applicants, because it requires that you already have a working closed-loop control algorithm, not a plan for one. Notice that you need only one of the three, and that they are ordered from most to least conventional in this space. The oxygenation and ventilation control algorithm is the most natural for an ECMO or ECCO2R company. The mean arterial pressure algorithm is the most natural for an autonomous resuscitation company, and DARPA cites the Pinsky 2024 porcine work as evidence that class of algorithm exists. The potassium removal algorithm is the most natural for a portable dialysis or blood purification company.
That structure tells you something about the intended applicant pool. DARPA expects one of three different kinds of company to walk in with one of three different kinds of demonstrated autonomy, and then to build the rest during Phase II. You are not expected to have all three. You are expected to have one, plus the hardware numbers, plus a credible plan to integrate the others.
The additional documentation asks
Beyond the four-part gate, DARPA lists specific things your feasibility documentation must address.
You must describe current O2 transfer and carbon dioxide removal rates that can be achieved by the proposed system. Give real measured numbers, not design targets.
The proposed system must directly interface with an oxygen source, such as a canister or an oxygen concentrator, to provide oxygenation and carbon dioxide removal to mitigate acidosis and lactate buildup. This is a hard interface requirement. A system that assumes wall gas is not a prolonged field care system.
Proposals should provide evidence for the maximum duration of support with their proposed system, ideally greater than 72 hours. Note "ideally." Duration is scored but not gated, and 72 hours is the aspiration that reflects the days-long evacuation delay DARPA is designing against.
Documentation should include, reference, or summarize all relevant information including but not limited to technical reports, test data, prototype designs and models, and performance goals and results.
Proposers must also describe the potential commercial applications as part of the feasibility substantiation.
What DARPA Is Actually Looking For
The objective
Develop, with large animal model testing, an autonomous, portable extracorporeal life support platform for prolonged field care that integrates resuscitation, cardiovascular and pulmonary support, and optionally electrolyte and medication delivery capabilities.
The clinical and operational problem
Severe hemorrhage is the number one cause of preventable combat deaths, followed by airway compromise, with increased artillery, thermobaric and incendiary munitions use potentially increasing lung injury prevalence in future conflicts. Following initial trauma, sepsis and multiple-organ failure predominate.
Improvements in point of injury care, tourniquets and hemostatic dressings and similar interventions, have significantly increased survival in early trauma phases. Such care is ideally followed by pre-hospital care from trained medical providers during casualty evacuation. However, as reflected by the large-scale combat operations in the Russia-Ukraine war and with Special Operations missions in remote, austere locations, access to definitive medical care may not be available for days, especially in conflict with near-peer adversaries.
More people surviving early phases of trauma combined with decreased evacuation opportunities highlights a pressing need for solutions that can provide advanced and sustained resuscitative care for the organ failure sequelae of severe trauma, such as hypotension, respiratory failure, and acute renal failure.
Why DARPA thinks this is now possible
The topic description contains a compressed technology readiness argument, and it is worth understanding because your proposal should either agree with it or explain where it is wrong.
A growing body of technical capabilities and supporting literature suggests that by focusing on the key drivers of mortality, advances in autonomous systems across several areas of critical care could be combined into a single ICU-in-a-Box.
Extracorporeal membrane oxygenation is an alternative to using intubation and mechanical ventilation, under deep sedation, for acute respiratory distress syndrome. Because an ECMO system is essentially just a pump and a membrane lung, it offers a strong opportunity to automate oxygenation support, along with other key combat casualty care needs.
Current ECMO systems require highly trained operators, largely because of the need to insert large cannulas and the associated thrombotic risks, but recent advances can mitigate these limitations. Assistive insertion devices and ECMO systems with smaller cannulas reduce the difficulty of insertion. Antithrombotic coatings, portable systems, and alternatives to conventional membrane oxygenators reduce thrombotic risk, at least over shorter periods. AI and machine learning advances in general, as well as ECMO management computer models, could support automation.
Once venous access is established for automated ECMO, it enables additional interventions. Automated algorithms have stabilized mean arterial pressure and heart rate for short periods following severe hemorrhage in porcine models. Renal replacement therapy could mitigate life-threatening electrolyte abnormalities. Extracorporeal blood purification techniques could remove inflammatory mediators, infectious agents, or toxins.
This SBIR seeks to combine such capabilities into a single, portable, integrated intervention and delivery platform for resuscitation, cardiovascular and lung support. There is additional potential to automate sedation, analgesia, and renal replacement therapies. Although these efforts remain relatively immature, their addition to the integrated system could further extend ICU-level, autonomous extracorporeal life support in the austere and operational setting.
The argument in one line: the venous access is the expensive part, and once you have paid for it you should get everything through it.
The scoping constraint that decides eligibility of the concept
DARPA is interested in novel approaches to develop a fully integrated, portable system that can provide key components of resuscitation during prolonged casualty care.
Approaches that only enable a user or users to interact with and control multiple different systems, meaning system of systems solutions, are not in scope. The goal is to create a single, portable device that is capable of providing all the desired clinical interventions through a single intravenous cannula inserted into a central vein, internal jugular or femoral.
Given the ultimate goal to be able to deploy the system in conditions where experienced medical care is not available, a primary goal of this SBIR is to develop and integrate algorithms that enable the system to be autonomous.
This is the sentence to read twice. A great many credible teams would naturally propose an integrated rack: an ECMO console, an infusion manifold, a hemofilter, and a supervisory controller. That is exactly what DARPA has ruled out. One device. One cannula. All interventions through it.
The Operating Concept, Which Defines Your Autonomy Requirements
DARPA lists assumptions and expectations that together describe who is standing next to this machine and what they can and cannot do. This is the most useful part of the topic for scoping your control system.
Remote monitoring and control are essential to engage remote expert guidance and intervention when the system experiences edge or unanticipated conditions.
A casualty is cannulated. Autonomous cannulation, or decision support for cannulation, is out of scope.
Local users will have basic medical training, for example a field medic, and can set up, initiate, and attach the automated system if guided. But once attached, the system should monitor the casualty itself and provide autonomous interventions to sustain mean arterial pressure, oxygenation, and ventilation. It should address alerts and alarms, meaning system functioning, autonomously, or engage a remote expert automatically without local operator intervention.
In addition to initiation of the device, local caregivers can be assumed to change IV bags after direction, retrieve and attach blood products after direction, and retrieve and attach medication after direction.
Sufficient displays to provide status information about the patient and the current and past treatments deployed by the system should be included.
It is also permissible to include a clinical decision support mode that a local operator could respond to in the event a remote expert is unavailable.
What that operating concept actually implies
The medic is a pair of hands, not a clinician. Every action the local user performs is prompted by the machine, described in the topic as "after direction." Your interface design problem is therefore instruction generation under stress, not clinical consultation.
Alarms must be handled without the local operator. This is a strong statement. Conventional ECMO alarm response is the entire justification for a bedside specialist. DARPA is asking you to either resolve the alarm autonomously or escalate to a remote expert automatically, with the medic in neither loop.
The remote expert is part of the architecture, not a fallback. Remote monitoring and control are called essential, which means bandwidth, latency, degraded-link behavior, and cyber security are design requirements rather than integration details. Note that network connection and cyber security appear explicitly in the SWaP-C3 requirement below.
The clinical decision support mode is permitted, not required. Offer it as a degraded operating mode for a denied-communications scenario and you address the obvious objection that a comms-dependent life support system is a fragile life support system.
Required Capabilities
DARPA lists these as requirements. Treat each as a section heading in your white paper.
Minimal patient contact and minimal sensing
The system must be readily deployable with minimal contact points with the patients.
Sensor packages should be minimized and be easily applied to monitor patient state. Proposals that do not require invasive arterial monitoring are preferred. Proposers must specify what sensors are being recommended, how they are intended to be used in austere and operational military conditions, and how they are providing the system sufficient physiological information to support the autonomy.
That last clause is the hard one. You are being asked to run closed-loop perfusion pressure control without an arterial line, which is the sensor a modern ICU would use for exactly this purpose. Your proposal has to close that observability gap explicitly: which noninvasive or intracircuit measurements substitute, what the error characteristics are, and how the controller stays safe when the estimate degrades.
One cannula
The system may have one patient-inserted cannula, preferably no larger than 15Fr (5mm). Proposers must specify which vessels they intend to use, jugular or femoral.
Fifteen French for a single-access circuit supporting 2 L/min or more of blood flow is a demanding hydraulic and hemolysis problem, and it is the reason the topic cites the 13Fr versus 15Fr cannula comparison literature. Address recirculation fraction, shear, and hemolysis directly.
Circuit design, medication delivery, and safety parameters
The intended circuit design must be provided and include how sufficient blood, fluids, and medications will be effectively delivered.
Proposals must specifically describe how the proposed solution manages continuous medication delivery, for example sedation and analgesia and vasopressors, and bolus fluids, for example blood or crystalloid, within the integrated circuit.
Proposers must also specify safety parameters that will be implemented in the integrated system.
Note "within the integrated circuit." Vasopressors, sedation, and blood products all enter through the same single access. That means your circuit has to handle continuous low-rate infusion and rapid bolus volume in the same plumbing, with the mixing, dosing accuracy, and air management problems that implies.
SWaP-C3 and the backpack
As DARPA ultimately envisions a system intended for use in prolonged field care scenarios, proposers must describe the planned size, weight, and power, plus network connection, cyber security, and cost considerations, together abbreviated SWaP-C3, for the system.
It is anticipated that further system development for miniaturization may occur beyond the scope of this SBIR, but the potential to integrate all the provided components in a portable form factor, for example a M9 backpack, must be demonstrated.
Read the concession and the requirement together. You do not have to deliver a backpack in 24 months. You do have to demonstrate the potential to get there, which in practice means a component-level mass, volume, and power budget that closes against a stated backpack envelope, plus a bill of materials, which is a named Month 24 deliverable.
Lung support
For lung support, the system will be able to provide ECMO functionality for direct oxygen transfer to the blood.
Preferably, full oxygen support, approximately 250 mL/min, would be achievable. In cases where partial oxygen support is proposed, at least 125 mL/min, proposers can assume that the patient is already intubated for respiratory support. Proposals that integrate with mechanical ventilation when present are preferred.
In addition to oxygen support, the system should also provide at least 80 mL/min CO2 removal.
There is a real strategic choice here. Full support at roughly 250 mL/min oxygen is the ambitious path and removes the ventilator from the field equipment set. Partial support at 125 mL/min is permitted, but you then inherit an intubated patient, which reimports the sedation, airway management, and ventilator logistics that the topic's own opening argument was trying to avoid. If you choose partial support, say why, and take the stated preference for ventilator integration seriously.
Cardiovascular support and the hemorrhage model
For cardiovascular support, the system must also be able to provide fluid resuscitation as needed.
It must be capable of maintaining perfusion pressure, not just blood pressure, throughout the validation tests, for example at least 24 hours, and be able to support significant hemorrhagic trauma models, for example a model emulating an uncontrolled bleeding scenario of at least 50 percent of the estimated blood volume over six hours.
This support can include blood, artificial blood products, freeze dried blood products, and crystalloid.
When fluid is ineffective at maintaining perfusion pressure, the system should titrate vasopressors to maintain specified mean arterial pressure.
All interventions must be autonomously controlled by the system.
The parenthetical "not just blood pressure" is a deliberate clinical distinction and you should honor it. A controller that holds a MAP number while tissue perfusion fails is the classic failure mode of pressure-targeted resuscitation. Explain what your system uses as a perfusion surrogate, whether lactate, mixed venous saturation, urine output, capillary refill, or an intracircuit measure, and how the controller arbitrates between fluid and vasopressor.
Algorithm development and validation
Proposers must describe the planned development and validation of the closed-loop auto-titration algorithms for control of the oxygen saturation level.
Likewise, they must describe the planned development and validation of the fluid resuscitation algorithms, as well as integration of the oxygenation and resuscitation algorithms into the overall system.
The word "integration" is doing work. Two independently correct controllers, one moving blood flow and sweep gas for gas exchange and one moving volume and vasopressor for pressure, are coupled through the same circuit and the same patient. Increasing blood flow to improve oxygenation changes preload and pressure. Describe the arbitration or supervisory layer, not just the two loops.
Animal model design
Proposers must clearly describe the design of all proposed systems and large animal model tests, as well as their relevance to clinically relevant scenarios, such as similarity to human intravascular blood flow, changes in blood oxygenation levels, trauma biomarkers such as lactate, potassium, and pH, thrombotic and hemolysis risk checks, and histological assessments.
Proposers may choose to utilize existing benchtop hardware and approaches for validation of the system functionality, or, alternatively, respondents may propose the development of iterative or new validation approaches as part of their proposal.
Optional Capabilities That Strengthen a Proposal
Additional capabilities of interest include renal replacement therapy and fluid management interventions to treat electrolyte derangements such as hyperkalemia.
For these, the system would provide basic kidney support via the same circuit that supports oxygenation and fluid resuscitation. This would include providing electrolyte removal and fluid resuscitation to compensate for acute metabolic derangements. This could include filtering the blood to remove small molecules, or other interventions such as absorption, to compensate for cytokines, endotoxins, and similar mediators that can impact sepsis or other inflammatory derangements.
More specifically the system should be demonstrated to be able to maintain adequate lactate levels, temperature, and pH, approximately within 20 percent of baseline values, for at least a 24-hour period.
Additional functionality that is not required but is of interest, and would boost the strength of a proposed solution, includes automated sedation and analgesia, and delivery of scheduled medications such as antibiotics or other as-needed medications such as bolus pain control.
Two notes. First, "via the same circuit" again. The optional capabilities are not bolt-ons, they must live inside the single-access architecture. Second, the temperature target inside the renal and metabolic bullet is easy to miss, and it implies thermal management of an extracorporeal circuit in an austere environment, which is a power budget item.
The Milestone Schedule, Which Is Effectively a Work Plan
DARPA specifies interim and end-phase goals for a 24-month base effort followed by a 6-month option, and says responders are strongly encouraged to propose additional interim assessments to further demonstrate progress toward the stated goals.
Month 1. Report on initial circuit architectures, sensors, algorithms, animal models, development strategy, and timeline.
Month 3. Interim report on integration of extracorporeal support subsystems, meaning sensor packages, lung and cardiovascular systems, plus any planned optional capabilities such as electrolyte support. Interim report on development of automation algorithms. Report on development of initial ex vivo and computational simulation testing environments.
Month 6. Report on development strategy for large animal models. Animal models may be used for testing each subsystem separately, at 6 hours for hemorrhage models and 12 hours for other interventions, including regulatory IACUC and ACURO timelines.
Month 9. Interim report describing performance, ex vivo and simulation, of the prototype system and automation algorithms, and refinements to ex vivo testing environments. Report on regulatory status and approval of large animal models.
Month 12. Interim report describing performance, ex vivo and simulation, of the prototype system and automation algorithms. Interim report describing development status of large animal models.
Month 15. Interim report describing in vivo performance of the prototype system in separate animal models. Report on clinical regulatory approval strategy, for example FDA engagements.
Month 18. Interim report describing in vivo performance of the prototype system in separate animal models. Report on strategy for developing a large animal model that combines assessments for all subsystems, for example a polytrauma model, in order to validate system performance during simultaneous deployment of all automation algorithms, maintaining hemostasis for 24 hours, including regulatory IACUC and ACURO timelines.
Month 21. Report on regulatory status and approval of the large animal polytrauma model.
Month 24. Final report summarizing approach, prototype architecture and algorithms, and separate large animal model testing results including thrombotic, hemolysis, and histological assessments as well as efficacy of algorithms in maintaining goal biomarkers such as SpO2, EtCO2, and MAP. Bill of materials for the prototype, plus SWaP-C3 feasibility for future fully portable designs, and use of consumables such as oxygen, fluids, and vasopressors. Report on regulatory development strategy and any FDA engagements. Report on development of the polytrauma model and recommendations for its use in a preclinical study for in vivo assessments of the prototype device, including updated recommendations for a regulatory strategy.
Option Period 1
Proposals that respond to Option Period 1 may also include a sequential 6-month option period for a pre-clinical pilot study to demonstrate and validate the functionality of their integrated breadboard system in a large animal model.
Month 25. Report on regulatory approval status for the 24-hour large animal model that combines all interventions, for example the polytrauma model. Report on experimental testing strategy and timeline.
Month 28. Interim report describing integration of all prototype subsystems and automation algorithms. Interim report describing in vivo performance of the prototype system in a 24-hour large animal polytrauma model.
Month 30. Final report documenting final prototype architecture and algorithms, methods, all results, and proposed strategy for a portable form factor compatible with far forward deployment in austere conditions, meaning a SWaP-C3 assessment, and final regulatory status and FDA engagements.
What the schedule tells you about risk
The schedule is built around animal regulatory approval, and it appears twice: subsystem models approved by Month 9, and a combined polytrauma model approved by Month 21. That is the schedule's critical path, not the engineering. IACUC plus ACURO review is a multi-month process that you do not control. A proposal that treats these as line items rather than as the dominant schedule risk is not being honest about the plan, and DARPA has told you where to look by writing regulatory timelines into two separate milestones.
Note also the sequencing logic. Subsystems are validated in separate animal models during the base period. The combined polytrauma model, with all algorithms running simultaneously for 24 hours, is what Option Period 1 buys. So the base period ends with a system that has been proven in pieces, and the option proves it whole. Your Month 24 deliverable set is written accordingly: a bill of materials, a SWaP-C3 feasibility assessment, and a recommendation for the preclinical study rather than the study itself.
The word "breadboard" in the Option Period 1 description is a deliberate expectation-setter. DARPA is not expecting a packaged product at Month 30.
Phase III Dual Use
This SBIR has potential applicability across DoW and commercial entities.
Commercial applications include integration of this autonomous extracorporeal support platform into civilian critical care transport, meaning rotor-wing, fixed-wing, and ground ambulance services; rural and community hospital use as a bridge-to-transfer where on-site critical care expertise is unavailable; and mass-casualty or disaster-response settings where trained critical care staff are scarce or evacuation times are long.
Military and DoW applications include incorporation into Prolonged Casualty Care and equipment sets for Special Operations Forces, forward surgical teams, and casualty evacuation platforms across air, ground, and maritime domains, including uncrewed evacuation systems. This enables extended en-route and prolonged field care for casualties with severe injuries, battle or disease non-battle, in contested or resource-limited operational environments. In these settings, an autonomous, portable extracorporeal life support system will provide options to sustain the force that do not currently exist.
The civilian case here is stronger than in most DARPA medical topics, because the same staffing shortage exists in the commercial market. ECMO capability is concentrated in a small number of high-volume centers, and the limiting resource is trained perfusion and intensive care staff rather than hardware. A device that reduces operator skill requirements addresses a documented civilian access problem, which is a real Phase III story rather than a courtesy paragraph. The rotor-wing and fixed-wing transport market in particular already pays for portable, battery-operated, oxygen-canister-fed equipment.
Funding, Cost Structure, and DARPA Mechanics
The award
$1,500,000 over a 24 month base, plus a $500,000 option over 6 months, for $2,000,000 across 30 months if the option is exercised.
The resources made available for each topic will depend on the quality of the proposals received and the availability of funds. The Government reserves the right to award all, some, one, or none of the options based on available funding and the performer's technical performance.
Be realistic about what $1.5 million buys against this scope. Large animal studies alone, across multiple separate subsystem models with IACUC and ACURO overhead, consume a substantial share. This is a topic where existing hardware, an existing animal facility relationship, and an existing regulatory pathway are worth more than a large engineering team.
Contract type, which you must elect
DARPA may award FAR-based contracts, firm-fixed-price or cost-plus reimbursement, or Other Transactions for Prototype under the authority of 10 U.S.C. 4021, subject to approval of the Contracting Officer or Agreements Officer respectively. Proposers must state their requested contract type in their proposal.
Cost-plus reimbursement requires including your Defense Contract Management Agency Final Determination Letter showing approval of your accounting system. An Other Transaction for Prototype requires including a completed OT using the Model OT for Prototype from the DARPA Small Business site, plus completed OT Certifications, both loaded in Volume 5, with at minimum the color-coded areas completed and redlines with explanations for any article you wish to negotiate. Firm-fixed-price requires no additional action.
For a program with animal regulatory schedule risk outside your control, the choice of contract type is worth real thought rather than defaulting to firm-fixed-price.
Templates are mandatory
Templates for Volume 2 Technical Volume and Volume 3 Cost Volume are provided as attachments on the DARPA Small Business website. Use of the DARPA Cost Proposal template is mandatory.
Technical and Business Assistance
Phase II awardees may request up to $25,000 per Phase II project. TABA funding is in addition to the cost ceilings and is not subject to profit or fee. Requests will be reviewed by the respective contracting office or specialist at time of award.
For this topic, regulatory consulting is the highest-value use of TABA. An autonomous, closed-loop, drug-delivering extracorporeal life support device is a genuinely novel regulatory object, and DARPA has already put FDA engagement strategy into the Month 15 and Month 24 deliverables. Getting experienced device regulatory counsel involved early is directly aligned with a contract requirement.
Questions and the FAQ
DSIP Topic Q&A will not be available for these DARPA topics. Technical questions must be submitted by October 14, 2026, by email to SBIR_BAA@darpa.mil with the topic number in the subject line, including the name, email address, and telephone number of a point of contact. Questions submitted within seven calendar days of the proposal due date may not be answered. DARPA posts a consolidated Frequently Asked Questions document under the topic number summary on its Small Business site, updated on an ongoing basis until one week prior to the proposal due date.
DARPA will not accept late proposals.
Classification, marking, and registrations
All proposals are required to be UNCLASSIFIED or CUI. Do not include any classified information in your proposal submission. Do not include any proprietary information on the Proposal Coversheet in Volume 1.
Proposal titles, abstracts, anticipated benefits, and keywords of proposals selected for contract award will undergo a DARPA Policy and Security Review and are subject to revision or redaction by DARPA. Final approved versions may appear on the DoW SBIR/STTR awards website and the SBA's award website at sbir.gov/awards.
Proposers should ensure they have an accurate and active entity registration on SAM.gov. Those engaging in ITAR or CUI work for DARPA must have CMMC Level 2 certification, though the projected requirement for this topic is Level 1. DARPA points to sprs.csd.disa.mil/nistsp.htm and notes Project Spectrum at projectspectrum.io as an assistance resource.
Venture capital, hedge fund, and private equity ownership
Proposers that are more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these as set forth in 13 CFR 121.702 are eligible to submit proposals in response to DARPA topics advertised within this BAA. Three conditions apply: register with the SBA Company Registry Database before submitting; submit the Majority-Owned VCOC, HF, and PEF Certification, with the SBIR VC Certification available on the DARPA Small Business site, in Supporting Documents Volume 5; and immediately notify the Contracting Officer, register in the appropriate SBA database, and submit the required certification if you enter that ownership class after submitting but before receiving a funding agreement.
This matters more here than on most topics. Medical device companies with working extracorporeal hardware are almost always venture funded, and DARPA's permissive posture keeps that pool eligible.
Evaluation and selection
All proposals will be evaluated in accordance with the evaluation criteria listed in the DoW SBIR Program BAA. DARPA will conduct an evaluation of each conforming proposal. Proposals that do not comply with the requirements detailed in this BAA and the research objectives of the corresponding topic are considered non-conforming and are therefore not evaluated nor considered for award.
Using the evaluation criteria, the Government will evaluate each proposal in its entirety, documenting the strengths and weaknesses relative to each evaluation criteria, and based on those will determine the proposal's overall selectability for funding. Proposals will not be evaluated against each other but on their own individual merit.
A selectable proposal is one where the strengths of the overall proposal outweigh its weaknesses, with no accumulated weaknesses that would require extensive negotiations or a resubmitted proposal. A non-selectable proposal is one where the strengths do not outweigh its weaknesses.
Proposing firms will be notified of selection or non-selection status within 90 calendar days of the closing date of the BAA. The Corporate Official indicated on the Proposal Cover Sheet will be notified by email. In accordance with the SBA SBIR/STTR Policy Directive, Appendix I, paragraph 4, subparagraph (d), DARPA will provide a technical evaluation narrative to the proposer for each proposal submitted in response to a topic. An informal feedback session may additionally be requested via email at sbir@darpa.mil, provided at the sole discretion of DARPA.
Company Commercialization Report information will not be considered by DARPA during proposal evaluations.
Protests regarding the selection decision should be submitted, as prescribed in FAR 33.106(b) and FAR 52.233-3, to DARPA Contracts Management Office, 675 N. Randolph Street, Arlington, VA 22203, by email to CMO_SBIRProtests@darpa.mil and sbir@darpa.mil.
Note the "non-conforming" language against the scoping constraint. A system of systems proposal is arguably non-conforming with the research objectives of the topic rather than merely weak, which means it may not be evaluated at all.
Post-award support
DARPA provides Transition and Commercialization Support Program services to Phase II and DP2 awardees upon contract execution at no cost to awardees. Awardees may also be eligible for the Embedded Entrepreneurship Initiative, an invitation-only program at DARPA's sole discretion, typically no more than $310,000 per awardee over the duration of the award, supporting a Senior Commercialization Advisor relationship, investor working group connections, and hiring an embedded entrepreneur to execute a Go-to-Market strategy.
The References
Twenty of them, the longest reference list in this DARPA release, and they map the proposal you are expected to write.
The combat casualty care case: Eastridge 2012 on death on the battlefield 2001 to 2011; Remondelli 2023 on casualty care implications of large-scale combat operations; Neff 2013 on extracorporeal organ support following trauma; Chovanes 2012 on the evolution of damage control surgery; Cohen 2012 on hemostatic resuscitation; Kotwal 2016 on the golden hour policy; Keenan and Riesberg 2017 on prolonged field care beyond the golden hour; Epstein 2023 on lessons from the war in Ukraine.
The ECMO technology case: Geetha 2024, a comprehensive review of extracorporeal membrane oxygenation; Szentgyorgyi 2025 on the evolution of ECMO and advanced developments; Conrad on the clinical trials of the intravascular oxygenator; Osmani 2026 comparing 13Fr and 15Fr arterial return cannulas for V-A ECMO in ECPR; Combes 2024, the European expert consensus on ECCO2R for acute hypoxemic respiratory failure, which is the source of the 80 mL/min CO2 removal figure.
The automation case: Pladet 2023 on clinical decision support for ECMO, subtitled "Will we fly by wire?"; Pinsky 2024 on autonomous precision resuscitation during ground and air transport of an animal hemorrhagic shock model; Brattain 2021 on an AI-enabled, ultrasound-guided handheld robotic device for femoral vascular access; Daga 2026 on closed-loop anesthesia; Nagata 2023 on automated control of propofol, remifentanil, and rocuronium versus anesthesiologist management; Aissou 2012 on pupillary reflex measurement for objective analgesia assessment; Wieringa 2025 on portable, wearable, and implantable artificial kidneys.
Three of these deserve particular attention. Pinsky 2024 is the existence proof for the mean arterial pressure algorithm option in the feasibility gate, and it is an animal transport study, which is close to the operational scenario. Combes 2024 is where the CO2 removal number comes from, so your gas exchange claims should be framed in its terms. Pladet 2023 is the closest thing in the literature to what DARPA is asking for on the control side, and its title question is the one your proposal has to answer.
Timeline and What to Do When
The dates
Topic opens: September 23, 2026
Technical question deadline: October 14, 2026, to SBIR_BAA@darpa.mil with the topic number in the subject line
Proposal deadline: October 21, 2026. DARPA will not accept late proposals
Selection notification: within 90 calendar days of BAA close
Base period: 24 months from award
Option Period 1: 6 additional months if exercised
A working backward plan
Before September 23. Test yourself against the four-part feasibility gate with measured data, not projections: 2 L/min blood flow with oxygenation and ventilation, 75 mL/min oxygen delivery, 40 mL/min CO2 exchange, and at least one working closed-loop algorithm from the three listed. Assemble the technical reports, test data, prototype designs, and performance results that substantiate it. Measure and document your actual maximum duration of support, and note how it compares to the greater-than-72-hour aspiration. Confirm your system interfaces directly with a canister or concentrator oxygen source. Decide jugular versus femoral and fix your cannula size. Line up your large animal facility and start the IACUC conversation now, because approval timelines are the schedule's critical path and appear in two separate milestones. Download the mandatory DARPA Volume 2 and Volume 3 templates. Read the FAQ and keep rechecking it. Decide your contract type and prepare the corresponding documents. Confirm SAM registration. If venture-backed, register with the SBA Company Registry and obtain the SBIR VC Certification.
September 23 through October 5. Draft the 20 page white paper and 15 slide deck. Lead with the feasibility evidence, then the single-device architecture, then the autonomy and remote expert concept of operations, then the required capabilities in DARPA's own order, then the animal model and regulatory plan. State plainly and early that your solution is a single device through a single cannula, because that is the screening question.
October 6 through October 14. Build the cost volume in the mandatory template across 24 months plus the 6 month option. Price large animal studies realistically, including per-study facility cost, veterinary support, IACUC and ACURO administrative burden, and the difference between 6-hour hemorrhage models and 12-hour intervention models. Price disposables, oxygenator and filter development, consumables, and regulatory consulting. Consider whether TABA covers the regulatory work.
October 15 through October 18. Assemble Volume 5 with contract-type documents and certifications, complete Volume 7 and the Volume 4 CCR, and run compliance: 20 page white paper, 15 slide deck, unclassified or CUI only, no proprietary information on the coversheet, mandatory cost template.
October 19 through October 20. Submit and certify in DSIP.
Frequently Asked Questions
What is DARPA SBIR topic DPA26BZ06-DV029?
DPA26BZ06-DV029 is a DARPA SBIR Direct to Phase II topic titled "ICU-in-a-Box: Autonomous Extracorporeal Multiple-Organ Support Therapies," released under the DoW 2026 SBIR Broad Agency Announcement, Release 6. The objective is to develop, with large animal model testing, an autonomous, portable extracorporeal life support platform for prolonged field care that integrates resuscitation, cardiovascular and pulmonary support, and optionally electrolyte and medication delivery capabilities.
How much funding is available?
The base award is $1,500,000 over 24 months, with a $500,000 option over 6 months for a pre-clinical pilot study, for a maximum of $2,000,000 across 30 months if the option is exercised. Phase II awardees may also request up to $25,000 in Technical and Business Assistance, which is in addition to the cost ceiling.
When is the proposal deadline?
The topic opens September 23, 2026 and proposals are due October 21, 2026 through the Defense SBIR/STTR Innovation Portal at dodsbirsttr.mil. DARPA will not accept late proposals.
Can I submit a Phase I proposal for this topic?
No. This topic solicits Direct to Phase II proposals only.
What must my existing prototype already do?
You must provide data showing a prototype, portable, battery operated extracorporeal system that achieves at least 2 L/min of blood flow with lung support, delivers at least 75 mL/min oxygen, exchanges at least 40 mL/min carbon dioxide, and includes at least one of three closed-loop algorithms: oxygenation and ventilation control within SpO2 and EtCO2 ranges via blood flow, sweep gas, and FiO2; mean arterial pressure maintenance using at least one vasopressor plus fluid as needed; or control of blood flow, ultrafiltration, and monitoring for potassium removal in an extracorporeal renal replacement or blood purification system.
Do I need all three algorithms?
No. You need at least one demonstrated. The three options correspond to three different kinds of company, and the expectation is that you bring one demonstrated autonomy capability and build the others during Phase II.
Is a system of systems approach acceptable?
No. DARPA states that approaches which only enable a user or users to interact with and control multiple different systems, meaning system of systems solutions, are not in scope. The goal is a single, portable device providing all the desired clinical interventions through a single intravenous cannula. Because non-conforming proposals are not evaluated, this is a screening issue rather than a scoring issue.
How many cannulas can my system use?
One. The system may have one patient-inserted cannula, preferably no larger than 15Fr (5mm), and proposers must specify whether they intend to use the internal jugular or the femoral vein.
Is autonomous cannulation part of this topic?
No. DARPA states that a casualty is assumed to be cannulated, and that autonomous cannulation or decision support for cannulation is out of scope.
What oxygen and CO2 performance does Phase II target?
Preferably full oxygen support of approximately 250 mL/min. Partial oxygen support of at least 125 mL/min is acceptable, but then you may assume the patient is already intubated for respiratory support, and proposals that integrate with mechanical ventilation when present are preferred. The system should also provide at least 80 mL/min CO2 removal.
What hemorrhage scenario must the system handle?
The system must be able to support significant hemorrhagic trauma models, for example a model emulating an uncontrolled bleeding scenario of at least 50 percent of the estimated blood volume over six hours, and must maintain perfusion pressure, not just blood pressure, throughout validation tests of at least 24 hours.
Can I use an arterial line for monitoring?
You can, but proposals that do not require invasive arterial monitoring are preferred. Sensor packages should be minimized and easily applied, and you must specify which sensors you recommend, how they work in austere and operational military conditions, and how they provide the system sufficient physiological information to support the autonomy.
Who operates the system in the field?
A local user with basic medical training, such as a field medic, who can set up, initiate, and attach the system if guided. After attachment the system monitors the casualty itself and provides autonomous interventions for mean arterial pressure, oxygenation, and ventilation. It must handle alerts and alarms autonomously or engage a remote expert automatically without local operator intervention. Local caregivers can be assumed to change IV bags, retrieve and attach blood products, and retrieve and attach medication, all after direction from the system.
Is remote connectivity required?
Yes. DARPA states that remote monitoring and control are essential to engage remote expert guidance and intervention when the system experiences edge or unanticipated conditions. Network connection and cyber security are also explicit elements of the SWaP-C3 description you must provide. A clinical decision support mode for use when a remote expert is unavailable is permitted.
Do I have to deliver a backpack-sized system?
Not within this SBIR. DARPA anticipates that further miniaturization may occur beyond the scope of this effort, but you must demonstrate the potential to integrate all provided components in a portable form factor, for example a M9 backpack, and a SWaP-C3 feasibility assessment plus a bill of materials are Month 24 deliverables.
What are the optional capabilities?
Renal replacement therapy and fluid management to treat electrolyte derangements such as hyperkalemia, provided through the same circuit, with demonstrated maintenance of lactate, temperature, and pH within approximately 20 percent of baseline for at least 24 hours. Also of interest, though not required, are automated sedation and analgesia and delivery of scheduled or as-needed medications.
What animal testing is expected?
Large animal model testing throughout. During the base period, separate models validate individual subsystems, at 6 hours for hemorrhage models and 12 hours for other interventions. A combined polytrauma model that runs all automation algorithms simultaneously for 24 hours is developed during the base period and executed in Option Period 1. IACUC and ACURO regulatory timelines appear explicitly in the Month 6 and Month 18 milestones.
What is the biggest schedule risk?
Animal regulatory approval. DARPA writes IACUC and ACURO timelines into two separate milestones and requires reports on regulatory approval status at Months 9 and 21. Those reviews are not under your control and gate the in vivo work that everything else depends on.
How long can my technical volume be?
The white paper shall not exceed 20 pages and the slide deck shall not exceed 15 slides.
Can I ask questions through DSIP Topic Q&A?
No. DSIP Topic Q&A is not available for DARPA topics. Technical questions go by email to SBIR_BAA@darpa.mil by October 14, 2026, with the topic number in the subject line. DARPA maintains a consolidated FAQ document on its Small Business site under the topic number summary.
Do I have to choose a contract type?
Yes. Proposers must state their requested contract type: FAR-based firm-fixed-price, FAR-based cost-plus reimbursement, or an Other Transaction for Prototype under 10 U.S.C. 4021. Cost-plus requires your DCMA Final Determination Letter, and an Other Transaction requires the completed Model OT and OT Certifications in Volume 5.
Is the cost template mandatory?
Yes. Use of the DARPA Cost Proposal template is mandatory, and templates for both Volume 2 and Volume 3 are attachments on the DARPA Small Business website.
What CMMC level applies?
The projected requirement for this topic is CMMC Level 1. Firms engaging in ITAR or CUI work for DARPA more broadly must have CMMC Level 2 certification.
Are venture capital backed companies eligible?
Yes. Firms more than 50 percent owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination as set forth in 13 CFR 121.702 may propose, provided they register with the SBA Company Registry Database before submitting, include the Majority-Owned VCOC, HF, and PEF Certification in Volume 5, and notify the Contracting Officer if they enter that ownership class after submission but before award.
How will my proposal be evaluated?
Against the evaluation criteria in the DoW SBIR Program BAA. Proposals are evaluated individually on their own merit rather than against each other. A selectable proposal is one where strengths outweigh weaknesses with no accumulated weaknesses requiring extensive negotiation or resubmission. Proposals that do not comply with the BAA requirements or the research objectives of the topic are non-conforming and are not evaluated.
Will I get feedback if not selected?
Yes. DARPA will provide a technical evaluation narrative for each proposal submitted, and an informal feedback session may be requested by email at sbir@darpa.mil, granted at DARPA's sole discretion.
What is the commercial market?
Civilian critical care transport by rotor-wing, fixed-wing, and ground ambulance; rural and community hospitals as a bridge-to-transfer where on-site critical care expertise is unavailable; and mass-casualty or disaster-response settings where trained critical care staff are scarce or evacuation times are long.
Who do I contact with questions?
Technical questions go to SBIR_BAA@darpa.mil with the topic number in the subject line, by October 14, 2026. General DARPA SBIR inquiries and feedback session requests go to sbir@darpa.mil.
Positioning Advice for Companies Considering This Topic
Answer the single-device question in your first paragraph. The scoping sentence ruling out system of systems solutions is the most consequential line in the topic, and a non-conforming proposal is not evaluated at all. Do not bury the architecture claim on page eight. State on page one that your solution is one portable device delivering all interventions through one cannula, and then prove it with a circuit diagram.
Pick your feasibility algorithm and lead with the data. You need one of the three closed-loop algorithms demonstrated, and which one you have tells DARPA what kind of company you are. Show the measured performance, the animal or bench conditions, the control bounds, and the failure behavior. Then explain how you extend to the other functions, because that extension is what the $1.5 million buys.
Solve the observability problem out loud. DARPA prefers no invasive arterial monitoring while requiring closed-loop perfusion pressure control. That tension is the technical heart of the proposal. Name your sensors, state their accuracy under motion, temperature, and hypoperfusion, explain how you estimate perfusion rather than just pressure, and describe controller behavior when the estimate degrades.
Take "perfusion pressure, not just blood pressure" literally. It is a clinically meaningful distinction and a reviewer with a critical care background will look for it. Explain what surrogate you use, how fluid and vasopressor are arbitrated, and how you avoid the well-known failure of hitting a MAP target while tissue perfusion collapses.
Describe the supervisory layer, not just the loops. Gas exchange control and hemodynamic control are coupled through one circuit and one patient. Increasing blood flow for oxygenation changes preload. Someone has to arbitrate. DARPA asked specifically about integration of the oxygenation and resuscitation algorithms, and that arbitration logic is the answer.
Design for the medic who is not a clinician. Every local action in the topic is "after direction." Your interface generates instructions, not consultations. Show what the display says, how the machine asks for a blood product, and what happens when the medic is doing something else.
Treat the remote expert link as a design requirement and then defeat the obvious objection. Remote monitoring and control are called essential, which invites the question of what happens in a denied-communications environment. The permitted clinical decision support mode is your answer. Build it, describe the degraded operating modes, and specify how long the system can run fully autonomously with no link.
Put the animal regulatory pathway at the front of your schedule risk discussion. IACUC and ACURO timelines appear in two milestones and approval status reports at Months 9 and 21. If you already have an approved protocol at a facility with a hemorrhagic shock or polytrauma model, that is your single strongest schedule credential. Say so early and name the facility.
Close the SWaP-C3 budget on paper. You are not required to build a backpack, but you must demonstrate the potential to reach one. A component-level mass, volume, and power table against a stated M9 backpack envelope, plus the bill of materials DARPA wants at Month 24, converts an aspiration into an engineering argument. Do not forget thermal management, since the optional metabolic capability includes maintaining temperature.
Be honest about hemolysis and thrombosis at 15Fr. Single-access, 2 L/min or more, days of runtime, and a 5 mm cannula is a hard combination, and DARPA cited the cannula comparison and antithrombotic coating literature because it knows. Recirculation fraction, shear, coating strategy, anticoagulation approach in a setting with no laboratory, and the thrombotic and hemolysis risk checks named in the Month 24 deliverable all belong in the white paper.
Choose full versus partial lung support deliberately and defend it. Partial support at 125 mL/min is allowed but assumes an intubated patient, which reintroduces the ventilator, the sedation, and the airway management that the topic's opening argument was trying to eliminate. If you go partial, explain the tradeoff and show how you integrate with mechanical ventilation, which is the stated preference.
Add interim assessments. DARPA strongly encourages responders to propose additional interim assessments beyond the listed milestones. Doing so costs you nothing in page count if done well and signals program management maturity on a schedule that has real regulatory uncertainty in it.
Use the slide deck for the circuit. Fifteen slides is a generous visual allowance next to a 20 page white paper. A single-access circuit that carries blood flow, gas exchange, medication infusion, bolus fluid, and optional filtration is far easier to understand as a diagram than as prose. Spend slides on the circuit schematic, the control architecture, the sensor placement, the SWaP-C3 packaging concept, and the animal test configuration.
