Sole Source Justification_GRT.Neuro.Device.15Sept2025 - Redacted.pdf

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

CONTROLLED UNCLASSIFIED INFORMATION

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I. Contracting Activity.

The contracting activity responsible for this action is Space Base Delta 3 at Los Angeles Air Force Base in El Segundo, California. This procurement is being managed through the local Contracting Office in support of the US Space Force's Guardian Resilience Team. The procuring office is acting on behalf of the clinical and research operations supporting human performance and general wellness initiatives for Space Force personnel at 483 N Aviation Blvd, Bldg 286, Room 113, El Segundo, CA 90245-2808.

II. Nature and/or description of the action being processed.

This action is a sole source acquisition for specialized neurotherapy and neuromodulation equipment and proprietary software from NeuroField, Inc. The award will be a firm-fixed-price purchase order, processed in support of behavioral health and human performance wellness activities conducted by the US Military Space Force. The sole source determination is based on market research indicating that NeuroField, Inc. is the only source able to meet all technical and programmatic requirements.

III. Description of supplies/services required to meet agency needs.

• One Q21 19-Channel EEG Amplifier with USB CANBus, battery, and battery charger for high-resolution quantitative EEG brainwave recording and neurophysiological assessment.

• One Octavia 4-Channel pEMF/LED Stimulator with accessories, providing pulsed electromagnetic field and photobiomodulation stimulation capabilities for research in cognitive performance and wellness protocols.

• Two Genesis units supporting tDCS, tACS, tRNS, advanced tPNS & tBNS, and tVNS neuromodulation, enabling a range of investigational brain stimulation modalities for experimental studies on cognitive and emotional function.

• Four 1070/810 nm and four 850/690 nm LED modules compatible with the Octavia and handheld devices, providing wavelength-specific photobiomodulation for neural research.

• One license for NeuroField Suite Software, including NeuroField EEG, ERP, and AI/Cloud Profiler, to allow unified device control, protocol programming, data acquisition, and analysis.

• Initial operator training and technical support to ensure effective setup, safe operation, and successful integration of all acquired equipment and software into agency research workflows.

IV. Statutory authority permitting other than full and open competition.

This acquisition is being conducted under the statutory authority of 41 U.S.C. 1901, as implemented by FAR 13.501(a), and pursuant to FAR 6.302-1, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.” Market research has demonstrated that NeuroField Inc. is the only responsible source capable of providing the fully integrated neurotherapy and neuromodulation system (including proprietary EEG/stimulators, associated software, accessories, and training) that meets all of the technical and programmatic requirements of the agency. No other vendor or product bundle was identified that could satisfy the unique specifications documented for this effort.

V. Demonstration that the contractor's unique qualifications or nature of the acquisition requires the use of the authority cited above (applicability of authority).

NeuroField, Inc. is uniquely qualified to fulfill this requirement due to its position as the sole manufacturer and supplier of an integrated neurotherapy and neuromodulation system that combines high-resolution, FDA-cleared EEG acquisition, proprietary multi-modal neuromodulation (including pEMF, tDCS, tACS, tRNS, and photobiomodulation), and unified software for equipment control, protocol development, and comprehensive data analysis. No other vendor provides a complete, commercially available solution that meets all technical, regulatory, and operational needs identified by the agency, including full modality integration, FDA clearance for EEG hardware, and support for human performance enhancement.

Comprehensive market research, including outreach to alternative vendors (e.g., ), demonstrated that competitors either lack the necessary technical integration, regulatory status, or do not offer all required modalities in a single compatible system. Assembling a solution from multiple vendors would raise significant risks around interoperability, data integrity, warranty/service fragmentation, and would not provide the software-supported workflow needed for the agency’s research environment.

Accordingly, the unique technical characteristics and integrated platform offered exclusively by NeuroField, Inc. necessitate use of

Sole Source (Including Brand Name) Justification - Simplified Procedures for Certain Commercial Items

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VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

Extensive market research was conducted to identify any and all potential vendors capable of providing the required integrated neurotherapy and neuromodulation system. This included comprehensive internet searches using targeted industry and technical terms; review of government contract databases such as SAM.gov and GSA Advantage; direct outreach to leading manufacturers and distributors including ; consultation with subject matter experts and current users; and assessment of recent industry trade shows and academic conferences for emerging solutions.

During this research, multiple small businesses and commercial suppliers were evaluated for their ability to deliver an integrated bundled solution that meets the agency’s technical, regulatory, and operational requirements. However, it was determined that only NeuroField, Inc. could supply all required modalities (e.g., FDA-cleared EEG hardware, multiple neuromodulation modalities, unified software) in a single, fully integrated and compatible system. Other vendors were excluded because they either lacked necessary modalities, could not provide integrated hardware/software, or failed to meet required compliance and interoperability standards.

All due diligence was exercised to ensure open consideration of potential sources. The sole source determination is supported by conclusive evidence that no other vendor or combination of vendors can satisfy the full scope of requirements without unacceptable risk to system compatibility, research workflow, and programmatic success.

VII. Determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.

The Contracting Officer has determined that the anticipated cost of this acquisition is fair and reasonable. This determination is based on a price analysis comparing NeuroField Inc.'s current pricing to advertised commercial rates and previous sales of similar neurotherapy and neuromodulation equipment in the open market. Market research confirms that the prices listed for the Q21 19-Channel EEG Amplifier, Octavia pEMF/LED Stimulator, Genesis units, LED modules, and integrated software are consistent with prevailing rates for research-grade, FDA-cleared, and investigational neurological equipment of comparable complexity and capability. There is no evidence of price inflation or unique government surcharges in the vendor’s quote, and the total invoiced amount reflects standard commercial terms. Therefore, the price is considered fair and reasonable given the unique technical requirements, integrated solution, and current marketplace conditions.

VIII. Description of the market research conducted and the results, or a statement of the reasons market research was not conducted.

Extensive market research was conducted to identify all vendors capable of supplying the required integrated neurotherapy and neuromodulation equipment and software. This included:

• Comprehensive internet searches using terms such as “EEG amplifier,” “neurofeedback system,” “pEMF stimulator,” “tDCS/tACS/tRNS neuromodulation device,” and “integrated neurostimulation research system.”

• Review of Federal Supply Schedule (GSA Advantage), government procurement databases (SAM.gov), and the AbilityOne program to check for any mandatory sources or existing contract vehicles with suitable offerings.

• Direct outreach and capability assessment involving leading commercial vendors and small businesses in the field—specifically NeuroElectrics, BrainMaster Technologies, NeuroCare Group, and Mind Media—to determine their ability to meet the requirement as a fully integrated hardware/software solution.

• Consultation with subject matter experts experienced in neurotherapy equipment procurement and research.

• Examination of vendor product sheets, technical documentation, peer-reviewed publications, and user forums as sources of validation for product capabilities.

The research confirmed that while several vendors offer EEG or neurostimulation equipment, only NeuroField, Inc. can provide a single, fully integrated system—including FDA-cleared EEG, proprietary multi-modal neuromodulation hardware (tDCS, tACS, tRNS, pEMF, photobiomodulation), unified software, and bundled training—that meets all agency performance, compatibility, and regulatory requirements. Other vendors were evaluated but excluded due to the lack of required

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As a result, the market research fully supports the determination that only one responsible source is available to satisfy the government’s unique acquisition requirements in this case.

IX. Any other facts supporting the use of Other Than Full and Open Competition.

In addition to the results of market research, several other factors further support this sole source determination. The equipment and software components provided by NeuroField, Inc. are proprietary and designed to function as an integrated system, ensuring seamless compatibility, effective workflow, and reliable technical support. Attempting to assemble and integrate similar capabilities from multiple vendors would create significant risk of incompatibility, operational delays, and increased total lifecycle costs due to fragmented service, technical support, and training gaps.

This acquisition directly supports behavioral health and readiness research efforts, and timely procurement is necessary to meet program milestones. Any delay or risk of failed integration could negatively impact critical research objectives and the development or implementation of Space Force human performance initiatives.

No other provider offers fully integrated, compatible hardware and software with the required scope of modalities and regulatory standing in a single-source solution, further reinforcing the appropriateness of non-competitive procurement.

Neurofield confirmed on 08 September 2025 that they are the only distributor for their products and the items of the subject requirement.

X. List of any sources that expressed, in writing, an interest in the acquisition.

During the course of market research and industry outreach related to this acquisition, no sources other than NeuroField, Inc.

expressed, in writing, an interest in or capability to fulfill the complete requirement as defined. While several vendors were contacted and their product capabilities reviewed—including — no other vendor submitted a written statement of interest or indicated, in writing, the ability to provide the fully integrated neurotherapy and neuromodulation system meeting all technical, regulatory, and programmatic needs of the agency. NeuroField, Inc.

is the only source to formally acknowledge and support the specific requirements of this procurement.

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required.

To encourage greater competition for future procurements of neurotherapy and neuromodulation systems, the agency will continue to conduct regular and thorough market research, monitor advancements in neurotechnology, and engage with industry through requests for information (RFIs), sources sought notices, and participation in relevant trade shows and conferences. These efforts are intended to identify emerging vendors, new technological developments, or commercial products that may meet or exceed the agency’s evolving requirements.

The agency will also review and refine its technical requirements and specifications with an eye toward maximizing compatibility, interoperability, and adherence to open industry standards wherever feasible. This could allow more vendors to compete if new integrated solutions become available. Additionally, the agency will communicate with potential suppliers regarding future needs and encourage them to consider developing fully integrated, compliant solutions to promote broader vendor participation.

Finally, the agency will reassess market conditions prior to any follow-on or related procurements to determine if additional sources have entered the market who are capable of providing the required integrated solution. These actions collectively support the agency’s commitment to advancing competition and reducing reliance on sole source awards for future requirements.

XII. Certification by the Contracting Officer.

As evidenced by my signature above, I have determined this document to be both accurate and complete to the best of my knowledge and belief.

XIII. Certification by the technical/requirements personnel.

As evidenced by my (our) signature(s) above, I (we) certify that any supporting data contained herein, which is my (our) responsibility, is both accurate and complete.

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Contracting without providing for full and open competition shall not be justified on the basis of lack of advance planning by the requiring activity or concerns related to the amount of funds available (e.g., funds will expire) (10 U.S.C. 3204)

VI. Description of efforts made to ensure that offers are solicited from as many potential sources as practicable.

(FAR 6.303-2(b)(6))

Describe all efforts taken (or to be to be taken) to ensure that offers are solicited from as many potential sources as practicable under the circumstances. Although Market Research is covered in Section VIII, the information in Section VI should correlate with the Market Research described in Section VI. The following issues should be addressed in this paragraph:

Sources Sought Synopsis (used as part of market research). If a sources sought synopsis was issued, state the date the synopsis was issued and a brief description of its content. If any responses were received, describe in detail the results of the screening process and the rationale for determining the unacceptability of any synopsis respondents. Reference FAR 13.105, Synopsis and Posting Requirements.

Other Actions. In this paragraph, discuss any other actions taken or planned to facilitate competition for this acquisition. The discussion should include actions tried or considered even if the actions were unsuccessful. If the efforts were unsuccessful, so state and describe why.

Qualifying Country Sources. If qualifying country sources have expressed interest, but are to be excluded, provide supporting rationale.

VII. Determination by the Contracting Officer that the anticipated cost to the government will be fair and reasonable. (FAR 6.303-2(b)(7))

Include a statement by the contracting officer that the anticipated cost will be considered fair and reasonable and provide the basis for this determination. The steps that will be taken to ensure the final contract price will be fair and reasonable are also described here. Describe the extent of cost or price analysis anticipated including the requirements for certified cost or pricing data, technical evaluations, and audits.

VIII. Description of the market research conducted and the results, or explain why market research was not conducted. (FAR 6.303-2(b)(8))

Generally, some form of market research should be conducted. Discuss any market research conducted pursuant to FAR Part 10 and describe results of that research. Market research is any effort undertaken to determine if sources capable of satisfying the agency's requirements exist and to determine if commercial items or non-developmental items are either available or can be modified so that they will satisfy the agency's needs. Market research should be focused not only on identifying alternate sources, but also on alternate equipment or substitutes that might fulfill the Government needs with only minor modification.

Regardless of the approach used, the results should provide a high level of confidence that no other qualified sources exist.

When other exceptions from the requirement to obtain full and open competition are relied upon, the market research might be limited to an examination of the acquisition history and experience with the marketplace under previous acquisitions for the same or similar items.

If no market research was conducted, so state and provide the rationale.

IX. Any other facts supporting the use of Other Than Full and Open Competition. (FAR 6.303-2(b)(9)(i))

Provide any other facts supporting the use of other than full and open competition, including an explanation of why technical data packages, specifications, engineering descriptions, statements of work, statements of objectives, or purchase descriptions suitable for full and open competition have not been developed, are not being developed, are not being used, or are not available.

X. List of sources, if any, that expressed interest in the acquisition. (FAR 6.303-2(b)(10))

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If a sources sought synopsis was done and all interested sources are included in Section VI, it is acceptable to state, “See Section VI above.”

XI. A statement of the actions, if any, the agency may take to remove or overcome any barriers to competition before making subsequent acquisitions for the supplies or services required. (FAR 6.303-2(b)(11))

Describe any actions taken or to be taken to foster competition for future acquisitions of the supplies or services being acquired.

Describe potential actions that could be taken to remove the barriers to competition that have been identified in the justification and include a milestone schedule, where available, for accomplishing these actions. For example, if a follow-on competitive acquisition is planned, so state and provide the planned award date, or state that the Government will attempt to acquire rights in technical data and computer software sufficient to compete follow-on acquisitions as a priced option in the contract action that is the subject of this Justification, or (if applicable) state how the Government intends to challenge nonconforming markings on technical data and computer software delivered to it under previous contracts so those markings can be removed in order that the technical data and computer software may be used in support of a follow-on competitive acquisition, or describe plans to qualify additional sources.

Address efforts to ensure competition for future spare parts and maintenance in support of systems or equipment covered by the justification, even when these acquisitions will be accomplished by other organizations. Include a discussion on available breakout data.

If no actions are planned, so state and provide reasons. If approval is sought for more than one year, explain why a sole source effort is required for the planned time duration.

For a non-competitive follow-on acquisition to a previous award for the same supply or service supported by a Justification citing the same authority, include a discussion of the actions planned to overcome barriers to competition established in the previous justification, the status of those actions, and the results of those actions. The approval authority shall determine whether the planned actions were completed. If the planned actions were not completed, the justification for the follow-on acquisition shall be approved by the approval authority one-level above the approval authority for the previous justification (see FAR 13.501(a)(2)). If the previous justification was approved by the Senior Procurement Executive (SPE), the approval remains at the SPE level.

[DFARS 213.501(a) and DFARS PGI 206.304(a)(S-70)(ii)]

XII. Certification by the Contracting Officer. (FAR 6.303-2(b)(12))

As evidenced by his/her signature, the contracting officer has determined this document to be both accurate and complete to the best of his/her knowledge and belief.

XIII. Certification by the technical/requirements personnel. (FAR 6.303-2(c))

As evidenced by their signatures, the technical and/or requirements personnel have certified that any supporting data contained herein, which is their responsibility, is both accurate and complete.