P03 SSJ_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for MPT up to SAT

Soterix Medical NIRSIT Standard System

36C250-26-AP-3243

Revision: 02 Effective Date: 12/30/2025 Page 1 of 5 Acquisition ID# 36C250-26-AP-3243

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW RFO 12 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C250-26-AP-3243

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541-26-3-8521-0100

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Network Contracting Office (NCO) 10 intends to award a new firm-fixed-price sole source purchase order for one (1) Soterix Medical NIRSIT Standard System with 204 Channels, including associated software, installation, and training, for the Cleveland VA Medical Center Pain Medicine Service. The system will be used to provide real-time functional Near- Infrared Spectroscopy (fNIRS) monitoring and measurement of cerebral oxygenation and blood flow to support advanced neurophysiological assessment and evaluation of patient response during pain management therapies and related clinical applications.

1 EA Soterix Medical NIRSIT Standard System

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 80 Days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Soterix Medical NIRSIT Standard System is a proprietary functional Near-Infrared Spectroscopy (fNIRS) platform that integrates high-density optical imaging, real-time Diffuse Optical Tomography (DOT), wireless data acquisition, anatomical localization, motion-artifact management, and advanced analysis capabilities within a single wearable system. The system utilizes 204 measurement channels to provide 4 mm x 4 mm spatial resolution and incorporates dense optical sensor architecture, photogrammetry localization, motion sensing and artifact-removal capabilities, and integrated software supporting real-time cerebral hemodynamic monitoring, 2D and 3D activation mapping, GLM/SPM analysis, block averaging, feature extraction, and channel-by-channel analysis. These integrated capabilities support high-

Effective Date: 12/30/2025 Page 2 of 5 Acquisition ID# 36C250-26-AP-3243 density assessment and localization of cerebral hemodynamic responses across the prefrontal cortex during neurophysiological assessment and task-based monitoring.

The requested system is required to support real-time neurophysiological assessment and monitoring within the Pain Medicine Service. Market research identified other commercially available fNIRS systems; however, the systems evaluated differed in channel configuration, system architecture, spatial imaging capabilities, or integrated hardware and software functionality and were not identified as meeting all of the Government’s minimum requirements in a comparable integrated configuration. A U.S.-manufactured BIOPAC system was specifically evaluated; however, its standard prefrontal configuration provides 18 measurement channels per imager, with configurations supporting up to 54 channels, and does not provide the required 204-channel high-density configuration.

Additionally, NIRSIT is manufactured by OBELAB and is exclusively distributed in the United States by Soterix Medical. Accordingly, Soterix Medical is the exclusive U.S./Canadian distributor for the NIRSIT system and associated proprietary software and support required by the Government.

4. Description of market research conducted and results or statement why it was not conducted: The Contracting Officer, working with the Pain Medicine Service, conducted market research to determine whether a domestically manufactured item could meet the Government's needs and to avoid the need for a nonavailability waiver if a compliant U.S.-made product could be found.

Before beginning that research, the Government identified the key features the system had to provide. At a minimum, the required system had to be a wearable functional near-infrared spectroscopy (fNIRS) platform suitable for clinical neurophysiological assessment, have an ergonomic design appropriate for patient use, offer sufficient portability for the clinical setting, and provide a 204-channel configuration, along with the required software, installation, and training.

To locate potential sources, the Government posted Sources Sought notice 36C25026Q0596 on SAM.gov from May 27, 2026 through June 4, 2026. No responses were received identifying a U.S.-made product capable of meeting the Government's minimum requirements. In addition, on May 21, 2026, the Contracting Officer reviewed GSA Advantage, National Contracts, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, OMB, and BIC using the keyword "functional near-infrared spectroscopy." SBA SBS was also reviewed on that date under NAICS 334516 using the same keyword. Those efforts did not identify a domestic source offering a compliant end product.

Effective Date: 12/30/2025 Page 3 of 5 Acquisition ID# 36C250-26-AP-3243

The Government then compared commercially available fNIRS systems against the minimum requirements. That review showed that the Soterix Medical NIRSIT Standard System was the only identified system that met all essential requirements without material compromise.

The BIOPAC Systems, Inc. Prefrontal Cortex fNIRS system, manufactured in the United States, was the primary domestic alternative identified during market research. However, it did not meet the Government's overall requirement because the requirement was not simply for any fNIRS device. The Government required a system that combined wearable design, ergonomic suitability for the intended patient use, sufficient portability for the clinical setting, and enough measurement-channel capability to support the agency's intended neurophysiological assessment and treatment-planning needs.

Although BIOPAC represented a domestic option, market research showed that it was not ergonomically designed for the intended use and provided limited measurement channels.

Those shortcomings were material, not minor. A system that lacks the necessary ergonomic design and sufficient channel capability cannot fully support the clinical application for which this requirement is being acquired and therefore cannot satisfy the Government's minimum need.

For that reason, BIOPAC was not rejected merely because another product was preferred. It was rejected because it could not meet the overall requirement as defined by the agency, whereas the Soterix Medical NIRSIT Standard System was identified as meeting the

Government's combined requirement for wearable ergonomic design, portability, required channel capacity, and overall functional suitability.

The NIRx Medical Technologies NIRSport2 system, manufactured in Germany, was also reviewed. Although capable of high-density measurement, its high-density configurations use a modular/scalable architecture and were not identified as providing all required capabilities in a comparable integrated 204-channel real-time DOT configuration. For this requirement, the Soterix NIRSIT Standard System better matched the Government’s combined requirements for an integrated wearable configuration, real-time DOT functionality, required channel configuration, and overall functional suitability.

The Artinis Medical Systems Brite24 system, manufactured in the Netherlands, and the Shimadzu LIGHTNIRS system, manufactured in Japan, were both found unsuitable because neither provided the required integrated 204-channel high-density configuration. Since the

Effective Date: 12/30/2025 Page 4 of 5 Acquisition ID# 36C250-26-AP-3243 required 204-channel configuration was one of the Government’s core functional requirements, neither system could meet the agency’s minimum need, while the Soterix NIRSIT Standard System could.

The Hitachi High-Tech ETG Series, manufactured in Japan, the OBELAB wearable fNIRS platform, manufactured in South Korea, and the Gowerlabs Ltd. LUMO system, manufactured in the United Kingdom, were also reviewed. The systems evaluated differed in channel configuration, system architecture, or integrated functionality and were not identified as meeting all of the Government’s minimum requirements in the required comparable integrated configuration. While certain alternative systems provide higher channel counts or high-density DOT capabilities, none were identified as meeting the

Government’s full combination of minimum requirements. By comparison, the Soterix NIRSIT

Standard System was the only system identified during market research that met the

Government’s full requirement as defined.

Overall, the market research showed that the Soterix Medical NIRSIT Standard System was not simply the Government's preferred option. It was the only identified system that met the minimum requirements for wearable ergonomic design, portability, required channel capacity, and overall functional suitability. The other systems were not ruled out because of convenience, preference, or price. They were ruled out because they did not meet one or more essential technical and functional requirements.

Based on that research, the Government concluded that no U.S.-made end product is available in sufficient and reasonably available commercial quantities and of satisfactory quality to meet the agency's requirement.

The NMR applies to this procurement under NAICS 334516. The acquisition file states that the SBA has provided an applicable waiver. Market research also showed that the VA and

SBA Rule of Two could not be met because no certified SDVOSB/VOSB vendors were identified that could provide the required Soterix Medical NIRSIT Standard System or a compliant equivalent that met the Government’s minimum requirements. The NIRSIT

Standard System is manufactured by OBELAB and exclusively distributed in the United States by Soterix Medical, Inc.; therefore, no other U.S. distributors are available to provide the required system. For those reasons, this procurement is recommended for sole-source award to Soterix Medical, Inc., the exclusive U.S. distributor of the required NIRSIT Standard

System.

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Contracting Officer's Certification: Purchase is approv ed in accordance with RFO 12. I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Rachelle J. Hamer Contracting Officer

NCO 10