FINAL CO Brand Name Justification NeuroStar Advanced Therapy System.pdf

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

Revision: 02 Effective Date: 12/30/2025 Page 1 of 3 Acquisition ID# 36C256-26-AP-3272

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 12.201 (c)

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

Acquisition Plan Action ID: 36C256-26-AP-3272

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Network

Contracting Office 16, Commercial Acquisition Team Little Rock, in support of VISN 16, Department of Veterans Affairs, VISN 16, Central Arkansas Veterans Healthcare System (CAVHCS), Geriatric Research, Education, and Clinical Center (GRECC), 220 Fort Roots Drive, North Little Rock, AR 72114-1707

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

The specific (brand name only) items being requested are the following: NeuroStar® Advanced Therapy System (which includes system accessories, components, and a service agreement).

The estimated period of performance for this acquisition is thirty (30) days after receipt of order (ARO) with a performance period not to exceed (NTE) three (3) months in duration (to account for delays, procurement lead times, and contractor payment). The total, estimated cost of this acquisition is $XXXXXX (Retracted for public notice posting).

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Statutory Authority Permitting Other than Full and Open Competition is the following: 6.103-1 Only one responsible source and no other supplies or services will satisfy agency requirements. It is specifically noted that competition will be utilized for this acquisition but brand name only items are required (and will only be accepted by the government) which in turn restricts competition. The associated regulatory guidance is 6.103-1(d) which states the following:

(d) Application for brand-name descriptions. Except as authorized at 6.103-5, use of brand-name descriptions, or specification of attributes peculiar to one manufacturer, prevents full and open competition and should only be used when justified and approved according to 6.104. This does not apply to “brand name or equal” descriptions as they provide for full and open competition..

Background: NeuroStar Advanced Therapy is a non-invasive, FDA-cleared transcranial magnetic stimulation (TMS) treatment for depression and related conditions. NeuroStar Advanced Therapy uses transcranial magnetic stimulation (TMS) to target underactive areas of the brain associated with mood regulation, helping to alleviate symptoms of Major Depressive Disorder (MDD), anxious depression, and Obsessive-Compulsive Disorder (OCD) in adults, and MDD in younger populations.

Specific features only available with the NeuroStar Advanced Therapy System include:

• The only TMS device to observe an 83% response rate and a 62% remission rate in adults.

• Only TMS device with proven efficacy in depression demonstrated through 2 randomized controlled trials.

• Only TMS system with 12-month durability data for adults.

• Over 16 years of clinical experience in the U.S. at over 1,100 practice locations with over 6.9 million treatments delivered.

• Precision Pulse TMS® Technology (pulse width optimized for cortical neuron stimulation)

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• TrakStar® Patient Data Management System, the most comprehensive patient data management system in the TMS field.

• Fast MT (unique proprietary algorithm assists the system operator in accurately finding the right Motor Threshold level and determining the appropriate TMS treatment dose for each patient)

• D-Tect™ MT Accessory (Simplifies the MDD MT process by visually reporting and comparing the magnitude of finger/thumb movements during the MT determination process).

• NeuroSITE™ Coil Positioning Frames (Simplifies the patient setup and coil positioning steps during treatments by leveraging the patient’s unique facial features).

Requirement For Brand Name: Brand Name, Exact Offerings Only are required for this acquisition. Or equal, or equivalent, alternate, and/or substitute offerings will not meet the government requirements (and these non-brand name offerings cannot be modified or altered to meet government requirements). The Central Arkansas Veterans Health Care System has been using the NeuroStar® Advanced Therapy System since 2012. This system is vital to the delivery of patient care for veterans and is intrinsically integrated within the facility’s patient care delivery network for the treatment of depression related conditions (and is used for research in other areas). This includes patient care/research collaboratory efforts that are often executed in partnership with their affiliate, The University of Arkansas, Medical Services Division. In addition to rendering treatment for depression related conditions, the Geriatric Research, Education, and Clinical Center (GRECC) uses basic and applied research to develop interventions needed for the age-associated loss of physical and cognitive abilities. GRECC research seeks to understand healthy aging and to solve problems of diseased aging in a holistic manner which includes magnetic stimulation of brain areas to improve behaviors and memory. The ultimate goal of such efforts is to prevent Alzheimer’s/Dementia. Successful completion of this research and competition for additional research funding is dependent upon the continued availability of the NeuroStar® Advanced Therapy System currently being used.

Conditions: The existing NeuroStar® Advanced Therapy System that is being used in the facility is reaching the end of its Original Equipment Manufacturer (OEM) lifespan which necessitates a replacement of this system. This procurement will enable needed replacement of this system for the following: 1). To ensure continuity of patient care to treat veterans with serious depression related conditions and 2). To maintain active research efforts that are currently being undertaken by GRECC in the field of Alzheimer’s/Dementia. To provide a direct match to existing equipment and to ensure compatibility, consistency, and uniformity at all levels a brand name purchase for the following is required by the government: NeuroStar® Advanced Therapy System.

4. Description of market research conducted and results or statement why it was not conducted: Limited market research was conducted for this procurement. The NeuroStar® Advanced Therapy System is available from the manufacturer, Neuronetics, Inc. and can also be obtained from the manufacturer’s exclusive distributor, Franklin Young International, Inc. There may be other (manufacturer authorized) providers available for this specific system that could be discovered when a competitive solicitation is executed for this procurement.

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5. Contracting Officer's Certification: This purchase meets the requirements of FAR 12.201(Promoting competition). Prior to award, a price fair and reasonableness determination will be made by the Contracting Officer in accordance with the criteria outlined in FAR 12.204 (a). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name: C. Robert Oravetz Date: 06-03-2026 Title: Contracting Officer