P03 Single Source Justification MPT to SAT.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C246-22-AP-2191

1. Contracting Activity: Department of Veterans Affairs, VISN 06, Network Contracting Office (NCO) 6, Purchase Request# 558-22-2-2734-0057, Durham VAMC, NC.

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

Durham VAMC MIECC Department has a brand name justification for the Interferential Neuromodulation System. This system will be used to deliver non-invasive, individualized TI brain stimulation to investigate its viability in facilitating fear extinction when applied to the ventromedial prefrontal cortex (vmPFC) of Veteran participants. Estimated amount $54,000.00.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: This system is the only integrated device and accessory set for clinical research on temporal interference (TI) stimulation and the first research / clinical grade stimulator, that provides customizable precise TI stimulation. Sotirex is the only vendor with a commercially available system for Interferential Neuromodulation that can deliver and individually optimized TI stimulation, as well as allow for MRI-safe stimulation. There is no other commercially available system for Interferential Neuromodulation that allows for MR-safe stimulation.

The Interferential Neuromodulation (Temporally Interfering (TI) Fields) System includes a four-channel stimulator, MR customization of the stimulator device so that stimulation may be applied in the MRI scanner, software required to target and individually optimize stimulation (up to 15 participants), and additional individualized modeling service by Soterix Medical, Inc. to optimize stimulation for remaining participants. This system will allow the application of individualized TI stimulation to deep brain structures of Veteran participants and study the viability of using the stimulation to facilitate fear extinction.

Sotirex is the only system from a US company that performs temporal interference (TI) stimulation and the only one that provides customizable precise TI stimulation. Even though there are other brain stimulation systems on the market, none of them have temporal interference (TI). TI stimulation involves stimulation at two locations on the scalp that differ in frequency by only a few Hz such as 2000 Hz and 2010 Hz to induce the formation of a standing wave or envelope wave. This type of envelope wave is critical to stimulating the deep structures of the brain like the amygdala and the ventromedial prefrontal cortex which are affected in PTSD.

4. Description of market research conducted and results or statement why it was not conducted:

Market research was conducted querying a VIP search using NAICS 339112 and Key words “deep brain stimulation” revealed no vendors capable of providing the Interferential Neuromodulation https://www.acquisition.gov/?q=/browse/far/13

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

System. The Sources Sought posted on 02/01/2022 yielded no results. Contacted the vendor, Soterix Medical, and they are the OEM and only provider for the Interferential Neuromodulation System.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Daleta Coles Date Contracting Officer https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466