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

36C250-26-AP-4390

Scrambler 2

Revision: 02 Effective Date: 12/30/2025 Page 1 of 3 Acquisition ID# 36C250-26-AP-4390

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

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

Acquisition Plan Action ID: 36C250-26-AP-4390

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: 541-26-3-250-0501

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, open-market, brand-name purchase order for one Scrambler Therapy ST-5A medical device, including delivery and setup support, for use by the Pain Medicine Service (PMS) at the CLE VAMC.

The Scrambler Therapy ST-5A is a non-invasive, non-opioid medical device designed to provide symptomatic relief for chronic, intractable, post-surgical, and post-traumatic pain.

The system uses advanced biophysical modulation through surface electrodes to transmit “no-pain” signals that retrain nerve pathways, providing immediate and sustained relief without medication.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: Four (4) Weeks ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The Scrambler Therapy ST-5A is a patented, proprietary pain management technology that differs significantly from conventional electrical stimulation devices. Unlike TENS units, which rely on the gate-control theory of pain blocking, the Scrambler Therapy system employs Shannon information theory to deliver variable, non-repetitive synthetic signals that remodel pain perception at the central nervous system level.

The system is manufactured exclusively by Delta International Services & Logistics, Inc. dba Erickson Strong Medical in Italy and distributed solely in the United States by Delta

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International Services & Logistics, Inc. dba Erickson Strong Medical, located in Magnolia, Texas. There are no American-made equivalents to the Scrambler Therapy ST-5A system .

The device has been clinically validated in independent studies conducted by the Mayo Clinic, Johns Hopkins University, and MD Anderson Cancer Center, with reported 80–90% effectiveness and no significant adverse effects. These features—algorithmic signal variation, non-opioid therapy modality, and independently verified clinical efficacy—are unique to the Scrambler Therapy ST-5A system and are not replicated by any other device on the market.

Acquisition of an alternate product would compromise the intended clinical outcome, hinder treatment of neuropathic pain, and limit the PMS’s ability to provide an evidence-based, opioid-reducing therapy con

4. Description of market research conducted and results or statement why it was not conducted: Market research was conducted by the Contracting Officer and Pain Medicine Service (PMS) to determine if there were other vendors capable of providing the scrambler device that meets CLE VAMC's specific requirements. The following sources were reviewed:

Delta International Services & Logistics, Inc. dba Erickson Strong Medical, the OEM in Rome, Italy, confirmed that Erickson Strong Medical, a verified small business, is the exclusive distributor and that the Scrambler Therapy ST-5A Technology Medical Device is manufactured in Italy.

A Sources Sought notice, 36C25026Q0070, was conducted from October 21, 2025, through October 29, 2025. One response was received: on October 21, 2025, Dave, via email at aykaconsulting1@gmail.com, requested to be added to the list of interested vendors. He was subsequently asked to provide the information requested in the Sources Sought notice;

however, no information was received.

On July 30, 2026, the Contracting Officer conducted market research by reviewing GSA eLibrary, National Contracts, ECAT, SAM.gov, Interagency Contract Directories, NAC, SEWP, FPDS, SCMC, OMB, BIC, and FDA using the keyword "scrambler device." No products or vendors capable of meeting the Government's requirement were identified through these sources. The Dynamic Small Business Search (DSBS) database was also reviewed under NAICS 334519, Other Measuring and Controlling Device Manufacturing, using the same keyword. The search identified two vendors; however, neither vendor was qualified because they do not manufacture or provide the Scrambler Therapy ST-5A Technology Medical Device. No other vendors capable of meeting the Government's requirement were identified.

Revision: 02 Effective Date: 12/30/2025 Page 3 of 3 Acquisition ID# 36C250-26-AP-4390

The VA and SBA Rules of Two cannot be attained for this acquisition. Recommend sole-source acquisition to Delta International Services & Logistics Inc. dba Erickson Strong Medical.

A FITARA review is not required for this procurement because the acquisition involves supplies and does not include the purchase or development of information technology hardware or software.

The NMR does not apply to this procurement due to the fact that Delta International Services & Logistics is the manufacturer of the Scrambler Therapy ST-5A device, which is exclusively sold within the USA by Delta International Services & Logistics, Inc. dba Erickson Strong Medical. The VA and SBA Rules of Two cannot be attained for this acquisition.

Recommend sole-source acquisition to Delta International Services & Logistics, Inc. dba Erickson Strong Medical.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 13.106-

1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Name Date Title

RACHELLE HAMER Digitally signed by RACHELLE HAMER Date: 2026.08.26 12:03:18 -04'00'