P03 RFO 8_SSJ GSAM 581_Redacted.pdf

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for Part 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.)

14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C241-26-AP-2021

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 1, in support of VISN 1, VACT, West Haven VAMC.

2237# 689-26-2-7077-0023

Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

West haven VAMC is looking to purchase a new NanoKnife 3.0 Irreversible Electroporation (IRE) device.

The current NanoKnife System 2.2.1 reached its end of life on November 1st, 2024. The Original Equipment Manufacturer (OEM) Angiodynamics is no longer performing repairs or maintenance services. Using the current device is becoming increasingly dangerous because there have been reports of machines malfunctioning mid treatment.

Order against: FSS Contract Number: 36F79718D0321

Name of Proposed Contractor: Marathon Medical Corp

Street Address: 3251 Lewiston St, Suite 16

City, State, Zip: Aurora, CO 80011

Phone: 303-339-4305

2. Description of Supplies or Services:

The estimated value of the proposed action is $433,417.09

The NanoKnife 3.0 System, made by AngioDynamics, uses Irreversible Electroporation (IRE). This is a non-thermal method in which short, strong electrical pulses create tiny holes in the cell membrane, disrupting the cell and causing it to die. IRE's main benefit is that it preserves the structure around cells, such as blood vessels and nerves. This allows for precise treatment even near important blood vessels, unlike traditional heat-based treatments.

3. Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAM/R 538.7104-3(b)(1)(i): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

GSAM/R 538.7104-3(b)(1)(ii): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

GSAM/R 538.7104-3(b)(1)(iii): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

GSAM/R 538.7104-3(b)(1)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA; or

GSAM/R 538.7104-3(b)(1)(v): A law expressly authorizes or requires that the purchase be made from a specified source.

GSAM/R 538.7104-4: Items peculiar to one manufacturer:

The NanoKnife 3.0 System by AngioDynamics is a minimally invasive, FDA-approved technology for prostate tissue ablation that uses Irreversible Electroporation (IRE). IRE employs electrical pulses to kill tumor cells without heat and is especially suited for tumors near vital structures like blood vessels, bile ducts, and nerves. It is commonly used for liver, pancreatic, renal, and prostate tumors, as well as certain lung, soft tissue, and benign tumors, particularly when traditional surgery is not feasible. Its precision allows for effective tumor ablation while preserving surrounding healthy tissue. Most IRE procedures are outpatient or require only a short hospital stay, allowing patients to resume normal activities quickly. Because electrical pulses target only tumor cells and spare surrounding structures, complications are minimized and recovery is typically faster and less painful than with conventional surgery. For example, in pancreatic cancer, the lack of tissue removal leads to shorter recovery. The current nanoknife device that is in place is past it’s EOL and the support date. There have been reports of machines malfunctioning mid treatment, expedited replacement is required. A subject matter expert in cancer treatment confirmed there is no other IRE device that has clinical data in prostate cancer other than the Angiodynamics product.

4. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102- 2(4) to aid the contracting officer in making this best value determination: Placing this order under a Federal Supply Schedule using FAR 8.405 procedures confirms that it represents best value and provides the lowest overall cost alternative. It leverages GSA’s pricing, competition, and efficient processes—while fulfilling mission requirements with high quality and low risk.

5. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted. The NanoKnife 3.0 System is a minimally invasive tumor ablation technology using Irreversible Electroporation (IRE) to destroy targeted tissue while preserving surrounding structures, offering precision, versatility, and functional protection. An email to Marathon Medical asking for a sole-source letter. They provided one that states they are the Sole Authorized SDVOSB Distributor for AngioDynamics, Inc products. An email was sent to the OEM, AngioDynamics, to ask whether Marathon Medical was the sole reseller. The OEM confirmed Marathon is the sole reseller. AngioDynamics is a small business that sells directly to non-VA clients;

when dealing with the VA, they use Marathon Medical.