P03 Single Source Justification-Aliya.pdf
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- Attached to
- 6515--INTENT TO SOLE SOURCE ALIYA ELECTRODE (5 PACK) Federal contract opportunity
- Solicitation number
- 36C24625Q0267
About this file
This is a Single Source Justification form from the Department of Veterans Affairs for a procurement under the Simplified Acquisition Threshold (SAT) of $250,000. The justification is for additional electrodes for the Aliya Pulsed Electric Field System at the Asheville VA Medical Center (1100 Tunnel Road Asheville, NC 28805).
The document justifies sole sourcing to Galvanize Therapeutics INC based on the proprietary nature of the Aliya System, which is the only FDA-approved non-thermal ablation system for all soft tissue ablations. The system uses biphasic monopolar pulsed electric field technology for surgical ablation of soft tissue and tumor treatment. Market research consisted of obtaining a sole source letter dated 10/9/2024 from Galvanize Therapeutics INC confirming they are the exclusive manufacturer with no authorized distributors. The acquisition is identified under PR: 637-25-1-109-0002 and Acquisition Plan Action ID: 36C246-24-AP-6050, with an effective date of 11/15/2024.
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| File | Type | Posted |
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| 36C24625Q0267.docx | DOCX document |
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Text version
VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT
Revision: 01 Effective Date: 11/15/2024 Page 1 of 1 Acquisition ID#:
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: 36C246-24-AP-6050
1. Contracting Activity:
Department of Veterans Affairs, VISN 6, Asheville VA Medical Center 1100 Tunnel Road Asheville, NC 28805
PR: 637-25-1-109-0002
2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:
The Asheville VA Medical Center has a requirement to procure additional electrodes for the Aliya Pulsed Electric Field System that is currently in use at the facilitys OR. The Aliya System is used for the surgical ablation of soft tissue including treatment of solid tumors and disrupting cellular homeostasis by utilizing non-thermal pulsed electric field energy.
3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:
The Aliya System is a biphasic monopolar pulsed electric field (PEF) system that induces cell death in a manner independent of thermal processes, enabling focal ablation without denaturing stromal proteins or inducing significant muscle contraction. The Aliya System is also the only FDA approved ablation system that is approved for all soft tissue ablations that is non-thermal which is safer for the patient. To ensure that the new electrodes are compatible with the current system they should be purchased directly from the manufacturer of the Aliya System (Galvanize Therapeutics INC).
4. Description of market research conducted and results or statement why it was not conducted:
The OEM Galvanize Therapeutrics INC has provided a sole source letter dated 10/9/2024 confirming that the system is a proprietery item and is to be exclusively purchased from them as there are no authorized distributers.
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.
Name Date Title https://www.acquisition.gov/?q=/browse/far/13 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466
| 2024-12-19T15:29:29-0500 | |
| JERRY MANN |
File details come from the government source that posted it. Updated .