36C24725Q0365 Special Notice.docx
DOCX document 24 KB Posted
- Attached to
- PENFS DEVICES Federal contract opportunity
- Solicitation number
- 36C24725Q0365
About this file
This is a Special Notice announcing the Department of Veterans Affairs (VA) Network Contracting Office 07's intent to award a sole source contract to NeurAxis, Inc. for 920 IB-Stim devices (percutaneous electrical nerve field stimulators - PENFS) to be delivered to the Atlanta VA Medical Center in Decatur, GA.
The devices will be used in a sham-controlled study exploring effectiveness for fibromyalgia symptoms, with both sham and true devices included for 230 participants. Each device is single-use, lasting 120 hours over five days. The NAICS code is 339113 with a size standard of 800 employees. Interested parties must submit capability statements by February 13, 2025, at 7:00 AM EST to Rudy A. Cortinez (rudy.cortinez@va.gov). The place of performance is the Atlanta VA Medical Center at 1670 Clairmont Rd, Decatur GA 30033.
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Text version
Special Notice Special Notice
| SUBJECT* |
| PENFS Devices |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 30901 |
| SOLICITATION NUMBER* |
| 36C24725Q0365 |
| RESPONSE DATE/TIME/ZONE |
| 02-13-2025 07:00 EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 15 DAYS AFTER THE RESPONSE DATE |
| RECOVERY ACT FUNDS |
| N |
| PRODUCT SERVICE CODE* |
| 6515 |
| NAICS CODE* |
| 339113 |
| CONTRACTING OFFICE ADDRESS |
| Department of Veterans Affairs |
VISN 7 Network Contracting Activity 501 Greene Street Hatcher Building - Suite 2 Augusta GA 30901
POINT OF CONTACT*
Contracting Specialist Rudy A. Cortinez rudy.cortinez@va.gov
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
NOTICE OF INTENT TO SOLE SOURCE
NOTICE OF INTENT TO SOLE SOURCE This notice is being published in accordance with Federal Acquisition Regulation (FAR) Subpart 5.101 requiring dissemination of information for proposed contract actions. This is a notice of intent to award a sole source contract, and is not a request for competitive quotes/proposals.
The Department of Veterans Affairs, Network Contracting Office (NCO) 07, located at 325 Folly Road, Charleston South Carolina is issuing this Notice of Intent (NOI) to inform industry contractors of the Government’s intent to execute a Sole Source Delivery Order under FAR Part 13, specifically FAR Part 13.501(a) (i) Only One Available Source. This notice satisfies the posting requirements at FAR Part 5.101.
The intended Contractor is NeurAxis, Inc 11611 N Meridian St STE 330 Carmel IN 46032-8914.Place of Performance for this requirement is for the Atlanta VA Medical Center 1670 Clairmont Rd. Decatur GA 30033.
The Atlanta VA Medical Center Decatur, request 920 IB-Stim devices for 230 participants. These devices are percutaneous electrical nerve field stimulators (PENFS) and will include both sham and true devices. This new sham-controlled study will explore their effectiveness for fibromyalgia symptoms by delivering electrical stimulation to certain cranial and occipital nerves. Each device is for single use, lasting 120 hours over five days, and aims to help manage pain. The study will also assess the safety and efficacy of the approach for fibromyalgia, although IB-Stim is already FDA-cleared for use in abdominal pain linked to IBS in young patients.
The North American Industry Classification System (NAICS) for this requirement is . The339113 Federal Supply Class (FSC/PSC) is 6515. The Small Business Administration (SBA) size standard for this sector is 800 Employees.
This notice of intent is neither a formal solicitation nor a request for competitive proposals. No solicitation document is available and telephone requests will not be honored. No award will be made on the basis of unsolicited quotations or offers received in response to this notice. Any response to this notice must show clear, compelling and convincing evidence that competition will be advantageous to the Government. The intent of this synopsis is for informational purposes only. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this action based on this notice is solely within the discretion of the Government.
All inquiries and concerns must be addressed in writing via e-mail to Rudy A. Cortinez, rudy.cortinez@va.gov with the following information referenced in the subject line, 36C247-25 -AP- 1690 – NeurAxis, Inc All interested parties who are responsible, certified, and capable may identify their interest and may submit a capabilities statement no later than 07:00 AM Eastern Standard Time (EST) on 13 February, 2025 to the above mentioned point of contact. The interested parties bear full responsibility to ensure complete transmission and timely receipt.
DESCRIPTION
| *= Required Field |
| Special Notice |
Special Notice
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