36C25024Q0620_1.docx

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6515--Equipment, Neurostimulation Device for Investigational, Ann Arbor
Solicitation number
36C25024Q0620
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This document is a Special Notice from the Department of Veterans Affairs, VA Healthcare System, VISN 11 Contracting Activity. The notice announces the government's intent to negotiate a sole source contract under Simplified Acquisition Procedures for five Transcutaneous Vagus Nerve Stimulation Research (tVNS R) devices from tVNS USA, sold by CoCart LLC, a small business located in Sioux Falls, SD. The tVNS R devices provide non-invasive transcutaneous auricular vagal nerve stimulation to alleviate symptoms of disorders related to sympathovagal dysfunction, such as Parkinson's Disease. The government believes only CoCart LLC possesses the required capabilities to successfully meet this requirement. Responses are due by July 17, 2024 at 4:00 PM Eastern Time. A firm fixed price contract with no option years is anticipated.

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Special Notice Special Notice

SUBJECT*
Equipment, Neurostimulation Device for Investigational, Ann Arbor

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*
49037
SOLICITATION NUMBER*
36C25024Q0620
RESPONSE DATE/TIME/ZONE
07-17-2024 4:00 PM EASTERN TIME, NEW YORK, USA
ARCHIVE
30 DAYS AFTER THE RESPONSE DATE
RECOVERY ACT FUNDS
N
PRODUCT SERVICE CODE*
6515
NAICS CODE*
334510
CONTRACTING OFFICE ADDRESS
Department of Veteran Affairs

Network Contracting Office 10

5500 Armstrong Rd.

Battle Creek MI 49037

POINT OF CONTACT*

Contract Specialist Brooke Hansen brooke.hansen@va.gov Phoned inquiries will not be accepted.

ADDITIONAL INFORMATION

AGENCY’S URL
https://www.va.gov
URL DESCRIPTION
Department of VA
AGENCY CONTACT’S EMAIL ADDRESS
brooke.hansen@va.gov
EMAIL DESCRIPTION
Contract Specialist

DESCRIPTION

Notice of Intent to Sole Source Requirement

The Department of Veterans Affairs, VA Healthcare System, VISN 11 Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 13.106-1, Only One Responsible Source for the following items listed below. The associated NAICS code for this medical equipment is 334510. The vendor, Cocart, LLC, is a small business, located at 101 S. Reid St., Suite 307, Sioux Falls, SD 57103-70454.

Description of equipment requirements:

The Bohnen lab is requesting five Transcutaneous Vagus Nerve Stimulation Research (tVNS R) devices from tVNS USA, sold by CoCart LLC. The tVNS R devices provide a non-invasive transcutaneous auricular vagal nerve stimulation. The device is a non-invasive treatment option that provides mild electrical stimulation to the auricular branch of the vagus nerve, which is accessible from the outer part of the ear. The vagus nerve allows for communication between the brain with many parts of the body, such as the heart, lungs, and digestive tract. The device itself is similar in appearance to a music playing device with earphones that connect to the outer portion of the ear and a long wire that is connected to a control box. These devices will provide therapeutic electrical impulses that are designed to alleviate symptoms of disorders that may be related to sympathovagal dysfunction, such as Parkinson’s Disease (PD). This stimulation may be able to improve heart rate variability. Novel emerging evidence from the literature has uncovered that decreased heart rate variability (HRV) both at rest and during walking could be a fundamental but, until recently, an unrecognized factor in the pathophysiology of freezing of gait (FoG), which is often considered one of the most debilitating symptoms of PD. Individualized HRV-informed programming of in-home use of a tVNS neural stimulator may offer a very novel therapy to treat gait disturbances, including FOG, in Veterans with PD. The tVNS R devices by tVNS USA, sold by CoCart LLC offer easily programable stimulation devices that can be adjusted to provide prescribed treatment to those with PD.

A firm fixed price contract with no option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This is not a Request for Proposal; this is a Notice of Intent to Sole Source requirement.

*= Required Field
Special Notice

Special Notice

File details come from the government source that posted it. Updated .