5-SIGNED- SSJ TMS Navigator rev.pdf

Exhibit 2

Sole/Single Source Justification

For Requirements

Exceeding $5,00, but not Exceeding $250,000

1. Requesting Organization.

a. Name of the Institute or Center

National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP)

b. Name of the Office / Division / Branch / Program Office Neuroimaging Research Branch

c. Project Officer Information.

Yihong Yang, Ph.D.

NIDA-IRP, 251 Bayview Blvd, Suite 200, Room 07A709 Baltimore, MD 21224

Email: yihongyang@intra.nida.nih.gov Phone: 443-740-2648

2. Project Description.

a. Project Title. Acquisition of MRI compatible TMS neuronavigation system

b. Acquisition purpose and objectives.

The NIDA-IRP requires a MRI compatible neuronavigation system for use with existing MRI compatible transcranial magnetic stimulation (TMS) device for accurate coil positioning during stimulation with the aim of experimental application to treat substance abuse (e.g., cocaine dependence).

c. Project background.

In the concurrent TMS and fMRI platform, which is being used to understand the TMS treatment effects on drug addiction, the localization cannot be done onsite due to incompatibility to MRI of the current navigator. The addition of the navigator will significantly improve the accuracy of brain localization. Such an improvement will substantially enhance the capability of performing research on the platform. Additionally, the improved localization provided by this system will allow for further scientific endeavors into using this platform on non-human primates.

TMS stimulation is sensitive to coil location, orientation and angle. In conventional TMS suite, the neuronavigation system provide us an effective way of positioning the coil for accurate and replicable stimulation of the site. The MRI compatible TMS system currently in use is a valuable tool for NIDA IRP to monitor and explore the instant/acute mailto:yihongyang@intra.nida.nih.gov stimulation effect combining TMS and fMRI, which can greatly help us understand the brain mechanisms of TMS stimulation systematically. However, the current arrangement of MRI compatible TMS system lacks the neuronavigation system as would be found in the conventional TMS suite. While providing precision in time domain, this compromises the necessary spatial accuracy.

The required device is a newly developed MRI compatible neuronavigation systems and has been reviewed for compatibility with our existing MRI compatible TMS system. With the inclusion of this MRI compatible neuronavigation system, more accurate TMS coil positioning inside the MRI chamber can be achieved and more reliable and reproducible data can be obtained.

d. Period of Performance / Expected Delivery Date.

Equipment to be delivered within 7 weeks upon contract award. Installation and on-site technical training to be scheduled within 30 days of delivery.

e. Total Estimated Dollar Value.

The total estimated dollar value of this acquisition is $86,060.00

3. Acquisition Authority. This acquisition is conducted under the authority of the Federal

Acquisition Regulations (FAR) Subpart 13.106-1. A(b) Soliciting from a single source. (1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, or industrial mobilization).

4. Justification Rationale.

Only one source is available:

The NIDA-IRP requires an MRI compatible neuronavigation system for use with existing MRI compatible transcranial stimulation device for the experimental application to treat substance abuse (e.g., cocaine dependence). After performing significant market research and contacting industry experts, it was found that the requested MRI compatible system, manfuctured by Localite, is the only commercially available solution on the market that can provide the unique capabilities that the program requires. In particular, the Localite TMS Navigator is the sole system that can perform inside/in-bore navigation (both online and offline). Additionally, the requested system is the only fully compatible neuronavigation system available for the existing, government owned, MRI compatible TMS system currently at the NIDA IRP, which was procured via MagVenture. MagVenture is the sole distributor of Localite products within the U.S., as certified by Localite.

Contact information:

Yordan Todorov Vice President, Operations, MagVenture Email: yt@magventure.com Phone: (973)-722-1362 (mobile); (888)-624-7764 (office) Fax: (678)-809-1415 2300 Lakeview Parkway, Suite 700 Alpharetta, GA 30009

5. Any other facts supporting the justification. None.

Project Officer Certification. The Project Officer, Technical or Requirements Personnel certifies that any data or information provided in support of this justification for the proposed acquisition has been reviewed and that to the best of our knowledge and belief is accurate and complete and the below signature recommends approval.

_Yihong Yang____ _____________6/15/2020_______ Project Officer Date

Contracting Officer Certification. The Contracting Officer certifies that the justification for the proposed acquisition has been reviewed and that to the best of my knowledge and belief the information and/or data provided to support the rationale and recommendation for approval is accurate and complete and the below signature denotes approval.

Contracting Officer Date