NOTICE OF INTENT to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: NIMH25007631

TITLE: The purpose of this acquisition is to purchase the Stereotactic focused ultrasound system, RK-50

2. CLASSIFICATION CODE:R499 – SCIENTIFIC CONSULTING SERVICES

NAICS CODE: 811210 – Electronic and Precision Equipment Repair and Maintenance

3. RESPONSE DATE: August 7, 2025, at 12:00 PM EST

4. PRIMARY POINT OF CONTACT:

Joe Kennedy Joseph.kennedy@nih.gov Phone: 262-391-7630

5. DESCRIPTION:

INTRODUCTION

This is a notice of intent, not a request for a quotation.

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT)

SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR

OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institute of Mental Health (NIMH) intends to negotiate on a sole source basis with FUS Instruments Inc., for one year.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

and SET ASIDE STATUS

The intended procurement is classified under NAICS code 811210 – Electronic and Precision Equipment Repair and Maintenance with a Size Standard of $34M.

This intended procurement will be a small business set-aside requirement.

REGULATORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: 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, brand-name OR industrial mobilization).

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) Number 2025-04, dated May 12, 2025.

DESCRIPTION OF REQUIREMENT

Purchase Description

Focused ultrasound (FUS) is an emerging non-invasive neuromodulation and therapeutic platform with broad applications in neuroscience, neurodegeneration, oncology, and drug delivery research. In particular, stereotactic focused ultrasound enables spatially precise modulation of brain regions in small animals, facilitating investigations into blood-brain barrier (BBB) permeability, targeted neuromodulation, and experimental sonodynamic therapy.

The RK-50 Stereotactic Focused Ultrasound System offers a comprehensive platform specifically designed for preclinical applications in mice and rats. It integrates a motorized 3-axis positioning system, custom treatment planning software with brain atlas support, and real-time acoustic monitoring—features critical for ensuring precision, reproducibility, and safety in small animal studies.

The system is optimized for delivering both single-point and multi-point acoustic exposures and supports key research modalities, including transient BBB opening and neuromodulation.

Specific Requirements

The objective of this purchase is to acquire the RK-50 system along with a TX-

50-1650-0 transducer for mouse studies. This setup will enable our laboratory to conduct controlled, targeted ultrasound interventions in vivo, which are essential for our ongoing and planned studies involving CNS drug delivery, aging-related neurovascular changes, and modulation of neural circuitry in mouse models of

Alzheimer's disease and related dementias (ADRD).

Salient Characteristics:

I. Three-axis motorized stereotactic positioning system for precise targeting in small animal brains (mice and rats)

II. Custom treatment planning software with integrated brain atlas and real-time acoustic monitoring

III. RF driving electronics including:

• Arbitrary waveform generator

• 15W amplifier

• Integrated RF power meter

IV. Single- and multi-point acoustic exposure capability for flexible treatment protocols

V. 4-channel digital oscilloscope for real-time capture of acoustic emissions and safety monitoring

VI. TX-50-1650-0 transducer (mouse compatible):

• Center frequency: 1.65 MHz ± 5%

• Spherically focused: 35 mm diameter, 24.5 mm focal length (f# = 0.7)

• Integrated ceramic hydrophone (825 kHz ± 5%) for in situ pressure monitoring

• Impedance matching circuitry (50 Ω ± 2%)

• Pressure calibration up to 1.0 MPa

VII. Mid-tower PC system with monitor, keyboard, and mouse included

VIII. Built-in software algorithms for:

• Blood-brain barrier permeability modulation

• Neuromodulation

• Sonodynamic therapy

Delivery Date

All goods and repairs listed in the specific requirements. Transportation of MRV2 to/from facility.

Period of Performance

The proposed period of performance shall be one base year.

Base: 9/1/2025 – 8/31/2026

Level of Effort n/a

Government Responsibilities n/a

Reporting Requirements N/A

OTHER CONSIDERARTIONS:

Data Rights

Section 508—Electronic and Information Technology Standards

Confidentiality of Information:

The Contractor will not disclose, publish, divulge, release, or make known, in any manner or to any extent, to any individual other than the authorized government employee, the content of any sensitive information provided under this contract.

For this requirement, the government may provide to the contractor information or data of a personal nature about individual(s) or proprietary information or data pertaining to this project, which is confidential. This requirement is expected to generate information or data which is confidential. The Contractor shall handle all sensitive information or data in a secure manner and consult with the authorized government employee prior to any release, disclosure, dissemination, or publication.

(INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted.

Specifically, FUS Instruments Inc. is the only vendor in the marketplace that can provide the services required by the National Institute of Health.

The intended source is:

FUS Instruments Inc.

4275 Kellway Circle, Suite 146

Addison, TX, 75001

The RK-50 system is specifically engineered to support advanced small animal research requiring non-invasive, targeted brain interventions. It enables high-resolution delivery of focused ultrasound to precise brain regions, which is critical for studies involving blood-brain barrier permeability, neuromodulation, and therapeutic ultrasound applications. Its seamless integration of stereotactic positioning, real-time acoustic feedback, and atlas-based treatment planning ensures experimental accuracy and reproducibility. The system's specialized design for mice and rats fills a current equipment gap in our lab, supporting both ongoing and future projects in aging, neurovascular research, and Alzheimer's disease models. This acquisition is restricted to FUS Instruments Inc.

CLOSING STATEMENT

THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.

Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID UEI), the Taxpayer Identification Number (TIN), and the certification of business size.

Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH25007631.

Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov

U.S. Mail and fax responses will not be accepted.

mailto:joseph.kennedy@nih.gov