36C24125Q0854.docx

SUBJECT*

Intent to Sole Source: Cardiac Slice System

GENERAL INFORMATION

SET-ASIDE

Providence VA Medical Center

830 Chalkstone Ave.

Providence RI

CONTACT INFORMATION

Network Contracting Office 1 (NCO 1) Contracting Officer (90C) 1 VA Center Augusta ME 04330

POINT OF CONTACT*

Contract Specialist Andrew Simard andrew.simard@va.gov Email Only

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

DESCRIPTION

Pre-Solicitation Notice of intent to award a sole source contract. This is not a solicitation. The Department of Veterans Affairs intends to negotiate a sole source contract with:

IONOPTIX LLC

396 UNIVERSITY AVE

WESTWOOD, MA 02090

H762ZD9TLFU7

This is not a solicitation. The Department of Veterans Affairs intends to award Cardiac Slice System located at the VAMC Providence, RI. IONOPTIX LLC is the Exclusive/Sole source vendor specializing in advanced scientific equipment manufacturing supporting research goals. The contractor will provide the required equipment. Since the intent is to procure this on a sole source basis, no solicitation will be posted to Contracting Opportunities SAM.gov.

The authority for this action is FAR 6.302.1-1 Only One Responsible source and no other supplies or services will satisfy agency requirements.

The NAICS 334516. The size standard is 1,000 employees. The PSC/FSC is 6640.

Interested persons may contact the Contracting Specialist by email at andrew.simard@va.gov regarding this procurement.

The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the Contracting Officer.

Response must be received by 09/15/2025 NLT 10:00am EST.

Presolicitation Notice Presolicitation Notice

Presolicitation Notice

STATEMENT OF WORK/Salient Characteristics

650-25-4-741-0231 – IonOptix Cardiac Slice System Acq Plan VA-25- 00088656

We are requesting purchase of the IonOptix Cardiac Slice System to work with our previously acquired (2022) IonOptix Fura-2 Calcium and Contractility acquisition system for Adult Primary CMs (cardiomyopathies).

In cardiac research, detailed insight into mechanical performance is crucial for developing targeted therapies and understanding how the heart adapts to pathological conditions. Pressure-volume (PV) loops provide a detailed representation of the heart's functions during each beat. One loop represents a complete cardiac cycle and shows how pressure and volume within the ventricle change as the heart fills with blood, contracts, ejects blood, and relaxes. PV loops are used in clinical care where in-depth cardiac mechanics are necessary to guide treatment or evaluate therapeutic interventions. Nowadays, in addition to traditional catheterization for PV loops in live animals, a technique using living myocardial slices (LMS) to study cardiac mechanical performance has been developed. The IonOptix Cardiac Slice system is the industry leader in this new technique and emerging as a powerful tool to advance cardiovascular research for the development of novel therapeutics.

Features of Cardiac Slice System

· Measure calcium and force simultaneously in cardiac slices

· Acquire mechanical work loop data

· Characterize cardiac tissue elastance and compliance

· Analyze mechanical work and power

· Control pre- and afterload force to model systolic and diastolic changes (including early vs. late diastole) Specifications Sensitivity range: 0.015-200 mN Force transducer frequency response: 750-850 Hz Motor range: -2.5 to 2.5 mm (20 nm resolution)

When we combine the new Cardiac Slice System with our previously acquired IonOptix Fura-2 Calcium and Contractility system, quantitative fluorescence and force are acquired simultaneously, while the force-feedback control allows mechanical work loop acquisition.

We are also requesting additional scientific equipment to work with the Cardiac Slice System. The Campden Vibrating Microtome – 9000SMZ will be procured separately. The Vibrating Microtome will be used to slice live myocardial tissues, which will then be analyzed on the IonOptix Cardiac Slice System.

The requested laboratory equipment will not be on the VA network. An existing microscope in the laboratory will be used in conjunction with this equipment.

Equipment will be located in Bldg 35, wet lab area.

Shipping address is:

Providence VA Medical Center 830 Chalkstone Ave.

Bldg 8, Warehouse Providence, RI 02908

Records Management Language for Statement of Work (SOW):

The following standard items relate to records generated in executing the contract and should be included in a typical procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

3. Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.

4. Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.

8. Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

9. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information

Page 1 of