Notice of Intent to Sole Source

Solicitation Number: 75N98026Q01129 Solicitation Type: Sole Source (Non-Competitive) Title: Myocardial Intramural Remodeling by

Transvenous tether (MIRTH) Implant Design Support and Feasibility Prototypes

NAICS / Size Standard: 541714/ 1,000 employees

Introduction

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

AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN

COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Resonetics, LLC to provide Myocardial Intramural Remodeling by Transvenous tether (MIRTH) Implant Design Support and Feasibility Prototypes to the Division of Intramural Research in accordance with the following information.

Background Information

The NHLBI Laboratory of Cardiovascular Intervention is developing the MIRTH intramyocardial ventricular loop implant system to support translational cardiovascular intervention research. MIRTH is intended to reshape ventricular geometry by deploying a flexible, tensioned loop within the myocardium while minimizing tissue injury and distributing mechanical load across the myocardial wall. This acquisition supports feasibility-stage prototype engineering, fabrication, and evaluation of the MIRTH implant, tensioning, delivery, and integrated prototype elements needed to assess whether the system can be advanced toward non-GLP in vivo feasibility evaluation. The effort is technically linked to related predicate intramyocardial device work, including the SCHMELLTALE guidewire effort and VINTAGE-related concepts, because the MIRTH system must interface with established intramyocardial navigation, access, and device-design constraints. The acquisition is needed to maintain engineering continuity, avoid duplication of specialized design work, and generate feasibility prototypes suitable for NHLBI technical evaluation.

Purpose and Objectives

The purpose of this acquisition is to acquire MIRTH Implant Design Support and Feasibility Prototypes.

Contractor Requirements

The Contractor shall provide engineering and prototype fabrication services addressing the following required characteristics:

• Implant concepts shall be flexible, conformable, and suitable for intramyocardial placement within the left ventricular wall.

• Implant concepts shall support load distribution along the myocardial wall to reduce localized stress and erosion risk.

• The system shall enable controlled and adjustable tensioning with repeatable performance.

• Delivery concepts shall support transvenous, catheter-based access with low-profile delivery and expanded in situ configuration.

• Deployment approaches shall minimize torsion, push/pull forces, and friction on myocardial tissue to the extent practicable for feasibility prototypes.

• Concepts shall be compatible with intramyocardial guidewire navigation techniques, including CTO-style wire and depth guidance methods.

Sole Source Justification

Resonetics, LLC is the sole-source provider for this requirement because successful execution of the MIRTH effort requires direct integration with proprietary predicate intramyocardial device work and exclusive technical data already held by Resonetics through authorized channels. Specifically, Resonetics is the incumbent developer for the related SCHMELLTALE guidewire effort and possesses foundational materials, design files, and technical assumptions from prior MIRTH, SCHMELLTALE, and VINTAGE initiatives. The scope of work goes far beyond generic prototype fabrication, demanding strict engineering continuity across project-specific catheter designs, intramyocardial navigation frameworks, and established data baselines. Furthermore, the work relies on complex confidentiality and data-sharing agreements among the NIH, Resonetics, and Antaracore Systems (whose scope is strictly governed by CRADA C-024-2026 under tightly restricted proprietary parameters). An award to any other source would necessitate the exhaustive transfer, re-creation, and re-validation of specialized technical knowledge, design histories, custom tooling context, and multi-party intellectual property frameworks.

Introducing a new contractor would result in unacceptable project delays, substantial duplication of costs that could not be recovered through competition, and severe technical risk to the feasibility-prototype objective.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart

12.102 (a), restricting competition. 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.

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial Services, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the services listed that meets the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management (SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

FAR clause at 52.204-13 System for Award Management Maintenance, applies to this acquisition.

The provisions at FAR clause 52.203-17, Contractor Employee Whistleblower Rights, applies to this acquisition.

The provisions at FAR clause 52.222-41, Service Contract Labor Standards, applies to this acquisition.

The provision at FAR clause 52.225-25, Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications, applies to this acquisition.

FAR clause FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, applies to this acquisition.

HHSAR clause 352.239-78, Information and Communication Technology Accessibility Notice

HHSAR clause 352.239-79, Information and Communication Technology Accessibility

HHSAR clause 352.232-71, Electronic Submission of Payment Requests

Additional Information

The North American Industry Classification System (NAICS) Code is 541714 and the Small Business Size Standard is 1,000 employees. This acquisition is being conducted under RFO FAR Part 12, Acquisition of Commercial Products and Commercial Services, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective March 13, 2026.

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. 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 Identifier (UEI), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. 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. 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.

All responses must be received by September 10, 2026, at 12:00PM ED and must reference synopsis number 75N98026Q01129. Responses shall be submitted electronically to noelle.decenzo@nih.gov.

Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

http://www.sam.gov/ mailto:noelle.decenzo@nih.gov