MIRTH_SOW.pdf

Statement of Work (SOW)

MIRTH Implant Design Support and Feasibility Prototypes

1. Project Title Myocardial Intramural Remodeling by Transvenous tether (MIRTH) Implant Design Support and Feasibility Prototypes

2. Introduction and Background The National Heart, Lung, and Blood Institute (NHLBI), Division of Intramural Research (DIR), Laboratory of Cardiovascular Intervention, conducts translational cardiovascular research focused on minimally invasive structural heart and heart failure interventions. The Government is developing Myocardial Intramural Remodeling by Transvenous Tether (MIRTH), a catheter-based ventricular remodeling approach intended to reduce left ventricular chamber size and wall stress by placing a tension element within the myocardial wall using catheter-based intramyocardial navigation.

Prior Government research has demonstrated the feasibility of intramyocardial guidewire navigation and MIRTH-like ventricular reshaping using non-dedicated tools. A purpose-built preclinical MIRTH system is now required to mature the technology for evaluation towards additional resource allocation.

The acquisition supports construction and evaluation of implant, delivery, deployment, and integrated feasibility prototype configurations for Government use in non-GLP feasibility evaluation. This contract explicitly excludes regulatory submissions, clinical-grade manufacturing, or commercialization.

3. Statement of Need and Objectives The Government requires support for engineering, fabrication, benchtop assessment, technical iteration, and delivery of feasibility prototype outputs. The objective is to obtain MIRTH feasibility prototype outputs sufficient to support Government assessment of implant/tensioning feasibility, delivery/deployment feasibility, and integrated-system readiness for non-GLP in vivo evaluation.

4. Product Specifications/Features/Salient Characteristics 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.

The requirement excludes GLP testing, regulatory submissions, clinical-grade manufacturing, commercial manufacturing, clinical study organization, and patent preparation or filing.

5. General Contractor Responsibilities The Contractor shall furnish personnel, materials, equipment, facilities, and other resources necessary to perform the following CLIN milestones within the not-to-exceed ceiling established by the order.

CLIN Milestone Required outputs Estimated duration

CLIN

Milestone 1 - Implant and Tensioning Feasibility

Fabricated prototype implant concepts, prototype tensioning and locking mechanisms demonstrating controlled adjustability, and down-selected implant/locking configuration suitable for Government feasibility evaluation.

14 weeks

CLIN

Milestone 2 - Implant Delivery and Deployment Feasibility

Fabricate prototype delivery and deployment systems compatible with intramyocardial navigation, demonstrated implant delivery behavior, and down-selected delivery/deployment approach for integrated system use.

14 weeks

CLIN

Milestone 3 - Integrated Functional System Prototypes and In Vivo Readiness

Integrated prototype system design; benchtop evaluation; design updates as required; and fabrication of integrated MIRTH implant systems for Government non-GLP in vivo evaluation. The proposal assumes approximately 6-10 full systems for the initial non-GLP in vivo evaluation, with final quantity determined by

NIH.

12 weeks

The Contractor shall participate in technical meetings with the Government as reasonably necessary to review progress, technical findings, prototype performance, cost status, and any proposed changes in technical direction.

The Contractor shall provide invoice detail sufficient to permit review against labor charges, direct expenses, materials, CLINs, and work performed during the billing period. If the order establishes labor categories and hourly rates, invoice details shall support review against those categories and rates.

The Contractor shall not proceed with substantial redirection of work outside the stated CLIN objectives without Government technical concurrence and Contracting Officer authorization when required.

6. Delivery or Performance Location Services will be performed primarily at Contractor facilities. Prototype articles and written deliverables shall be delivered to:

Dursun Korel Yildirim, PhD Building 10, Room B1D511, 9000 Rockville Pike, Bethesda, MD 20892

7. Delivery Date Requested period of performance after award: 9 months, estimated September 30, 2026, through June 30, 2027.

Final period of performance may vary depending on actual award date.

8. Inspection and Acceptance Inspection and acceptance shall be performed by the Government technical contact or other authorized Government representative designated by the Contracting Officer.

Acceptance shall be based on delivery of required prototype articles, design outputs, and technical summaries described in this SOW. For time-and-materials/labor-hour invoicing, invoice acceptance shall require Government review that labor and material charges are consistent with the contract and work performed during the billing period.

9. Point of Contact To be provided upon award.

10. Security No routine contractor physical access to NIH facilities is anticipated. If occasional NIH access is required, Contractor personnel shall comply with NIH security, escort, badging, and facility-access requirements.

NIH information is confidential. The Contractor shall protect Government-furnished and third-party confidential information in accordance with applicable agreements and contract requirements.

11. Government Furnished Property (GFP) and Government Furnished Information (GFI) No physical Government-furnished property is anticipated. The Government may furnish or authorize access to Government-furnished information relevant to MIRTH, Schmelltale guidewire work, Ventricular Intramyocardial Navigation for Tachycardia Ablation Guided by Electrograms (VINTAGE)-related device context, and related preclinical feasibility information. Such information shall be used only for performance of this requirement and shall be controlled in accordance with applicable confidentiality obligations.

12. Invoices Invoice routing will be finalized by the Contracting Officer or acquisition administrator.

Invoices shall be submitted no more frequently than monthly unless otherwise authorized. Invoices shall include only services rendered and allowable direct expenses incurred during the billing period. Invoices shall be billed at the rates and in accordance with the Contract Line Item Number (CLIN) or Schedule of Items established in the order. Invoice detail shall be sufficient to support Government review of labor charges, direct expenses, materials, CLINs or schedule items, and services performed against the not-to-exceed ceiling.

The Contractor shall submit invoices to the Department of Treasury Invoice Processing Platform at https://www.ipp.gov and any additional address required in the order.