Myocardial Intramural Remodeling by Transvenous tether (MIRTH) Implant Design Support and Feasibility Prototypes

The National Heart, Lung, and Blood Institute (NHLBI) intends to award a sole-source purchase order to Resonetics, LLC for Myocardial Intramural Remodeling by Transvenous tether (MIRTH) Implant Design Support and Feasibility Prototypes, with responses due September 10, 2026, by 12:00 PM ET.

The procurement is noncompetitive. Resonetics is the incumbent developer of related SCHMELLTALE guidewire efforts and possesses proprietary predicate device work, design files, and technical data from prior MIRTH and VINTAGE initiatives. The NHLBI states that contractor transition would be impractical due to established multi-party confidentiality agreements.

Work is performed at NIH in Bethesda, Maryland over an estimated 9-month period (September 30, 2026, through June 30, 2027) under three Contract Line Items. The contractor shall provide engineering, fabrication, benchtop assessment, technical iteration, and delivery of feasibility prototypes to support Government non-GLP in vivo evaluation. Deliverables exclude regulatory submissions, clinical-grade manufacturing, and commercialization.

Required implant characteristics include flexibility and conformability for intramyocardial placement, load distribution capability, controlled and adjustable tensioning with repeatable performance, transvenous catheter-based delivery with low-profile configuration and expanded in situ capability, and compatibility with intramyocardial guidewire navigation techniques. The contractor shall deliver 6–10 full integrated prototype systems, participate in technical meetings, and submit monthly invoices to the Department of Treasury Invoice Processing Platform with detailed labor and direct-expense documentation.

Responses must include unit price, list price, shipping and handling costs, delivery period, payment discount terms, F.O.B. point, UEI, TIN, and business size certification. All offerors must maintain active SAM registration. NAICS 541714 applies; small business size standard is 1,000 employees.