Sol_75N98026Q01139.pdf

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10 Center Drive Building 10 Room B1D501C

National Institutes of Health OD - Office of Logistics and Acquisition Operations 6100 Executive Blvd., Room 6B05 Bethesda, MD 20892-7511

75N98026Q01139

NICHOLAS CAPOBIANCO

+10

000-000000 Dursun Korel Yildirim

20892

09/03/2026

09/14/2026 1300 ED

Multiple

Bethesda

MD

The purpose of this NON-COMPETITIVE

COMBINED SYNOPSIS / SOLICITATION is to provide NHLBI with Advanced Metal 3D

Printing System for Interventional

Device Design and Catheter Prototyping.

The following FAR clauses and Provisions are applicable to this award.

FAR 52.204-13 System for Award

Management Maintenance (Oct 2018);

FAR 52.204-18 Commercial and Government

Entity Code Maintenance (Aug 2020);

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NSN 7540-01-152-8067

75N98026Q01139

FAR 52.212-4 Contract Terms and Conditions -In addition to all the applicable commercial

Products and Commercial Services (Nov 2023)

FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION

Title: Advanced Metal 3D Printing System for Interventional Device Design and Catheter Prototyping

Solicitation Number: 75N98026Q01139

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is 75N98026Q01139. This solicitation is issued as a Notice of Intent (NOI) for a non-competitive combined synopsis/solicitation to award a purchase order without providing for full and open competition (brand-name).

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold. Additional authority includes 41 U.S.C. 1901 and FAR 6.302-3(a)(2)(ii).

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, intends to negotiate and award a firm-fixed-price purchase order on a non-competitive basis to Xact Metal, Inc., 200 Innovation Blvd, Ste 257, State College, PA 16803 for one

(1) Advanced Metal Laser Powder Bed Fusion (LPBF) 3D Printing System, including required software, accessories, installation, and on-site operator training, in support of the National Heart, Lung, and Blood Institute (NHLBI), Division of Intramural Research. Market research conducted in accordance with FAR Part 10 concluded that the Xact Metal XM200-series LPBF platform is the only commercially available system that simultaneously satisfies all of the Government's mandatory salient characteristics — including qualified processing of titanium alloys, copper, and stainless steel on a single multi-material platform; feature precision of 50 microns or finer; an integrated glovebox for safe handling of reactive metal powders; single-phase 100–240 VAC laboratory power compatibility; a compact laboratory footprint; and total configured price within the Government's estimated ceiling. Competing systems either lack qualified copper LPBF processing, do not achieve the required feature resolution, require industrial-grade three-phase infrastructure incompatible with the intended installation location, or exceed the Government's estimated price at the required configuration.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective 03/13/2026.

(iv) The associated NAICS code is 333248 – All Other Industrial Machinery Manufacturing, and the small business size standard is 500 employees. This requirement is not set aside for small business.

(v) Description of Requirement:

The NHLBI Division of Intramural Research requires a metal additive manufacturing system to support the in-house design and rapid prototyping of miniature, high-precision metallic components used in interventional cardiovascular devices, including catheter-based technologies, MRI-compatible devices, and devices incorporating integrated sensing functionality. The system shall enable fabrication of complex geometries and fine-featured components that cannot be manufactured using conventional machining techniques.

The system shall meet, at minimum, the following salient characteristics:

• Laser spot size or equivalent feature precision of 50 microns or finer;

• Qualified processing of titanium alloys (e.g., Ti-6Al-4V) suitable for structural and MRI-compatible interventional devices;

• Qualified processing of copper for development of conductive and sensing-enabled device components;

• Qualified processing of stainless steel and other commonly used engineering metals;

• Multi-material capability supporting a range of metal powders without fundamental system modification;

• Integrated system for safe handling of reactive metal powders, including titanium, through an enclosed or controlled environment (e.g., glovebox or equivalent);

• Compact footprint suitable for installation and operation within a biomedical research laboratory;

• Compatibility with standard single-phase laboratory electrical infrastructure (100– 240 VAC, 50–60 Hz);

• Inclusion of all required software, accessories, and operational components necessary for full system functionality;

• Provision of on-site installation and operator training.

The system shall be delivered, installed, and made fully operational within sixty (60) days after contract award. Installation and training shall be coordinated with the Government technical point of contact.

(vi) Delivery Location:

National Heart, Lung, and Blood Institute (NHLBI) Building 10, Room B1D501C Bethesda, MD 20892

(vii) [Reserved]

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) A written notice of award or acceptance of an offer, issued to the successful offeror within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer (or part of an offer) before the expiration date, whether or not discussions are conducted, unless a written notice of withdrawal is received prior to award.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices: None.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xiv) Submission Requirements:

This is a Notice of Intent to sole source. It is not a request for competitive quotations.

However, any responsible source that believes it can meet all of the salient characteristics identified in paragraph (v) above may submit a capability statement, proposal, or quotation for consideration by the Government. Responses must include sufficient technical information to demonstrate that the offered item meets each mandatory salient characteristic. Statements of capability that do not clearly demonstrate the ability to meet all salient characteristics will not be considered.

Price quotations shall include, at a minimum: unit price, list price, shipping and handling costs, delivery timeframe after award, delivery terms, prompt payment discount terms, F.O.B. point (destination or origin), product or catalog numbers, product descriptions, and any other relevant information.

Evaluation factors may include, but are not limited to: past performance, technical capability, special features, trade-in considerations, expected lifecycle, warranty, maintenance availability, and environmental or energy efficiency considerations.

Respondents claiming to be manufacturers or authorized resellers of the specified brand-name product, or claiming an equivalent product that meets all salient characteristics, must provide:

(a) Product, catalog, model, and/or part number(s); (b) Product description; (c) Documentation demonstrating that the offered item meets all required salient characteristics; (d) Quantity; (e) Estimated price or cost; (f) Shipping, handling, and/or installation charges; and (g) Delivery timeframe after receipt of order.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received no later than Monday, September 14, 2026, at 1:00 PM EDT, and must reference solicitation number 75N98026Q01139. Responses shall be submitted electronically to nicholas.capobianco@nih.gov.

If no responses are received that demonstrate the capability to meet all salient characteristics, the Government intends to proceed with award to Xact Metal, Inc. on a sole-source basis. This notice is not a request for competitive quotations, and the Government is not obligated to award a contract as a result of this synopsis.

(xv) Point of Contact:

Nicholas Capobianco Contracting Specialist National Institutes of Health Email:

nicholas.capobianco@nih.gov https://www.sam.gov/ mailto:nicholas.capobianco@nih.gov mailto:nicholas.capobianco@nih.gov

Statement of Need (SON)

The Statement of Need is required for all product orders over $15,000. The statement describes the labs goals and how the purchase of the goods or services will advance those goals.

1. Project Title

Advanced Metal 3D Printing System for Interventional Device Design and Catheter Prototyping

2. Statement of Need and Objectives

The National Heart, Lung, and Blood Institute (NHLBI) requires a metal additive manufacturing system to support the design and rapid prototyping of miniature components for interventional medical devices, including catheter-based technologies.

The primary objective of this acquisition is to enable in-house fabrication of complex, high-precision metallic components that cannot be manufactured using conventional machining techniques. These capabilities are critical to advancing research and development of next-generation interventional devices, including devices intended for use in interventional magnetic resonance imaging (MRI) environments and devices incorporating integrated sensing functionality.

Without this capability, the laboratory would be unable to prototype certain device geometries and materials, resulting in reliance on external vendors. This would introduce delays, increased costs, and reduced flexibility in iterative design and testing processes, thereby negatively impacting research timelines and innovation.

3. Product Specifications/Features/Salient Characteristics

The Government requires a metal 3D printing system with the following mandatory characteristics:

• Ability to produce high-resolution parts with a minimum laser spot size or equivalent precision of 50 microns or finer

• Capability to process and print titanium alloys (e.g., Ti-6Al-4V) suitable for structural and MRI-compatible interventional devices

• Capability to process and print copper for development of conductive and sensing-enabled device components

• Capability to process and print stainless steel and other commonly used engineering metals

Title