SAM_-_Pre-Solicitation__75N94025Q00202_1.pdf

75N94025Q00202

INTRODUCTION

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

OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION.

The National Institutes of Health, National Institute of Child Health and Development (NICHD), in support of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), intends to award a purchase order without providing for full and open competition to ATCOR MEDICAL INC USA for SphygmoCor XCEL PWA and PWV Non-invasive Medical Device

BACKGROUND

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity;

and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life. Arterial stiffness is an established indicator and independent risk factor of atherosclerotic heart disease, a major cause of morbidity and mortality in the world. The assessment of arterial stiffness by pulse wave velocity and central blood pressure is a validated marker for the development and progression of cardiovascular disease and is an important risk assessment tool. Arterial stiffness may be affected by endothelial function through differences in vessel wall smooth muscle tone or by alternations in the integrity of the vessel wall.

Importantly, endothelial dysfunction and hence arterial stiffness may be modifiable, especially in certain high-risk groups. This request is for SphygmoCor XCEL PWA and PWV Non-invasive medical device and the associated supplies needed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to evaluate the relationship of pulse wave velocity and coronary artery structure & endothelial function with atherogenic and remnant lipoproteins and its relation to vascular aging in study patients.

The SphygmoCor XCEL PWA/PWV system is the only FDA-cleared device indicated for the measurement of central blood pressure and pulse wave velocity with combined technology in one machine. It is an innovative, safe and non-invasive testing device that reflects the vascular health of medium to large vessels.

The procedure takes only 15 minutes to produce test reliable and reproducible results. This makes it a specialized tool for research in special populations, such as children and adolescents. Using this FDA-cleared device will minimize risk and maximize benefit to our research participants and provide high quality research data needed for NIH studies. The device is needed to evaluate patients on NIH IRB approved protocols to fulfill the NIDDK mission of improving care and understanding of patients with diabetes and metabolic diseases. This device helps NIDDK labs to further understand the factors associated with vascular aging and atherosclerotic prevention.

JUSTIFICATION

Arterial stiffness is an established indicator and independent risk factor of atherosclerotic heart disease, a major cause of morbidity and mortality in the world. The assessment of arterial stiffness by pulse wave velocity and central blood pressure is a validated marker for the development and progression of cardiovascular disease and is an important risk assessment tool. Arterial stiffness may be affected by endothelial function through differences in vessel wall smooth muscle tone or by alternations in the integrity of the vessel wall. Importantly, endothelial dysfunction and hence arterial stiffness may be modifiable, especially in certain high-risk groups. This request is for SphygmoCor XCEL PWA and PWV Non-invasive medical device and the associated supplies needed by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to evaluate the relationship of pulse wave velocity and coronary artery structure &

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

endothelial function with atherogenic and remnant lipoproteins and its relation to vascular aging in study patients.

The SphygmoCor CPV and SphygmoCor XCEL PWA/PWV device is needed to evaluate patients on NIH Institutional Review Board (IRB) approved protocols to fulfill the NIDDK mission of improving care and understanding of patients with diabetes and metabolic diseases. This device helps NIDDK labs to further understand the factors associated with vascular aging and atherosclerotic prevention. The required SphygmoCor XCEL PWA and PWV Non-invasive medical device is already in use at the NIH for protocol procedures. We require another device, and the same exact device is needed to meet the protocol needs and ensure integrity in data collection across the multi-site study that is approved at the NIH and Children’s National Hospital. To our knowledge, ATCOR MEDICAL INC is the developer and sole provider for the SphygmoCor system. They hold proprietary patents and knowledge for the technology of this device, which is essential to our research mission. Specifically, this equipment is essential to meet one of the primary endpoints to measure pulse wave velocity and outlined in the protocol and without this device, the study project analysis will be stalled and severely impacted. If we are unable to purchase the equipment it will increase the risk benefit ratio for participants and impede programs, resulting in a waste of government resources.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 339112 Surgical and Medical Instrument Manufacturing, size standard in number of employees 1,000

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2025-05 effective 08/07/2025. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000) and FAR Subpart 12- Acquisition of Commercial Items.

STATUTORY AUTHORITY

This acquisition is conducted under the authority of FAR 13.106(b)(1) Soliciting from a single source - For purchases not exceeding the simplified acquisition threshold.

PLACE OF DELIVERY

NIH/NIDDK

BLDG 10-CRC, Suite 5-5940, RM 5-5942 10 Center Drive Bethesda, Maryland 20892

DESCRIPTION OF REQUIREMENT

The SphygmoCor XCEL PWA/PWV system is needed for obtaining primary and secondary outcome data for NIH IRB-approved research protocols and is used by multiple investigators. The instrument must measure central blood pressure and carotix femoral pulse wave velocity in a single platform.

SphygmoCor XCEL PWA/PWV system, including:

o SpygmoCor tonometer o PWV Cuff Adult (11-85cm) o PWV Cuff Large Adult (13-124cm) o PWA Cuff Adult 23-33 cm o PWA Cuff Large Adult 31-40cm o PWA Cuff Ex-Large Adult 38-50cm _ ARM only o Power adaptor o Power cable – US o USB Cable o Cuff Hose 2m

Notebook computer with factory installation and testing of SphgmoCor software

Comprehensive Hardware and Software Maintenance Contract - commences after the completion of the initial warranty period.

o All parts and labor for the Electronics Module and the tonometer.

o USA-based technical support personnel with response guaranteed within 48 hours of receipt of shipped system at the vendor facility or from receipt of support request (during weekends, response time will be within 72 hours from receipt of shipped system). On-site support available within the USA.

o Replacement with a loaner system if vendor cannot resolve the issue within the prescribed time.

o Return of repaired unit to the customer within four (4) weeks of receipt of same at a service center.

o Software upgrades during the term of the contract.

Delivery by 30 Days After Receipt of Order (ARO).

CLOSING STATEMENT

This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability in response to this notice and may submit a capability statement, which shall be considered by the agency. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement. 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 respondents must have an active registration in the System for Award Management (SAM) www.sam.gov. All responses to this notice shall be submitted electronically by 5:00 PM Eastern Standard Time, on September, 10th, 2025 to jacob.balenson@nih.gov and shall include pre-solicitation # 75N94025Q00202 in the subject line.