Metaox: Optical Monitor of Metabolic Rate of Oxygen Consumption (Demo with Option to Buy)

NOTICE OF INTENT TO SOLE SOURCE

NOI-NIAID-24-2231501

NAICS 334516

This is a Notice of Intent, not a request for proposal. The National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health (NIH) intends to negotiate on other than full and open competition basis with ISS Medical, Inc. Meta-ox, Optical Monitor of Metabolic rate of Oxygen Consumption (demo with option to buy).

The Department of Health and Human Services (DHHS), National Institute of Health (NIH), National Institute of Allergy and Infectious Diseases (NIAID), Division of Extramural Activities (DEA) began a project in 2002 to perform onsite administrative assessments of the administrative operations and procedures of foreign grant recipients and contractors receiving funds from NIAID. The project provides foreign recipients with proper oversight of awards by way of performing onsite international financial systems reviews and provides related administrative technical assistance that supports the NIAID grant, cooperative agreement, and contract awardees.

If any vendor submits a capability statement, the statement must address the following requirements to be considered. Capability statements that do not address each of the bulleted items, will not be considered.

MetaOx performs simultaneous measurements of tissue oxygenation and blood flow in the same location. From these measurements, the following physiologic parameters can be estimated:

Cerebral tissue hemoglobin concentration and hemoglobin oxygen saturation

Microvascular cerebral blood flow (CBF)

Oxygen extraction fraction (OEF)

Cerebral metabolic rate of oxygen consumption (CMRO2)

Changes in tissue oxygenation, CBF, OEF, and CMRO2 over time

Clinical applications for infants and children (e.g., after cardiac surgery in those born with heart defects):

Assess pre-operative cerebral hemodynamics.

Monitor postoperative changes.

Monitor the cerebral oxygen metabolism.

Assess cerebrovascular reactivity.

Response to treatment

Nutrition and brain health

Clinical applications in adults:

Measure the impairment of cerebrovascular reactivity in ischemic stroke patients.

Estimate autoregulation and CBF responses in patients with traumatic brain injury and subarachnoid hemorrhage.

Assess cerebrovascular reactivity in response to pharmacologically induced vasodilation in healthy adults and in patients suffering from carotid artery stenosis and/or occlusion.

Risk assessment in patients with steno-occlusive lesions of the internal carotid artery.

Monitor adult patients undergoing carotid endarterectomy.

Assess hemodynamic responses of adults to low-frequency repetitive TMS applications.

Study CBF response variations with age.

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL. All responsible sources that could provide comparable services may submit a capability statement that will be considered. The documents must be submitted via the NIAID electronic Simplified Acquisition Submission System (eSASS) website at https://esass.nih.gov, (subject line to reference NOI-NIAID-24-2231501 by 2:00 pm eastern standard time September 13, 2024. All vendors must register in the eSASS system to submit a quotation. Instructions on how to register / submit quotes are included on the website. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f). All responsible sources may submit an offer that will be considered by this Agency.