NOI_XSTAT.doc

NOI – Consumable X-STAT Technology The Naval Medical Logistics Command (NMLC) intends to negotiate the below requirement on a sole source basis (in accordance with 41 U.S.C. 1901 (see also FAR Part 13.501(a)), on behalf of the Naval Medical Research Unit – San Antonio (NAMRU-SA). The proposed source is RevMedx, Inc. 25999 SW Canyon Creek Road, Suite C Wilsonville, OR 97070. The requirement is for a Firm, Fixed-Price (FFP) contract to engage 15 major trauma centers in the United States and selected deploying military commands to receive the XSTAT-30 and XSTAT-12 products. These products are to be utilized at the point of injury by Emergency Medical Services (EMS) personnel as well as the devices will be made available for Emergency Department treatment.

Traumatic hemorrhage remains the leading cause of potentially survivable deaths of warfighters. Completion of this project will markedly improve the prehospital care and transportation management of non-compressible truncal/torso hemorrhage not amenable to tourniquet treatment, an injury responsible for approximate 70% of hemorrhage related mortalities. This contract will be used to evaluate and improve data available for a medical device (XSTAT) specifically designed to treat this injury type. To directly address this knowledge shortfall, this contract will generate a significant dataset of human-use outcomes with XSTAT. Data from XSTAT's currently approved indication of use (4 hours) will be acquired from ease-of-use reports and used to enhance fielding of the product.

This notice of intent is not a request for competitive quotes and no solicitation document exists for the requirement; however, if a vendor challenges the basis for this requirement, please submit a capability statement that includes sufficient detail and with convincing evidence that clearly demonstrates the capability to meet the government’s minimum requirements specified above. Capability statements shall not exceed 5 (8.5 inch x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information, or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement or to proceed with a sole source procurement.

Capability statements are due by 1300 Eastern Time, 19 Aug 2019. Capability statements shall be submitted by email ONLY as a Microsoft Word or Adobe PDF attachment to the following address: andrew.a.hampton3.civ@mail.mil. No phone calls will be accepted.