Intracavitary Honcompressible Technological Solution

1. SUBJECT: The United States Army Medical Acquisition Activity (USAMRAA) is conducting market research on technological solutions for intracavitary noncompressible (abdominal) hemorrhage, commonly referred to as internal bleeding, for field use in a battlefield setting. This market research may also assist with the further development or refinement of the U.S. Army and Department of Defense (DoD) requirements. 2. DISCLAIMER: This sources sought notice is issued solely for information and planning purposes and does not constitute a solicitation. Neither unsolicited proposals nor any other kind of offers will be considered in response to this sources sought notice. Responses to this sources sought notice are not offers and will not be accepted by the Government to form a binding contract. Respondents are solely responsible for all expenses associated with responding to this sources sought notice. All information received in response to this sources sought notice that is marked Proprietary will be handled accordingly. Information received in response to this notice will not be returned. At this time, the Government will not entertain any questions concerning the composition, requirements, or the nature of services to be performed under any future requirements. 3. BACKGROUND: Intracavitary noncompressible hemorrhage, or internal bleeding, represents a significant cause of preventable death in the military. Additionally, intracavitary noncompressible hemorrhage leads to significant deaths each year in the civilian population. Currently, there are no existing point-of-injury therapies to treat intracavitary noncompressible hemorrhage. In resource-constrained environments, such as the battlefield, the only option for patients is to be transported to surgical capabilities to control this type of hemorrhage. The U.S. Army Medical Materiel Agency (USAMMA) has identified a need for an intracavitary noncompressible technological solution for use by troops in deployed environments. 4. REQUIREMENTS: The Government is seeking a cost-effective portable intracavitary noncompressible hemorrhage solution method for treating wounds. The solution shall be lightweight, durable, and operable on the battlefield. The solution shall be able to be used in-flight and in austere environmental conditions. Responses shall address the requirements identified in paragraph 4a. of this source sought notice. Responses shall include a representative sample of the solution for limited examination. Sample items submitted will not be returned. 4a. MANDATORY REQUIREMENTS: The product developer's technology shall: Demonstrate hemostasis within 4-minutes by delivery and transport of hemostatic material throughout abdominal cavity to the injury in pre-clinical models. Maintain stoppage of blood loss for 3-hours; achieve and maintain hemostasis throughout transport to surgical care in pre-clinical models. Be administered at point-of-injury / pre-hospital treatment. Be simple to use and does not require identification or direct access to source of hemorrhage. Be a product that is less than 2-pounds; compatible with field use, compact, and lightweight. Be easily, safely, and completely removed later in surgical settings. The product developer intends to obtain U.S. Food and Drug Administration (FDA) clearance/approval for a technological solution intended to treat intracavitary noncompressible truncal hemorrhage. The product developer shall provide the following research support services (tasks): Pre-clinical or bench studies to support clearance/approval and military use of the solution. Serve as the FDA sponsor. Preparation and submission of applications and all documentation required for FDA clearance/approval. Clinical studies to support clearance/approval and military use of the solution, in accordance with FDA regulations, International Conference on Harmonisation (ICH) guidelines, and all applicable DoD and Army regulations and policies. Develop and prepare training program for end users that will meet FDA and U.S. Army requirements. Manufacture and supply Good Manufacturing Practice (GMP) and FDA-compliant articles for clinical studies, and to support the DoD fielding strategy for the solution. 5. CONTACT INFORMATION: Responses to this sources sought notice are due no later than (NLT) 5:00pm EST on 29 December 2017. Responses to this sources sought notice shall be addressed to Mr. Christopher Sult at christopher.m.sult.civ@mail.mil. This sources sought notice is not a commercial solicitation and the Government will not pay for any information or items in reference to this notice. 6. RESPONSE SUBMISSION: Responses in reference to this sources sought notice shall be submitted via e-mail. Please include point of contact (POC), phone number, email address, and web site information. Respondents shall certify whether the company they represent is a U.S. business. The response should describe the company's capability to offer, field, and sustain a solution as characterized by the requirements addressed in this notice.