Research and Development Services for the research study titled - Therapeutic Effects of the PTP Inhibitor (NVG-291) on Sensorineural Hearing Loss After Precise Blast- induced Auditory Injury (ST1199 TP Inhibitor).

THIS IS A REQUEST FOR INFORMATION (RFI)/SOURCES SOUGHT (SS) NOTIFICIATION TO INCLUDE INDUSTRY FEEDBACK RFI Number: HT9425-24-RFI-0105 1. Title: Research and Development Services for the research study titled - Therapeutic Effects of the PTP Inhibitor (NVG-291) on Sensorineural Hearing Loss After Precise Blast- induced Auditory Injury (ST1199 TP Inhibitor). 2. Contracting Office: United States Army Medical Research Acquisition Activity (USAMRAA) 3. Location: The United States Air Force (USAF) 59th Medical Wing, Science and Technology Office located at Joint Base San Antonio - Lackland Air Force Base, Texas. 4. Summary: This RFI/SS is issued solely for information and planning purposes and shall not be construed as a solicitation, restrict the Government as to the ultimate acquisition approach, or serve as an obligation on the part of the USAMRDC. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are advised that the United States Government will not pay for any information or administrative costs incurred in response to this RFI. All costs associated with responding to this RFI/SS will be solely at the interested responder's expense. Not responding to this RFI/SS does not preclude participation in any future Request for Proposal, if any is issued. No evaluation letters and/or results will be issued to Responders responding to this RFI/SS. The information resulting from this RFI/SS will determine interest and capabilities available in the marketplace; and will assist in developing acquisition strategy. 5. Background/Scope: The USAF 59th Medical Wing, Science and Technology Office has a requirement for research and development services. This research study is titled - Therapeutic Effects of the PTP Inhibitor (NVG-291) on Sensorineural Hearing Loss After Precise Blast- induced Auditory Injury (ST1199 TP Inhibitor). The intent for this requirement is to validate a small-scale, multiple blast-induced hearing injury and characterize the features of auditory dysfunction in the rat model and investigate the effects of NVG-291 on mitigating sensorineural hearing damage following a precise blast-induced hearing injury. Effects of repeated exposure to low level blast overpressures have been linked to significant impaired auditory symptomatology and the exacerbation of existing symptoms. There is a clear unmet need to investigate therapeutic interventions in animal models to mitigate neuroinflammation and neurodegeneration in the auditory system due to blast exposure. NVG-291, which is developed by the NervGen as a regenerative and neuroplasticity enhancing compound, has been demonstrated to facilitate improvements in sensory systems impairment and damage, while it has not yet been studied in sensorineural hearing loss (SNHL) resulting from blast injury to the ears. The objective of this study is to establish the efficacy of PTP-sigma inhibition with NVG-291 in promoting neural repair and functional recovery in rat models of SNHL, which will be induced by single blast of varying characteristics (overpressure and overpressure duration), as well as bursts of repeated pressure jumps using a small-scale multi-driver shock tube (MDST). The objectives of this requirement include: (1) Validate a small-scale, multiple blast-induced hearing injury and characterize the features of auditory dysfunction in the rat model; and (2) Investigate the effects of NVG-291 on mitigating sensorineural hearing damage following a precise blast-induced hearing injury. How to Respond: Please submit a Capability Statement that describes relevant experience, expertise, and capabilities based upon the size and scope of this requirement as outlined in the Background/Scope section. Each response should include the following business information and must not be more than ten (10) pages in length: a) Company name, mailing address, e-mail address, telephone, website address (if available), and the name, telephone number, and e-mail address of a point of contact having the authority and knowledge to clarify responses with Government representatives. b) Name, title, telephone number, and e-mail addresses of individuals who can verify the demonstrated capabilities identified in the responses. c) Unique Entity ID number, CAGE Code, and company structure (Corporation, LLC, partnership, joint venture, etc.). Companies also must be registered in System for Award Management (SAM, at www.sam.gov) to be considered as potential sources. d) Any and all Government IDIQ Contracts (e.g., Federal Supply Schedule, OASIS, etc.) you currently hold (to include the vehicle and your contract number) that could be used to fulfill this requirement. e) Describe your organization's specific and relevant experience and expertise to fulfill this requirement. Experience must be of similar size and scope. Please provide examples or provide references of previously completed deliverables related to this requirement. f) Provide Information relating to capabilities, novel ideas, industry best practices, industry capabilities to meet the needs of the Government's requirement as outlined in the Background/Scope section above. Do not regurgitate the Background/Scope section, rather, outline company specific capabilities that match the work outlined for the Government to make a fair capabilities determination. Capability statements will be reviewed for (1) Relevant experience based on the size and scope of the outlined requirement; (2) Company specific capabilities that match the work outlined in the Background/Scope section . The formal closing date for this RFI/SS and for the submission of all responses is NLT 09 July 2024 at 10:00AM Eastern Time. All responses shall be submitted electronically using PDF or MS Word formats to the POC, Ms. Lisa Wells Roark at lisa.l.wellsroark.civ@health.mil and Mr. Jeremy McMurry at Jeremy.l.mcmurry.civ@health.mil. The Government will not entertain questions regarding this RFI/SS. All responses received will be considered; however, a determination by the Government not to compete the proposed requirement based upon responses to this notice is solely within the discretion of the Government.