Prototype Solutions for Peripheral Nerve Injury

Purpose

This solicitation, issued by MTEC, represents a Request for Project Proposals (RPP) for MTEC support of the U.S. Army Medical Research and Materiel Command (USAMRMC) Clinical and Rehabilitative Medicine technology objective. Strategic oversight for the award(s) supported by this RPP will be provided by USAMRMC.

MTEC operates under a prototype Other Transaction Agreement (pOTA) with USAMRMC. Proposed prototype projects should not be exploratory in nature and do require a foundation of preliminary data. As defined in the OTA Guide dated January 2017, a prototype project can generally be described as a preliminary pilot, test, evaluation, demonstration, or agile development activity used to evaluate the technical or manufacturing feasibility or military utility of a particular technology, process, concept, end item, effect, or other discrete feature. Prototype projects may include systems, subsystems, components, materials, methodology, technology, or processes. By way of illustration, a prototype project may involve: a proof of concept; a pilot; a novel application of commercial technologies for defense purposes; a creation, design, development, or demonstration of technical or operational utility; or combinations of the foregoing, related to a prototype. The quantity should generally be limited to that needed to prove technical or manufacturing feasibility or evaluate military utility.

Scope of Work

The overarching goal of this program is to provide biomanufacturing for an emerging area of medical technology and innovation to support standard procedures toward a device, biologic, or combination prototype to maintain, re-establish, or regenerate myoneural connections. Applications to MTEC should clearly state how the proposed research provides an innovative solution to a critical problem in muscle denervation.

Applications must address one or more of the following focus areas in nerve regeneration or endorgan health. Specifically, MTEC seeks biomanufacturing and/or prototype development of a device, biologic, or combination prototype that supports:

1. Maintenance of the post-synaptic junction in denervated muscle.

2. Re-establish myoneural connections in the periphery.

3. Co-regeneration of nerve and muscle.

The current effort aims to promote highly innovative, groundbreaking research; high-impact research with near-term clinical relevance; multidisciplinary, synergistic research; and translational studies to support the fluid transfer of knowledge from basic principles to clinical solutions. Purely in vitro efforts will not be considered. Please note that awards are not to be exploratory in nature and require a foundation of preliminary data. To be eligible, prototypes must be (at a minimum) at a Technology Readiness Level (TRL) 3. Research involving animal or human subjects is allowed, in accordance with the Proposal Preparation Guidelines (PPG).

The expected period of performance should not exceed 36 months.

Points of Contact

For inquiries, please direct your correspondence to Biomedical Research Associate Chuck Hutti, Ph.D. at Chuck.Hutti@ati.org.