The Medical Technology Enterprise Consortium (MTEC) is excited to post this announcement for a Request for Project Proposals (RPP) entitled, "Volumetric muscle loss (VML) repair following extremity trauma." The goal of this research is to develop an off-the-shelf biologic prototype capable of preventing, mitigating or treating traumatic large-volume muscle loss (VML) injuries of the extremities. While such injuries are devastating, irreversible, and uniformly associated with long term disability, recent advances in regenerative medicine have made new approaches possible. The Government seeks to assess the potential for repurposing products already commercially available or in clinical development for related indications, such as critical limb ischemia, iatrogenic muscle injuries, Duchene's muscular dystrophy, compartment syndrome, and severe sports medicine injuries. Products capable of regenerating or repairing multiple tissue types or creating a therapeutic wound environment will also be considered. MTEC: The MTEC mission is to assist the U.S. Army Medical Research and Materiel Command (USAMRMC) by providing cutting-edge technologies and supporting life cycle management to transition medical solutions to industry that protect, treat, and optimize Warfighters' health and performance across the full spectrum of military operations. MTEC is a biomedical technology consortium collaborating with multiple government agencies under a 10-year renewable Other Transaction Agreement (OTA), Agreement No. W81XWH-15-9-0001, with the U.S. Army Medical Research Acquisition Activity (USAMRAA). MTEC is currently recruiting a broad and diverse membership that includes representatives from large businesses, small businesses, "non-traditional" government contractors, academic research institutions and not-for-profit organizations. Technical Background: The exact incidence of VML following combat trauma is unknown and has not been rigorously assessed. Estimates from civilian trauma indicate that ~250,000 open fractures occur per year in the US, and these commonly involve a component of VML injury. In the military, a study of battlefield injuries in 14,500 Service members evacuated from OEF/OIF from 2001-2013 suggests high VML incidence. Approximately 77% had musculoskeletal injuries and many had open soft tissue extremity wounds. Roughly 8% of all medically evacuated patients received a disability rating specifically for VML injury. The estimated life-time disability cost per patient is $340,000-440,000 in addition to medical costs and lost wages. Recovery is uniformly poor, leading to significant long term disability, and leading to increased rates of delayed amputation of technically salvageable, but functionally deficient limbs. There is no agreed upon standard of care for this condition, and no clinically available therapy that can address the loss of function for this condition. The current standard of care for VML involves the use of free muscle transfer (i.e., muscle flaps) for bone coverage followed by extensive physical rehabilitation. However, most muscle flap procedures are not intended to restore muscle function except in limited circumstances. Functional muscle transfer including vasculature and innervation have been shown to improve strength to an injured muscle group. However, such procedures require a level of surgical expertise available only in limited, specialized centers. It is unlikely that there will be a single solution for VML repair. Interventions will likely be required along the continuum of care, beginning close to the point of injury or during initial damage control surgery. In the course of market research, multiple products have been identified which may potentially prevent additional muscle loss and stimulate a repair response early in the course of injury. Such products may be highly valuable in a prolonged field care situation. Such interventions may offer significant improvements over currently limited treatment options. Work Plan: The focus of this RPP is to develop an advanced prototype of an off-the-shelf biologic capable of preventing, mitigating or treating traumatic large-volume muscle loss (VML) injuries along the continuum of care. The prototype must be able to repair injured muscle tissue to a degree suitable for extremity repair and reconstruction. The work is expected to be conducted in two phases over a 5 year period of performance as follows. Phase 1 (up to 2 years): An existing FDA-regulated commercial or clinical investigational product will be repurposed for VML and tested in one or more well-controlled animal bridging studies. The repurposed product must be an existing product (at a minimum of TRL 7) with demonstrated clinical benefit for at least one related skeletal muscle disorder indication, where at least one successful FDA-regulated Phase 2 clinical trial has been completed. In addition, the product should have a plausible mechanism for benefit in VML injuries. Studies will progress logically based on outcomes through go/no-go decisions after each study has achieved appropriate objectives. Product(s) will first be tested in a small proof of concept study in a rodent model. If successful, a large animal model will be used for confirmation. The optimal timing of the intervention may also be evaluated in one or more appropriate models. Phase 2 Optional Follow-on work (up to 3 years): If preclinical development studies are successful, the Awardee may be offered an optional extension to conduct a small proof-of-concept clinical trial in VML-injured patients. Further negotiations will be conducted between the Awardee, MTEC, and the Government if proceeding to a clinical trial becomes feasible. Financial Framework: The U.S. Government (USG) currently has available approximately $2 million (M) for Fiscal Years (FY), FY18, FY19, and FY20 to fund Phase 1. It is possible that additional funds of at least $2.5M for FY21 and FY22 may become available for the continuation of this project through Phase 2. MTEC anticipates that a single award will be made. The Period of Performance (POP) is 24 months for Phase 1, and an additional 36 months for Phase 2 if milestones/deliverables are achieved in Phase 1. Administrative Information: Full proposals are due no later than November 13, 2018 at 12:00pm EST. The RPP is posted to the MTEC website (mtec-sc.org) and a notice will be posted to FedBizOpps (fbo.gov) to notify interested parties. MTEC membership is required for the submission of a full proposal in response to this MTEC RPP. Offerors submitting Full Proposals as the prime contractor must be MTEC members of good standing by November 8, 2018. To join MTEC, please visit http://mtec-sc.org/how-to-join/ A Proposers Conference via webinar will be held for interested parties to have their questions answered by the Government after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled. For inquiries regarding this announcement, please direct your correspondence to the following contacts: • Technical questions Dr. Lauren Palestrini, MTEC Director of Research,
[email protected] Mr. Bill Howell, MTEC Chief Operating Officer,
[email protected] • Contracting questions Ms. Rebecca Harmon, MTEC Contracts Administrator,
[email protected] • Administrative questions Ms. Kathy Zolman, MTEC Program Manager,
[email protected] • Membership questions Ms. Stacey Lindbergh, MTEC Executive Director,
[email protected] For more information about this RPP, please visit the MTEC website (a link is included in the attachment incorporated into this posting).