MTEC - Far Forward Burn Treatment (FFBT)

The Medical Technology Enterprise Consortium (MTEC) is excited to post this summary announcement for a Other Transaction Agreement (OTA) for prototype project Request for Project Proposals (RPP) focused on the development of treatments for severe burn injuries in a far-forward, austere environment to address the harmful sequelae of the burn injury during prolonged care, which could extend for several weeks post-injury. This RPP focuses on the following four capability gaps: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing cover. Background It is anticipated in future conflicts that the Army will have to fight and win across multiple domains in contested locations where air, ground, and nautical evacuations of casualties will be extremely challenging. Evacuating casualties within theater may take days or weeks. Additionally, the explosive weapons that will likely be used against US forces will be more powerful than what has been used to date, resulting in higher numbers of casualties with significant burn injuries including larger, more severe burns. Only minimal burn wound management tools are available in the pre-hospital environment, consisting primarily of silver-containing wound dressings to prevent/minimize infection until the casualties expedient evacuation to the San Antonio Military Medical Center Burn Center for definitive treatment. Unfortunately, the future burn casualty may not have the benefit of the early evacuation to the burn center that was available during recent conflicts. As such, there is a significant need to push burn treatment capabilities much farther forward in order to begin burn treatment as early as possible. By closing the time gap between burn injury and burn treatment with solutions that can be reasonably provided by non-medical personnel (i.e., buddy care) or medical first responders (e.g., medics) in a pre-hospital setting, morbidity and mortality rates can be significantly decreased. The Government is seeking burn interventions that are simple and effective enough to be used in a pre-hospital setting. These tools will need to enable providers from the point of injury through Role 3 Hospital Centers to treat severe burn injury for up to several weeks post-injury. It is imperative that these solutions be simple enough that non-licensed medical providers (e.g., medics) can administer them, and effective enough to decrease morbidity and mortality rates and improve outcomes over current in-theater burn treatment options. It is expected that multiple burn treatment solutions will be needed, and may be used in concert with one another, to provide the needed burn treatment capabilities in theater. These solutions will need to address: burn conversion prevention, infection prevention, non-surgical debridement, and temporizing coverage/dressings that protect the burn wound and may promote early healing. Technological advances that contribute to product solutions that meet these requirements will be considered as possible candidates for fielding by the Burn Treatment Skin Repair acquisition program, which is managed by the Burn Treatment Skin Repair (BTSR) Integrated Product Team (IPT). Solution Requirements Simple and effective solutions are required to treat severe burn injuries as early as the point of injury and throughout in-theater care. The Army has identified four capability areas that would enable this far-forward burn treatment: Burn conversion prevention, Infection prevention, Non-surgical debridement, and Temporizing cover. Offerors should only propose technology solutions that are currently at a Technology Readiness Level (TRL) of 4 or above and currently in development or commercially available. While there are desired solution characteristics unique to each of the burn treatment capability areas being sought, there are some characteristics that are common to them all. These common characteristics (which apply to all treatment capabilities) are strongly preferred at the time of submission. However, the Government will consider proposals that thoroughly demonstrate the ability to achieve these common characteristics during the period of performance (if those capabilities do not currently exist). It is also anticipated that some product solutions may satisfy, or have the potential to satisfy, more than one of these burn treatment capability areas. In instances where a product has sufficient data supporting its use in one area (e.g., infection prevention), but there is evidence that is may also be useful in another area (e.g., burn conversion prevention), optional tasks can be incorporated into any resultant award to address indications for additional areas where the product solution may have utility. The Government reserves the right to negotiate any proposed optional tasks with the Offeror if recommended for funding and/or award under only one burn treatment capability area. Common Characteristics for All Capabilities In the far forward environment, it is important for interventions to be as simple, safe and effective as possible. As such, the following characteristics apply to all four desired capabilities: Prototype must be capable of achieving an indication for use on large (>20% total body surface area (TBSA)) burns. Prototype must be capable of achieving an indication for use on full-thickness burns. Regulatory strategies can include a seeking a deep-partial thickness indication as a bridge to a full-thickness burn indication. Prototype must not negatively impact use of other downstream burn or lifesaving treatments in the care of burn-injured individuals, specifically those treatments being sought after within this RPP. Prototype must be capable of being administered by a medic quickly and easily at the point of injury and Role 1. Prototype must be capable of achieving a shelf life of at least two years at room temperature. Prototype must not require climate controlled transit or storage at maturity. Prototype must eventually become a commercially viable product or technology that will be brought to market. Capability-specific Characteristics In addition to the Common Characteristics for All Capabilities listed above, each capability has specific desired characteristics listed below. A. Burn conversion prevention Prevents conversion of partial-thickness burns to deep partial-thickness or full-thickness burns, ideally within 24 hours of being administered Single dose/application per 24 hours is preferred, but not required Shows efficacy in limiting the expansion and/or depth progression of burns B. Infection prevention Topically administered product that can be applied immediately after a burn to prevent infection and/or after infection has set in as a treatment Control broad range of bacterial infections; control of fungal infections and resistant pathogens preferred Low risk of causing resistance C. Non-surgical debridement in pre-hospital setting Complete procedure/course of treatment is 24 hours or less Does not require sedation or anesthesia for pain management; causes minimal pain per FDA-approved scales preferred Fully mitigates the toxicity of eschar Requires minimal ancillary equipment such as batteries, power supply, etc. D. Temporizing coverage/dressing for burn wounds that may promote healing Can be used to cover/dress burn wounds both at initial treatment and also after debridement Provides a barrier over the burn wound in the absence of grafting Coverage material is thin, conformable, breathable, able to move with patient and non-toxic; preference for coverage materials that are bio-absorbable, and enable healing of the burn wound preferred but not required Can be left in place for up to 5 days, preferably longer Does not require multiple dressing changes and/or mitigates/eliminates the deleterious effects of dressing changes Scope Work of Base Period of Performance 1 (PoP1): The initial base PoP1 (which is limited to a period not to exceed 24 months), should be focused on tasks relevant to advance the prototype to the next TRL. Project scope should be proposed based on the prototype's maturity at the time of submission. After completion of the base PoP1, all performers under any resultant award will participatin in an in process review (see "Go/No-Go Decision Point" and "Acquisition Approach & Rolling Downselection" sections below for more details) before continuing with any subsequent tasks (referred to as "PoP2") in support of the prototype project. The Offeror's initial proposal in response to this RPP shall address PoP1 and PoP2 tasks. Go/No-go Decision Point: Prior to the end of the base PoP1, the Government will conduct an in process review (IPR), in which the Awardees will attend and participate in, to assess the work completed for each PoP1 Awardee. The IPR will be either a virtual or an in-person meeting at USAMRDC at Fort Detrick, MD. Following the IPR, the Government intends to down-select Awardees to a smaller number for continuation of funding for the conduct of follow-on work representing PoP2 or the subsequent PoP of the prototype project. This down-select represents the Go/No-Go Decision point between PoP1 (base) and PoP2 (subsequent). Potential for Follow-on Work: Potential follow-on work to include PoP2 (but may also include additional, non-competitive tasks negotiated after award) may be awarded based on the advancement in prototype maturity during the base PoP1. Potential follow-on work may include tasks related to advancement of prototype maturity, and/or to expand the use or utility of the prototype. Potential Funding Availability and Period of Performance: The U.S. Government (USG) currently has approximately $7.5 million (M) available for the base PoP1. An additional $7M of funding is anticipated for the performer(s) that is selected for the continuation of prototype development under the subsequent PoP (PoP2) of the resultant award(s), after the Go/No-go Decision Point. MTEC anticipates that multiple awards will be made. Awards resulting from this RPP are expected to be made are expected to be made as early as Fiscal Year 2021 or in Fiscal Year 2022. POP1 is expected to be up to 24 months. Acquisition Approach & Rolling Downselection This RPP and the source selection process will be conducted using a two-staged approach. In Stage 1, current MTEC members are invited to submit White Papers using the mandatory format contained in the full RPP (which can be located by visitng MTEC's website). The Government will evaluate White Papers submitted and will select those that best meet the Government's current technology priorities for further consideration using the criteria in Section 3 of the RPP. Offerors whose proposed solution is selected for further consideration based on White Paper evaluation will be invited to submit a proposal in Stage 2. Notification letters will be sent upon completion of the Government's Stage 1 technical evaluation and will contain specific Stage 2 proposal submission requirements for those Offerors selected for further consideration. Offerors are hereby notified that the Government intends to utilize a rolling downselect approach during the performance of prototype projects awarded as a result of this RPP. Using this approach, the Government intends to award prototype projects, structured into two PoPs, with an initial base period (PoP1) reflecting the first of the two PoPs. After an In-Process Review (IPR), an evaluation of project deliverables and other considerations to include progress towards completion of the base PoP1 tasks, the Government intends to award a second PoP, referred to as the subsequent PoP (PoP2), to the performer(s) that demonstrates a best value approach for follow-on tasks. Award decisions for the subsequent PoP2 work will be made during the Go/No-go Decision Point which is expected to occur prior to the end of the base PoP1. MTEC The MTEC mission is to assist the U.S. Army Medical Research and Development Command (USAMRDC) by providing cutting-edge technologies and supporting effective materiel 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, - nontraditional government contractors, academic research institutions, and not-for-profit organizations. Administrative Information White Papers are due no later than March 8, 2021 at 12:00pm Eastern Time. The full version of the RPP is posted to the MTEC website (mtec-sc.org); this notice is intended to notify interested parties of the available solicitation. MTEC membership is required for the submission of a White Paper in response to this MTEC RPP. An Offerors submitting a White Paper as the prime contractor must be an MTEC member of good standing by March 4, 2021. 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 USG DoD after the RPP is posted. MTEC Members will be notified when the Proposers Conference is scheduled. Points of Contact Please direct your inquiries and correspondence to the following contacts: Questions concerning contractual, cost or pricing related to this RPP should be directed to the MTEC Contracts Administrator at contact@example.gov Technical and membership questions - Dr. Lauren Palestrini, MTEC Director of Research, contact@example.gov Administrative questions - Ms. Kathy Zolman, MTEC Director of Program Operations, contact@example.gov To view this solicitation, visit https://www.mtec-sc.org/solicitations/