Her bør Softox kjenne sin besøkelsestid (takk til polsmannen på Hegnar forumet): https://govtribe.com/opportunity/federal-contract-opportunity/mtec-prevention-of-combat-wound-infections-mtec2103woundinfection
“The goal of this RPP is to develop prototype solutions that enable prevention of Warfighter wound infections on the battlefield as close to the point of injury as possible to enable speedy return of Warfighters to duty and without requiring evacuation to higher roles of care. Therefore, this requirement is focused on a multi-layered approach to protecting Warfighters against wound infections. The proposed solution(s) is expected to be part of a system to provide an adequate response to complex traumatic penetrating injuries that can lead to wound infections.”
"An ideal solution would meet the following requirements (not listed in order of importance):
Broad and rapid microbicidal (bacterial and/or fungal) activity with a shelf life of at least a year. For proposed solutions that may have to be opened multiple times, it is preferred that the “use within” period is at least one year.
Ease of use, small and lightweight (i.e., should fit in a combat medic’s medical bag) without the need for additional logistic considerations, e.g., cold/warm storage, impact protection, additional supplies/products to enable use.
When placed into a wound, the product should not stain the skin or surrounding exposed underlying tissue and should be easily removable (i.e., washed out of the site of placement with sterile water or saline).
The product should be usable and efficacious in austere environment conditions, as well as packaging that maintains integrity in wide temperature ranges (between 0-45oC), and also in conditions of high and low humidity.
Demonstrable efficacious use of the product on the wound for at least three days in austere environmental conditions referenced above.
At the end of the PoP, the performer(s) is expected to have successfully achieved the following milestones:
Completed Good Laboratory Practice (GLP)-compliant study demonstrating acceptable safety and efficacy profile in relevant animal model(s), human dose equivalent, and route of administration as intended for human use.
Completed a Phase 1 clinical trial demonstrating adequate safety and preliminary efficacy profile in optimized dose and schedule.
A Defined Regulatory Pathway: An adequately defined, detailed regulatory pathway towards a Medical Device, Biologics License or New Drug Application, including (but not limited to) Phase 2 and 3 study plans validated by formal communication with the FDA.
Evidence that production is capable of scale up and available quantities of the product are adequate to support the remainder of clinical development.
Demonstrated stability of product(s) for at least one year at 0-45oC and under conditions of high humidity.
POTENTIAL FUNDING AVAILABILITY AND POP
The Government Department of Defense (DoD) currently has approximately $4 Million (M) available for a PoP for up to 24 months. Cost sharing, including cash and in kind (e.g., personnel or product) contributions are strongly encouraged, have no limit, and are in addition to the $4M in Government funding to be provided under the resultant award(s)."
kjenner jeg ikke orker å lese det tunge stoffet der nå senkvelds:man_shrugging: