RevMedx Inc’s XSTAT®

This is a follow on R&D effort whose focus primarily is on the development of a "Sponge Pouch" for XSTAT® family of devices. The XSTAT® family of devices are proprietary, Food and Drug Administration (FDA) approved hemorrhage control devices, used for treatment of non-compressible hemorrhaging, which is the leading cause of death on the battlefield, resulting from deep penetrating large caliber or blast wounds which cannot be treated using a tourniquet or traditional manual compression techniques. The device accomplishes this by applying a group of small, rapidly expanding sponges into a wound cavity, creating great internal pressure and a barrier to blood flow. The R&D will include the following: Design and development of the “Sponge Pouch” to include product validation testing, biocompatibility and sterilization reporting, and conduct of associated FDA regulatory activities and compliance, thereby improving performance by increasing the effectiveness of XSTAT® as it pertains to efficient/complete removal of sponges in the operating theater and/or upon arrival at definitive care facilities.