Injectable Expanding Powder for Treatment of Noncompressible Hemorrhage
Abstract
This research will leverage a novel technology platform with multiple U.S. Food and Drug Administration (FDA) clearances to develop the LifeDust™ injectable expanding powder hemostatic System (LifeDust) for the treatment of intracavitary non-compressible hemorrhage from soft tissue injuries (e.g., a shrapnel injury in the abdomen). LifeDust contains key patented materials that have recently demonstrated superior clinical performance in vascular closure compared to the clinical standard of care. This makes LifeDust ideal to treat injuries that are not proximal to the surface or easy to access and accordingly remain the leading cause of death (~85%) from all bleeding-related trauma cases. LifeDust is formulated through proprietary modifications to a naturally occurring biopolymer that can rapidly expand upon deployment into the intracavitary space and has demonstrated the ability to effectively seal even traumatic injuries exhibiting aggressive blood loss. LifeDust is a durable, lightweight powder designed to require little preparation and training for use to increase survival in pre-hospital environments through the decisive management of internal bleeding and stabilization of severely injured patients during transportation to a trained trauma surgeon. LifeDust can be delivered through a small handheld syringe dispenser; the material can easily be removed once the patient is safely in the care of a trained surgeon. Upon wetting with blood, the powder expands dramatically into a foam within a closed cavity adhering to the site of injury and creating a seal to decisively manage bleeding, while leaving soft tissue or organs undamaged within the abdomen due to the soft nature of the resulting foam material. In example, an alternative formulation from Medcura’s platform (liquid-gel based injectable foam) has successfully met efficacy and acute safety endpoints in non-GLP studies using the same lethal porcine bleeding model required by the FDA to support an Investigational Device Exemption (IDE) for this indication. The primary objective of this project is to complete preclinical efficacy and safety testing as an internal proof of concept for LifeDust in treating internal non-compressible hemorrhage. The FY20 PRMRP Topic Area for this application is “Hemorrhage Control” and the applicable Area of Encouragement is: “Development of new and innovative capabilities to stop non-compressible intracavitary hemorrhage.” Research supported by this grant will extend the use of Medcura’s well-established technology platform to develop a hemostatic system that can stabilize bleeding patients during prolonged field care by using a durable, novel expanding powder: LifeDust. Expanding powders are the future of acute wound treatment on the battlefield and in emergency medical services, given their durable, easy-to-use, and lightweight characteristics. LifeDust is designed for easy application by a skilled caregiver, an unskilled “buddy” or even by the Service Member themselves. The broader impact of this project should be the development of additional external and topical solutions for battlefield and trauma medicine. Medcura has mitigated many of the key project risks through numerous past preclinical and clinical studies, some of which have been submitted in support of now cleared products by the FDA. Key Project Risks and Sources of Mitigation Risk: Inadequate efficacy for traumatic bleeding, especially in extremely difficult-to-access, and control, intracavitary spaces. Mitigation: Recent successful studies using an alternative formulation of Medcura’s technology in a lethal porcine bleeding model demonstrated decisive bleeding management to a non-compressible injury. Medcura has also successfully undertaken multiple non-lethal porcine surgeries, where early formulations of LifeDust have repeatedly achieved decisive hemostasis with only a few minutes of compression. Risk: Common safety issues for novel biomaterials (e
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 05, 2021
- Source ID
- W81XWH2110886
Entities
People
- Matthew Dowling
Organizations
- United States Army