LifeScience Plus announced that its military-grade new hemostatic wound-care product, BloodSTOP iX Battle Matrix, has achieved a 100% survival rate during pre-clinical trials testing severe femoral artery lacerations mimicking a battlefield gunshot or shrapnel wound. The study, which was conducted on swine at an accredited research laboratory at PMI, an accredited research laboratory in Silicon Valley, utilized GLP protocol validated by the US Army Institute of Surgical Research and the US Food and Drug Administration. Far beyond any of its competitors, BloodSTOP iX Battle Matrix was shown to dramatically minimize blood loss, maintain hemostasis without re-bleeding, and continue to allow circulation to the lower leg, preventing any need for amputation. Results of the study indicate that the BloodSTOP iX Battle Matrix’s advanced technology could save hundreds of thousands or even millions of lives at disaster sites or in the midst of war-zones such as the multinational battling in the Middle East and other areas of unrest.
BloodSTOP iX Battle Matrix is a biocompatible, non-irritating, woven matrix of fibers made from all-natural plant compounds. When applied to a wound it quickly absorbs blood and exudates. BloodSTOP iX Battle Matrix then transforms into a gel to seal the wound with a protective transparent layer, actively aiding in blood coagulation and creating an optimal environment for wound healing.
The pre-clinical study, which was conducted on swine over a two-week period, examined BloodSTOP iX Battle Matrix’s effectiveness in stopping the bleeding using a standard military and FDA approved protocol: a 6mm arteriotomy made to the femoral artery using a vascular punch. BloodSTOP iX was the only hemostatic wound-care product in the study to achieve a 100% survival rate — meaning all of the pigs that were treated with BloodSTOP iX survived.
When in contact with blood, BloodSTOP iX Battle Matrix rapidly formed a sticky gel that adhered to and helped form a safe and effective “seal membrane” over the site of injury, rapidly and conspicuously halting blood loss. After the completion of the hemostatic assessment, researchers elected to determine the strength and tenacity of the “seal membrane” as an indicator of potential disruption of the coagulant.
This pre-clinical GLP study demonstrated the efficacy of BloodSTOP iX Battle Matrix in controlling severe bleeding in several important parameters including time of achieving initial hemostasis and post-treatment blood loss, showcasing its potential usage in the battlefield.
At conclusion of the protocol, lab technicians proceeded to flex and stretch the pig’s right leg five times in order to simulate walking and test hemostasis stability. This test is a crucial part of the process as re-bleeding is particularly dangerous and can be life-threatening, especially in a non-controlled environment such as the battlefield. In pigs treated with BloodSTOP iX Battle Matrix, no re-bleeding or oozing was observed. With competitor product Kaolin gauze, re-bleeding visibly occurred upon physical movement near the wound.
Results of the study show that BloodSTOP iX Battle Matrix successfully minimized blood loss. A subsequent angiogram showed that blood continued to properly circulate to the pig’s lower leg, providing nutrients and oxygen to surrounding tissue, a critical element in preventing amputation.
The results of the pre-clinical study show promise in BloodSTOP iX Battle Matrix’s capacity to save lives. They demonstrate that the technology minimizes blood loss, allows for circulation to limbs, and prevents re-bleeding. In critical situations like a battlefield or ground zero of a natural disaster or any environment in which controlled medical care is not readily available, BloodSTOP iX Battle Matrix can be counted on to stabilize bleeding until a proper medical facility can be accessed.
BloodSTOP iX products are USFDA cleared for emergency and therapeutic use in the control of bleeding from the skin and other surface wounds where temporary control of bleeding is required. The results of this study have not yet been reviewed by USFDA.
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