ClotFoam® Biomedica Management Corporation

A Fibrin Sealant Embedded in an Adhesive Scaffold; Designed to Stop Severe Bleeding Right Away. No Need for Pressure, Staples or Sutures.

Indication Composition Mode of Action Advantages Unique characteristics

ClotFoam® is a second-generation fibrin sealant embedded in a highly adhesive scaffold; an advanced technology that bypasses the fibrinogen cleavage, producing a strong fibrin polymer-always active, always strong, always effective. ClotFoam is indicated for use in cases of severe hemorrhage in trauma, in laparoscopic, urinary or brain surgery, where compression and/or sutures cannot be applied. ClotFoam can also be applied as an anti-adhesive hemostatic in general surgery. It is a product in a viscous liquid phase, composed of three parts containing the scaffold and fibrin components. When mixed, the solutions form a foamy gel that anchors firmly to the bleeding site with an elastic clot. The foam technology allows non-invasive application and dissemination of the hemostatic agent in the peritoneal or other body cavities; adheres and compresses lacerated or wound tissue to prevent flow of blood; and maintains the necessary components over the wound to produce a platelet plug, followed by a fibrin clot, that stimulates the coagulatory cascade. Rapid formation of a strong hydrogel, effective cleavage, and an instantaneous polymerization produce a functional clot, which supported by the scaffold ensures that the sealant remains at the site of application without being washed away by the flow of blood. High adhesive strength characterize the clot and helps close the wound. ClotFoam is a plasmin-depleted aprotinin-and-thrombin-free (human) fibrin sealant presenting no risk of autoimmune reaction, and minimal risk of anaphylactic or systemic reaction to human blood products. ClotFoam's fibrin components can be kept in a refrigerator at 4°C for more than 16 weeks. It is provided in a 3-barrel magazine, ready-to-use. No need to unfreeze, mix or dissolve components. Unlike other fibrin sealants, it does not present a risk of thrombin self-cleavage and fibrinogen proteolitic degradation, which can severely reduce the efficacy of the agent over time. " A non-compressible sealant technology: No need of sponges, patches, sutures or stitches. " It can be used in cases of severe intracavitary hemorrhage, including liver trauma grade IV; laparascopic surgery; urinary, gynecological and brain surgical procedures. " It polymerizes almost instantly anchoring a strong clot over lacerated tissue. " It does not present thrombin to the immune system. It is plasmin depleted and does not require aprotinin. " Its shelf life is longer than any other fibrin sealant. It can be kept in solution at 4°C for more than 16 weeks with no loss of activity. " It is ideal for general surgery because it has significant anti-adhesive properties, in addition to the hemostatic effect. " It is more cost-effective than available fibrin sealants. Designed for severe trauma, and fine-tuned for use in minimally-invasive procedures.