ClotFoam is a surgical sealant and hemostatic agent designed to be used in cases of non-compressible hemorrhage. It can be applied in the operating room through laparoscopic ports, or directly over lacerated tissue in laparotomy procedures or outside the operating room through a mixing needle and/or a spray injection method following abdominal, chest, extremities or other intracavitary severe trauma to promote hemostasis. Its crosslinking technology generates an adhesive three-dimensional polymeric network or scaffold that carries a fibrin sealant required for hemostasis. When mixed, Clotfoam produces a foam that spreads throughout a body cavity reaching the lacerated tissue to seal tissue and promote the coagulation cascade. The viscoelastic attachment properties of the foam as well as the rapid formation of a fibrin clot that ensure that the sealant remains at the site of application without being washed away by blood or displaced by movement of the target tissue.
Method To Produce Fibrin Monomer In Acid Media For Use As Tissue Sealant
George David Falus - New York City NY, US Leonid Medved - Ellicot City MD, US
Assignee:
Biomedica Management Corporation - Brooklyn NY
International Classification:
A61K 38/36 A61K 38/00
US Classification:
530344, 530381, 530382
Abstract:
A hemostatic agent designed for use in cases of non-compressible hemorrhage. It can be applied through a mixing needle and/or a spray injection method following abdominal, chest, extremities or other intracavitary severe trauma to promote hemostasis, or it can be used for laparoscopic procedures or other surgical procedures in which compression is not possible or recommended. Its crosslinking technology generates an adhesive three-dimensional polymeric network or scaffold that carries a fibrin sealant required for hemostasis. When mixed, it produces a foam that spreads throughout a body cavity reaching the lacerated tissue to seal tissue and promote the coagulation cascade. The fibrin components are produced by a novel dialysis method which does not present thrombin to the immune system and can be maintained in solution for six weeks without significant proteolytic degradation.
Tissue Sealant For Use In Noncompressible Hemorrhage
ClotFoam is an hemostatic agent designed for non-compressible hemorrhage. It can be applied outside the operating room through a mixing needle and/or a spray injection method following abdominal, chest, extremities or other intracavitary severe trauma to promote hemostasis, or it can be used in the operating room for laparoscopic procedures or other surgical procedures in which compression is not possible or recommended. Its crosslinking technology generates an adhesive three-dimensional polymeric network or scaffold that carries a fibrin sealant required for hemostasis. When mixed, Clotfoam produces a foam that spreads throughout a body cavity reaching the lacerated tissue to seal tissue and promote the coagulation cascade. The viscoelastic attachment properties of the foam as well as the rapid formation of a fibrin clot that ensure that the sealant remains at the site of application without being washed away by blood or displaced by movement of the target tissue .
Purified Ethyl Ester Sophorolipid For The Treatment Of Sepsis
George Falus - New York NY, US Maja Nowakowski - Port Washington NY, US Martin Bluth - Southfield MI, US John Aikens - Oak Brook IL, US
Assignee:
Biomedica Management Corporation - Brooklyn NY
International Classification:
A61K 31/7048 A61P 31/00 C12P 19/62
US Classification:
514 31, 435 76
Abstract:
A microbial ethyl esther sophorolipid derivative with no acetylated groups produced by species, for treating and preventing sepsis/septic shock. The method of producing sophorolipids is through microbial resting cells of . The sophorolipids obtained from resting state cultures are isolated as a complex mixture of compounds and then decanted as a dense oil from the culture broth, subsequently washed to remove free fatty acids. Secondary chemical transformation via base catalyzed hydrolysis is used to reduce the 8 possible structural sophorolipid species to a single moiety, the 17-L-[(2′-O-b-D-glucopyranosyl-b-D-glucopyranosyl)-oxy]-cis-9-octadecenoate de-acetylated free acid. The compound acts primarily through decreasing inflammatory cytokines and eliciting other synergistic anti-inflammatory mechanisms by blocking TLR4-CD14 upstream of the inflammatory signaling cascade. The compound can be administered either intraperitoneally or intravenously at single or multiple doses of 5-30 mg/kg of weight in solvent media or in capped nanoparticles, preferably within 48 hours of sepsis inception.
The present invention trademarked ClotGel is a fibrin II-based hemostat made of two components that are mixed into a single syringe to be delivered as an adjunct or primary treatment in moderate intraoperative hemorrhage and in trauma. It can be applied topically to the wound either on the skin in a laparatomy or as non-invasive manner in surgical procedures. Its cross-linking technology generates an adhesive stable fibrin clot required for hemostasis. The agent consists of a cross-linked gelatin that is homogenized in a solution of fibrin monomer in acetic acid, which is reconstituted before use from a lyophilized fibrin monomer. When both components are mixed into a syringe they produce a viscous gel-like composition that is polymerized and stabilized when in contact with blood. The attachment properties of the composition, as well as the rapid formation of a fibrin clot, ensures that a strong stable blood clot is formed over a bleeding wound within 2 minutes of application.
George David Falus - New York City NY, US Leonid Medved - Ellicot City MD, US
Assignee:
Biomedica Management Corporation - Halethorpe MD
International Classification:
A61K 38/45 A61M 11/02 A61K 38/36
Abstract:
ClotSpray is a sprayable fibrin-based hemostatic agent applied from an aerosol can. The agent is intended for use as an adjunct or primary treatment in moderate intraoperative hemorrhage and treatment of burns. It can be applied topically to the wound from an aerosol can without need of preparation, unfreezing or interruption during the length of the surgical procedure. Its crosslinking technology generates an adhesive fibrin sealant required for hemostasis. The attachment properties of the gel as well as the instant formation of a fibrin gel ensures that a strong stable fibrin clot will control light to moderate bleeding from a wound.
George David Falus - New York City NY, US Leonid Medved - Ellicott City MD, US
International Classification:
A61L 24/10
US Classification:
514 136
Abstract:
ClotGel is a single-component hemostatic agent designed for use as an adjunct or primary treatment in moderate intraoperative hemorrhage and in trauma. It can be applied topically to the wound either on the skin in a laparatomy or as non-invasive manner in surgical procedures. Its crosslinking technology generates an adhesive stable fibrin clot using a single component (fibrin II) required for hemostasis. The agent is a mixture of lyophilized polymerized fibrin II and fibrin II monomer which is polymerized and stabilized when in contact with the blood. The attachment properties of the gel, as well as the rapid formation of a fibrin clot, ensures that a strong stable fibrin clot is formed within 1 minute of application.