Hemaseel® HMN fibrin sealant
Fibrin sealant is a biological tissue glue with sealing, haemostatic and adhesive properties which are essential to wound healing. The action of the fibrin sealant simulates the last step of the physiological process of coagulation and, depending on its applications, can arrest bleeding and close wounds, thus reducing the amount of blood required in transfusions. It is used in surgical procedures as an adjunct to wound healing and is resorbed naturally by the human body. It has the mechanical strength to attach tissues together and to last through the first phase of the body’s healing process. It adheres firmly to wound surfaces and quickly sets, or polymerizes, to form a white, rubber-like mass, which continues to gain in strength for hours following the application. Fibrin sealant is also believed to have adhesion prevention properties, preventing the adhesion, or fusion, of neighbouring tissues or organs following certain surgical procedures. It is also believed to be an effective drug delivery device. Fibrin sealant has become an accepted tool in many fields of surgery.
Haemacure's proprietary fibrin sealant is derived from its patented, high-yield fibrinogen and thrombin extraction technology and is made of two human plasma proteins, fibrinogen and thrombin.
Haemacure's fibrin sealant was applied to 151 subjects and patients in phases I, II and III clinical trials without any serious adverse event attributable to the product being reported. The safety and efficacy of Haemacure's fibrin sealant were demonstrated in these trials. The product is to enter new pivotal Phase II/III trials under the Investigational New Drug application that is currently open with the FDA. New phase III trials are required as the product will be manufactured in a facility different from the one where the product was manufactured for the prior clinical trials.
Haemacure believes that its fibrin sealant has applications in a wide array of surgical specialties, including general and abdominal surgery, cardio-thoracic and vascular surgery, gynaecology and urology surgery, neurosurgery, ear, nose and throat surgery, and reconstructive and plastic surgery. Haemacure also believes that fibrin sealant can be an effective drug delivery vehicle.
At present, the leading commercial fibrin sealant available in the United States, Canada and Europe contains aprotinin, a bovine protein with serious adverse experiences now reported in the medical literature. Haemacure believes that the introduction of a human fibrin sealant product, such as Hemaseel HMN, would provide significant clinical advantages as compared to fibrin sealant containing bovine-derived components.
Haemacure plans on launching its fibrin sealant Hemaseel HMN on the market by the end of 2010 or beginning of 2011.