The Market

The current topical hemostat market is dominated by liquid fibrin sealants, collagen sheets coated with a mixture of fibrinogen and thrombin, and thrombin products that are used in various types of surgery. The combined annual worldwide sales of these products is estimated at approximately €800 million and is expected to grow to over €1 billion in the next five years.

Fibrinogen sealant products are considered to be very effective topical haemostats and contain both active thrombin and fibrinogen. These products work by providing excess fibrinogen and thrombin at the site of injury and bypass the complete clotting cascade.

Several formulations of fibrinogen and thrombin have been developed. The most common formulation is the liquid fibrin sealant product in which fibrinogen and thrombin are stored separately as a frozen liquid or lyophilized powder.  Before use both components need to be reconstituted or thawed and loaded into a two-compartment applicator device that allows mixing of the two components and delivery to the wound. Because of the laborious preparation, these liquid products are not easy to use.

Another formulation is as a collagen fleece coated with fibrinogen and thrombin, which are provided in a dry form. A disadvantage of the pre-coated patches or dressings is that they are difficult to use on deep penetrating wounds. Furthermore, currently available pre-coated products are expensive compared to liquid fibrin sealants.

Thrombin products contain active thrombin either alone or in combination with collagen particles or a gelatin sponge.  These products work through enhancing fibrin formation by locally increasing the amount of active thrombin to a supraphysiological level, but depend on the endogenous fibrinogen for efficacy. Because the endogenous fibrinogen concentration in blood is relatively low (1-2 g/L) these products are only suitable for mild to moderate bleeding.

FibrocapsTM, the proposed name of the company’s lead biologic, is being studied to help stop bleeding during surgery and after trauma injury. A Phase II clinical trial in the Netherlands examining the use of Fibrocaps for mild and moderate bleeding during liver surgery was recently concluded. Also being evaluated are the drug’s:

•    Ease of preparation and application
•    Readiness for use and blending at ambient temperature
•    Utility in different formats (e.g.sprays and bandages)
•    Conformance to the shape of the wound

Fibrocaps may also have a potential application in acute trauma outside hospital settings, where ease-of-use and product stability at room temperature may be key factors. It is projected that the introduction ofFibrocapsinto the market for topical hemostats will allow it to capture a significant portion of a currently estimated €800 million market opportunity.