ProFibrix Completes Enrollment of Phase II Study with Fibrocaps
LEIDEN, The Netherlands & SEATTLE - ProFibrix B.V., a leader in the development of innovative products for hemostasis, today announced that it has completed patient enrollment in its two (U.S. and Dutch) prospective, randomized, controlled, multi-center Phase II studies with lead product Fibrocaps in surgical hemostasis. A total of 124 patients have been randomized across three different surgical indications: peripheral vascular surgery, spinal surgery, and liver resection surgery. The study has a 28-day follow-up and results are expected to be reported before the end of 2011.
Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical fibrin sealant being developed to stop bleeding during or after surgery. Fibrocaps is clearly differentiated from existing liquid tissue sealants and hemostats: it is ready for immediate use, and is stable at room temperature.
ProFibrix (www.profibrix.com) was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA, USA. The company leverages its expertise in fibrinogen technology to develop and bring to market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.
Jan Öhrström, MD, CEO
About Gilde Healthcare Partners
Netherlands-based Gilde Healthcare Partners is a transatlantic growth equity investor focused on private healthcare technologies and services. It has EUR 450 million under management and is actively looking to lead new investments in therapeutics, diagnostics, medical devices and services.
Gilde successfully builds healthcare businesses across Europe and US, investing up to EUR 15 million in a single portfolio company. By investing in companies with clear, achievable business models, Gilde has used its financial resources and network to create significant value for both its investors and the entrepreneurs it backs. For a list of Gilde’s portfolio companies please visit the website at www.gildehealthcare.com.
Gilde Healthcare II is supported by the European Communities Growth and Employment Initiative, MAP - ETF Start up Facility.