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ProFibrix Obtains Government Loan of up to $7.4 Million to Support Clinical Development of its Lead Hemostasis Product Fibrocaps(TM)


1/7/2010 8:57:36 AM

LEIDEN, The Netherlands and SEATTLE, Washington, January 7 /PRNewswire/ -- ProFibrix B.V., a leader in the development of innovative products for hemostasis and regenerative medicine, today announced that SenterNovem, an agency of the Dutch Ministry of Economic Affairs, has granted the company a loan under its new Innovation Credit scheme of potentially up to EUR 5 million to finance the further clinical development of its unique new hemostat Fibrocaps(TM).

The loan consists of an initial commitment of EUR 2.75 million, with the possibility to call on an additional EUR 2.25 million when and if certain development milestones are met.

Jaap Koopman, PhD, Chief Executive Officer of ProFibrix said: "On the back of our recent successful B round in which we raised EUR 8 million (~ US $11 million), we are very pleased to further solidify the financial basis of ProFibrix. Loans under this special scheme are awarded to innovative projects with a strong commercial potential. This loan will be instrumental in financing the Phase II and III development of our lead product Fibrocaps."

Fibrocaps is based on a mixture of two essential blood clotting proteins, fibrinogen and thrombin, and is a unique dry powder topical tissue sealant that rapidly stops bleeding after or during surgery. Fibrocaps has major advantages over existing liquid tissue sealants: it is ready for immediate use, is stable at room temperature, highly effective and fast acting. Fibrocaps is currently in a Phase II clinical trial in the Netherlands with results expected early in 2010.

ProFibrix expects to submit an Investigational New Drug Application (IND) for Fibrocaps to the U.S. Food and Drug Administration in the first half of 2010, and to conduct a combined phase II/III pivotal study in various surgical indications.

ProFibrix will present at the Biotech Showcase, which takes place in conjunction with the JP Morgan Healthcare Conference in San Francisco, on Tuesday, January 12, 2010 at 8:40 a.m. in the "Regimental" room at the Marines' Memorial Club & Hotel, 609 Sutter Street, San Francisco.

About ProFibrix

ProFibrix (http://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 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.

About SenterNovem and the Innovation Credit scheme

SenterNovem (http://www.senternovem.nl) is an agency of the Dutch Ministry of Economic affairs that promotes sustainable development and innovation with various financial instruments. The Innovation Credit (innovatiekrediet) scheme is aimed at supporting high risk, and commercially attractive development projects with an interest-bearing loan of which repayment is waived if the project fails.

CONTACT: ProFibrix B.V., Jaap Koopman, Ph.D., CEO, Tel: +31(0)6-21628475,
E-mail: j.koopman@profibrix.com; ProFibrix Inc., Jan Ohrstrom, MD, COO,
Tel: +1-2069105404, E-mail: j.ohrstrom@profibrix.com



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