Study with Fibrocaps(TM) Lead product on track for market launch in 2014

LEIDEN, The Netherlands & SEATTLE, Jun 06, 2012 (BUSINESS WIRE) -- ProFibrix B.V., a leader in the development of innovative bioactive products to stop bleeding (hemostasis), today announced the start of its pivotal Phase III clinical trial with Fibrocaps (FINISH-3) in spine, liver, vascular and soft tissue surgery.

FINISH-3 is a multicenter, randomized, single-blind, controlled Phase III trial of Fibrocaps in 672 surgical patients with mild to moderate surgical bleeding. The main objectives of the study are to demonstrate superior efficacy of Fibrocaps vs. gelatin sponge within each surgical indication, and to confirm the overall safety results from the Phase II Fibrocaps trials completed in 2011.

Dr. Paul Frohna, Chief Medical Officer of ProFibrix said: "We are very pleased to announce the randomization and treatment of the first patients in the international FINISH-3 trial less than 4 months after completing our End-of-Phase II meeting with the U.S. FDA. Based on the excellent Phase II study results, the investigators are very eager to enroll their patients into our study and we remain on track for regulatory filings in the U.S. and EU in 2013. Based on the product's unique properties, and the overwhelmingly positive feedback we are receiving from the surgical community, we believe Fibrocaps should be able to capture a substantial share of the US$ 1 billion topical hemostat market."

The Fibrocaps used in the pivotal Phase III clinical trial has been manufactured by ProFibrix's commercial manufacturing partner Nova Laboratories Limited (Leicester, UK). Peter White, Managing Director of Nova Laboratories said: "It is great to be part of this exciting project and to manufacture the Phase III product and I am looking forward to our long term collaboration."

About Fibrocaps

Fibrocaps is 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.

About the FINISH-3 trial

FINISH-3 is a prospective, randomized (2:1), single-blind, controlled, pivotal Phase III trial of Fibrocaps vs. active control in 672 subjects undergoing spinal (n=168), liver (n=168), vascular (n=168) and soft tissue surgery (n=168). The study will be conducted at 65 sites across Europe and the U.S. Estimated completion date is May 2013.

For more details on the study, please go to http://www.clinicaltrials.gov .

About ProFibrix

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.

SOURCE: ProFibrix

HemCon Adds Barry Starkman as CEO

HemCon Medical Technologies, Inc., an industry leader in hemorrhage control technologies and developer of lyophilized (freeze-dried) human plasma for the U.S. Army, announced today the appointment of Barry Starkman as Chief Executive Officer. Starkman joins HemCon with more than 30 years of experience in biologics and medical technology manufacturing.

"As we reorganize and restructure with the objective of successfully exiting Chapter 11, Barry is an extremely important addition to the HemCon team. His leadership and expertise will prove valuable in realizing the full potential of our lyophilized plasma program (LyP program), and in developing the optimal strategy for the Medical Device division," said Bill Wiesmann, Chairman and Co-Founder of HemCon. "Barry rounds out our executive team, working with Nick Hart who will continue his role as President and CFO."

As Chief Executive Officer, Starkman's focus will be on the execution and delivery of the LyP program through Phase 2 clinical trials and planning and executing on facility expansion to allow HemCon to enter Phase 3 clinical trials for the LyP program. He will also review the Medical Device division fully to determine the optimal means by which this business can be developed and contribute towards HemCon's overall financial performance.

Starkman's experience spans pharmaceutical products, biotech, and medical devices, matching the commercial applications for HemCon's LyP Program and Medical Devices division. His background also includes manufacturing management in the areas of facilities design, cGMP manufacturing requirements and Lean 6 Sigma applications.

Prior to joining HemCon, Starkman served as Vice President of Operations at Promega, where he was responsible for global manufacturing, planning and logistics for the $300 million organization. Starkman had previously overseen the design, construction, start-up and operation of Genentech's $450 million state-of-the-art formulation, packaging and distribution facility in Portland, serving as General Manager. Earlier in his career, Starkman worked for 24 years for Merck taking on increasing responsibility which culminated at Director of Manufacturing within Vaccine Operations.

"I am thrilled to become part of the HemCon team and bring my leadership skills to a company with breakthrough innovation in the plasma world and a proven track record of efficacious and safe medical devices which give HemCon immense potential," said Barry Starkman. "I look forward to working with the team in a timely exit from Chapter 11 and then helping HemCon realize its potential as a highly successful and viable enterprise."

HemCon Medical Technologies, Inc. ( www.hemcon.com ), founded in 2001, develops, manufactures, and markets innovative technologies for rapid delivery of plasma and hemostatic devices for the control of bleeding resulting from trauma or surgery. HemCon products are designed for use by military and civilian first responders as well as medical professionals in hospital and clinical settings where rapid supply of plasma and control of bleeding are of critical importance. HemCon is headquartered in Portland, Ore., with additional commercial operations in Ireland and the Czech Republic.

SOURCE: HemCon Medical Technologies, Inc.