ProFibrix

ProFibrix B.V. was a biopharmaceutical company focused on developing products for hemostasis and regenerative medicine. The company was established in 2004 by founder and Chief Scientific Officer Jaap Koopman, PhD, whose extensive background in fibrinogen research formed the core of the company's scientific foundation. ProFibrix operated from its headquarters in Leiden, The Netherlands, and a subsidiary in Seattle, Washington, which facilitated its clinical trials and access to the U.S. market.

The company's core business centered on leveraging its specialized knowledge of fibrinogen technology to create solutions for the surgical bleeding market. Its primary client base consisted of hospitals and surgery centers. ProFibrix's flagship product was Fibrocaps™, a dry powder topical fibrin sealant designed to control bleeding during surgical procedures. Composed of fibrinogen and thrombin, two essential blood-clotting proteins, Fibrocaps™ was developed as a ready-to-use product that remained stable at room temperature, eliminating the need for frozen storage or thawing required by many existing liquid fibrin sealants. A complementary spray device was also developed to aid in its application.

The development of Fibrocaps™ progressed through several key milestones, including successful Phase II and Phase III (FINISH-3) clinical trials. The positive results of the FINISH-3 trial, which enrolled 719 patients across various surgical indications, demonstrated the product's efficacy and safety in controlling mild to moderate surgical bleeding. This success was a pivotal event, leading to the acquisition of ProFibrix by The Medicines Company in August 2013. The deal involved an initial payment with potential for further milestone-based payments, valuing the transaction at up to $240 million. Following the acquisition, Fibrocaps™ was later rebranded as RAPLIXA™ and subsequently acquired by Mallinckrodt from The Medicines Company in 2015.

Keywords: hemostasis, fibrin sealant, surgical bleeding, fibrinogen technology, regenerative medicine, topical hemostat, blood clotting, biopharmaceutical, Fibrocaps, Jaap Koopman, The Medicines Company acquisition, RAPLIXA, clinical trials, drug development, surgical products, tissue sealant, dry powder sealant, vascular surgery, spinal surgery, liver resection