Plas-Free has developed ClearPlasma, an extracorporeal device designed to effectively and specifically extract plasma proteins responsible for hyperfibrinolysis.
The Plas-Free device enables physicians to improve transfused plasma and shift the hemostasis from hyperfibrinolysis to coagulation, subsequently preventing massive bleeding.
The company's medical device removes plasminogen from blood or plasma.
It is a module unit that can be incorporated into conventional apheresis systems, designed to remove key factors of the fibrinolytic system, resulting in blood and plasma products with enhanced coagulation properties for improved treatment of excessive bleeding.The safety of ClearPlasma has been proven by pre-clinical studies in accordance with the regulatory pathways.
Swine laceration models showed a 55% reduction of bleeding, which was coupled with the absence of any thrombolytic events or alteration of blood composition.
These results together with pyrogenetic studies demonstrate the safety of the device and its potential medical use.Plas-Free is currently conducting clinical studies to demonstrate the device's safety and efficacy in upper gastrointestinal bleeding patients.
It will then seek CE-mark status and FDA approval.