Plasfree has developed ClearPlasma, an innovative filtration system that modifies human plasma to improve the treatment of massive bleeding. By extracting plasminogen, an important protein responsible for dissolving blood clots, ClearPlasma™ enhances coagulation and favours haemostasis. ClearPlasma™ transforms blood plasma through a sophisticated filtration method based on chemical adhesion.
ClearPlasma™ is a disposable filter that can be incorporated either in Apheresis systems (on line) or regular plasma bags (off line), thus not affecting common clinical practices. ClearPlasma™ safety has been proven by pre-clinical studies in accordance to 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.
Decrease of 55% bleeding.
By efficiently removing fibrinolytic proteins such plasminogen, ClearPlasma™ decreases the activity of the endogenous fibrinolytic system and increases the efficiency of coagulation. Patients transfused with plasminogen-free plasma will show an increased capacity to form stable haemostaic clots, thus reduced bleeding tendency thus potentially saving more lives.
PlasFree pre-clinical data show that ClearPlasma™ can reduce by 45% the number of regular plasma units durign excessive bleeding, thus improving the clinical outcome, reducing costs and transfusion bags used and subsequently reducing the time of hospitalization. Moreover, the use of ClearPlasma can prevent certain expensive corrective measures, such as antifibrinolytic therapy, that may be required after standard plasma transfusion.
It is safe.
ClearPlasma™ significantly reduces the concentration of plasminogen, without altering other coagulation parameters, such as fibrinogen concentration or Partial Thromboplastin Time (PTT). Importantly, no thromboembolic or other adverse events were found in swine and in additional pre-clinical safty tests.
Easy to use.
ClearPlasma™ can be integrated in current practices (apheresis systems and blood bags) causing minimal distress to the patients. Transfusion time is not affected by the filtration process, and no extra training is needed for physicians. Plasminogen-depleted plasma obtained can be stored between + 4 ˚C and + 8 ˚C till its use.
Main advantages of the solution with respect to competing solutions: No other competitor offers a solution containing coagulation factors but fibrinolytic factors-free. Currently, FFP is the main treatment of bleeding disorders. Although FFP is relatively cheap and safe to use, it often fails to halt bleeding due to the presence of components of fibrinolytic cascade. To address this problem, antifibrinolytic therapy using TXA have been used. However, these therapies have shown several main disadvantages such as their effectiveness is limited to the first 3 hours and more importantly, post and arterial thrombotic events. Another alternative to FFP is C.Octaplas. C.Octaplas is a sterile, frozen solution of pooled human plasma from several
FFP - Fresh frozen plasma
TXA - Tranexamic acid
C. Octaplas - solvent/ detergent (S/D) treated, pooled human plasma
rFVIIa - Recombinant activated clotting factor VII
donors that has been treated with a solvent detergent process. Although the method is quite cost-effective, it does not address fibrinolytic activity and its use has been related to a high risk of transmitting infectious agents and adverse transfusion reactions due to blood groups mismatches. Finally, rFVIIa is an expensive but potent procoagulant used mainly in treating haemophilia. Unlike ClearPlasma, rFVIIa does not induce the inhibition of the fibrinolytic activity. Moreover, it causes side-effects like increasing the rate of thromboembolic events in intracranial haemorrhage and cardiac surgery[i]. See the table below showing the performance of ClearPlasma vs competing solutions.
Unique selling proposition: ClearPlasma is a cost-effective, easy-to-use filtration system attachable to current Apheresis systems and plasma unit bags without changing the procedure's duration or consuming physician's attention. It is a new product that exhibits pro-coagulant and anti/fibrinolytic properties at the same time that can effectively reduce bleeding (55%). ClearPlasma stops blood flow in bleeding patients, reducing the units of plasma needed during transfusion (45%) and hence reducing treatment costs and mortality.