Clinical study results:

The company has successfully completed open label phase of a clinical trial evaluating the safety and efficiency of ClearPlsama on upper gastrointestinal bleeding patients in Israel. We found efficacy indications using ClearPlasma on those bleeding patients which was demonstrated by reducing the time of bleeding, decreasing the number of platelets units needed for halting the bleeding, and finally in 2 out 5 patients, ClearPlasma helped reduce the hospitalization time. No adverse events or thromboembolic event were found using our technology. In parallel, the company is performing a multi-center clinical study (Italy and Czech-Republic with overall 50 patients) double blind randomized in upper gastrointestinal bleeding and already enrolled 10 patients. All sites report positive feedback on the use of the device and the simplicity to integrate it with their systems. In addition, to the upper GI clinical study the company is initiating a clinical study evaluating ClearPlasma efficiency in cardiac operations. This clinical study will be used as part of the approval needed for the FDA and for promotion activities in Europe.

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More Information about Plas-Free clinical trial can be found  in the link below: 

(https://clinicaltrials.gov/ct2/show/NCT04174989?cond=clearplasma&draw=2&rank=1) 

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Pre-Clinical results

ClearPlasma™ efficacy

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ClearPlasma™ was tested in several animal models with massive bleeding

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1. Tail Bleeding assay is widely used as an in vivo assessment of haemostatic action in rodents (1). The company has performed several experiments utilizing this model and has demonstrated that ClearPlasma™  reduces the amount of bleeding by more than 50%. 

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ClearPlasma™  was  Reduces the amount of bleeding in more than 50%. The blood cell pellet from the bleeding test was centrifuged and the supernatant was aspirated. Pellet size was then measured using a ruler. A. Pellet size results for each mouse; B. Statistical analysis of pellet size measurement. Statistics were calculated using One-way ANOVA followed by posthoc LSD/SCHELF( p<0.05 considered significant). (N=20 for each group) .

 

2. liver lacerations model- this model mimics trauma sustained to the liver. These trauma events can occur through either a blunt force such as a car accident, or a penetrating foreign object such as a knife. The company exmined  ClearPlasma™    using this model in pigs.  The Company demonstrated that plasma transfusion using  ClearPlasma™  reduces the amount of bleeding by more than 50%, improves the hemodynamic parameters and benefits the animal condition.

ClearPlasma™ safety

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The company examined the safety of the device and the improved plasma in several aspects:

Its effect on thromboembolic events, Pyrogenicity or Haemolysis of red blood cells.  The company demonstrated that ClearPlasma did not increase the levels of thromboembolic events, fever or Haemolysis.

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