Following the examination of our DSMB committee, Plas-Free proudly announces the completion of the open label phase evaluating CLearPlasma in Upper gastrointestinal bleeding performed in Gemelli Roma, Italy, led by Prof. Francesco Franceschi.
Plas-Free would like to thank the DSMB members and the Chairman, Dr. Cohen Omri for their professional evaluation of the clinical study.
Plas-Free has successfully completed the open label clinical phase in five upper Gastrointestinal bleeding patients using ClearPlasma in leading hospitals in Israel.
ClearPlasma demonstrated safety and initial efficiency indicated by the reduction of blood loss and more.
PlasFree is happy to announce initiating its first clinical study examining its Medical Device CLearPlasma in Upper Gastrointestinal bleeding patients (https://clinicaltrials.gov/ct2/show/NCT04174989?term=clearplasma&draw=2&rank=1).
PlasFree has received funding from the European Union’s Horizon 2020 research and innovation program SME Instrument Phase 1 grant. EU project 882231 - ClearPlasma.
PlasFree has successfully passed Stage 2 assessment confirming its management system by BSI (notified body).
PlasFree has received Seal of Excellence from the European Commission
PlasFree has successfully pass Stage1 assessment confirm the management system is and ready to proceed to Stage 2 for the CE mark assessment done by BSI ( notified body)
Plasfree is now an ISO 13485 certified medical device company