Improving Patient Care Through Technology

Resusix®

entegrion website art product boxes-FIELD MEDICNE

Benefits:

  • +2 Year Shelf Life
  • Inactivates Enveloped Viruses
  • Free of Micro Particles and Cell Fragments
  • Cold Chain Storage Not Required
  • Rehydrated for Transfusion in Minutes

An alternative to Fresh Frozen Plasma (FFP) is needed for the immediate treatment of patients with severe hemorrhage.

Resusix is a pooled, pathogen reduced, dehydrated plasma product being developed by Entegrion to provide a reliable source of coagulation factors and volume replacement available immediately, wherever needed.

The Resusix technology is based on methods developed in response to the HIV epidemic of the 1980’s.  As a result of this epidemic, solvent detergent (S/D) treatment of plasma was introduced on a large scale to inactivate enveloped viruses such as HIV, Ebola, Dengue, Zika and many others.  Additionally, the S/D treated plasma product is filtered multiple times, removing cell fragments and micro-particles, resulting in a product that is only albumin and coagulation factors.  This process provides a level of safety far beyond fresh frozen plasma (FFP) which relies on donor questionnaires to eliminate high risk donors, and limited testing prior to transfusion.  Entire countries such as Norway and Sweden have switched to S/D plasma as their only source of plasma for transfusions.

A primary issue affecting the efficacy of FFP is donor variability (U. Salge-Bartels), which results in significant differences in the coagulation and protein content within individual units of single donor plasma. S/D treatment allows for the pooling of multiple plasma donors, providing standardization of the level of protein and coagulation factors for each dose derived from the plasma pool, giving the clinician predictability in dosing.  Due to this standardization, evidence suggests that in goal directed therapy, less S/D plasma is needed to correct coagulopathy than normal FFP (Bindi).

The Resusix technology yields a dehydrated plasma product derived from the pooling and S/D treatment process via spray drying.  The spray drying process is rapid and well controlled, allowing the dehydration of the S/D plasma on a sub second timescale.  This resulting reconstituted product has a coagulation profile that meets the rigorous standards set in EU Pharmacopeia for S/D plasma.

Easy-to-use and fully portable, Resusix offers a valuable advantage in remote and austere settings for both military and civilian use. With an extended shelf life of more than two years, the longer storage capacity breaks the cold chain restrictions of frozen blood plasma.

Resusix is entering phase 2 clinical development.