Viatar asked Evergreen Research Inc. (ERI) to work with them to design a mechanical system that could remove circulating tumor cells (CTCs) from the bloodstream of patients with stage 4 cancer. Research has demonstrated that accomplishing this removal would allow the immune system to focus on the original and/or metastasized tumors, working with whatever therapy is applied. ERI was pleased to have been selected as the design and manufacturing partner for Viatar.
ERI designed and manufactures the Viatar Oncopheresis System to accomplish this important purpose. An examination of the mechanical characteristics of CTCs associated with most solid tumor cancers, showed them to be rigid, unlike red and white blood cells which are very flexible, bending or changing shape when needed.
So Viatar and ERI designed a system using a polymer sheet with approximately 170 million 5 micron holes, drilled using an automated laser. The filter media was then mounted into a cylindrical housing which directs the blood in a cross-flow manner to filter the CTCs without clogging. Blood cells pass through easily. CTCs do not.
The system has shown over 90% CTC removal efficiency in animal and laboratory testing. First-In-Human testing is expected to begin in 2020.
Design of all hardware and software
Design of tubing set
Prototyping for testing and qualifications
Performance-Laboratory verification testing
Setup the QMS (Quality Management System)
All required design control documents to support testing and qualification
Prototype systems for testing and qualification
Sterile tubing sets and assembly of prototype filter cartridges for testing and qualification