FDA Clearance of Plasma Collection Technology

BOCA RATON, Florida, 10 March 2022 CSL Plasma, the plasma collection business of global biotherapeutics leader CSL Behring, today welcomes the regulatory clearance of the Rika Plasma Donation System developed by Terumo Blood and Cell Technologies, a medical technology company based in Lakewood, Colorado.

As Terumo Blood and Cell Technologies has shared, anticipated benefits of the new plasmapheresis system include technology to support a safe, efficient, and improved experience for plasma donors, as well as an improved experience for CSL Plasma employees.

CSL Plasma believes additional features of the new Rika system can enable the collection of more plasma, in shorter periods of time, supporting quality and safety, and ultimately better serving patients who rely on plasma-based therapies. These benefits include:

  • Rika completes one plasma collection in 35 minutes or less on average.
    • When considering prior average CSL Plasma donation times, this could represent a nearly 30% reduction in average donation time for donors.
  • It ensures there's not more than 200 milliliters of blood outside the donor's body at one time. This is expected to improve the donor's comfort during the donation and reduce the occurrence of a red cell loss deferral.
  • It is designed with an advanced user interface to guide CSL Plasma front-line employees who operate the device.

"This milestone helps bring to life how we demonstrate innovation, collaboration and patient-focus, part of the CSL Values that underpin our commitment to manufacturing and delivering life-saving and life-extending medicines around the world," said CSL Chief Operating Officer Paul McKenzie. "We continue to evolve as a leading biotechnology company, investing in our core plasma business.

"Continued innovation that benefits our employees and plasma donors speaks to how we are driven by our promise to save and improve lives around the world."

CSL Plasma will begin implementation of the new device at centers in the Denver, Colorado, area in coming months.

"There is a critical and ongoing need for human plasma to produce life-saving medicines for people with serious and rare diseases," said CSL Plasma General Manager Michelle Meyer. "CSL Plasma's decision to work with Terumo Blood and Cell Technologies is consistent with our business goals to improve the donor and employee experience through innovation and remain the plasma donation center of choice. We look forward to rolling out this new technology."

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