US FDA clears Terumo Blood and Cell Technologies' new plasma collection technology

The Rika Plasma Donation System is designed to optimize plasma collection to help patients affected by life-threatening illnesses

• The Rika Plasma Donation System (Rika) is designed for donor comfort and safety. On average, it completes plasma collections in 35 minutes or less, ensures there is never more than 200 millilitres of blood outside the donor's body at one time and has an advanced control system to guide device operators.
• Rika will debut in CSL Plasma centers in the United States. CSL Plasma is a subsidiary of global biotherapeutics company CSL Behring, which manufactures lifesaving plasma-derived therapies for people in more than 100 countries.
• It can take 130 plasma donations to treat the annual needs of just one patient with a primary immune deficiency, according to the Plasma Protein Therapeutics Association.

Lakewood, CO., US, March 10, 2022 - Today the U.S Food and Drug Administration (FDA) cleared the new plasma collection system developed by Terumo Blood and Cell Technologies (Terumo BCT), a medical technology focused on the experience of plasma center employees and donors. It includes safety features to minimize operator errors and collects plasma in 35 minutes or less. Rika will debut this spring in a limited market release at CSL Plasma collection centers in Denver, Colorado area. Plans are underway for rollout at addition; CSL Plasma centers in 2022.

Rika was developed in response to the industry's need for technological advancement and process improvements to drive efficiency and quality while maintaining donor safety and a sufficient plasma supply.

Investing in the source plasma industry is a natural evolution in the Terumo Blood and Cell Technologies portfolio given its experience and leadership in apheresis technology. The company spends three times more than the industry average in development as an innovation partner to customers globally.

"Rika will revolutionize plasma collection center operations," said Antoinette Gawin, President and Chief Executive Officer, Terumo Blood and Cell Technologies. "We innovated around the donor and plasma center experience, creating an entire new ecosystem. At the heart of our innovation is operational efficiency designed to collect plasma in 35 minutes or less. This will help meet the need for plasma-derived therapies. Today, as an example, it could take 130 donations to treat one patient with a primary immunodeficiency for a year. This is such an important moment for us to contribute to society through healthcare and fulfill our purpose of reaching more patients."

The new technology is focused on donor and plasma collection center employee experience. A collection time of 35 minutes or less, combined with volume of 200 milliliters or less outside the donor's body, can mean a more comfortable donation experience. Rika's advanced control system enhances donor safety by monitoring the process and providing alerts and visual cues that guide the operator. Rika makes automatic adjustments during each procedure, enabling a more seamless operator experience and the ability to spend more time with the donor.

Rika is part of an extensive ecosystem that integrates plasma collection technology, IT solutions, services and program support. All this is anticipated to support center productivity and efficiency to optimize plasma collections and meet the needs of patients who rely on plasma-derived therapies.

“With this crucial milestone achieved, we look forward to rolling this new technology out to our U.S. collection centers,” 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.”