RANCHO CORDOVA, Calif.,
June 18, 2019 /PRNewswire/
-- ThermoGenesis Corp., a wholly owned subsidiary
of Cesca Therapeutics (Nasdaq: KOOL), and a market leader
in automated cellular processing, today announced that it
has received Health Canada approval of its next-generation
AXP®II system for cord blood processing.
The AXP® II, together with the company's companion, single-use,
cell separation set, provides automated, rapid and reproducible
harvesting of stem and progenitor cells from collected units of
umbilical cord blood in a "functionally-closed" sterile system. The
system, which received 510(k) market clearance from the U.S. Food
& Drug Administration (FDA) in November
2018, is used by premier public and private cord blood
banks, worldwide. It provides customers with upgraded
functionality, user interface and compatibility with newer
operating systems and features an improved docking station, and
XpressTRAK® software to maintain compliance with
Current Good Manufacturing Practice (cGMP) and Current Good Tissue
Practice (cGTP) regulations.
Haihong Zhu, President of
ThermoGenesis, stated, "Health Canada's approval of the AXP® II --
following its approval of the PXP® System earlier this year --
marks the achievement of yet another key milestone and should allow
us to meaningfully expand our footprint with a best-in-class system
that, today, continues to hold a market-leading position. That
said, we look forward to building on our customer base by offering
Cord Blood Banks throughout Canada
with the ability to undertake cord blood processing with a system
that generates mononuclear cell (MNC) recoveries of >90% and
CD34+ stem and progenitor cell recoveries of > 95%."
More About the AXP® II System
The AXP® II is a proprietary, automated system for the
separation, processing and storage of hematopoietic stem cell
concentrates from cord blood. Its functionality:
- automates the volume reduction process,
- provides consistent buffy coat concentration volumes,
- ensures high recoveries of mononuclear cells in a targeted
volume, and
- allows for simultaneously processing of multiple cord blood
units in one centrifuge.
The AXP® II System includes the AXP II Device, AXP II
Docking Station, AXP Processing Bag Set, XpressTRAK® software
and accessories.
About ThermoGenesis
ThermoGenesis develops,
commercializes and markets a full suite of solutions for automated
clinical biobanking, point-of-care applications, and automation for
immuno-oncology. The Company has developed an automated,
functionally closed CAR-TXpress™ Platform to streamline the
manufacturing process for the emerging CAR-T immunotherapy market.
For additional information, please visit:
www.thermogenesis.com.
About Cesca Therapeutics Inc.
Cesca Therapeutics
Inc. is a market leader in cell processing technologies and
autologous cell therapies for regenerative medicine. For more
information, visit: www.cescatherapeutics.com.
Forward-Looking Statement
The statements contained
herein may include statements of future expectations and other
forward-looking statements that are based on management's current
views and assumptions and involve known and unknown risks and
uncertainties that could cause actual results, performance or
events to differ materially from those expressed or implied in
such statements. A more complete description of risks that could
cause actual events to differ from the outcomes predicted by Cesca
Therapeutics' forward-looking statements is set forth under the
caption "Risk Factors" in Cesca Therapeutics' Annual Report on Form
10-K and other reports it files with the Securities and Exchange
Commission from time to time, and you should consider each of those
factors when evaluating the forward-looking statements.
Company Contact:
Wendy
Samford
916-858-5191
ir@thermogenesis.com
Investor Contact:
Paula
Schwartz, Rx Communications
917-322-2216
pschwartz@rxir.com
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SOURCE Cesca Therapeutics Inc.
