RANCHO CORDOVA, Calif.,
Nov. 19, 2018 /PRNewswire/ -- Cesca
Therapeutics Inc. (NASDAQ: KOOL), a market leader in automated cell
processing and point-of-care, autologous cell-based therapies,
today announced that its device subsidiary,
ThermoGenesis® Corp., has received 510(k) clearance from
the U.S. Food & Drug Administration (FDA) for its proprietary
AXP® II AutoXpress® Platform (AXP II) for
clinical blood banking.
The AXP II, in combination with the Company's companion,
single-use, cell separation set provides automated, rapid and
reliable harvest of stem and progenitor cells from collected units
of umbilical cord blood in a "functionally-closed" sterile
system. The AXP II is the next-generation of the original AXP
system, which received market clearance in 2007 and is currently
used by premier public and private cord blood banks, worldwide. The
AXP II upgrades functionality, user interface and compatibility
with newer operating systems and features improved docking station,
and XpressTRAK® software to maintain compliance with
Current Good Manufacturing Practice (cGMP) and Current Good Tissue
Practice (cGTP) regulations.
Philip Coelho, ThermoGenesis'
chief technology officer, commented, "Receipt of 510(k) clearance
from the FDA for the AXP II is an important step for the Company
and may expand market adoption as it provides cord blood bank
customers with an automated system that achieves mononuclear cell
(MNC) recoveries >90% and CD34+ stem and progenitor cell
recoveries > 95%. The Company intends to build on this momentum
as we continue to support clinical development in the significant
market of cell-based therapeutics, particularly in the
immuno-oncology field, where we already have begun to play an
important role."
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (the "Company") develops, commercializes
and markets a range of automated technologies for CAR-T and other
cell-based therapies. Its device division, ThermoGenesis Corp.,
provides a full suite of solutions for automated clinical
biobanking, point-of-care applications, and automation for
immuno-oncology. The Company is developing an automated,
functionally-closed CAR-TXpress™ platform to streamline the
manufacturing process for the emerging CAR-T immunotherapy market.
For additional information, please go to:
http://www.cescatherapeutics.com.
Company
Contact:
|
Investor
Contact:
|
Rx
Communications
|
Cesca Therapeutics
Inc.
|
Paula
Schwartz
|
Wendy
Samford
|
917-322-2216
|
916-858-5191
|
pschwartz@rxir.com
|
ir@cescatherapeutics.com
|
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content:http://www.prnewswire.com/news-releases/cesca-therapeutics-receives-510k-clearance-to-market-its-axp-ii-autoxpress-platform-for-clinical-cord-blood-banking-300752902.html
SOURCE Cesca Therapeutics