BioInformant

Your Global Leader in Stem Cell Market Research

MENUMENU
  • Blog
    • Interviews
  • News
  • Stem Cells
    • iPS Cells
    • MSCs
    • HSCs
    • Adipose SCs
    • Neural Stem Cells
  • Exosomes
  • CAR-T
  • Cord Blood
  • Shop
    • Products
    • Submit PR
    • Advertise
  • About
    • Testimonials
    • Story
    • Guarantee
    • Contact
  • Home
  • Blog
    • Stem Cells
      • HSCs
      • iPS Cells
      • MSCs
      • Neural Stem Cells
      • Adipose SCs
    • Exosomes
    • Cell Therapy
      • CAR-T
    • Cord Blood
    • Stem Cell News
    • Interviews
  • COVID-19
  • Shop
  • Submit PR
  • Company
    • Advertise
    • Testimonials
    • Story
    • Job Posts
    • Guarantee
    • Privacy Policy
    • Contact
Home » Cesca Therapeutics Receives 510(k) Clearance to Market Its AXP® II AutoXpress® Platform for Clinical Cord Blood Banking

Cesca Therapeutics Receives 510(k) Clearance to Market Its AXP® II AutoXpress® Platform for Clinical Cord Blood Banking

December 4, 2018 By Cade Hildreth (CEO) 1 Comment

RANCHO CORDOVA, Calif., Nov. 19, 2018— 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.

Discover class-defining bioproduction tools.

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.

bitbio

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.

iPSC-derived cardiomyocte therapy

To learn more about the rapidly evolving cord blood sector, view the “Global Cord Blood Banking Industry Report.”

Cord Blood Banking Report 2018

Pluristyx
3.1/5 - (7 votes)

Filed Under: Cord Blood, Press Releases Tagged With: Cesca Therapeutics, cord blood

Related

About Cade Hildreth (CEO)

Cade Hildreth is the Founder of BioInformant.com, the world's largest publisher of stem cell industry news. Cade is a media expert on stem cells, recently interviewed by the Wall Street Journal, Los Angeles Business Journal, Xconomy, and Vogue Magazine. 

Comments

  1. VINCE says

    December 4, 2018 at 11:22 pm

    Anytime a company receives such an approval from the FD that caters specifically to the regenerative sector it’s a positive.

    Reply

Tell Us What You Think! Cancel reply

Nanocellect

Marathon Products

Let’s Get Social

  • Facebook
  • Twitter
  • LinkedIn
  • Pinterest
  • Instagram
Menu
  • Blog
  • Stem Cell News
    • Press Releases
  • Stem Cells
    • HSCs
    • iPS Cells
    • MSCs
    • Neural Stem Cells
    • Adipose SCs
  • Exosomes
  • Cell Therapy
    • CAR-T
  • Cord Blood
  • Interviews

Cart

Featured Posts

PolarityTE RMAT

PolarityTE Announces FDA RMAT Awarded to Its Designation Granted to SkinTE®

Advanced Therapy | What is a RMAT Designation (and Who Has One)?

What Is An RMAT? List of Publicly Announced RMAT Designations (64)

i-peaces-cell-manufacturing

I Peace accelerates allogeneic iPSC-derived cell therapies with a high throughput method to identify a large number of donors with specific HLA haplotypes

My Tweets

BioInformant's World-Class Clients

  • Submit Press Release
  • Advertise
  • Privacy and Terms

Copyright © 2022 · BIOINFORMANT, Your Global Leader in Stem Cell Market Research

| Email: Info@BioInformant.com | Phone: 703-859-7617 |

800 Corporate Drive, Suite 301, Stafford, VA 22554, United States

Disclaimer: All statements made on this website are NOT expressed as medical claims or advice. They are not intended to diagnose, treat, cure or prevent any disease or condition. If you have a health condition or concern, consult your physician or health care provider.