Navigation Links
ThermoGenesis Announces Acceptance of AXP® Submission by Regulatory Body in China

RANCHO CORDOVA, Calif., Oct. 11, 2011 /PRNewswire/ -- ThermoGenesis Corp. (NASDAQ: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, said today that its submission for approval of the AXP® AutoXpress® (AXP) which is used to concentrate stem cells from cord blood, has been accepted by the State Food & Drug Administration (SFDA) in China. This represents the successful completion of product testing and the administrative acceptance of the submission.  Final technical review is now in process and is the final step requiring completion prior to in-country registration approval and commercial sales of the system.

"This is an important step in the regulatory process and we are hopeful that we will receive regulatory approval for the AXP in China by early calendar 2012, if not before," said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.

"We have established a strong footprint for our cord blood products in China through several major customer and distribution agreements with leaders in the country's regenerative medicine sector. We believe the China cord blood market could equal or surpass that of the U.S. and reach $200 million by the middle of the decade," he noted.

"Our cord blood relationships in China include our distributor Fenwal, Inc., a global medical technology company that has formed a joint venture with Golden Meditech in China to focus on blood collection and transfusion products, which we believe gives Fenwal a distinct 'in-country' competitive advantage. In addition," he continued, "our initial efforts in China have yielded three cord blood bank customers, including Beike Biotechnology Co., Ltd., Nanshan Memorial Medical Institute, and BoyaLife, our largest operating cord blood banking customer in China. Adoption of the AXP processing system enables these banks to substantially scale their processing operations in a closed, sterile system to meet growing customer demand and to achieve important quality accreditations such as from the AABB," he said.

About ThermoGenesis Corp.

ThermoGenesis Corp. ( is a leader in developing and manufacturing automated blood processing systems and disposable products that enable the manufacture, preservation and delivery of cell and tissue therapy products. These include:

  • The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
  • AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood. The MXP is used for the preparation of cell concentrates, including stem cells, from bone marrow aspirates in the laboratory setting.
  • The Res-Q® 60 BMC (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates.
  • The CryoSeal® FS System, an automated device and companion sterile blood processing disposable, used to prepare fibrin sealants from plasma in about an hour. The CryoSeal FS System is approved in the U.S. for liver resection surgeries. The CryoSeal FS System has received the CE-Mark which allows sales of the product throughout the European community.

This press release contains forward-looking statements.  These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. Several factors including timing of FDA and foreign regulatory approvals, changes in customer forecasts, our failure to meet customers' purchase order and quality requirements, supply shortages, production delays, changes in the markets for customers' products, introduction timing and acceptance of our new products scheduled for fiscal year 2012, and introduction of competitive products and other factors beyond our control could result in a materially different revenue outcome and/or in our failure to achieve the revenue levels we expect for fiscal 2012.  A more complete description of these and other risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in our annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.

ThermoGenesis Corp.
Web site:
Contact: Investor Relations
+1-916-858-5107, or

SOURCE ThermoGenesis Corp.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. ThermoGenesis Corp. to Announce Fourth Quarter and Year End Results for Fiscal 2011 on September 12, 2011
2. ThermoGenesis Announces China Customer Implements Cord Blood Products
3. ThermoGenesis Announces Sale of BioArchive Systems In Asia as Company Increases Presence In Key Market
4. ThermoGenesis Reports 15 Percent Increase in First Quarter Revenues; Improved Bottom Line
5. Thermogenesis Corp. to Announce First Quarter Fiscal 2010 Results on November 5, 2009
6. ThermoGenesis Receives Notice Related to Nasdaq Minimum Closing Bid Price Rule
7. ThermoGenesis Reports Fourth Quarter and Fiscal 2009 Results
8. ThermoGenesis Announces Expanded Collaboration With Celling Technologies
9. ThermoGenesis Provides Update on Fiscal 2009 Results
10. ThermoGenesis Announces Abstracts to Be Presented at Upcoming Stem Cell Therapy Conference
11. ThermoGenesis Says FDA Concurs with Plan for Previously Announced AXP(TM) Bagset Recall
Post Your Comments:
(Date:11/24/2015)... PUNE, India , November 24, 2015 ... to a new market research report "Oligonucleotide Synthesis Market ... Equipment), Application (PCR, Gene Synthesis, Diagnostic, DNA, RNAi), End-User ... to 2020", published by MarketsandMarkets, the market is expected ... 1,078.1 Million in 2015, at a CAGR of 10.1% ...
(Date:11/24/2015)... SHPG ) announced today that Jeff Poulton , Chief ... Annual Healthcare Conference in New York City , ... p.m. GMT). --> SHPG ) announced today that ... Jaffray 27 th Annual Healthcare Conference in New ... 8:30 a.m. EST (1:30 p.m. GMT). --> Shire plc ...
(Date:11/24/2015)... , Nov. 24, 2015 /PRNewswire/ - Aeterna Zentaris ... today that the remaining 11,000 post-share consolidation (or ... Warrants (the "Series B Warrants") subject to the ... on November 23, 2015, which will result in ... giving effect to the issuance of such shares, ...
(Date:11/24/2015)... Switzerland (PRWEB) , ... November 24, 2015 , ... InSphero ... organotypic 3D cell culture models, has promoted Melanie Aregger to serve as Chief Operating ... Ms. Aregger served on the management team and was promoted to Head ...
Breaking Biology Technology:
(Date:11/10/2015)... , Nov. 10, 2015  In this ... the basis of product, type, application, disease ... in this report are consumables, services, software. ... are safety biomarkers, efficacy biomarkers, and validation ... report are diagnostics development, drug discovery and ...
(Date:11/4/2015)... , November 4, 2015 ... new market report published by Transparency Market Research "Home Security ... Trends and Forecast 2015 - 2022", the global home security ... 30.3 bn by 2022. The market is estimated to ... period from 2015 to 2022. Rising security needs among ...
(Date:10/29/2015)... -- Daon, a global leader in mobile biometric authentication ... version of its IdentityX Platform , IdentityX v4.0. ... have already installed IdentityX v4.0 and are seeing ... UAF certified server component as an option and ... These customers include some of the largest and most ...
Breaking Biology News(10 mins):