Navigation Links
ThermoGenesis Announces Filing of 510(k) Application for MarrowXpress


RANCHO CORDOVA, Calif., June 4 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, today announced that it has submitted a 510(k) pre-market notification application to the FDA requesting regulatory clearance for its MarrowXpress(TM) (MXP(TM)), a device designed for the processing of bone marrow in a laboratory setting.

The device is a derivative of the Company's approved AutoXpress(TM) (AXP(TM)) Platform that is used to volume reduce and collect stem cells from umbilical cord blood.

"This is an important milestone in the Company's product diversification and growth strategy. We are hopeful that the regulatory process will be facilitated because the MXP is based on a currently approved device," said Dr. William Osgood, Chief Executive Officer.

Osgood said the Company expects to receive a CE Mark for the MXP this month, which would enable the Company to begin commercial marketing of the device in Europe.

"The use of adult stem cells to treat a variety of diseases and injuries is very promising. There are a number of clinical trials already underway, and in several countries it is a practice of medicine for indications such as critical limb ischemia, coronary artery disease and orthopedic conditions. We have had very encouraging discussions with leading research centers in both the U.S. and Europe regarding the potential use of the MXP in ongoing clinical trials and look forward to getting this device into the clinical setting. We believe this could ultimately represent a multi-billion dollar market opportunity for the Company," he added.

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 products include:

-- The BioArchive(R) System, an automated cryogenic device, is used by

cord blood stem cell banks in more than 25 countries for

cryopreserving and archiving cord blood stem cell units for

transplant. GE Healthcare is the non-exclusive global distribution

partner for the BioArchive System.

-- AXP(TM) AutoXpress Platform (AXP(TM)) is a proprietary family of

automated devices that includes the AXP and the MarrowXpress(TM) and

companion sterile blood processing disposable for harvesting stem

cells in a closed system. The AXP device is used for the processing of

cord blood. GE Healthcare is the exclusive global distribution

partner for the AXP cord blood product. The MarrowXpress is used for

isolating stem cells from bone marrow. ThermoGenesis sells the

MarrowXpress directly to global customers.

-- The CryoSeal(R) FS System, an automated device and companion sterile

blood processing disposable, is used to prepare fibrin sealants from

plasma in about an hour. We received FDA approval to market the

CryoSeal FS System in liver resection surgeries in July 2007. The

CryoSeal FS System has received the CE-Mark. From a marketing

perspective, the CE Mark is the European equivalent to an FDA

approval, in that it allows sales of the product throughout the

European community. Asahi Medical is the exclusive distributor for the

CryoSeal System in Japan and the Company markets through independent

distributors in Europe and South America.

-- The Thrombin Processing Device(TM) (TPD(TM)) is a sterile blood

processing disposable that prepares activated thrombin from a small

aliquot of plasma in less than 30 minutes. The CE-Marked TPD is

currently being marketed in Europe by Biomet, Inc., subsidiary Biomet

Biologics, Medtronic, Inc. and independent distributors.

This press release contains forward-looking statements, and such statements are made pursuant to the safe harbour provisions of the Private Securities Litigation Reform Act of 1995. 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 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 2008, 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 2008. 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©2008 PR Newswire.
All rights reserved

Related medicine news :

1. ThermoGenesis Announces 510(k) Clearance for AutoXpress(TM) Cord Blood Processing System
2. ThermoGenesis Corp. Reports First Quarter 2008 Results
3. Thermogenesis Announces New Initiative to Address Veterinary Regenerative Medicine
4. HHS Announces $75 Million in Supplemental Funding to States for Pandemic Flu Preparedness
5. CRC Health Group Announces Acquisition of Bayside Marin Recovery Center, San Rafael
6. UHW Announces: Antelope Valley Hospital Caregivers and Board Vote to Ratify First Union Contract With SEIU UHW-West
7. HEI, Inc. Announces Sale of RFID Division Assets
8. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
9. Mettler-Toledo International Inc. Announces Webcast of Presentation at Thomas Weisel Partners 2007 Healthcare Conference
10. Z Trim Announces Revocation of Gregory Halpern Severence Agreement
11. Brooke Franchise Corporation Announces Selected July Results
Post Your Comments:
(Date:11/29/2015)... Viejo, CA (PRWEB) , ... November 29, 2015 ... ... an all new and unique analog distortion effect tool designed specially for Final ... their footage, and create limiltess looks with the easy-to-use modification controls. Destoying and ...
(Date:11/29/2015)... Jose, CA (PRWEB) , ... November 29, 2015 , ... ... Area, is proud to announce their December, 2015, featured apartment community: Epic. In showcasing ... for corporate housing in the tight Bay Area rental market to efficiently find housing ...
(Date:11/28/2015)... ... ... Safe storage for contraceptive devices may not always be easy to find. However, ... other from Bradley Beach, New Jersey, there is an easy solution to the problem. ... NuvaRings more often than necessary. As such, it affords peace of mind and eliminates ...
(Date:11/28/2015)... ... November 28, 2015 , ... Beginning November 30th at 6:00 a.m. EST until 11:59 ... savings. , With possible savings of up to 20% off orders $80 or more to ... the website every few hours. , As a competitive e-commerce website for skin care and ...
(Date:11/27/2015)... Toronto, Canada (PRWEB) , ... November 28, 2015 , ... ... How do we outperform our billings from last year? , This question has not ... many organizations are coming to the retirement age and the younger workforce don’t share ...
Breaking Medicine News(10 mins):
(Date:11/26/2015)... 2015 ) ... "2016 Future Horizons and Growth Strategies in ... Supplier Shares, Country Segment Forecasts, Competitive Intelligence, ... --> ) has announced ... Horizons and Growth Strategies in the German ...
(Date:11/26/2015)... November 26, 2015 ... addition of the  "2016 Future Horizons ... Therapeutic Drug Monitoring (TDM) Market: Supplier ... Emerging Opportunities"  report to their offering.  ... announced the addition of the  "2016 ...
(Date:11/26/2015)... 2015 Research and Markets ( ... "2016 Future Horizons and Growth Strategies in the ... Country Segment Forecasts, Competitive Intelligence, Emerging Opportunities" ... --> --> This new 247-page ... therapeutic drug monitoring market, including emerging tests, technologies, ...
Breaking Medicine Technology: