Navigation Links
ThermoGenesis Announces FDA Authorization to Market MarrowXpress(TM) (MXP(TM))
Date:7/14/2008

INITIAL APPLICATION WILL BE FOR USE IN POINT-OF-CARE BONE MARROW PROCESSING

RANCHO CORDOVA, Calif., July 14 /PRNewswire-FirstCall/ -- ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, today said it has received authorization from the FDA to begin marketing its MarrowXpress (MXP) device for use in a clinical laboratory setting or intraoperatively for preparation of a cell concentrate from bone marrow.

Last month, the Company announced it had submitted a 510(k) pre-market notification application to the FDA. Upon its review, the FDA determined that the device was exempt from the agency's pre-market notification requirements and will instead be regulated as laboratory equipment labeled for a specific medical use. The device is a derivative of the Company's AutoXpress(TM) (AXP(TM)) Platform that is used to volume reduce and collect stem cells from umbilical cord blood.

"This notification that we can immediately begin marketing our MXP device is a major regulatory milestone for the Company and particularly exciting since we received this notification just several weeks after filing our submission, and since it follows by less than a month from having received the CE-Mark enabling us to market the device in the European Community," noted Dr. William Osgood, Chief Executive Officer.

Bone marrow derived stem cells are the dominant source of stem cells studied in regenerative medicine clinical trials for treating several large patient population diseases and injuries including blood disorders, ischemic heart diseases, peripheral artery diseases, and diabetes. According to the latest statistics, there are 24 million people in the U.S. Centers f
'/>"/>

SOURCE ThermoGenesis Corp.
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2 3 4

Related biology technology :

1. ThermoGenesis Announces Receipt of CE Mark for MarrowXpress(TM)
2. ThermoGenesis Names Dr. Mahendra Rao to Board of Directors
3. ThermoGenesis Subsidiary Vantus Announces Stem Cell Agreement With UC Davis Center For Equine Health
4. ThermoGenesis Corp. Announces Voluntary Recall of Selected Lots of AXP Bag Sets
5. ThermoGenesis Corp. Reports 48 Percent Growth in Second Quarter Revenues Year Over Year
6. ThermoGenesis Corp. to Announce Second Quarter Fiscal 2008 Results on February 6, 2008
7. ThermoGenesis Corp. to Announce First Quarter Fiscal 2008 Results on November 8, 2007
8. ThermoGenesis Corp. to Present at 2007 Global Life Sciences Conference on Thursday, September 27, 2007
9. ThermoGenesis Corp. Reports Fourth Quarter and Fiscal Year 2007 Results
10. ThermoGenesis Corp. to Announce Fourth Quarter and Year End Results for Fiscal Year 2007 on September 12, 2007
11. NuVasive Announces Web Cast and Conference Call of Second Quarter 2008 Results

Post Your Comments:
*Name:
*Comment:
*Email:
(Date:11/24/2009)...Ontario, Nov. 24 Dow Agr...he assets of Hyland Seeds, a division of Thompsons...and Seeds will further expand Dow AgroSciences, cu...e introduction of SmartStax(TM) in 2010 and ...gy in corn in 2012. The transactional close is exp...
(Date:11/24/2009)...24 /PRNewswire-Asia/ -- NOD Pharmaceuticals Inc. a...) has allowed the patent application for,its nano-... NOD technology is a highly efficient approach t...ve nano-particles to enable oral delivery of drugs...ogy is a platform technology,that can be applied t...
(Date:11/24/2009)... endpoint has been met for patients with advanced-...QUEBEC CITY, Nov. 24 /PRNewswire-FirstCall/ - AEte..."Company"), a global biopharmaceutical company foc...unced positive efficacy data from a Phase 2 study ...S-108 (formerly AN-152), in patients with advanced...
(Date:11/24/2009)...ovember 24 Health Robotics today a...enture with a group of selected,investors. This re...nder the,name Health Robotics Canada, Inc. and wil...v. Room of the Future concept, which includes the,....v.SOFT(TM), and OMM(TM).,Health Robotics Canada I...
Breaking Biology Technology:Dow AgroSciences Canada Announces Agreement to Acquire Hyland Seeds 2Dow AgroSciences Canada Announces Agreement to Acquire Hyland Seeds 3AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endometrial Cancer 2AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endometrial Cancer 3AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endometrial Cancer 4Health Robotics Continues its Global Expansion With December 09 ASHP's Launch of Joint Venture in Canada 2Health Robotics Continues its Global Expansion With December 09 ASHP's Launch of Joint Venture in Canada 3
...HINGTON, Jan. 3 Danaher Corporation (NYSE:,DHR) a...r, H. Lawrence,Culp, Jr. will be presenting at the...o on Tuesday, January 8 at 11:00 a.m. EST. The aud...anaher.com . The presentation will be,archived on ...orporation is a leading manufacturer of Profession...
...G KONG, Jan. 3 /Xinhua-PRNewswire-FirstCall/ -- Ch...aq: CTDC; "the Company" or "CTDC"), a,provider of ...focusing on,solar energy business in China, today ...o showcase the first SnO2 production line at China...28, 2007., Accompanied by Mr. Alan Li, our Chairm...
...SING, Mich., Jan. 3 Neogen Corporation,(Nasdaq: ... second quarter,of FY 2008, which ended Nov. 30, i...er. Adjusted for a 3-for-2 stock split, net income...to the prior year,s $0.17.,Neogen,s second quarter...cord for the 25-year-old company., Year-to-date n...
Other Biology Technology:CTDC Holds a Ribbon Cutting Ceremony to Showcase First SnO2 Production Line 2CTDC Holds a Ribbon Cutting Ceremony to Showcase First SnO2 Production Line 3Neogen Reports 34% Increase in Net Income, 23% Increase in Revenues 2Neogen Reports 34% Increase in Net Income, 23% Increase in Revenues 3Neogen Reports 34% Increase in Net Income, 23% Increase in Revenues 4Neogen Reports 34% Increase in Net Income, 23% Increase in Revenues 5
(Date:11/25/2009)...ced in the stomach, may be used to boost resistanc...ase, Yale School of Medicine researchers report in...al of Neuroscience . , Parkinson,s disease is ca...rea of the midbrain known as the substantia nigra,...duced production of dopamine in late-stage Parkins...
(Date:11/25/2009)..., 2009 Soil is the linchpin of the environment, w...Despite that, many students see soil as "just dirt...science educators are challenged with the task of ...ical importance of soil in the environment. , A...cience teachers at University of Nebraska-Lincoln,...
(Date:11/24/2009)...t has been prescribed by traditional healers in Br...nd stomach pain to fever and flu. , Now for the f...e been able to scientifically prove the pain relie...wn as Brazilian mint. , Testing this ancient Sout...r Graciela Rocha was able to show that when prepar...
Breaking Biology News(10 mins):Hormone ghrelin can boost resistance to Parkinson's disease 2It's not just dirt! 2Got a pain? -- Have a cup of Brazilian mint 2Xanodyne Announces New President CEO and Completes 2438 Million Equity Financing 47880 1Xanodyne Announces New President CEO and Completes 2438 Million Equity Financing 47880 2In Both the U S and Mexico we Must Advance not Retreat From Strategic Government Goals Regarding Drug Addiction and Drug Related Crime Says Narcono 47878 1In Both the U S and Mexico we Must Advance not Retreat From Strategic Government Goals Regarding Drug Addiction and Drug Related Crime Says Narcono 47878 2Cardiogenesis Announces Presentation of its PHOENIX 28R 29 Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally In 4536 1Cardiogenesis Announces Presentation of its PHOENIX 28R 29 Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally In 4536 2Cardiogenesis Announces Presentation of its PHOENIX 28R 29 Combination TMR Plus Stem Cell Delivery System at the International Society of Minimally In 4536 3
... and flies keeps blood sugar under control in mice...m. The findings suggest therapeutic interventions ...rders, such as type 2 diabetes, which frequently a...und that mice with an excess of the protein Sirt1 ...erance and enhanced insulin secretion in response ...
...ls grow along proper paths during embryonic develo...-cord neurons from regenerating after injury, rese...nd. In cultured cells, the researchers found that ...nsulates and stabilizes long nerve fibers in adult...ve cells to grow through myelin that is released w...
...n, show for the first time that bacteria, in addit...tation of the sparkling wine known as Cava. They r...eting of the American Society for Microbiology. , ...nctive impact upon sparkling wine quality in terms...nce, especially for premium quality wines," says N...
Other Biology News:Sea Ice May Be on Increase in the Antarctic 2Researchers find molecule that inhibits regrowth of spinal nerve cells 2Researchers find molecule that inhibits regrowth of spinal nerve cells 3After the yeast is gone bacteria continue to develop flavor of sparkling wine 2
MetaMorph from Universal Imaging Corporation (a subsidiary of Molecular Devices)
Pyronin Y from Sigma-Aldrich
...fast and simple integration of loxP-sites into lar...tion of transgenic mouse models). The included lox...eomycin / kanamycin selection in prokaryotic and e...r (gb2) for expression of kanamycin resistance in ...
...nt to offer true walk-away automation of magnetic ...ogy to isolate cells by either positive or negativ...4 samples at one time. RoboSep is easily controlle...l user interface makes it simple and fast to set u...
Biology Products: