Navigation Links
ThermoGenesis Announces Registration of Res-Q in India; Commercial Sales Expected to Begin in Current Quarter
Date:4/13/2011

RANCHO CORDOVA, Calif., April 13, 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 Res-Q™60 BMC System (Res-Q) has been registered by the Central Drugs Standard Control Organization of India (CDSCO), allowing its commercial sale in the country. Res-Q is a point of care system used for the preparation of cell concentrates, including stem cells from bone marrow aspirate.

"This is a major regulatory milestone for the Company and our market expansion strategy," said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis. "We appreciate the efforts of TotipotentSC (MK Alliance, Inc.), our South Asian partner, in achieving this approval and look forward to working with them on the commercial launch of the product," he added.

The Company said it is ready to initiate the market roll out for Res-Q in India and expects to record initial revenues from the launch during the current quarter, supported by existing clinical trial programs also managed through Totipotent's clinical division.

According to the MK Alliance Chairman, Kenneth L. Harris, "New stem cell technologies, such as Res-Q, are being adopted at a gradual but growing rate in India – a macro market which enjoyed double digit growth despite a challenging economic environment. We believe in cellular medicine and that this device can have an important impact on the clinical cell therapy platform we make available to the medical community."

During the last quarter, Totipotent initiated enrollment in a clinical evaluation to establish the safety and efficacy of Res-Q for use in treating patients with Critical Limb Ischemia (CLI). Enrollment in the study is expected to be completed in the near future. This phase 1b trial is one among several the group expects to execute through its 50 plus partner hospital network sites.

Located in the U.S. and India, TotipotentSC serves as the exclusive distributor for Res-Q and MXP™ MarrowXpress™ in India, Malaysia, Thailand and Mauritius for all fields of use except the human orthopedic market, which is non-exclusive, and is the Company's non-exclusive distributor in South Africa for all fields of use. In these regions, TotipotentSC supports clinical progress in the stem cell field through specialized product and service support.  

About ThermoGenesis Corp.

ThermoGenesis Corp. (www.thermogenesis.com) 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.

About TotipotentSC

TotipotentSC and its sister company TotipotentRX are majority-owned subsidiaries of MK Alliance, Inc. a California corporation dedicated to advancing cellular therapies through innovative devices, application kits, clinical trials, and patient therapies.  TotipotentSC specializes in development, manufacture and marketing of device and kit-related technologies which can be tethered with proprietary clinical protocols in the regenerative medicine market.  MK Alliance, Inc. currently supplies products and services throughout Europe, US and South Asia.  As the first clinical stem cell device and consulting company established in South Asia, MK Alliance's client base has grown to five locations including a GMP medical device manufacturing/assembly facility, two clinical laboratory facilities and two marketing offices.

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 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 2011, 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 2011.  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: http://www.thermogenesis.com
Contact: Investor Relations
+1-916-858-5107, or
ir@thermogenesis.com


'/>"/>
SOURCE ThermoGenesis Corp.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Major China Regenerative Medicine Company Adopts ThermoGenesis Cord Blood Stem Cell Processing And Storage Technologies
2. ThermoGenesis Reports Second Quarter 2011 Results; Increased Presence in China
3. ThermoGenesis Announces Agreement for AXP and BioArchive Cord Blood Systems With Major Chinese Stem Cell Company
4. ThermoGenesis Corp. to Announce Second Quarter Fiscal 2011 Results on February 10, 2011
5. ThermoGenesis Corp. and TotipotentSC Receive Approval for Phase Ib Clinical Trial of Res-Q™ 60 BMC for Treatment of Critical Limb Ischemia
6. ThermoGenesis Corp. Files Shelf Registration Statement on Form S-3
7. ThermoGenesis Signs Major Bone Marrow Product Distribution Agreement in China
8. ThermoGenesis Reports 35 Percent Increase in First Quarter 2011 Revenues, Adds Strategic Advisor and Inks China Distribution Deal With Nanshan Memorial Medical Institute
9. ThermoGenesis Corp. to Announce First Quarter Fiscal 2011 Results on November 4, 2010
10. ThermoGenesis Announces Platelet Rich Plasma (PRP) Res-Q Cardiovascular Licensing Agreement
11. ThermoGenesis Announces Fourth Quarter Revenues of $7.2 Million; Reduces Net Loss to $171,000
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/29/2017)... 2017  Cellect Biotechnology Ltd. (NASDAQ: APOP ... the functional selection of stem cells, today provided a ... quarter ended March 31 st , 2017. ... the first quarter of 2017," said Dr. Shai Yarkoni, ... the treatment of the first blood cancer patient in ...
(Date:5/24/2017)... 2017  ivWatch LLC today announced the launch ... to enable seamless integration of ivWatch,s groundbreaking IV ... pumps and other devices. By integrating ivWatch technology ... help health care customers deliver a higher level ... IV therapy. "The ivWatch OEM Board ...
(Date:5/22/2017)... 22, 2017  As the specialty pharmacy industry ... to make the revolutionary shift from volume-based to ... ensuring positive patient outcomes and shaping the future ... focus away from clinical trials and toward data ... specialty drug therapy utilization in precise patient populations. ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... June 23, 2017 , ... 21 Middle East and ... has selected 21 leaders from government, business and civil society in 11 countries across ... U.S. this fall, engaging in a transformative exchange of knowledge and ideas with the ...
(Date:6/23/2017)... ... June 23, 2017 , ... Ross Insurance ... With the Federal Emergency Management Agency’s (FEMA) recent update of flood zones, more ... 2012, the Biggert-Waters Act was enacted to reflect the actual risk in flood ...
(Date:6/23/2017)... ... June 23, 2017 , ... The Katyl Agency, ... to families and business owners in and around Lackawanna County, is joining Meals ... in the area. , Meals on Wheels of NEPA provides hand-delivered and nutritious ...
(Date:6/23/2017)... ... June 23, 2017 , ... Radabaugh & Associates, a locally ... business owners in North Central West Virginia, is embarking on a cooperative charity ... residents in the region. , The Stepping Stones organization offers a series of ...
(Date:6/22/2017)... ... June 22, 2017 , ... Plastic Surgery Associates is proud to report ... 2017. Each year, research and information firm, Castle Connolly, releases their list of the ... this marks the 3rd time that Dr. Canales has been recognized by ...
Breaking Medicine News(10 mins):