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ThermoGenesis Corp. and TotipotentSC Receive Approval for Phase Ib Clinical Trial of Res-Q™ 60 BMC for Treatment of Critical Limb Ischemia
Date:1/26/2011

RANCHO CORDOVA, Calif., Jan. 26, 2011 /PRNewswire/ -- ThermoGenesis Corp. (Nasdaq: KOOL), a leading supplier of innovative products and services that process and store adult stem cells, and TotipotentSC, a U.S. company with a large India presence in medical devices, cellular therapy and clinical research management, announced today they have received approval from Fortis Escorts' (New Delhi) Independent Ethics Committee to proceed with a Phase Ib clinical trial in patients suffering from Non-Reconstructable Critical Limb Ischemia (CLI) utilizing ThermoGenesis' Res-Q™ 60 BMC system.

CLI, an advanced stage of peripheral artery disease, is characterized by peripheral arterial obstruction resulting in a severe reduction in blood flow to the extremities (hands, feet and legs).  This chronic vascular disorder presents symptoms progressing from mild discomfort to severe rest pain, skin ulcers and major tissue death.  CLI may result in limb amputation if not properly treated.  CLI afflicts millions of patients globally, and has a significant impact in the Indian population.  As such, CLI is a heavy burden on the Indian healthcare system with an estimated 20 million patients suffering from various stages of the disease.

The objectives of the trial are to assess safety and efficacy of stem cells derived from autologous concentrated bone marrow prepared using the Res-Q system.  Specific primary endpoints include safety of the cell processing and delivery plus limb salvage rates in 15 patients suffering from the most advanced stage of peripheral artery disease.  Each enrolled patient will have been determined medically unsuitable for further traditional modalities of treatment.  

The Res-Q system is CE-Marked for Europe and is an exempt Class I device in the U.S. as a laboratory single use sterile (disposable) bone marrow concentration device.  

"We are pleased to manage this clinical trial in collaboration with ThermoGenesis.  The trial will be conducted at the prestigious Escorts Heart Institute in New Delhi, which is part of the Fortis Healthcare network where TotipotentSC has a long term exclusive partnership for advancing the clinical adoption of adult cellular therapies," said Ken Harris, Chairman and CEO of MK Alliance, Inc. the parent company of TotipotentSC.

"We are looking forward to the initiation of enrollment in this clinical evaluation and are pleased to be collaborating with TotipotentSC as it shepherds the process in-country.  The early experience with the Res-Q in orthopedic procedures has been positive and we believe it will prove to be a valuable tool in treating CLI patients.  In addition, these types of clinical programs are an integral element of our strategy to increase awareness of and appreciation for the effectiveness of the device," said J. Melville Engle, Chairman and Chief Executive Officer of ThermoGenesis.

About TotipotentSCTotipotentSC, headquartered in Los Angeles and New Delhi, is a subsidiary of MK Alliance, Inc., a privately held company focused on the clinical scale up, manufacturing, and testing of cellular therapy devices.  MK Alliance, Inc. also holds a majority ownership in TotipotentRX Corporation, which focuses on the scale-up, manufacturing and delivery of adult cellular therapies, having world class GMP facilities in Gurgaon, India.

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.

  • 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.comContact: Investor Relations+1-916-858-5107, orir@thermogenesis.com
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    SOURCE ThermoGenesis Corp.
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