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.
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.
SOURCE ThermoGenesis Corp.