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.