RANCHO CORDOVA, Calif., Feb. 11, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced that the Company has received approval from the India Drug Controller General ("DCGI") for the import and commercialization of its MarrowXpressTM ("MXPTM") System in India.
"We are very pleased to receive approval from the DCGI for our MXP System for bone marrow stem cell processing specifically for the preparation of intra-operative at the point-of-care or clinical laboratory preparation of bone marrow concentrate," said Ken Harris, President and leader of Cesca's clinical programs. "In collaboration with Fortis Healthcare, India is a major focus in our bone marrow transplant initiative. Cesca is uniquely positioned to provide proprietary services and technology that will positively impact the lives of a growing number of patients in the region. With a current bone marrow market of approximately 30,000 to 40,000 patients per year and only 1,000 bone marrow transplants conducted annually in India, our reach and technology give us a first mover advantage that will benefit patients with hematological and oncological disorders across South Asia," continued Harris.
Cesca provides in-house GMP cell laboratory services, scientific support, and medical technology to Fortis' cutting edge program at the Fortis Memorial Research Institute, including use of Cesca's proprietary "CellWerks" approach that employs the MXP Platform. Cesca's technology and services expand both pediatric and adult patient access to life saving cellular treatments by enabling a number of transplants that might otherwise not be an option for the patient. These include:
- ABO Major Mismatched Transplants: The MXP System effectively removes the undesired red blood cells from a mismatched donor bone marrow unit without compromising the quantity and viability of targeted stem cells. This is especially important in pediatric transplants.
- Matched Unrelated Donor Programs: Volume debulking of undesired red blood cells and plasma of matched unrelated donor cells.
- Haploidentical Program: Enabling mismatched transplants by simultaneously reducing or eliminating the unwanted red blood cells, donor plasma containing harmful antibodies, and improving the efficiency for depleting harmful T-cells from the haploidentical (half-matched donor's) cells.
- Cord Blood Transplant Program: Cord blood processing and storage for the cutting edge double cord blood transplant.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
- SurgWerks™; proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
- CellWerks™; a proprietary stem cell laboratory kit for the processing of target cells used in the treatment of oncological and hematological disorders.
- The AutoXpress® (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
- The MarrowXpress® (MXP); a derivative product of the AXP and its accompanying disposable bag set, for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood (RBC's and plasma) from bone marrow (stem cells) to a user defined volume in 30 minutes while retaining over 90% of mononuclear cells (MNCs).
- The Res-Q™ 60 (Res-Q); a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The BioArchive® System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant.
Forward Looking Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements, including FDA approval, timing of the Company's submission of IDE applications, or amendments to such applications, and outcomes from such submissions. Further, clinical trial outcomes are not predictable, and results may vary from the Company's expectations, including the start of any such clinical trials, patient follow up issues, and costs associated with such trials. Further description of other risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files 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:Cesca Therapeutics Inc.