RANCHO CORDOVA, Calif., Sept. 19, 2016 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that the United States Patent & Trademark Office (USPTO) has granted the Company the first two of a family of patent applications related to Cesca’s proprietary methods for the treatment of ischemic cardiovascular disorders, such as critical limb ischemia (CLI) and acute myocardial infarction (AMI). The patents (numbered 9,393,269 and 9,402,867) protect key components of Cesca’s SurgWerks™ technology platform, designed for the delivery of autologous regenerative stem cell therapies in a point-of-care environment. The Company previously announced that the SurgWerks™ platform had been approved by the FDA for use in Cesca’s phase III, pivotal trial for the treatment of late stage, poor option and no option CLI patients.
“We have been focused on developing and refining our methods for the optimal handling of cells throughout the surgical procedure to ensure their viability and potency, as well as optimizing the delivery method to minimize shear stress on the cells,” said Dalip Sethi, Ph.D., Cesca’s Director of Clinical Research. “These patents reinforce the initial design and proof of concept work related to the use of our SurgWerks™ platform in a point-of-care setting, further strengthening our intellectual property portfolio as we continue our discussions with the FDA in order to move ahead with our phase III trial for CLI in the near future.”
The patent claims cover rapid concentration and delivery of bone marrow derived stem and progenitor cells such as hematopoietic stem cells (HSCs), mesenchymal stem cells (MSCs), endothelial progenitor cells (EPCs) and CXCR4 positive cells with a reduced amount of red blood cells (RBCs). The SurgWerks™ processing platform includes a “smart” cell processing module for optically monitored separation and concentration of cell components of interest during centrifugal fractionation.
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of cellular therapies and delivery systems 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 therapeutics. These include:
- The SurgWerks™ System (in development) - a proprietary system comprised of the SurgWerks™ Processing Platform, including devices and analytics, and indication-specific SurgWerks™ Procedure Kits for use in regenerative stem cell therapy at the point-of-care for vascular and orthopedic diseases.
- The CellWerks™ System (in development) - a proprietary cell processing system with associated analytics for intra-laboratory preparation of adult stem cells from bone marrow or blood.
- The AutoXpress® System (AXP®) - a proprietary automated device and companion sterile disposable for concentrating hematopoietic stem cells from cord blood.
- The MarrowXpress™ System (MXP™) - a derivative product of the AXP and its accompanying sterile disposable for the isolation and concentration of hematopoietic stem cells from bone marrow.
- The BioArchive® System - an automated cryogenic device used by cord blood banks for the cryopreservation and storage of cord blood stem cell concentrate for future use.
- Manual bag sets for use in the processing and cryogenic storage of cord blood.
Forward-Looking Statements and Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
This press release includes statements of future expectations and other forward-looking statements regarding, among other things, the Company’s SurgWerks™ system and the phase III pivotal clinical trial, that are within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current views and assumptions, speak only as of the date hereof and are subject to change. Forward-looking statements can often be identified by words such as “anticipates,” “belief,” “intend,” “may,” “could,” “would,” “potential,” “continue,” and similar expressions and include, but are not limited to, statements regarding research, development and commercialization of the SurgWerks™ system, patent applications and grants and the initiation of a Phase III pivotal clinical trial. These forward-looking statements are not guarantees of future results and are subject to known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially and adversely from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by these forward-looking statements is set forth under the caption "Risk Factors" in our Annual Report on Form 10-K, in our Quarterly Reports on Form 10-Q, and in other reports filed with the Securities and Exchange Commission from time to time, and you should also consider each of those factors when evaluating the forward-looking statements. We undertake no obligation to revise or update publicly any forward-looking statements for any reason, except as required by law.