CLI Data From Cesca's Phase I/Phase II and Feasibility Studies to be Presented at the American Heart Association-Scientific Sessions Conference by Richard Powell, M.D.

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Cesca Therapeutics Inc.
KOOL
, an autologous cell-based regenerative medicine company, today announced that Dr. Richard Powell, MD is presenting Cesca's feasibility data on critical limb ischemia (CLI) at the American Heart Association-Scientific Sessions Conference in Orlando, Florida. The data presented will summarize results from two cardiovascular clinical studies, which enrolled no-option CLI patients (high risk for near term amputation) and used Cesca's patented point-of-care technology (SurgWerksTM) to prepare autologous bone marrow derived stem cells for lower extremity transplant. CLI is a late phase form of peripheral artery disease (PAD), which is often associated with diabetes, and can result in severe non-healing ulcers and potential loss of limb due to the lack of blood circulation. While medications and surgical options are available to advanced cases of the disease, approximately 70,000 patients undergo major amputations and an additional 135,000 minor amputations each year in the U.S. alone. In June, Cesca received FDA IDE approval for its CLIRST III pivotal CLI trial (see www.clinicaltrials.gov, NCT02538978). Dr. Richard Powell, Chief of Vascular Surgery for Dartmouth-Hitchcock Medical Center, is the Lead Principal Investigator for Cesca's CLIRST III trial. "CLI and resulting amputation rates continue to be a major unmet medical need globally and new solutions, like Cesca's SurgWerks technology, have the potential to relieve debilitating pain, improve quality of life and extend the lives of countless patients. This trial does a better job of directing cells into the affected limb through optimized cell delivery needles. I'm encouraged by the SurgWerks technology and the data from Cesca's preliminary studies, and look forward to the initiation of this pivotal trial," said Dr. Powell. Dalip Sethi, Ph.D., Senior Clinical Scientist at Cesca Therapeutics commented, "Dr. Powell's experience in CLI clinical trials, particularly those in regenerative medicine, has provided invaluable insight that we anticipate will have a positive impact on our upcoming study. The results Dr. Powell is presenting were included in our submission to the U.S. FDA which resulted in approval to conduct the CLIRST III trial. We are excited by the prospect of starting this final stage in our path towards commercialization and ultimately making this technology available to patients." Christy Hansen, DNP, MSN, RN-CCRC, Clinical Trial Field Operations Manager for the CLIRST III trial, added, "The CLIRST III trial differs from previous trials in that it provides rapid point-of-care technology, minimizes treatment variability and streamlines the experience of treating CLI patients. Our inclusion/exclusion criteria have been developed to facilitate enrollment rates of Rutherford Category 5 patients while optimizing the length of follow-up needed to analyze treatment efficacy." 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 CellWerksTM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in 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 device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user- defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs). 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.
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