RANCHO CORDOVA, Calif., March 26, 2014 (GLOBE NEWSWIRE) -- Cesca Therapeutics, Inc. (Nasdaq:KOOL), an autologous cell based regenerative medicine company, announced it has submitted a pre-IDE (Investigational Device Exemption) information package to the U. S. Food and Drug Administration (FDA) for the use of the SurgWerks™ CLI Therapy designed to treat no option patients with late stage critical limb ischemia (CLI).
"In conjunction with the pre-IDE package, we have requested a meeting with the FDA during the summer of 2014 to work cooperatively on the clinical and regulatory plan of the pivotal trial. The pre-IDE submission with the FDA is a significant milestone on our path to advance SurgWerks-CLI towards commercialization in the United States," said Matthew Plavan, Chief Executive Officer of Cesca Therapeutics. "Following feedback from the upcoming meeting with the FDA, we plan to initiate the pivotal clinical trial for SurgWerks-CLI in multiple US based hospital sites," he continued.
The pre-IDE documentation has been submitted to the FDA in order to obtain the agency's guidance on several key criteria regarding the regulatory pathway; the proper approach to refine the clinical and statistical plan considering the no-option status of the prospective subjects; the consideration of the combination of several devices into a single kit to ensure proper dosing and quality, and to ensure Cesca Therapeutics is working closely and cooperatively with the FDA review team. The basis for pre-IDE submission is data from an analysis of the 17 patient dataset collected in Cesca's feasibility/Phase Ib trial announced this past January. Pre-IDE submissions and meetings are strictly voluntary and any comments or recommendations made in the review of protocols or during these meetings are not binding on the FDA or the Company.
About Cesca Therapeutics
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. We are a leader in developing and manufacturing automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
-- SurgWerks™ Platform, a proprietary stem cell therapy point-of-care kit system for treating vascular and orthopedic indications that integrate the following indication specific systems:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
-- 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 MarrowXpress Platform (MXP), a derivative product of the AXP and its accompanying disposable bag set, isolates and concentrates stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood from bone marrow to a user defined volume in 30 minutes, while retaining over 90% of the 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 cryopreserving and archiving cord blood stem cell units for transplant.
This press release contains forward-looking statements. Such forward-looking statements include but are not limited to that Cesca Therapeutics Inc. will provide unmatched world-class capability and service to its clients. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. A more complete description of 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 Cesca Therapeutics 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:Cesca Therapeutics Inc.