Therapeutic Approach and Clinical Delivery
The Cesca clinical program is designed with two models of clinical delivery:
- SurgWerks® – Rapid Intra-operative Use
- CellWerks™ – Rapid Laboratory Use under the direction of a licensed physician
Our vision is to provide fully optimized therapeutic “kits“, which are under investigational use, ultimately seeking marketing approval with the US FDA (or appropriate equivalent). The SurgWerks®and CellWerks™kits revolutionize how autologous cellular therapies are conducted. At the core of successful clinical outcomes is the achievement of a therapeutic dose which guarantees cell viability and potency throughout the process of source material collection, target cell selection, characterization/dose determination, and final delivery of the cells to the patient. Cesca is developing a unique and patent protected system designed to achieve cGMP cell manufacturing process control in a rapid 60-90min process either intra-operatively (SurgWerks®) or in the processing lab (CellWerks™).
Note : The SurgWerks and CellWerks products have not be approved by the U.S. FDA for diagnosing, treating, or preventing disease.