Cesca Therapeutics Business Overview
Cesca Therapeutics is engaged in the research, development, and commercialization of cell-based therapeutics for use in regenerative medicine. We focus in three target markets to serve patients, physicians and partners:
- Cellular Therapeutics
- Medical/Diagnostic Device Development and Commercialization
- Cell Manufacturing and Banking
Therapies: Cesca’s lead therapeutic technology platform, SurgWerks® (an intraoperative rapid system for harvesting, selection/purification, testing, and delivering a therapeutic dose of autologous bone marrow derived or peripheral blood derived cells and proteins), is currently in various stages of clinical trials as a potential treatment for acute myocardial infarction, critical limb ischemia, and orthopedic injuries.
Our therapies are designed for rapid (60-90 minute) use at the bedside and per U.S. regulations include all integrated equipment, diagnostics, devices, and software to produce the specified autologous therapeutic cell dose. Our therapeutic platform (SurgWerks®) is built upon decades of experience in engineering and development of biologic device technologies and thus our approach is protected through a comprehensive device design and method patent portfolio.
Medical and Diagnostic Devices: Cesca designs, manufactures and sells advanced devices created specifically for the regenerative medicine bioprocessing market. This market includes biologic collection, transport, processing/washing, characterization/analysis, and cryopreservation. We view the regenerative medicine bioprocessing market as essential to the success of clinical trials through the control of quality of small and large scale cellular manufacturing in three distinct markets (below). Cesca provides an indication-specific device/protocol program called “CellWerks™” for select applications in the following three markets:
- Umbilical Cord Blood Banking
- Bone Marrow Transplantation
- RegenMed BioProcess (Clinical/Commercialization Stage Regen Med Companies)
Cell Manufacturing and Banking Services: At our international subsidiaries, Cesca operates advanced clinical cell manufacturing, processing, testing, and storage facilities compliant with Good Manufacturing Practices, Good Tissue Practices, and Good Laboratory Practices. We can support the production of a personalized medicine prescription or a large scale batch process. Patient samples, batch samples, and therapeutic aliquots are all labeled per ISBT 128 and stored in our long term cryogenics facility. In addition, Cesca’s clinical research organization is the only specialized, in-hospital, cell therapy CRO globally. We leverage the company’s unique expertise in designing, managing, and completing cell based clinical trials including the ability to support various device prototyping and validation typically required in a combination product. These services ensure patient safety under Good Clinical Practices (GCP), quality laboratory documentation under Good Laboratory Practices (GLP), and quality cell processing and handling under both Good Manufacturing Practices (GMP) and Good Tissue Practices (GTP). In partnership with Fortis Healthcare we have assembled the industry’s only fully integrated cell therapy clinical research organization (CRO) team to execute at every level of our in-house clinical trials, providing complete and seamless cellular drug and device clinical services.