Denis Michael Rhein

TotipotentRX Corp. is engaged in the research, development, and commercialization of cell-based therapeutics for use in regenerative medicine. They operate three distinct businesses to serve patients, physicians and partners: Therapeutics Division, Contract Services Division, Cell Manufacturing and Banking Division. Therapies: They lead therapeutic technology platform, TotiCell™ (an intraoperative rapid system for harvesting, preparing, testing, and delivering a therapeutic dose of autologous bone marrow derived or peripheral blood derived cells and proteins), is currently in varying stages of Phase 1b trials as a potential treatment for acute myocardial infarction, critical limb ischemia, non-healing ulcers and osteoarthritis. Their patented therapies are designed for rapid (under 60 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. Contract Trial Services: TotipotentRX's clinical research organization is the only specialized cell therapy CRO globally.They 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. Their full service cellular biologicals and medical devices services include clinical study design, cost effective contract Phase I-II clinical trials, regulatory consultation, physician training and support for cellular product oversight, handling and delivery of the cellular therapy, and fully validated laboratory services for cellular bioanalytics. The services offered 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 they have assembled the industry's most experienced cell therapy CRO team to execute at every level of their client's clinical trial, providing complete and seamless cellular drug and device clinical services. TotipotentRX brings its expertise in medical management, cellular manufacturing, and regulatory affairs to any project in regenerative medicine. Cell Manufacturing and Banking Services: The Company operates advanced clinical cell manufacturing, processing, testing, and storage facilities compliant with Good Manufacturing Practices, Good Tissue Practices, and Good Laboratory Practices. They 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 its long term cryogenics facility.