RegenMed Therapeutic is a clinical-stage cell therapy company discovering and developing cell therapy products. RegenMedTX is focusing its resources on large patient populations where the standard of care involves significant costs and potentially complicated procedures with comorbidities that result in reduced quality of life and increased mortality.
Using its Organ Regeneration Platform™, RegenMedTX is pioneering the development of products comprised of a patient’s own (autologous) cells, that have been programmed in the body to restore damaged kidney tissues by engrafting into, repairing, or replacing damaged tissues or organ. The Company’s product candidates harness the body’s intrinsic ability to repair and restore damaged tissues to native-like organs and tissues. This ability has the potential to delay or eliminate the need for chronic disease therapies, organ transplantation, and the administration of anti-rejection medications. RegenMedTX’s product candidates are designed to replace less effective therapies or become the standard of care treatment in diseases with few or no current therapeutic options.
RegenMedTX’s lead clinical program is the Neo-Kidney Augment™, which is intended to prevent or delay dialysis and transplantation by increasing renal function in patients with advanced chronic kidney disease (CKD). According to the United States Renal Data System, there are approximately 26 million adults in the U.S. who have CKD, and there are 100,000 new patients who start on dialysis each year. $39 billion in direct U.S. costs each year are attributable to patients with end-stage renal disease, which is associated with an approximate 20% mortality rate per year and an average life expectancy of a patient initiating dialysis of approximately four years. The Neo-Kidney Augment uses a patient’s own cells, procured by a needle biopsy of the patient’s kidney, to create an injectable product candidate that can catalyze the regeneration of functional kidney tissue. In clinical studies, diseased kidney function was improved by the selected renal cells that form the active biological component of the Neo-Kidney Augment. In these studies, Neo-Kidney Augment was shown to be safe and well tolerated and renal function was shown to be enhanced after implantation.
RegenMedTX Phase 2 clinical program is built on the success of a Phase 1 clinical study which enrolled 7 type II diabetic patients with CKD3b/4 chronic kidney disease. The Neo-Kidney Augment cell therapy was shown to be safe and well tolerated.
The Company owns or licenses a wide range of U.S. patents and patent applications that provide broad protection for its technology platform, including composition, design and methods of manufacture. The Company’s corporate headquarters, research and development laboratories, and cGMP manufacturing facility are located in Winston-Salem, North Carolina.
FDA has approved a Phase II, Open-Label Safety and Efficacy Clinical Trial of RegenMedTX’s Autologous NEO-KIDNEY AUGMENT (NKA) in Patients with Type 2 Diabetes and Chronic Kidney Disease (CKD).
RegenMedTX’s management team averages more than twenty years of experience, with over 150 years cumulative, in the discovery, development, manufacturing and commercialization of biotechnology, pharmaceutical, and device products. They are guided by a vision to bring transformational medical technology to patients with chronic kidney disease and are advancing multiple products through clinical development toward commercialization.