Who We Are
Caladrius is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of cell therapies designed to reverse disease and/or promote the regeneration of damaged tissue. The Company is developing first-in-class therapeutics based on the characteristics of naturally occurring CD34+ cells and their ability to stimulate the growth of new microvasculature. The Company’s platform technology leverages these cells to enable the body’s natural repair mechanisms using formulations unique to each medical indication.
Clinical Development Programs
The Company’s goal is to develop and commercialize products that address important unmet medical needs based on a broad and versatile portfolio of candidates. Our current product candidates include: XOWNA® (formerly CLBS16), the subject of a newly initiated Phase 2b study in the U.S. for the treatment of coronary microvascular dysfunction (CMD); CLBS12 (HONEDRA® in Japan), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (CLI) and Buerger’s Disease based on the results of an ongoing clinical trial; CLBS201, designed to assess the safety and efficacy of CD34+ cell therapy as a treatment for diabetic kidney disease (DKD); and CLBS14 (OLOGO™ in the U.S.), a Regenerative Medicine Advanced Therapy (RMAT) designated, Phase 3 ready therapy for which the Company is in discussion with the U.S. Food and Drug Administration (FDA) to finalize a protocol of appropriate and practical size in subjects with no-option refractory disabling angina (NORDA).