Caladrius Biosciences, Inc. is a clinical-stage biopharmaceutical company dedicated to the development of cellular therapies designed to reverse disease. We are developing first-in-class cell therapy products based on the finely tuned mechanisms for self-repair that exist in the human body. Our technology leverages and enables these mechanisms in the form of specific cells, using formulations and modes of delivery unique to each medical indication.
The Company’s current product candidates include: HONEDRA® (formerly CLBS12), recipient of SAKIGAKE designation and eligible for early conditional approval in Japan for the treatment of critical limb ischemia (“CLI”) based on the results of an ongoing clinical trial; CLBS14, a Regenerative Medicine Advanced Therapy (“RMAT”) designated therapy for which the Company has finalized with the U.S. Food and Drug Administration (the “FDA”) a protocol for a Phase 3 confirmatory trial in subjects with no-option refractory disabling angina (“NORDA”); CLBS16, the subject of both a recently completed positive Phase 2a study and a newly initiated Phase 2b study in the U.S. for the treatment of coronary microvascular dysfunction (“CMD”); and CLBS119, an emergent CD34+ stem cell therapy responding to the COVID-19 pandemic and the potentially permanent damage the virus inflicts on the lungs of many patients.
At Caladrius Biosciences, our mission is to bring new, innovative and treatment paradigm-changing medical therapies to market based on our unique expertise and experience, and in so doing, to improve patients’ lives and create value for our shareholders.
Research and Discovery
To accomplish our mission and see our vision through to the end we are combining state-of-the-art science with the body’s intricate biologic systems, and are working to leverage our bodies’ development of cell capabilities with complex and specific functions. We believe that each study we perform expands the foundations of cell therapy and biologic science and believe that our research and discovery will have meaningful and lasting influence. We pledge to use our experience and knowledge to advance science, research and development.
We conduct all of our work in order to ultimately benefit the patients who put their trust and hope in our hands. We will continue to pursue therapies in areas of significant unmet medical need so that we can have the greatest impact on them. We know it won’t be easy, but we are committed to striving to successfully guide our product candidates through the development process in order that they may ultimately reach and serve the patients.