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Clinical Pipeline

ARDS

We have established a diverse portfolio of diseases and conditions for treatment in the area of regenerative medicine area, with an emphasis on treating critical care indications. We are applying our patented and proprietary stem cell product candidate, MultiStem®, which we believe has the potential to treat many diseases and conditions, with a focus in neurological, inflammatory and immune disease areas, cardiovascular, and some pulmonary indications. These represent major areas of clinical need, as well as substantial commercial opportunities.

Our most advanced program is exploring the treatment of ischemic stroke, which represents the leading cause of serious disability in the United States, Europe, Japan, China and many other regions around the world. The potential for MultiStem to treat ischemic stroke is currently being evaluated in a registrational trial in Japan by a collaborative partner, HEALIOS K.K., and in a pivotal Phase 3 clinical trial being conducted by us primarily in North America and Europe under an FDA Special Protocol Assessment, or SPA. In addition, this program received the Fast Track designation, as well as the Regenerative Medicine Advanced Therapy, or RMAT, designation from the FDA. These designations are designed to accelerate the development, regulatory review and subsequent commercialization of product candidates like MultiStem cell therapy for ischemic stroke, if the clinical evaluation demonstrates appropriate safety and therapeutic effectiveness.

In recent years, we have advanced several MultiStem programs to the clinical development stage and have also established many preclinical programs through our internal efforts and a broad network of collaborations, where we have worked with investigators at over 30 institutions across the U.S., Europe, and select sites in Asia and Australia. Below displays our progress on our primary indications. For a summary of all preclinical indications please visit our business development page.

ARDS
clincal pipeline
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We believe that our pipeline can be broadened over time, driven by our technologies, capabilities and approach, and that our MultiStem cell therapy has significant therapeutic potential across a range of clinical indications.

By maintaining a lean infrastructure, and working collaboratively with others, including leading academic researchers, clinical centers, contract research organizations and contract manufacturing organizations, we are able to efficiently and cost effectively advance multiple programs in parallel.