Caladrius Biosciences Receives SAKIGAKE Expedited Review Designation in Japan for CLBS12 for Treating Critical Limb Ischemia
Caladrius Biosciences, Inc. (CLBS)
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Source: GlobeNewswire
BASKING RIDGE, N.J., April 10, 2018 (GLOBE NEWSWIRE) -- Caladrius Biosciences, Inc. (Nasdaq:CLBS) (“Caladrius” or the “Company”), a development-stage biopharmaceutical company with multiple technology platforms targeting autoimmune and select cardiology indications, announces today that the Company has received SAKIGAKE designation from the Japan Ministry of Health, Labour and Welfare (“MHLW”) for CLBS12 for the treatment of critical limb ischemia (“CLI”). CLBS12 is currently in a Phase 2 trial in Japan for the treatment of no-option CLI, a severe obstruction of arterial blood flow to the extremities in patients that results in severe pain at rest and/or non-healing ulcers, which carry a risk of amputation. The SAKIGAKE designation is part of Japan’s effort to accelerate the development and approval of regenerative medicines. The Pharmaceutical and Medical Devices Act (“PMDA”) enables an expedited path to conditional approval for regenerative medicine products that show suffic
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