Cesca Receives Approval for Medicare Coverage

Cesca Therapeutics Inc. KOOL, an autologous cell-based regenerative medicine company, today announced that it has received approval for Medicare coverage for the investigational device exemption ("IDE") study protocol entitled: Critical Limb Ischemia Rapid Delivery by SurgWerks-CLI Kit and VXP System ("CLIRST III") from the Centers for Medicare and Medicaid Services ("CMS"), a federal agency within the United States Department of Health and Human Services. According to the official correspondence from CMS, Cesca's IDE study was consistent with conditions specified in the IDE regulations and was therefore approved for Medicare coverage. This approval extends coverage across all Medicare administrative regions. "We are very pleased with the CMS's decision to approve our potentially life changing, pivotal clinical study in critical limb ischemia ("CLI") for Medicare reimbursement," said Robin Stracey, Chief Executive Officer of Cesca. He added, "Achieving Medicare reimbursement is a significant milestone. Medicare reimbursement will further the Company's efforts to find an effective treatment for CLI, the most severe form of peripheral arterial disease ("PAD"). Often associated with chronic foot and leg ulcers and leading to approximately two hundred thousand major and minor amputations per year, Medicare reimbursement will help the Company reduce the cost of our clinical trial as the team at Cesca works toward fulfilling a major unmet medical need."
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