IDE Study Protocol Critical Limb Ischemia by SurgWerks™-CLI Kit and VXP System ("CLIRST III") Meets Requirements of Center for Medicare and Medicaid Services for Reimbursement
RANCHO CORDOVA, Calif. / CRWEPRESSRELEASE / December 2, 2015 - Cesca Therapeutics Inc. (NASDAQ: 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."
About Cesca Therapeutics Inc.
Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development, and commercialization of autologous cell-based therapeutics for use in regenerative medicine. We are a leader in developing and manufacturing automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:
- SurgWerks™ Platform, proprietary stem cell therapy point-of-care kit systems for treating vascular and orthopedic indications that integrate the following indication specific systems:
* Cell harvesting
* Cell processing and selection
* Cell diagnostics
* Cell delivery
- CellWerksTM Platform, a proprietary stem cell laboratory kit for processing target cells used in the treatments of oncological and hematological disorders.
- AXP® AutoXpress® Platform (AXP), a proprietary family of automated devices that includes the AXP and the MXP® MarrowXpress® and companion sterile blood processing disposables for harvesting stem cells in closed systems. The AXP device is used for the processing of cord blood.
- The MarrowXpress® Platform (MXP), a derivative product of the AXP and its accompanying disposable bag set, isolates and concentrates stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control optical sensors that volume-reduces blood from bone marrow to a user defined volume in 30 minutes, while retaining over 90% of the MNCs.
- The Res-Q™ 60 (Res-Q), a point-of-care system designed for the preparation of cell concentrates, including stem cells, from bone marrow aspirates and whole blood for platelet rich plasma (PRP).
- The BioArchive® System, an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries for cryopreserving and archiving cord blood stem cell units for transplant.
Forward Looking Statement
The statements contained herein may include statements of future expectations and other forward-looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.
Media Contact: Sean Leous, PCG Advisory Group
Source: Cesca Therapeutics Inc.