RANCHO CORDOVA, Calif., Aug. 27, 2014 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, today announced the presentation to the Centers for Medicare and Medicaid Services ("CMS") of its case study highlighting the potential clinical benefit and cost savings of its SurgWerks®-CLI cell therapy for treatment of non-operable Critical Limb Ischemia ("CLI"). Ken Harris, President of Cesca Therapeutics, participated along with other regenerative medicine industry representatives, and presented one of two case studies in the presentation organized and led by the Alliance for Regenerative Medicine ("ARM"), a global advocacy organization that promotes legislative, regulatory, reimbursement, investment, technical and other initiatives to accelerate the development of safe and effective regenerative medicine technologies.
Cesca was honored to participate with ARM and its fellow members in establishing dialogue with CMS as the agency begins evaluating this new field of medicine. Key messages delivered were the potential curative nature of regenerative therapies being developed by ARM's members like Cesca, and Cesca's SurgWerks-CLI therapy was highlighted as an example which has the potential to deliver such promise in no-option critical limb ischemia patients.
CLI is the most severe form of Peripheral Arterial Disease ("PAD") affecting over 2 million patients in the United States. It is often associated with chronic foot and leg ulcers leading to approximately 200 thousand amputations per year. A diagnosis of CLI statistically results in a 25% mortality rate and a 25% amputation rate within one year. The cost of CLI-related amputations to Medicare is estimated by the Sage Group to be $25 billion per year. The current standard of care for CLI is surgical revascularization which is expensive, highly invasive and often fails to restore proper blood supply to the patient's affected limb(s).
Cesca Therapeutics has developed a cellular therapy currently in clinical trials to treat patients with CLI that has the potential to significantly mitigate the disease symptoms, including saving the legs of certain patients and has the potential to reduce the current cost of CLI by billions of dollars. In its case study to CMS, the Company highlighted the results of its Phase I/II clinical trial treating 17 patients with CLI with its SurgWerks-CLI cell therapy. "We experienced an 82% major amputation free rate in the Intent-To-Treat patients, and significant reductions in hard clinical endpoints including VAS pain scores and a meaningful improvement in the 6 minute walk test," said Ken Harris, President of Cesca Therapeutics. "We enjoyed the opportunity to discuss with CMS representatives our unique clinical approach to treating this devastating disease using our proprietary bone marrow derived stem cell therapy, and our plans for conducting the pivotal trial," continued Harris.
The SurgWerks-CLI proprietary 60 minute process includes:
- Harvesting a patient's own bone marrow with a stem cell optimized trocar
- Testing the stem cells real time for dose and quality using Cesca's proprietary Q-Cyte diagnostic device
- Using Cesca's proprietary smart vision system (called the VXP) to select a patient specific therapeutic stem cell dose
- Delivering the therapeutic stem cell dose into the targeted angiosomes of the patient's leg using Cesca's proprietary tissue infusion needle
"We have developed our SurgWerks-CLI cell therapy to optimize the cell harvesting, selection and delivery of a patient's own stem cells in a procedure administered within 60 minutes right at the patient's bedside," said Matthew Plavan, CEO of Cesca Therapeutics. "This clinical approach is a key differentiating element of our unique commercialization strategy that we believe will result in significant adoption of our SurgWerks therapy with a cost point targeted to be below the current standard of care, thereby significantly reducing the cost of care for CLI patients," continued Plavan. "Another critical element of our commercialization strategy is understanding medical coverage and reimbursement criteria as early in the clinical development cycle as possible in both the private payer and CMS reimbursement programs," said Plavan.
Based on the compelling early efficacy results observed in the Cesca's Phase I/II clinical trial treating no option CLI patients, the Company is pursuing FDA approval to conduct a pivotal (Phase III) trial under an IDE regulatory pathway in the first half of 2015.
About Cesca Therapeutics
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, a proprietary stem cell therapy point-of-care kit system for treating vascular and orthopedic indications that integrate the following indication specific systems:
- Cell harvesting
- Cell processing and selection
- Cell diagnostics
- Cell delivery
- 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 Statements
This press release contains forward-looking statements. Such forward-looking statements include but are not limited to that Cesca Therapeutics Inc. will provide unmatched world-class capability and service to its clients. These statements involve risks and uncertainties that could cause actual outcomes to differ materially from those contemplated by the forward-looking statements. A more complete description of risks that could cause actual events to differ from the outcomes predicted by our forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports we file with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements.