NEW YORK, NY -- (Marketwire) -- 12/19/12 -- LifeSci Advisors, LLC, a leading provider of investment research and investor relations services in the life sciences sector, today announced that it has initiated coverage of Cytomedix, Inc. (OTCQX: CMXI), an autologous regenerative therapies company focused on the commercialization of innovative technologies for orthopedics and wound care. The Company's ALDH Bright Cell therapeutics have the potential to become leading treatments for stroke and other cardiovascular diseases. Cytomedix markets the Angel Concentrated Platelet Rich Plasma (cPRP) System, which recently received expanded FDA approval for the processing of blood or bone marrow aspirates to produce cPRP. Sales of the Angel System have grown approximately 20% year over year. The Company also markets the AutoloGel System, the only FDA approved device for the preparation of an enhanced platelet rich plasma gel for the treatment of exuding wounds such as leg ulcers, pressure ulcers, and diabetic ulcers, and for the management of mechanically or surgically debrided wounds.
On August 2, 2012, the Centers for Medicare and Medicaid Services (CMS) issued a National Coverage Determination (NCD) for autologous blood-derived products for wound healing. In the final NCD, CMS confirmed coverage for autologous PRP in patients with diabetic, pressure, and/or venous wounds. CMS reimbursement for the AutoloGel System is expected to begin in Q1 2013 opening up the majority of the multi-billion dollar wound care market to Cytomedix by providing access to millions of Medicare beneficiaries in need of advanced wound therapies. The catalyst provided by Medicare coverage could advance the AutoloGel System to a prominent position as a leading protocol for advanced wound care and significantly propel sales over the next several years.
We anticipate clinical trial data from the Phase II RECOVER-Stroke study of Cytomedix's ALD-401 Bright Cell therapy for ischemic stroke to be available in early 2014. The trial already passed a critical safety test when the independent Data Safety Monitoring Board recommended the continued enrollment of patients after no safety issues were detected in the first 10 patients.
"Cytomedix's Bright Cell therapeutic autologous stem cell development platform has the potential to successfully introduce innovative, effective therapies for patients suffering from stroke and other cardiovascular diseases," said Andrew I. McDonald, Ph.D., Managing Director at LifeSci Advisors. "Importantly, the Company's considerable early clinical success with Bright Cell therapies shows that these autologous treatments are safe and well tolerated by patients. Moreover, the early efficacy signals have begun to validate the therapeutic potential of Bright Cells. This attractive long term opportunity is balanced by significant commercial opportunities with the Company's commercial products, especially the AutoloGel System which could experience significant growth over the next few years due to upcoming Medicare reimbursement coverage."
ALDH Bright Cells have potent regenerative properties, promoting angiogenesis and tissue healing and protecting cells from ischemic conditions. Additional Bright Cell therapy programs include ALD-301 for peripheral arterial disease, which has successfully completed a Phase I/II clinical trial in critical limb ischemia. Cytomedix recently announced a Phase II clinical trial of ALD-301 in patients with Intermittent Claudication. The study will be funded by the NIH and managed by the Cardiovascular Cell Therapy Research Network (CCTRN). The Company is also collaborating with Duke University Medical Center on an open-label, Phase I clinical trial for ALD-451 as a treatment for cognitive deficits arising from the treatment for malignant glioma.
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