NEW YORK, NY--(Marketwire - December 19, 2012) - 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.
In a 37-page Initiation Report by LifeSci Advisors, we explain the commercial value of the company's actively marketed products plus the scientific basis and commercial prospects for the therapeutic programs coming out of Cytomedix's proprietary cell therapy program using ALDH Bright Cells. On February 8, 2012, Cytomedix announced the acquisition of Aldagen, Inc., a private company developing therapies based around the ALDH Bright Cell technology. All of the clinical programs acquired in the Aldagen deal are based on the use of a proprietary process to isolate a particular group of stem cells derived from bone marrow. These cells express high levels of the enzyme aldehyde dehydrogenase (ALDH), and are known as ALDH Bright (ALDH(br)) Cells. Cells with high ALDH activity have been shown to be very potent in their ability to help regenerate tissue, especially through the promotion of angiogenesis.
Dr. McDonald's full Initiation Report is available to download at no cost at the LifeSci Advisors website, www.lifesciadvisors.com. In addition to this Initiation Report, LifeSci Advisors will also provide ongoing coverage and event-based research updates on the Company as developments occur.
The LifeSci Advisors research team is led by Dr. Andrew I. McDonald, an industry veteran with more than 15 years of healthcare industry experience. Prior to co-founding LSA, Dr. McDonald was the Senior Biotechnology Analyst at Great Point Partners, a leading health care investment firm with over $500 million under management. Before Great Point, he was Co-Head of Healthcare Research and Lead Biotechnology Analyst at ThinkEquity Partners, a boutique investment banking firm focused on growth companies. Dr. McDonald holds a Ph.D. in organic chemistry from the University of California, Irvine, and, earlier in his career, worked as a medicinal chemist at both Pfizer and Cytokinetics.
About LifeSci Advisors:
LifeSci Advisors (LSA) is a leading research firm and communications consultancy dedicated to the life sciences industry. The firm provides strategic counsel, customized marketing communications, comprehensive research reports and investor relations services to companies that specialize in the discovery, development and commercialization of drugs, drug delivery systems, medical devices and diagnostics. To learn more about LSA, visit the company's website, www.lifesciadvisors.com.
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