April 16, 2012

Cytomedix Stands Taller than Competition with New Treatment for Diabetic Foot Ulcers and More

The biotechnology industry is thriving and one of the fastest growing markets available for investment today. Within the industry, the diabetes sector is outpacing most others. In late February, leading business intelligence provider GBI Research released its Diabetes Therapeutics Market to 2017 report. The analysis detailed why the firm sees the global diabetes therapeutic industry growing from $29.3 billion 2010 at a compound annual growth rate of 7.1 percent to $47.2 billion in 2017. While many investors seem to think that the most lucrative investments are in traditional drugs like Novo Nordisk AS’s (NYSE: NVO) Victoza, Merck & Co.’s (NYSE: MRK) Januvia or the highly touted new blood-sugar-lowering drug, dapagliflozin, from Bristol-Myers Squibb Co. (NYSE: BMY) and AstraZeneca PLC (NYSE: AZN), the diabetes space generates billions annually related to some serious complications associated with the dreaded disease. As such, the upside to many smaller companies, such as Cytomedix, Inc. (OTCBB: CMXI), that are poised for rapid growth in the diabetes space with their new technologies should not be overlooked.

Diabetic foot ulcers (DFUs) are the most common foot injuries leading to lower extremity amputation, occurring in 15 percent of patients with diabetes and preceding 84 percent of all lower leg amputations. Globally, 366 million people currently have diabetes with that number expected to mushroom to more than 550 million (10% of the world’s population) by 2030, according to the International Diabetes Federation. At a 15% clip, that will put the number of people suffering from the ulcers at more than 20 million. The vast majority of diabetic foot complications resulting in amputation begin with the formation of skin ulcers. In these cases it is difficult to repair and rebuild the lost extracellular matrix (ECM) because diabetes mellitus is a metabolic disorder that impedes normal healing that would be seen in a non-diabetes patient. This is where Cytomedix, a leader in the commercialization of innovative autologous therapies that promote healing by harnessing the innate regenerative capacity of platelets and adult stem cells, offers a revolutionary technology that outstrips current wound care therapies and provides a convenient and cost-effective new approach.

The company’s PRP (Platelet Rich Plasma)-based AutoloGel™ System revitalizes a patient’s natural healing processes by delivering a topical gel containing growth factors, cytokines and chemokines for cell growth and formation of new tissue. According to the Cytomedix website,

“By delivering both fibrin matrix and platelet releasate to the chronic wound bed, the AutoloGel System re-establishes the natural balance the body needs to escape the inflammatory phase so restoring the natural healing process.”

A prospective, randomized, controlled trial sponsored by Cytomedix demonstrated both safety and efficacy of AutoloGel with 81.3% of wounds in the majority DFU wound size group fully healing as compared to 42.1% in the control group which received a saline gel therapy. Additional positive data on the AutoloGel System was recently published in a feature article in the April 2012 issue of Ostomy Wound Management showing that in 39 limb salvage patients in Japan, 83% of the wounds progressed to complete healing in an average of 145.2 days (p=0.00002) using an average of 6.1 AutoloGel treatments.

Importantly, Cytomedix is awaiting a May 9, 2012 decision from the Centers for Medicare & Medicaid Services (CMS) on reimbursement coverage of the AutoloGel System. Medicare covers nearly 11 million people with diabetes currently and, traditionally, private insurers will follow the path set forth by CMS in supporting insured treatments. With approximately 26 million diabetes patients diagnosed in the U.S., sales could catapult ahead for Cytomedix if CMS begins covering AutoloGel.

Clearly, the diabetes population alone could provide a solid backbone for exponential growth for Cytomedix, but it is only a portion of what the company has to offer. For brevity’s sake, this article has only focused on the massive potential of AutoloGel in the diabetes arena. Cytomedix’s PRP technology has multiple uses in wound therapy outside of just DFUs and the company’s portfolio covers a wide array of regenerative therapies that are already generating meaningful revenue. The company has recently completed the acquisition of Aldagen and their robust and differentiated pipeline of regenerative cell therapies. The newly acquired “ALDH Bright Cell” technology has been shown to be a marker of a cell’s ability to grow. In other words, it can differentiate, identify and measure the vitality of cells to determine which are highly metabolic to facilitate the growth of new tissue.

Regenerative medicine has become a busy space with numerous companies looking to answer the question, “What is going to be the best therapy across several applications?” With its wide spectrum covering wound therapy, angiogenesis (which can be used for several types of ischemia and multiple other indications) and inflammation treatments, Cytomedix is answering that question. It’s uniquely positioned and stands head-and-shoulders above most other OTC biotechnology companies as it already has commercial products in the marketplace generating revenues as it relentlessly pursues advancement of its other proprietary products.

For more information, please see the following resources:

• Company Website • Recent SEC Filings