Cytomedix Reports Second Quarter 2012 Financial Results and Provides Corporate Update

GAITHERSBURG, MD--(Marketwire -08/14/12)- Cytomedix, Inc. (CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies, today reported financial results for the three and six months ended June 30, 2012.

Separately, the Company announced that it accepted the early termination of the previously announced exclusivity period granted to a top 20 global pharmaceutical company and ceased negotiations for a distribution agreement for the Company's AutoloGel System in wound care, which would have expired August 30, 2012. The $4.50 million received by Cytomedix to date for this exclusivity was non-refundable. The Company is now free to re-engage with other interested parties experienced in wound care to pursue potential partnerships and commercial agreements for the product.

Financial Highlights for the Second Quarter (all comparisons are with the 2011 second quarter)

Clinical and Corporate Highlights of the Second Quarter and Recent Weeks

Management Discussion

Martin P. Rosendale, Chief Executive Officer of Cytomedix, said, "During the second quarter we continued to make significant strides in advancing our position as a fully integrated regenerative medicine company as we achieved a number of key milestones that position us for future growth. In addition, our commercial products posted record quarterly sales and we made important advances with our products and pipeline.

"The agreement to end the exclusivity period and cease negotiations for an AutoloGel distribution agreement is not a reflection of the clinical or commercial value of AutoloGel in wound care, but rather is a result of a unique set of circumstances with the potential partner that precluded arriving at a favorable outcome. I want to emphasize that the decision is in no way tied to the final CMS determination for CED. Moreover, we received $4.50 million in non-dilutive financing for providing the exclusivity period and are now in a position to reengage in discussions with other interested potential partners. We are encouraged by the interest in PRP in wound care since the CMS final decision was published. With the early release of the exclusivity period, we will accelerate discussions with potential experienced wound care partners.

"We were very pleased that CMS reversed its long-standing non-coverage decision for autologous PRP and has now agreed to coverage through its CED program. This provides for an appropriate research study with practical study designs we are confident will demonstrate that patients treated with AutoloGel consistently experience clinically significant health outcomes. Importantly, payment for the product under CED is expected to be sufficient to cover the anticipated cost of collecting the evidence. We have already begun our interaction with CMS following the release of the final decision memo and look forward to further defining the specifics of the protocols for the research studies and clinical questions to be answered through the CED program."

Commenting on clinical progress with the Company's ALDH bright cell technology, Mr. Rosendale said, "Our Phase II RECOVER-Stroke trial has expanded to new sites and we look forward to our next milestone, which will be the DSMB safety assessment following the treatment of the initial 30 patients. We reasonably expect this to occur during the fourth quarter and continue to maintain that the ALDH bright cell population offers a novel and differentiated cell population with significant clinical upside. In addition we were pleased to report the initiation of a Phase I collaboration with the Duke University Medical Center with funding from the Robertson Clinical & Translational Cell Therapy Program. We expect to announce and initiate another sponsor-funded Phase II clinical study by year end in a peripheral arterial disease indication. These studies are intended to leverage our positive clinical experiences in critical limb ischemia and stroke.

"The first half of the year was marked by significant progress in areas that are important to our strategic plan. We expect the second half of the year to be equally productive as we work toward achieving a number of value-creating clinical and corporate milestones," concluded Mr. Rosendale.

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Cytomedix Reports Second Quarter 2012 Financial Results and Provides Corporate Update

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