Cytomedix dermatology news

Cytomedix will restructure R&D to reduce cash burn and focus on commercializing AutoloGel for chronic wound care. By year end, the company will "substantially" conclude its financial support of the Phase II RECOVER-Stroke trial with ALD-401 and the underlying ALDH Bright Cell technology. RECOVER-Stroke has enrolled 39 patients and Cytomedix plans to continue enrolling in the trial until year end, with a goal of enrolling 50 patients. ALD-401 comprises stems cells derived from bone marrow expressing high levels of aldehyde dehydrogenase. Cytomedix said it is exploring strategic options for continuing its clinical programs beyond year end, which may include technology transfer, a spinout or licensing. Depending on the company's efforts to pursue strategic alternatives, Cytomedix may decide to conclude and unblind the trial at year end. The company said it restructured its Durham, N.C., R&D facility to bring available resources and spending in line with expected enrollment in the ongoing clinical programs. At June 30, Cytomedix had $3.4 million in cash and a six-month operating loss of $9.7 million.

In July, Cytomedix said the Centers for Medicare & Medicaid Services (CMS) issued proposed guidelines covering Medicare reimbursement for its AutoloGel System, which isolates and activates platelet-rich plasma (PRP) from a patient's own blood and is then used to produce a gel for use on exuding wounds. CMS placed the reimbursement code for AutoloGel in the ambulatory payment classification, which the company said provides limited reimbursement for use of the product in the outpatient setting. Cytomedix requested CMS revise the proposed rule so as to not deny any Medicare beneficiaries' access to AutoloGel. The final rule will be issued in November and take effect on Jan. 1, 2014 (see BioCentury, July 15). ...