Key Developments: Cytomedix Inc (CMXI.OB)
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Latest Key Developments (Source: Significant Developments)
Cytomedix Inc Announces CFO Change-Form 8-K
Cytomedix Inc reported in its Form 8-K that on March 29, 2013, Andrew S. Maslan, the Chief Financial Officer (CFO) of Cytomedix, Inc. (Company), tendered his resignation as the Company’s CFO and Secretary effective as of May 10, 2013. On March 30, 2013, the Board appointed Mr. Steven S. Shallcross as the Company’s Executive Vice President, Chief Financial Officer (CFO), Secretary and Treasurer, commencing on as of May 10, 2013. Full Article
Cytomedix Inc Announces Positive Results With Angel cPRP in Veterinary Application
Cytomedix Inc announced that positive data on the Angel(R) cPRP system in a veterinary application treatment of persistent mating induced endometritis (PMIE) in mares were recently presented at the 3rd annual conference of the North American Veterinary Regenerative Medicine Association (NAVRMA) in Savannah, GA. Treatment with PRP was shown to be associated with a statistically significant reduction in certain endometrial pro-inflammatory cytokines and inducible nitric oxide synthetase (iNOS), both known to be involved in the pathology of PMIE. Many mares fail to respond to conventional therapies and recent studies have shown a link between PMIE and the expression of certain cytokines. Nitric oxide is also believed to play a role in uterine clearance. The study investigated 9 barren mares with a history of PMIE. During the treatment cycle, whole blood was processed using the Angel cPRP system and the resultant PRP was brought to a final volume with platelet poor plasma and infused into the uterus. All mares were then inseminated with motile sperm. Evaluation of endometrial biopsies showed that in mares treated with PRP there was down-regulated expression of pro-inflammatory molecules, IL-1b, IL-6, IL-8 and iNOS, compared with untreated mares (p < 0.05). Full Article
Cytomedix, Inc. Announces Collaboration With Duke University On Phase I Clinical Study Of ALD-451 In Malignant Glioma
Cytomedix, Inc. announced the initiation of a Phase I clinical study with ALD-451 in brain cancer patients in collaboration with Duke University Medical Center. The open-label study will enroll up to 12 patients and is intended to demonstrate the feasibility and safety of ALD-451 when administered intravenously in World Health Organization (WHO) grade IV malignant glioma patients following surgery, radiation therapy and treatment with temozolomide. The trial also will obtain an initial description of the effects of ALD-451 on neuro-cognition. The clinical study is open for enrollment having received Investigational New Drug clearance from the U.S. Food and Drug Administration and Investigational Review Board clearance from Duke University Medical Center(ClinicalTrials.gov Identifier: NCT01639612). Full Article
Cytomedix, Inc. Announces Publication Of Positive AutoloGel Wound Healing Data In Ostomy Wound Management
Cytomedix, Inc. announced the publication of positive clinical data regarding its AutoloGel(TM) System in the April 2012 issue of Ostomy Wound Management in an article entitled, A Retrospective, Longitudinal Study to Evaluate Healing Lower Extremity Wounds in Patients with Diabetes Mellitus and Ischemia Using Standard Protocols of Care and Platelet-Rich Plasma Gel in a Japanese Wound Care Program. The purpose of this retrospective study was to capture evidence-based treatment outcomes in limb salvage patients with complex ulcerations treated in Japanese wound care centers using AutoloGel platelet-rich-plasma gel (PRP). The study involved 40 wounds in 39 severely compromised patients with comorbidities of diabetes mellitus (DM), lower limb arteriosclerosis, ischemia and infection. The majority of the patient population (34 or 85%) had DM and 24 of those also had arteriosclerosis. Diabetic foot wounds were Wagner Grade lll (77%) (deep ulcers with cellulitis or abscess formation, often with osteomyelitis) and lV (23%) (localized gangrene). Skin perfusion pressures of less than 40 mm Hg were recorded in 25 or 63% of the patients, and less than 30 mm Hg in 20 or 50% of the patients indicating critical limb ischemia which can impair healing. The study included a run-in period of 75.3 days on average, during which revascularization and/or debridement along with standard-of-care therapy with advanced modalities were administered. Full Article
Cytomedix, Inc. Appoints David E. Jorden As Executive Chairman
Cytomedix, Inc. announced that David E. Jorden has been appointed as Executive Chairman of the Company's Board of Directors. Mr. Jorden has served on the Company's Board since September 2008 and will replace Acting Chairman of the Board, James Benson, who will remain on the Company's Board and as its Principal Director. Full Article
Cytomedix, Inc. Announces Option Agreement With Global Pharmaceutical Company For Distribution Of AutoLogel System In Chronic Wound Market
Cytomedix, Inc. announced the execution of a letter agreement granting an undisclosed global pharmaceutical company an exclusivity period until December 31, 2011, to conduct further due diligence regarding the AutoloGel System. In exchange, Cytomedix will receive a $2 million non-refundable option fee within 15 days. The parties are negotiating an exclusive license and supply agreement whereby the AutoloGel System would be distributed through a dedicated, hospital-based sales force. Any final agreement, which remains subject to the successful conclusion of due diligence and negotiation between the parties, is expected to incorporate an upfront license payment, a product development payment covering the second generation AutoloGel device, and a negotiated profit sharing arrangement on future U.S. based sales of the AutoloGel System in the chronic wound care market. Full Article
Cytomedix, Inc. Submits 510(k) to FDA for Bone Marrow Aspirate Concentrate Indication for Angel System
Cytomedix, Inc. announced the recent submission of a 510(k) to the U.S. Food and Drug Administration ("FDA") for use of the Angel Whole Blood Separation System for processing a bone marrow aspirate. The expanded indication includes processing a mixture of blood and bone marrow, a rich source of stem cells. Full Article
Cytomedix, Inc. Completes Two Convertible Note Financings
Cytomedix, Inc. announced that it has closed two convertible note financings with new and existing investors, raising gross proceeds of $1.2 million at closing. The Company placed a three year convertible note with a single accredited investor totaling $1.3 million with an initial funding of $600,000 available at closing, another $200,000 available within 60 days of the closing date provided certain conditions are met, and the remaining $500,000 anticipated to be available in monthly installments beginning in February 2012. Thereafter, another $1.5 million may become available to the Company on substantially the same terms, upon mutual agreement of the parties. The notes carry a one-time 4% interest charge payable upon issuance and are convertible at a discount to future market prices of the Company's common stock determined at the time of conversion with the initial $800,000 of the funding subject to a conversion ceiling of $0.80 per share. The Company also placed an aggregate of $600,000 in 12% short-term convertible notes with several accredited investors and long term shareholders of the Company. Quarterly cash interest payments under these notes will commence on September 30, 2011, with the notes maturing on March 31, 2012. The proceeds from the foregoing transactions will be used for general corporate and working capital purposes. Full Article
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