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CYTOMEDIX INC NEW Message Board

  • lettucecometogether lettucecometogether Mar 16, 2013 1:29 AM Flag

    if enough shareholders get upset at management robbing the till, we can remove them

    party over. cant keep reaching into our purses and wallets while shareprice drops

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    • they don't serve the small raise...
      lets see do you listen to a criminal who posts under differnet aliases and spams scam investment stock links which are now under investigation on a yahoo stock chat site or a well respected CEO?

      "We are pleased with this capital infusion, as it provides us with the necessary capital to execute on our strategic growth plans," said Martin Rosendale, Chief Executive Officer of Cytomedix. "This capital will facilitate our continued growth following the record product sales we achieved in the fourth quarter of 2012, the expansion of the AutoloGel System with Medicare coverage, and the international growth of the Angel cPRP System."

      "Angel is positioned as a 'best in class' PRP device that represents a significant engineering advance in the separation of whole blood and bone marrow for clinical use and offers clear competitive advantages over other currently available systems."

      "A unique feature of Angel is its flexible therapeutic output, which allows physicians to generate customized platelet concentrates at the point-of-care," said Aarti Shetty, research analyst at Frost & Sullivan. "Our analysis suggests that this is a product that could ultimately have broad use in a large number of orthopedic procedures."

      The Angel cPRP System is intended to be used in the clinic or intraoperatively at the point-of-care for the safe and rapid preparation of platelet rich plasma (PRP). It was initially cleared by the FDA for whole blood processing and recently received 510K clearance to process bone marrow aspirate to produce platelet concentrates. The system is designed to produce consistently high platelet yields using a fully automated process and represents a significant engineering advance in autologous whole blood and bone marrow separation. Angel's advantages compared with other commercially available systems include: 1) high platelet yields, 2) significant reduction in pro-inflammatory cells, 3) rapid processing time, 4) adjustable hematocrit from 0%-25%, and 5) flexible final cPRP volumes. Proprietary software automatically adjusts the separation parameters to deliver a consistent, high quality product.

      Also...

      ANGEL willl generate at least 13 million in 2013.

      Cytomedix will be working with wound care centers around the country to build its registry just as Medtronic did with leading cardiac centers. The company will be using Intellicure to aid in the collection and analysis of the data as it is being generated. Management tells us that each use of AutoloGel will generate a profit to the company. That`s important for investors to understand. CED allows Cytomedix to earn a profit as it collects the data and funnels that back to CMS for review. That`s different from a traditional clinical trial which normally cost companies money. Cytomedix will be selling AutoloGel with CMS coverage, and booking revenues as it ramps.

      Duke and Maimi University are funding the ALD-401 studies and the 13-month Phase I/II trial, funded by the National Heart, Lung, and Blood Institute at the National Institutes of Health, is the first ever to directly compare the safety and efficacy of mesenchymal stem cells taken from patients with those provided by a donor. Thirty patients with chronic ischemic cardiomyopathy received various doses of MSCs. Half received their own stem cells, while the other half received donor stem cells. The study results suggest that using donor cells may speed up treatment.

      Cytomedix also has about 6 milllion in cash on hand.

      lets see do you listen to a criminal who posts under differnet aliases and spams scam investment stock links which are now under investigation on a yahoo stock chat site or a well respected CEO?

      Martin Rosendale, Chief Executive Officer
      Mr. Rosendale joined Cytomedix, Inc. in March 2008 as COO and he was appointed Chief Executive Officer in July 2008. Prior to joining Cytomedix, Mr. Rosendale was Chief Executive Officer of Core Dynamics, Inc. where he managed their Israel based R&D program and initiated U.S. commercial operations for cryobiology and cell lyophilization technologies. Mr. Rosendale has more than 24 years of specialty medical experience. He has held leadership positions for the past 15 years with American Red Cross, SangStat, North American Vaccine and ZLB Bioplasma, in addition to serving on the boards of the Transplant Recipients International Organization and the American Red Cross Biomedical Services, San Jose Region. Mr. Rosendale earned a Bachelor of Science degree in Microbiology from California State University.

      Let me take a minute now and speak off script. Cytomedix has now been transformed into a fully integrated and broad-based regenerative medicine company. In the past three months alone, we have achieved a favorable national coverage decision for AutoloGel and an additional FDA 510(k) clearance for the Angel system. Essentially my entire business career has involved the commercialization of biological therapies. So my focus is always on the fundamentals of the business. Therefore, I rightly leave the valuation of this company to the experts and the market in general. But I would be remiss if I didn’t tell you, this company has never been in such an attractive fundamental position.

      As I just stated, having achieved a national coverage decision and a 510(k) clearance in a three-month period is something that I suspect most companies could not claim today. With respect to a potential partnership as I said, we have several ongoing discussions, a number of them look very promising. These discussions are with companies that have deep reach into the wound care marketplace or have a large commercial presence with a sales organization that’s ideally suitable for our products and to facilitate the success of AutoloGel going forward.

      These discussions do take time and I know it’s a difficult to ask, but I ask you all to be patient with us as we work through this but I can assure you the process will go smoothly. Having been through the process recently as you all know, our entire system was fully validated. The value of the technology was validated, our ability to scale manufacturing was validated, our ability to promote and effectively market the process in the marketplace was validated through interviews with key opinion leaders and other healthcare providers in the field. We will pass scrutiny with any other company that we are in discussions with today. So I am confident in our discussions, I am confident in our progress.

      As I said, my focus is always on the fundamental of the business. The fundamentals at Cytomedix are strong. We are in a better position than we have ever been before and I am excited unfortunately my laryngitis is probably preventing me from communicating that fully on the call this morning. But I am excited, I am enthusiastic. Our team here is extremely optimistic. We are looking forward to the coming weeks and months and anticipate reporting to you the achievement of additional milestones very soon.

      We even have John Hopkins and Duke Medical Centers in our corner.

      • Under our license agreement, as amended, with Johns Hopkins University (“JHU”), JHU has granted us an exclusive, worldwide license, under its patents relating to flow sorting of stem cell populations based on a fluorescent ALDH substrate (the “JHU Patents”). Under the terms of the JHU license agreement, as amended, we are obligated to pay a 3% royalty on revenues relating to therapeutic products based on the JHU Patents, and up to 7% on revenues relating to other products based on the JHU patents, subject to an annual minimum of $10,000. We must also pay up to $222,500 in the aggregate upon the satisfaction of specified development milestones. The Company bears all costs to maintain the patents. This agreement terminates with the expiration of the patents in 2016.

      • Under our license agreement with Duke University (“Duke”), Duke has granted us an exclusive, worldwide license under its patents and applications that relate to methods for isolating and manufacturing ALDHbr cell populations (the “Duke Patents”). Under the terms of the Duke license agreement, we are obligated to pay up to a 1% royalty to Duke on all revenues relating to the Duke Patents, subject to an annual minimum or $5,000 (which will increase to $25,000 upon the achievement of specified development and commercialization milestones). The Company bears all costs to maintain the patents. This agreement terminates with the expiration of the patents in 2018

      First Stroke Patients in Florida Treated in Miller School Stem Cell Trial
      24/01/2013

      "Yavagal performed Anderson’s study procedure on January 11, making him the second person to be enrolled in the University of Miami/Jackson Memorial Hospital arm of the nationwide trial known as RECOVER-stroke. Approximately 100 patients in the U.S. will be enrolled and randomized within the trial. About 60 of those patients will receive an intra-carotid infusion of stem cells, while the others will receive a placebo. None will know what they received until the trial’s end. Twenty patients are expected to be enrolled in the Miller School trial".

      The first two stroke patients have been enrolled in a phase 2 clinical trial of a revolutionary new treatment for ischemic stroke being conducted at the University of Miami/Jackson Memorial Hospital.

      The trial, using a patient’s own bone marrow stem cells, is the first intra-arterial stroke stem cell trial in the U.S., and the two UM/Jackson patients are the first in Florida to participate.

      Led by Dileep Yavagal, M.D., assistant professor of neurology and neurological surgery, the trial is examining the efficacy of ALD-401, derived from bone marrow, to repair and regenerate tissue following an ischemic event.

      James Anderson, a physical education teacher from Maine, is hopeful that participating in the double-blind study will help him recover more quickly. “Stroke is not an easy problem. I liked something that was progressive and I could be involved in.”

      Four days before Christmas, Anderson and his wife Barbara had just arrived in Naples to visit his mother-in-law when he suddenly grew very pale. Having run three miles the day before, they had no warning that he was having a major stroke. Anderson was given tissue plasminogen activator (tPA) at a West Coast hospital, but was soon airlifted to Jackson Memorial Hospital, a comprehensive stroke center, because of the severity of the stroke. That’s when Yavagal, who is also Director of Interventional Neurology at UHealth, visited the 58-year-old to explain the study.

      Once either tPA is administered to break up a blocked artery or a clot-removal procedure is performed, there are no approved therapies for persisting neurological disabilities seen in a significant number of stroke patients despite treatment and rehabilitation. Yavagal believes ALD-401, which is derived from ALDHbr cells isolated from bone marrow and is injected within weeks of a primary ischemic stroke, has the potential to be one. Manufactured by Aldagen, a wholly-owned subsidiary of Cytomedix, Inc., ALD-401 contains all cell types thought to repair and regenerate tissue following an ischemic event and offers multiple mechanisms of action.

      The middle school teacher’s wife, Barbara, said they discussed it with the family and she and James “felt it was right and a way to help others as well…. We really want to be in on the beginning of this so others can benefit.”

      Yavagal performed Anderson’s study procedure on January 11, making him the second person to be enrolled in the University of Miami/Jackson Memorial Hospital arm of the nationwide trial known as RECOVER-stroke. Approximately 100 patients in the U.S. will be enrolled and randomized within the trial. About 60 of those patients will receive an intra-carotid infusion of stem cells, while the others will receive a placebo. None will know what they received until the trial’s end. Twenty patients are expected to be enrolled in the Miller School trial.

      Yavagal is a leader in research of the intra-arterial delivery of stem cells for stroke and has been funded for this research over the last four years. He works in close collaboration with Joshua M. Hare, M.D., Director of the Interdisciplinary Stem Cell Institute, to translate the promise of stem cells for stroke patients. He is on the national steering committee of the RECOVER-Stroke trial.

      With intra-arterial delivery, the cells are delivered directly to the brain via the carotid artery, avoiding their becoming trapped in the lungs and liver, which occurs when stem cells have been administered intravenously. Yavagal, who is also Co-Director of Endovascular Neurosurgery and a faculty member of the Interdisciplinary Stem Cell Institute, says this trial is “hugely significant” because of its delivery method. Despite the availability of tPA and clot-removal procedures, fewer than 40 percent of stroke patients regain their independence.

      Anderson was left paralyzed along his left side but can speak. The first person to be enrolled, a 60-year-old Hialeah man, is using a walker but has lost his speech for now. The study is blinded, so neither patient knows whether they received the stem cells or not. They will receive MRI and CT scans regularly to monitor their progress.

      An avid fisherman, Anderson instills exercise as a way of life to his students. For now, he’s receiving occupational and recreational therapy along with speech and physical therapy. He is hopeful that his rehabilitation and the stem cell treatment will decrease his recovery time, allowing him to return to his “regular life” sooner. Anderson says he finds encouragement from Yavagal. “I’m inspired by him whenever I see him and talk to him. He’s progressive and cares about people.”

      University of Miami Less

      Sentiment: Strong Buy

 
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