Nachdem im Hot Pharma Stocks bereits darüber geschrieben wurde, nun ein eigenes Thema. (Preise unter 0.5)
Ich habe bereits öfters auf die Insider Käufe hingewiesen.
Nun hab ich bei Biomedrep. gesehen dass Ihnen diese Käufe auch aufgefallen sind.
http://www.gurufocus.com/InsiderBuy.php?symbol1=gtf&Submit=Search+Inside...
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+0.025 (4.33%)
Cytomedix, Inc. (NYSE Amex: GTF) has some upcoming catalysts in 2011 that could potentially help transform their company. Cytomedix develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis.
Currently they have two devices that they are actively marketing: AutoloGel™ System and the Angel® Whole Blood Separation System. AutoloGel™ is a device for the production of platelet rich plasma (PRP) gel derived from the patient’s own blood for use on a variety of exuding wounds. Angel® is a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma (PPP) and PRP in surgical settings.
Cytomedix intends on submitting a new 510(k) application with the FDA for material enhancements to the AutoloGel System late in 2010 or early in 2011. The re-designed device allows for the rapid preparation of platelet rich plasma (“PRP”) in a semi-closed system, improves the ease of use by eliminating a significant number of steps involved in the process and lowers cost of goods. Higher margins and The AutoloGel System is the only PRP device cleared by the U.S. Food and Drug Administration (“FDA”) for use on a variety of exuding wounds
Currently, their products lack of reimbursements from Medicare, which is certainly hindering their sales. However, Cytomedix is meeting with CMS in January to discuss re-filing for approval on reimbursement. CMS reimbursement could be a game changer for them in late-2011 and beyond. As CEO Martin Rosendale said in their 3Q 2010 filing,”..we have made considerable progress with the development of the dossier for our planned submission for reconsideration of reimbursement with the Centers for Medicare and Medicaid Services (“CMS”) that includes robust clinical and scientific data, as well as compelling economic data. The clinical data package includes the outcomes of 285 wounds treated with the AutoloGel system and recorded in our ongoing patient registry. The initial analysis of this data fully supports previous AutoloGel System clinical studies and reflects the positive outcomes we continue to see in clinical practice.”
We think there is clear clinical evidence supporting the use of the AutoloGel in chronic wounds. They have collected data on 65 wounds of differing types across 50 patients and 11 facilities. Importantly, the average duration of these wounds before the first treatment with AutoloGel was 48 weeks. The AutoloGel System produced a favorable clinical response in 97% of the wounds treated with a mean reduction in wound volume of 62% in less than three weeks of treatment on average. Since then, they have collected data on an additional 215 wounds, which they are currently analyzing and will be used as additional clinical evidence in their re-application for Medicare Part B reimbursement by CMS. Cytomedix management has made significant efforts in 2010 to increase the medical community’s awareness of their devices; they’ve presented at more than 5 highly attended wound care management conferences. Data from this additional post-marketing study could also be helpful in increasing the device’s use.
Zack’s analyst, Jason Napodano,CFA, currently has them rated as ‘Outperform’ with a $1.50 price target. As he says in a recent note to investors, “We believe the company is on a clear path toward profitability thanks to growing revenues, high margin products, and a low-cost structure. Based on our NPV analysis, a market capitalization closer to $60 million, or approximately $1.50 per share, more fairly values Cytomedix.”
One more thing that Cytomedix has going for them: HUGE insider buying by David Jorden, their Executive Director. As they say, there are 1000 reasons to sell a stock, but there is only 1 reason to buy. They currently have a $13 million committed equity finance agreement with Lincoln Park Capital; no denying it is dilutive, but Cytomedix needs cash until they can obtain broader reimbursements for their device. We barely touched on the Angel system and their With increasing revenues and positive future catalysts, we like the risk-reward at these levels and believe that 2011 could be promising for this medical device manufacturer.
Disclosure: Long GTF
von: Written by Patrick Crutcher
der Typ hat schon ein paar hammersachen angesagt!
Fazit; gehört auf watchlist, willige evtl. erste tranchen nehmen.
Hab hier noch Vagnums post ausm Hot Pharma kopiert...
das problem/die chance ist das:
selbstverständlich haben sie auch schon produkte auf dem markt.
Equities research analysts at Zacks Investment Research reiterated an “outperform” rating on shares of Cytomedix, Inc. (NYSE: GTF) in a research note to clients and investors on Friday. The analysts currently have a $1.50 price target on the stock.
Analyst Jason Napodano wrote, ” In our view, the biggest catalyst for shares of Cytomedix on the horizon is the submission for reconsideration of AutoloGel with Medicare / Medicaid. Based on our conversations with management, this filing should take place in the first quarter 2011. We have seen a significant increase in data since the first submission was rejected by CMS in 2003. We believe that Cytomedix is well positioned of growth in the coming quarters. At today’s market value of only $20 million, Cytomedix is far undervalued. We see a market value of $60 million as more fairly valuing the potential for both AutoloGel and the Angel PRP system. As such, we are reiterating our Outperform’ rating and $1.50 near-term price target.”
Cytomedix, Inc. (Cytomedix) is a biotechnology company that develops, sells and licenses regenerative biological therapies to primarily address the areas of wound care, inflammation and angiogenesis. The Company markets the AutoloGel System, a device for the production of platelet rich plasma (PRP) gel derived from the patient’s own blood. The AutoloGel System is cleared by the United States Food and Drug Administration (FDA) for use on a variety of exuding wounds.
Shares of Cytomedix, Inc. (NYSE: GTF) traded down 6.54% during mid-day trading on Friday, hitting $0.5701. Cytomedix, Inc. has a 52 week low of $0.39 and a 52 week high of $1.75. The stock’s 50-day moving average is $0.52 and its 200-day moving average is $0.53. On average, analysts predict that Cytomedix, Inc. will post $0.00 EPS next quarter. The company has a market cap of $24.1 million and a price-to-earnings ratio of N/A.
Ich bin auch dabei @ 0.5793
GTF: Cytomedix Armed With Significant Data For AutoloGel CMS Reconsideration
Quote:
GAITHERSBURG, Md., Jan. 21, 2011 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (NYSE Amex:GTF) ("the Company" or "Cytomedix") announced today that beginning with the opening of trading on or about January 25, 2011, the Company's common stock is expected to be quoted on the OTC Bulletin Board, and will cease trading on the NYSE Amex. The Company also expects to be issued a new trading symbol for quotation on the OTC Bulletin Board and will announce the new ticker symbol once it has been assigned.
http://www.thestreet.com/story/10982077/1/cytomedix-common-stock-to-trad...
joah, neuer penny stock hier. Firma ist aber ok, denke sollten wir weiterverfolgen...
Tja, das heisst wohl aussitzen ... :roll:
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-0.122 (-20.80%)
Cytomedix CEO Issues Shareholder Update
Quote:
GAITHERSBURG, Md., Feb. 2, 2011 (GLOBE NEWSWIRE) -- Cytomedix, Inc. (OTCBB:CMXI), ("the Company" or "Cytomedix") a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that Martin P. Rosendale, the Company's President and Chief Executive Officer, issued the following letter to shareholders providing a general corporate update:Dear Shareholders:
Having just completed a successful, important and transformative year for Cytomedix, I wanted to provide you with an update on our commercial progress and to set the stage for what we believe will be a year of exciting and notable developments for Cytomedix. At the outset, let me share with you a short list of projected milestones for the first half of 2011. Below in my comments, I will address most of these in further detail.
Submit Medicare reimbursement reconsideration for wound care
Submit FDA 510(k) application for enhanced AutoloGel(TM) PRP device
Submit one FDA 510(k) application for a new Angel(R) indication
Complete the Angel and activAT(R) manufacturing transition and transfer CE marks
Continue to collect clinical data and publish two clinical articles
Most recently, we transitioned the trading of Cytomedix's common stock to the over-the-counter markets, and the stock is now being quoted on the OTC Bulletin Board under our new ticker symbol of "CMXI." First, I want to make clear that our fundamental business is no different today under our new trading symbol than it was a week ago on the NYSE Amex. Having exhaustively considered various avenues available to us, we determined that the cost and dilution to the existing shareholders would have been unnecessarily excessive as we believe the capital required to execute on our business plan was already committed and available through our October 2010 registered direct offering and the $11.5 million in financial commitments provided under two separate equity purchase agreements. We remain optimistic that the underlying liquidity in our stock can be maintained and we will do everything possible to promote continued transparency and visibility into our trading activity.
Let me turn now to Cytomedix's business progress, because it is these fundamental commercial and strategic developments that will impact our long term success.
As you are aware, the vast majority of my professional career has been spent in the commercialization of biologic therapies, specifically plasma proteins, blood derived products, and vaccines. What initially drew me to Cytomedix was a strongly held personal belief that this company's fundamental approach to the science and technology of tissue repair and rejuvenation is the correct approach. Therapies produced by the AutoloGel and Angel systems are based on the common premise that a complex combination of proteins, signal molecules and growth factors is necessary to address the highly complex biological mechanisms of interconnected molecular and cellular activity required to facilitate the regeneration of healthy tissue. With our technology platforms, we are working to harness the body's own naturally evolved regenerative mechanisms to promote better and faster clinical outcomes in a holistic manner as opposed to a narrowly-targeted approach. Much has been learned in the past 10-15 years concerning the vast role that plasma-derived proteins and related molecules play in molecular biology, with the promise of far more to come. We are actively engaged in these conversations with thought leaders and experts in the field, and fully expect to establish a leadership position in the evolving development of a deeper understanding of the underlying science and related clinical applications.
Angel
The substantial overlap in technology and therapeutic mechanisms between the AutoloGel and Angel systems is what motivated our strategic decision to acquire the Angel product line from the Sorin Group last spring. With 9 months of ownership under our belt, we are very pleased with our progress to date in integrating Angel into the Cytomedix business, and the potential we see for the asset in the months and years to come. Our experience with Angel, and growing familiarity with its strengths, supports our contention that it is truly a 'best in class' product in its market with product features and capabilities that set it apart from competing devices. This assertion stands in contrast to Angel's relatively modest single digit share in the marketplace and highlights a meaningful opportunity to not only grow with the market but to capitalize on a substantial market share opportunity. As we have discussed, our highest priority post-acquisition was to directly connect with the existing domestic Angel customers and ensure the continuation of those important revenue streams. While we experienced some small individual customer account losses in the transition, our net attrition has been zero and, in fact, Angel revenues are clearly up from their run-rate at the time we purchased the business from Sorin.
Today, we are actively prospecting new customers, winning new business under multi-year arrangements that benefit us now and in future periods, and have a full sales and evaluation pipeline. In addition to the direct Cytomedix sales force we have in the field, we are fortunate to have highly-skilled and long-term industry sales representatives operating independently and successfully to win new business. In combination with the expanded indications we intend to pursue this year, we believe our outlook for growth in Angel in the U.S. market is strong and sustainable.
In Europe, the Angel acquisition provided us with a mix of direct sales and small distribution arrangements in selected countries. Under the leadership of our international sales and marketing consultant, Michael Joos, we have embarked on a well-defined European expansion plan. In Europe, as well as in the U.S., we expect to benefit from the expertise of Dr. Peter Everts, a member of our recently formalized scientific advisory board. Dr. Everts is a world recognized expert in platelet rich plasma (PRP) and its associated clinical uses and, as a long time Angel user, will be instrumental in helping guide our product development and clinical strategies.
The transition of manufacturing and other related activities prevented us from giving the European opportunity our full attention at the outset. In December 2010, we were pleased to announce receipt of ISO 13485 Certification, which certifies Cytomedix as a provider of high-quality devices for the medical industry and allows the Company to operate commercially in Europe and in Canada. Moreover, we expect to complete the manufacturing transition and transfer the CE Marks for Angel and activAT in the coming weeks. With these certifications secured, we can focus on expansion opportunities in the international markets which we believe can and will be a substantial contributor to overall Angel growth later in 2011 and into the future.
AutoloGel and CMS Reimbursement
Our commercial revenues for the AutoloGel System posted healthy year-over-year growth figures, yet remain modest. However, this does not diminish our enthusiasm for its long term potential. 2011 will be a critical year for laying further groundwork that will help us realize this potential. In simple terms, AutoloGel works well - especially in the context of a market still facing a substantial unmet medical need where accepted clinical success in the treatment of non-healing chronic wounds is considered to be somewhere around 50%. Since completely reformulating the scientific and clinical message in early 2009, and effectively re-launching the product with a much more clinically intensive effort, we have essentially been pursuing three basic aims:
1) Educating a skeptical clinical community which has seen scores of wound care products that failed to deliver in real world clinical practice
2) Collecting critically important data to build a robust, verifiable and credible data set that can be appropriately analyzed, published and presented to healthcare providers and payers.
3) Focusing the above efforts primarily in markets dominated by prospective payment systems which will benefit from cost savings and clinical efficacy such as Long Term Acute Care and Veterans Hospital facilities
The educational efforts have been an unqualified success. In addition to establishing a growing collection of wound care clinicians who have experienced notable clinical success with their patients, the ongoing data collection continues to support and validate the clinical efficacy of AutoloGel as demonstrated in the pivotal, randomized, controlled trial that led to AutoloGel's marketing clearance from the FDA. From a reimbursement perspective, the shortcoming in that study was considered to be its relatively small size, notwithstanding its statistical significance. Consequently, a fundamental goal has been to collect high-quality data to validly demonstrate clinically relevant outcomes in a larger number of AutoloGel-treated patients. The core of this expanded data set has been an ongoing wound registry populated by wounds of various etiologies at multiple clinical sites. It is further supplemented by data on 100 wounds from our post-market surveillance study and data from another 100 wounds collected by Millennia, our partners in Japan, in conjunction with their ongoing clinical and regulatory approval process in Japan. Throughout 2010, various aspects of this evolving data set have been published as peer-reviewed articles in industry journals and/or have been presented at various industry conferences and medical meetings. In the care settings where this registry has been collected, the outcomes have been consistent and unequivocally positive: previously non-healing wounds can have their fundamental wound trajectory immediately and positively impacted to such a degree that over a short treatment period of approximately 3 weeks (the typical length of stay in these care facilities) the physical wound size in area and/or volume is significantly reduced.
A subset of this data is currently in the final stages of manuscript preparation and is expected to be submitted for peer reviewed publication in the coming weeks. This data set is unique in that we were able to obtain the 'run-in' data for this subset of patients and, therefore, know the nature of their wound treatment prior to initiating AutoloGel treatment, its length and outcomes, and we can even estimate the cost of prior treatment. In essence, the run-in data provides the control for comparison and allows the data to be analyzed in that context. The analysis being applied to this data is novel and, in our opinion and that of the experts involved with us on this effort, is establishing an important new standard in terms of assessing clinically meaningful and relevant outcomes. The outcomes are highly statistically significant and we eagerly look forward to their publication later this year.
The ultimate outcome of efforts at health care reform may still be subject to debate, but it seems reasonably intuitive and obvious that greater cost effectiveness is a necessary condition of any overall solution. Based on previously published pharmacoeconomic studies, and more importantly, on data such as the article about to be submitted for review and publication, we strongly believe that an effective therapy such as AutoloGel can play an important role in providing cost effective outcomes to the health care system while delivering clinically meaningful and beneficial outcomes for patients.
This is the straightforward message we plan to convey to CMS during our upcoming reimbursement discussions. We are only modestly behind schedule with where we had hoped to be in terms of actively engaging CMS on the topic of an official reimbursement reconsideration request for PRP for wound care. Our important focus has been and continues to be to 'get it right.' Our current expectation is to meet with CMS as soon as practical and to file the formal resubmission request shortly following that meeting. As previously discussed, if CMS agrees to a reconsideration, these actions begin a formal 180 day review process by CMS in advance of a preliminary determination. We would expect to meet again with CMS during that 180 day period where we will be joined by a collection of industry key opinion leaders and stakeholders for a comprehensive review of all the applicable data and literature (clinical and scientific). We are excited to engage in this process as we believe the data, clinical outcomes, and cost benefits all point toward a favorable conclusion that supports the reimbursement of this technology for the benefit of patients and the system as a whole.
Another significant development that promises to have a meaningful impact on clinical adoption of AutoloGel will be the planned introduction of the redesigned AutoloGel centrifuge - what we internally refer to as AutoloGel 2.0. The new device, developed with the assistance of some creative biomedical engineers in Israel, offers a completely proprietary means of plasma and platelet separation that is simpler and more straightforward than our current system. This streamlines the process and provides for a more aseptic environment that may be more conducive for certain developing orthopedic indications. At the point of care, we believe the improved ease-of-use will be of real benefit to treating clinicians and expect it to have a favorable impact on product adoption. Importantly, these new enhancements provide additional intellectual property opportunities for which we have already filed patent applications. The device and its components are in the required stages of validation and, based on anticipated feedback from the FDA, we expect to file for 510(k) marketing clearance in the coming three months.
Business Development Opportunities
We currently have more business development opportunities in front of us than we have had cumulatively over the past couple of years. Most of these are inbound inquiries that are largely due to our heightened profile in the marketplace and within the broad arena of regenerative medicine. This enhanced visibility is mainly a result of our acquisition of Angel and, importantly, because the Angel product itself is drawing interest. With the integration of Angel now well in hand, we are turning our full attention to these opportunities. We are very optimistic that we can succeed in delivering attractive agreements in the coming year that will offer strong third party validation of our approach to these markets. The range of potential opportunities is broad at this time and could range from expanded geographic distribution arrangements with larger companies interested in securing a PRP solution to more narrowly-targeted collaborations in areas of specific clinical interest. Clearly, the broad orthopedics area continues to garner interest and attention as access to clinical data and physician experience advances. Our early initiatives in the hair restoration market as well as early-stage discussions within the plastic surgery area also leave us encouraged about the potential for our PRP solutions in these growing markets.
In Closing
We are very excited about the opportunities ahead for your Company as we continue to build on the clinical data and positive patient outcomes with our unique PRP products that harness the body's own naturally-evolved regenerative mechanisms to promote better and faster clinical outcomes. As an organization, we have a number of goals and objectives for 2011 and beyond, but our overriding and primary goal is to expand our footprint in our core markets and to drive sustainable growth in product sales for both Angel and AutoloGel. We are confident we have the right strategy in place to leverage the multitude of opportunities before us and we look forward to reporting to you on our progress in these areas. We thank you, our loyal shareholders, for your ongoing support and encouragement as we strive to make 2011 another transformative year for Cytomedix.
Sincerely,
Martin P. Rosendale
President and Chief Executive Officer
http://finance.yahoo.com/news/Cytomedix-CEO-Issues-pz-971706141.html?x=0
