Dallas, Texas (November 16, 2011) – StockGuru Shines its Spotlight on CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to treat life-threatening illnesses. The Company announced its financial results for the third quarter of fiscal 2011, yesterday and closed on November 15, 2011, at $0.132, trading in a fifty-two week range of $0.48 to $0.085.
The Company’s research and development costs were $779,589 and $526,043 for the three months ended September 30, 2011 and 2010, respectively. The Company had losses of $1,728,927 and $788,436 for the three months ended September 30, 2011 and 2010, respectively. Historically, the Company’s losses have resulted principally from costs incurred in the research and development of its polymer technology, and general and administrative expenses, which together were $1,131,982 and $738,431 for the three month periods ended September 30, 2011 and 2010, respectively. Cash and cash equivalents were $2,296,147 as of September 30, 2011.
Dr. Phillip Chan, Chief Executive Officer, stated, “CytoSorb™ represents one of the only, yet most promising, new therapies commercially available in the European Union designed to help treat sepsis and other critical care illnesses by the reduction of cytokine storm. With Eli Lilly’s recent, unexpected, and unfortunate withdrawal of Xigris from all markets worldwide due to a lack of mortality benefit in a required post-marketing study, it has only reinforced the tremendous unmet medical need for sepsis and the opportunity it represents for CytoSorb™. Xigris had previously been the only therapy approved to treat sepsis in the U.S. and E.U. for approximately the past decade.”
Dr. Chan continued, “Although we just began our controlled market release for CytoSorb™ just two short months ago, we are very encouraged by the market reception so far. The response at both the German Sepsis Society Congress and the European Society of Intensive Care Medicine Conference to CytoSorb™ was excellent. We have been busy following up more than several hundred leads with a core group of physicians interested to evaluate CytoSorb™ in both sepsis and other critical care indications. What appears to resonate with physicians about CytoSorb is that it finally represents a simple and logical way to address cytokine storm and the ravages of an immune system gone awry in sepsis, something they know causes multiple organ failure, but have never been able to address before. It is this realization that appears to be driving interest to learn more about CytoSorb™, to use it in clinical practice, and to initiate or participate in additional studies. Our observation is the data from our European Sepsis Trial is being viewed as confirmatory… that the therapy is first and foremost safe, that it is clinically proven to reduce cytokine storm in septic shock, and that there is encouraging early data that shows mortality and other clinical benefits. Based upon this interest, we have been able to arrange in-person meetings with many of the physicians we have met. We are also encouraged by a number of our European Sepsis Trial investigators who have seen our therapy work in real life and have enthusiastically agreed to participate in more clinical trials with us, including our dosing study. We are working diligently to convert this interest into sales of CytoSorb and expect to have revenue this year, though modest given the limited nature of this controlled market release. The desire to try CytoSorb™ in different indications outside sepsis is also encouraging because it confirms our assertion that CytoSorb™ has the potential to be used in other life-threatening illnesses such as acute respiratory distress syndrome, trauma, burn injury, and pancreatitis and could lead to other studies that could change the treatment paradigm of critical illnesses in the ICU. Our interim head of sales and marketing is a German physician who spent the past decade launching and marketing new medical devices, including extracorporeal blood purification therapies, to ICUs across Germany, and has commented that the interest in CytoSorb™ as a new product is much greater than what he has witnessed for other new products in the past and that it is robust and real.”
Dr. Chan continued, “We have spent the past seven months since CE Mark approval putting the pieces in place to drive success of CytoSorb™ in the German marketplace. We have ramped commercial production of CytoSorb™, more than doubled our headcount, and are currently manufacturing sufficient inventory at our ISO 13485 certified facility to meet near-term demand. We have eliminated a major stumbling block to commercialization by establishing a reimbursement path in Germany for CytoSorb™ at a reimbursement price point that exceeds our initial estimates. We have released positive data from our European Sepsis Trial on safety and efficacy to help support sales and are moving forward to get these data published. We have begun our controlled market release to help refine our marketing approach and battle-test our organization. We have exhibited at major critical care conferences, and discussed our data to build our sales pipeline and increase awareness of CytoSorb™. We have put into place an interim head of sales and marketing and are in the process of building a permanent sales team ahead of the formal launch in Germany early next year. We continue to focus on new studies such as our dosing study to generate more data to support clinical usage and sales. We have had early informal discussions with independent distributors in a number of E.U. countries to accelerate our reach into the rest of Europe. And we continue to talk with and discuss our data with potential strategic partners who have maintained an ongoing dialog with the company. Building this foundation in a relatively short period of time was through a tremendous effort by CytoSorbents, but one that has prepared us well for the future. Although building the market for new products takes time, we are encouraged by what we are seeing in the marketplace and our positioning right now, and thank our shareholders for their continued support and patience. We will plan to have a shareholder letter in the near future to expand upon other exciting developments at the company.”
For additional information and full financial results, please see our Form 10-Q filed with the SEC on November 14, 2011, which is available at www.sec.gov.
About CytoSorbents, CytoSorb™, and HemoDefend
CytoSorbents Corporation is a critical care-focused therapeutic device company using blood purification to treat life-threatening illnesses. Its purification technology is based on biocompatible, highly porous polymer beads that can actively remove toxic substances from blood and other bodily fluids by pore capture and adsorption. In March 2011, CytoSorb™, the Company’s flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, and can now be sold throughout the European Union (E.U.) under the CE Mark to be used in cases where cytokines are elevated. The goal of CytoSorb™ is to modulate the immune system by removing excessive cytokines, often called “cytokine storm,” in critically-ill patients that can lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death. CytoSorb™ has demonstrated statistically significant reductions in mortality in septic patients at high risk of death and is now available for sale in Germany for the treatment of critical care illnesses under a controlled market release, with a planned broad product launch in Germany anticipated for the first half of 2012 and availability in other E.U. countries, assuming adequate and timely funding, and continued positive results from our clinical studies. HemoDefend is a development-stage blood purification technology platform for the blood transfusion industry intended to reduce transfusion reactions and safeguard the quality and safety of blood products. The HemoDefend technology utilizes the Company’s polymer bead technology to remove many substances, such as antibodies, free hemoglobin and inflammatory mediators, that can cause potentially serious and sometimes fatal transfusion reactions. CytoSorb™ and HemoDefend are just two of a number of different resins the Company has designed for various medical applications, including improved dialysis, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, removal of chemotherapy drugs during treatment of cancer with high dose regional chemotherapy, drug detoxification, and others.
This press release includes forward-looking statements intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release are not promises or guarantees and are subject to risks and uncertainties that could cause our actual results to differ materially from those anticipated. These statements are based on management’s current expectations and assumptions and are naturally subject to uncertainty and changes in circumstances. We caution you not to place undue reliance upon any such forward-looking statements. Actual results may differ materially from those expressed or implied by the statements herein. CytoSorbents Corporation and CytoSorbents, Inc believe that its primary risk factors include, but are not limited to: obtaining government approvals including required FDA and additional CE Mark approvals; ability to successfully develop commercial operations; dependence on key personnel; acceptance of the Company’s medical devices in the marketplace; the outcome of pending and potential litigation; compliance with governmental regulations; reliance on research and testing facilities of various universities and institutions; the ability to obtain adequate and timely financing in the future when needed; product liability risks; limited manufacturing experience; limited marketing, sales and distribution experience; market acceptance of the Company’s products; competition; unexpected changes in technologies and technological advances; and other factors detailed in the Company’s Form 10-K filed with the SEC on March 31, 2011, which is available at http://www.sec.gov.
To get free alerts on this and other similar stocks, please register here:
What is the StockGuru Spotlight?
Many companies covered in The StockGuru Spotlight have positive increases in both volume and share price. While this is not true in all cases, StockGuru strives to cover companies in The StockGuru Spotlight that are worth of our readers’ attention.
StockGuru looks for potential break-out candidates in The StockGuru Spotlight. Many of these companies have had recent news and appear to be getting the attention of investors. StockGuru does not typically feature companies in The StockGuru Spotlight that are compensating StockGuru for this coverage. There are times when StockGuru covers a stock in The StockGuru Spotlight that had previously compensated Stockguru. Where that is the case, a proper disclosure is included below. StockGuru and its partners, employees and writers never hold shares, short positions, warrants or any other current position in a stock featured in The StockGuru Spotlight.
To feature a company in The StockGuru Spotlight please contact the Publisher at email@example.com. If our reader is a key person for a publicly traded company, StockGuru can consider that company for either a StockGuru Spotlight or a StockGuru Profile. Please contact the StockGuru Publisher John Pentony at this email address: firstname.lastname@example.org.
Stockguru.com (“SG”) provides its members with the latest news, press releases, and trade alerts for all the companies highlighted on the site StockGuru.com. SG utilizes information believed to be reliable herein prepared all material. The information contained herein is not guaranteed by SG to be accurate, and should not be considered to be all-inclusive. The owner, publisher, editor and their associates are not responsible for errors and omissions. SG encourages readers and investors to supplement the information in these reports with independent research and other professional advice. All information on featured companies is provided by the companies profiled, or is available from public sources and SG makes no representations, warranties or guarantees as to the accuracy or completeness of the disclosure by the profiled companies or the information contained herein. The companies that are discussed in this opinion have not approved the statements made in this opinion. This opinion contains forward-looking statements that involve risks and uncertainties. This material is for informational purposes only and should not be construed as an offer or solicitation of an offer to buy or sell securities. SG is not a licensed broker, broker dealer, market maker, investment banker, investment advisor, analyst or underwriter. Please consult a broker before purchasing or selling any securities viewed on http://www.Stockguru.com or mentioned herein.
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E the Securities Exchange Act of 1934, as amended and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “may”, “future”, “plan” or “planned”, “will” or “should”, “expected”, “anticipates”, “draft”, “eventually” or “projected”. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, including the risks that actual results may differ materially from those projected in the forward-looking statements as a result of various factors, and other risks identified in a company’s annual report on Form 10-K or 10-KSB and other filings made by such company with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and SG undertakes no obligation to update such statements. StockGuru is occasionally compensated for coverage. When this is the case, SG clearly indicates this with a disclosure of all compensation received in the past and present. Additionally SG also discloses any anticipated compensation in the future. Compensation is typically in cash. Sometimes a company pays SG in restricted shares. Pentony Enterprise and its associated companies does not take free trading shares for any reason at anytime. StockGuru is not a registered investment adviser or a broker-dealer. StockGuru makes no recommendation that the purchase of securities of companies profiled in this web site is suitable or advisable for any person, or that an investment in such securities will be profitable. In general, given the nature of the companies profiled and the lack of an active trading market for their securities, investing in such securities is highly speculative and carries a high degree of risk.
John Pentony, Publisher, Stockguru.com
Tel: +1 469 252 3031