SOURCE: CytoSorbents Corporation
MONMOUTH JUNCTION, NJ--(Marketwire - Nov 15, 2011) - CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to treat life-threatening illnesses, announced its financial results for the third quarter of fiscal 2011.
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. Additional information is available for download on the Company's website: www.cytosorbents.com
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.