MONMOUTH JUNCTION, NJ--(Marketwire - Aug 13, 2012) - CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to modulate the immune system to prevent or treat organ failure caused by life-threatening illnesses, announced a corporate update and its financial results for the three months ended June 30, 2012.
Key recent accomplishments include:
- Official launch of CytoSorb® in Germany, following successful completion of our controlled market release
- Establishment of a direct veteran sales force in Germany, led by Dr. Christian Steiner, Vice President of Sales and Marketing
- Award of a DARPA $3.8 million contract under its "Dialysis-like Therapeutics" sepsis program
- Successful completion of the U.S. Army Phase I SBIR grant in trauma with submission of the up to $1 million Phase II SBIR grant proposal
- Analyst coverage initiation from Zacks Small Cap Research and Brean Murray
Dr. Phillip Chan, Chief Executive Officer, stated, "We are pleased with the continued momentum we are building and the execution of a number of important milestones that will help contribute to the success of the Company."
Commercialization: "Following the successful completion of our controlled-market release, we officially launched CytoSorb® in Germany at the end of June with the hiring of Dr. Christian Steiner, our new Vice President of Sales and Marketing, and 3 additional veteran sales people. Dr. Steiner and one representative started full-time at the end of June, while the other two began at the beginning of August. The team has now completed their training and has already begun to set-up meetings with their own previously established critical care network.
"The market reception continues to be very encouraging. Since the last earnings update, we have grown the number of sites interested to use CytoSorb®. We are also beginning to see some unsolicited interest from physicians who have heard about our technology.
"Sepsis continues to drive the most interest and usage in the technology, but as expected, other indications such as lung injury, cardiac surgery, trauma, liver failure, pancreatitis, and transplant surgery have also been generating additional interest. We have also now opened accounts in the neighboring DACH, or German speaking countries, of Switzerland and Austria, where CytoSorb® has recently been used to successfully treat a critically-ill septic patient.
"Between now and the end of the year, we will also be exhibiting at 7 major conferences, giving us ample opportunity to increase market awareness of our technologies."
Research and Development: "We are excited that our technology is gaining increased recognition and funding, particularly by the military and U.S. Department of Defense, where our U.S. Army Phase I SBIR grant in trauma and our recent DARPA $3.8 million contract for sepsis will help us to develop next generation blood purification technologies. After successfully completing the Phase I portion of the SBIR grant in trauma, we have submitted our Phase II SBIR grant application, worth up to $1 million in funding over one year, and hope to hear of a funding decision by the end of the year. Grants are becoming an excellent source of non-dilutive capital to help us drive innovation.
"In conjunction with grant income, we will continue to invest significant resources into new product and technology development, as well as intellectual property."
Increased Investor Awareness: "We are pleased that analysts at both Zacks and Brean Murray are now following the developments of our company. Investors can visit our investor website at http://www.cytosorbents.com/invest.htm for instructions on how to obtain these reports. One of our major near term goals is to communicate the story to not only retail investors, but to institutional investors who have the ability to take a fundamental, long term approach."
Dr. Chan concluded, "Each of these achievements highlights CytoSorbents' strategy for growth. As expected, the majority of our resources are focused on driving the commercial success of CytoSorb®, the key to the Company's future. However, new products in our research and development pipeline have the potential to fuel significant additional value, through a combination of new products to sell, non-dilutive grant and contract funding, and potential out-licensing revenue."
Financial Results for the Second Quarter of 2012
CytoSorbents generated product revenues of $33,042 and $-0-, and $49,935 and $-0-, for the three and six month periods ended June 30, 2012 and 2011, respectively. Revenues in the current six month period were part of an initial test market phase of CytoSorb® with the company exploring direct sales to hospitals in Germany (without a dedicated sales force in place) and sales to distributor networks in other parts of Europe. The device was not available or approved for sale during the first six months of 2011.
Our research and development costs were $665,750 and $854,827, for the three months ended June 30, 2012 and 2011, respectively, and $1,309,031 and $1,613,984 for the six months ended June 30, 2012 and 2011, respectively. The Company had net losses of $1,047,310 and $2,473,906 for the three and six month periods ended June 30, 2012. In comparison, we had losses of $1,341,182 and $2,555,766 for the three and six month periods ended June 30, 2011. Historically, our losses have resulted principally from costs incurred in the research and development of our polymer technology, and selling, general and administrative expenses, which together were $958,930 and $1,871,677 for the three and six month periods ended June 30, 2012 and $1,046,629 and $2,075,878 for the three and six month periods ended June 30, 2011. As of June 30, 2012 we had cash on hand of $1,741,839.
For additional information please see the company's 10Q report for the period ended June 30, 2012 filed on August 13, 2012 on www.sec.gov.
About CytoSorbents, CytoSorb®, and HemoDefend
CytoSorbents Corporation is a critical care focused therapeutic device company using blood purification to modulate the immune system and fight multi-organ failure in 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. Approved in the European Union in 2011 as a cytokine filter to be used in clinical situations where cytokines are elevated, CytoSorb® can be used in many different illnesses seen in the intensive care unit, including sepsis, trauma, burn injury, acute respiratory distress syndrome, and pancreatitis. The goal of the therapy is to reduce the excessive production of cytokines, or "cytokine storm", seen frequently in these conditions that would otherwise drive massive inflammation and lead to the failure of vital organs - the leading cause of death in the ICU for which only supportive care exists. The primary goal of CytoSorb® is to be used early enough to prevent patients from reaching this level of illness severity. When used later in patients with organ dysfunction or failure, the goal of CytoSorb® is to reduce recurrent injury caused by ongoing inflammation, potentially helping the body to heal and recover. CytoSorb® has demonstrated statistically significant reductions in mortality in septic patients at high risk of death in early studies and is now being sold in Germany for the treatment of critical care illnesses, with availability in other E.U. countries planned in the future, 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 a much broader range of substances, such as antibodies, free hemoglobin, drugs and inflammatory mediators that can cause potentially serious and sometimes fatal transfusion reactions. CytoSorb® and HemoDefend are just two of a number of different polymers the Company has designed for various medical applications, including improved dialysis, reduction of post-surgical complications, the potential treatment of inflammatory and autoimmune disorders, rhabdomyolysis in trauma, 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 30, 2012, which is available at http://www.sec.gov.
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