|By Marketwired .||
|November 21, 2012 04:34 PM EST||
MONMOUTH JUNCTION, NJ -- (Marketwire) -- 11/21/12 -- CytoSorbents Corporation (OTCBB: CTSO), a critical care-focused company using blood purification to reduce inflammation as a means to prevent or treat organ failure caused by life-threatening illnesses, announced a corporate update and its financial results for the three months and nine months ended September 30, 2012.
Key recent accomplishments include:
- Revenue of $605K in Q3 2012 consisting predominantly of our first DARPA milestone payment, with modest product sales from a transitional third quarter where our sales team completed its training and began a direct sales effort. Q4 2012 product sales are nearly $70K to date
- Expansion to more than 60 key opinion leaders throughout Germany, Austria and Switzerland who are interested in using or are currently using CytoSorb®
- Active discussion and planning of at least 6 new investigator-initiated human pilot studies in a growing list of critical care applications
- Accelerated development and achievement of initial milestones under our recently announced $3.8 million DARPA multi-year agreement for the treatment of sepsis, coinciding with receipt of the first milestone payment
- Award of an up to $1 million U.S. Army Phase II SBIR for trauma and burn injury research, currently in contract negotiations
- Showcase of our technology at five major international medical conferences including two formal scientific presentations, and two key investor conferences
Dr. Phillip Chan, Chief Executive Officer, commented, "We are very pleased with our recent progress. From a commercialization standpoint, the third quarter of 2012 was a transitional period marking the beginning of our formal direct sales effort in Germany, Austria and Switzerland. Our sales force came together in August 2012, and in the span of only a few months, the Company has generated cumulative sales of approximately $83K. With many key opinion leaders enthusiastic about working with us, our focus in the near future will be to harness this interest to drive broader awareness and usage amongst like-minded colleagues at their institutions. We are grateful for the continued positive reception of CytoSorb® amongst an increasing number of critical care physicians, as well as new studies that many of them are proposing. In addition, we are encouraged by positive CytoSorb® treatment case reports demonstrating benefit in patients with a number of different critical illnesses such as sepsis, pancreatitis, liver disease, lung injury, and others.
"To further augment sales generated by our direct sales force, we are in the process of establishing relationships with certain critical care focused distributors. The goal is to create multiple revenue drivers that, when layered together, can potentially accelerate our growth."
Dr. Chan continued, "In terms of our research and development initiatives, we are thankful that DARPA and the U.S. Army have recognized the potential of our technology for the treatment of sepsis, trauma, and burn and smoke inhalation injury, with the total award of approximately $5 million in non-dilutive funding to the Company during the third quarter. These awards are intended to help advance our technologies and are milestone-based, with the majority of the funds expected to be earned over the course of the next several years. Because they cover both direct and indirect (e.g. fixed overhead) costs, they have the ability to significantly offset our cash needs."
Dr. Chan concluded, "We continue to be very excited about this unique potential opportunity to revolutionize the future of critical care medicine with CytoSorb® -- hopefully saving lives while reducing exorbitant healthcare costs. We plan to issue a more in depth shareholder update in January that will review our progress and discuss the Company in greater detail. In the meantime, we thank our investors for their continued support."
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 surface adsorption. In 2011, CytoSorb®, the Company's flagship product, achieved European regulatory approval as an extracorporeal cytokine filter, allowing it to be sold throughout the European Union (E.U.) under the CE Mark, to be used in clinical situations where cytokines are elevated. The goal of CytoSorb® is to modulate the immune system by reducing "cytokine storm" in critically-ill patients that could otherwise lead to deadly inflammation, multiple organ failure, immune dysfunction, and often death in common illnesses such as sepsis, trauma, burn injury, acute respiratory distress syndrome, and pancreatitis. 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, Austria and Switzerland 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 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 the blood supply. 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 polymers the Company has designed for various medical applications, including improved dialysis, reduction of post-surgical complications in cardiac surgery, treatment of inflammatory and autoimmune disorders, radio-imaging contrast removal in imaging and interventional radiology procedures, and the treatment of rhabdomyolysis, drug overdose, and others. Additional information is available for download on the Company's website: http://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.
CYTOSORBENTS CORPORATION (a development stage company) CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (amounts in thousands, except per share data) (unaudited) Nine Months Ended Three Months Ended September 30, September 30, 2012 2011 2012 2011 ------------ ------------ ------------ ------------ Revenues Sales $ 64 $ --- $ 14 $ --- Grant income 675 --- 591 --- ------------ ------------ ------------ ------------ Total revenues 739 --- 605 --- ------------ ------------ ------------ ------------ Expenses Cost of revenue 261 --- 142 --- Research and development 1,854 2,394 554 780 Legal, financial and other consulting 386 260 151 94 Selling, general and administrative 916 814 359 352 ------------ ------------ ------------ ------------ Total operating costs and expenses 3,417 3,468 1,206 1,226 ------------ ------------ ------------ ------------ Operating loss (2,678) (3,468) (601) (1,226) Other expenses, net 448 817 51 503 ------------ ------------ ------------ ------------ Net loss (3,126) (4,285) (652) (1,729) Preferred stock dividend 1,871 2,354 630 735 ------------ ------------ ------------ ------------ Net loss available to common stockholders $ (4,997) $ (6,639) $ (1,282) $ (2,464) ============ ============ ============ ============ Earnings per share: Basic and diluted earnings per share $ (0.03) $ (0.04) $ (0.01) $ (0.01) ============ ============ ============ ============ Basic and diluted weighted average shares outstanding 193,383,650 153,796,011 204,438,894 168,230,680 ============ ============ ============ ============ CYTOSORBENTS CORPORATION (a development stage company) CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands) (unaudited) September 30, December 31, 2012 2011 ASSETS: Cash and cash equivalents $ 2,061 $ 1,186 Accounts receivable, net 52 36 Inventories 626 431 Prepaid expenses and other current assets 116 44 -------------- -------------- Total current assets 2,855 1,697 Property and equipment, net 135 155 Other assets 278 271 -------------- -------------- TOTAL ASSETS $ 3,268 $ 2,123 ============== ============== LIABILITIES AND STOCKHOLDERS'EQUITY: Accounts payable $ 729 $ 676 Accrued expenses and other current liabilities 374 558 Convertible notes payable, net 973 294 -------------- -------------- Total current liabilities 2,076 1,528 Convertible notes payable, net --- 276 -------------- -------------- Total liabilities 2,076 1,804 -------------- -------------- Total stockholders' equity 1,192 319 -------------- -------------- TOTAL LIABILITIES AND EQUITY $ 3,268 $ 2,123 ============== ==============
Dr. Phillip Chan
Chief Executive Officer
(732) 329-8885 ext. *823
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Sep. 28, 2016 01:23 PM EDT
Businesses are struggling to manage the information flow and interactions between all of these new devices and things jumping on their network, and the apps and IT systems they control. The data businesses gather is only helpful if they can do something with it. In his session at @ThingsExpo, Chris Witeck, Principal Technology Strategist at Citrix, will discuss how different the impact of IoT will be for large businesses, expanding how IoT will allow large organizations to make their legacy ap...
Sep. 28, 2016 01:00 PM EDT Reads: 112
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, will discuss how VPaaS enables you to move fast, creating scalable video experiences that reach your...
Sep. 28, 2016 01:00 PM EDT Reads: 1,102
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
Sep. 28, 2016 01:00 PM EDT Reads: 3,540
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Sep. 28, 2016 12:30 PM EDT Reads: 5,098
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
Sep. 28, 2016 12:30 PM EDT Reads: 4,107
SYS-CON Events announced today that SoftLayer, an IBM Company, has been named “Gold Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. SoftLayer, an IBM Company, provides cloud infrastructure as a service from a growing number of data centers and network points of presence around the world. SoftLayer’s customers range from Web startups to global enterprises.
Sep. 28, 2016 12:30 PM EDT Reads: 1,034
One of biggest questions about Big Data is “How do we harness all that information for business use quickly and effectively?” Geographic Information Systems (GIS) or spatial technology is about more than making maps, but adding critical context and meaning to data of all types, coming from all different channels – even sensors. In his session at @ThingsExpo, William (Bill) Meehan, director of utility solutions for Esri, will take a closer look at the current state of spatial technology and ar...
Sep. 28, 2016 12:20 PM EDT Reads: 156
The vision of a connected smart home is becoming reality with the application of integrated wireless technologies in devices and appliances. The use of standardized and TCP/IP networked wireless technologies in line-powered and battery operated sensors and controls has led to the adoption of radios in the 2.4GHz band, including Wi-Fi, BT/BLE and 802.15.4 applied ZigBee and Thread. This is driving the need for robust wireless coexistence for multiple radios to ensure throughput performance and th...
Sep. 28, 2016 12:00 PM EDT Reads: 1,649
SYS-CON Events announced today that Secure Channels will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. The bedrock of Secure Channels Technology is a uniquely modified and enhanced process based on superencipherment. Superencipherment is the process of encrypting an already encrypted message one or more times, either using the same or a different algorithm.
Sep. 28, 2016 12:00 PM EDT Reads: 1,721
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Sep. 28, 2016 12:00 PM EDT Reads: 4,404
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Tintri VM-aware storage is the simplest for virtualized applications and cloud. Organizations including GE, Toyota, United Healthcare, NASA and 6 of the Fortune 15 have said “No to LUNs.” With Tintri they mana...
Sep. 28, 2016 12:00 PM EDT Reads: 2,897
Fifty billion connected devices and still no winning protocols standards. HTTP, WebSockets, MQTT, and CoAP seem to be leading in the IoT protocol race at the moment but many more protocols are getting introduced on a regular basis. Each protocol has its pros and cons depending on the nature of the communications. Does there really need to be only one protocol to rule them all? Of course not. In his session at @ThingsExpo, Chris Matthieu, co-founder and CTO of Octoblu, walk you through how Oct...
Sep. 28, 2016 12:00 PM EDT Reads: 2,275
What are the new priorities for the connected business? First: businesses need to think differently about the types of connections they will need to make – these span well beyond the traditional app to app into more modern forms of integration including SaaS integrations, mobile integrations, APIs, device integration and Big Data integration. It’s important these are unified together vs. doing them all piecemeal. Second, these types of connections need to be simple to design, adapt and configure...
Sep. 28, 2016 11:49 AM EDT Reads: 247
Creating replica copies to tolerate a certain number of failures is easy, but very expensive at cloud-scale. Conventional RAID has lower overhead, but it is limited in the number of failures it can tolerate. And the management is like herding cats (overseeing capacity, rebuilds, migrations, and degraded performance). Download Slide Deck: ▸ Here In his general session at 18th Cloud Expo, Scott Cleland, Senior Director of Product Marketing for the HGST Cloud Infrastructure Business Unit, discusse...
Sep. 28, 2016 11:45 AM EDT Reads: 2,396