Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
I sold half my position at 9.50 and bought back down at 8.75 which seems like we're moving up from. GLTA
In the news release, CytoSorbents to Host Key Opinion Leader Call on the Use of CytoSorb Blood Purification to Remove Antithrombotic Medications in Patients at Risk of Bleeding, issued 29-Jun-2020 by CytoSorbents Corporation over PR Newswire, we are advised by the company that the conference call details and webcast information has changed. To reflect this, the third hyperlink in the first paragraph has been updated. Additionally, the "Key Opinion Leader Call Details" section after the third paragraph has been updated.
Did anyone check out the webinar? I'm working from home today but did not have a chance to watch it.
Moderators: Please sticky that PR!
Sticky this report?
Link to report
Dawsone James Institutional Research CTSO report
https://seekingalpha.com/news/3421109-cytosorbents-announces-preliminary-fy18-results
CytoSorbents (CTSO +8.1%) expects $22.3M, with additional 2018 grant revenue expected upon finalization of invoicing vs. a consensus of $22.69M.
Full-year product sales in 2018 of ~$20.2M (+51% Y/Y) and record Q4 2018 product sales of ~$5.4M.
2018 blended gross product margins in excess of 72%.
More than 56,000 CytoSorb cumulative treatments delivered, up from 35,000 treatments a year ago.
Cash position of ~$22.3M (Dec. 31, 2018).
CytoSorbents Issues Stockholder Letter with Preliminary 2018 Financial Results
CytoSorbents achieved another year of record growth with total revenue of more than $22.3 million, including product sales of approximately $20.2 million, a 51% increase from a year ago
MONMOUTH JUNCTION, N.J., Jan. 7, 2019 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ: CTSO), a critical care immunotherapy leader commercializing its CytoSorb® blood purification technology to treat deadly inflammation in critically-ill and cardiac surgery patients around the world, issues a stockholder letter from Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, and pre-announces preliminary unaudited fourth quarter 2018 and full-year 2018 results ahead of filing its Form 10-K.
Preliminary 2018 Financial Highlights:
The Company expects to announce record results including:
Full year 2018 total revenue of at least $22.3 million, with additional 2018 grant revenue expected upon finalization of invoicing
Full-year product sales in 2018 of approximately $20.2 million, an increase of approximately 51% compared to$13.4 million in 2017, and record Q4 2018 product sales of approximately $5.4 million
2018 blended gross product margins in excess of 72%, mixing higher margin direct sales and lower margin distributor and partner sales
More than 56,000 CytoSorb cumulative treatments delivered, up from 35,000 treatments a year ago
End-of-year cash position of approximately $22.3 million (12/31/18)
Dear Stockholders and Friends,
By most measures, 2018 was another outstanding year for CytoSorbents. Cumulative worldwide usage of CytoSorb grew by 60%, with CytoSorb credited in helping to save the lives of many patients around the world in a rapidly expanding library of peer-reviewed medical journal publications. This resulted in annual product sales growth in excess of 50%, helping to establish CytoSorb as an important therapeutic option for critically-ill and high-risk cardiac surgery patients in many hospitals across our geographic footprint of 53 countries. Reflecting our rapid growth, CytoSorbents was once again recognized as one of the fastest growing companies in North America across all industries, as named by the Deloitte 2018 Fast 500 in November 2018.
During the year, the Company achieved many notable milestones, among them:
European Union label expansion of CytoSorb to now include the removal of bilirubin, for the treatment of acute liver disease, and the removal of myoglobin, for the treatment of severe trauma. This opens up additional massive markets for CytoSorb, targeting hospitalized patients with acute exacerbations of chronic liver disease, the latter of which afflicts more than one in every 10 people in the world, and severe trauma, a significant percent of the 56 million hospitalizations for trauma each year
The smooth opening of our new CytoSorb manufacturing facility in June, quadrupling our production capability. It speaks to the dedication and experience of our engineering, manufacturing, and quality teams that we transitioned relatively seamlessly to full production out of the new facility in the fourth quarter. We expect that additional process improvements with volume manufacturing will enable us to achieve greater than 80% product gross margins on a quarterly basis in 2019
We initiated our first pivotal trial in the United States, the 400-patient randomized, controlled REFRESH 2-AKI study, designed to support FDA regulatory approval of CytoSorb® for use in high risk cardiac surgery to reduce post-operative acute kidney injury. Following FDA approval of a trial protocol amendment in September, the study has been progressing well, with a total of 39 patients expected to be enrolled by the end of this week, up from 24 at the beginning of December. This was excellent progress by our clinical team and trial sites, despite the holiday season. This is roughly on target with our expected enrollment of approximately 1 patient per site per month. We now have 19 centers actively enrolling with an additional four sites coming on-line soon
The 250-patient randomized, controlled, German government-funded REMOVE endocarditis trial also continues to march forward, with now 87 patients enrolled at 10 active sites. An interim analysis on inflammatory mediators on the first 50 patients is scheduled for this month
Meanwhile, our internal research and development programs, in large part funded by non-dilutive government grants and contracts, have continued to innovate, enabling the rapid development of new technologies, such as HemoDefend™. Supported by approximately $5 million in funding from the National Heart, Lung, and Blood Institute (NHLBI) - a division of National Institutes of Health (NIH), as well as U.S. Special Operations Command (USSOCOM), we are preparing to begin a pivotal trial intended to support U.S. FDA approval of our HemoDefend-RBC™ packed red blood cell (pRBC) filter in the U.S. HemoDefend-RBC is a point-of-transfusion blood filter designed to reduce non-infectious contaminants in pRBCs that can cause potentially life-threatening transfusion reactions. If approved in the U.S. and elsewhere, the product could be applicable to the more than 100 million pRBC units transfused each year worldwide. However, our initial target markets will be focused on patients who are at highest risk of transfusion reactions, including patients who receive large amounts of blood as in trauma, gastrointestinal bleeds, cardiac and other high risk surgery, cancer, blood disorders, and others. Many of these markets overlap those targeted by CytoSorb, giving us an opportunity to either license the technology or leverage it across our established distribution
CytoSorbents was added to the Russell 2000 Small Cap Index and Russell 3000 Indexes in June as part of the annual FTSE Russell reconstitution
In addition to saving lives, an important theme for 2018 was achieving quarterly operating breakeven, excluding non-cash expenses and clinical trial costs. This was to remind investors how inherently profitable our high margin, disposable "razorblade" business model can be at a relatively modest revenue number. In fact, we were very close to achieving quarterly operating breakeven, as defined, in the past several quarters, with an operating loss of $300K and $380K in Q2 and Q3 2018, respectively, with Q4 results pending. As stated earlier, our business model becomes even more attractive as improved manufacturing efficiencies from our new plant are expected to drive blended product gross margins to at least 80% on a quarterly basis this year, while helping to keep the cost of CytoSorb to hospitals and patients at a very affordable level.
Having demonstrated the growth and profit potential of our business model, with a solid base of revenue, and strong product gross margins, we are now well-positioned to generate significant gross profit that can be utilized to fund some combination of growth, clinical studies, and profitability. For example, on a base of $20 million in product sales and 72% blended product gross margins, our gross profit was approximately $14 million in 2018. But at $30 million in sales and 80% blended gross margins, gross profit would be $24 million. And at $50 million in sales, and 82% blended gross margins, gross profit would be $41 million. If we can drive faster growth, these economics have the potential to generate significant excess cash to not only fund all of our operating needs, but also to drive true GAAP (generally accepted accounting principles) profitability over the next couple of years, where potentially 50 cents or more on every dollar in sales will drop to EBITDA (Earnings Before Interest, Tax, Depreciation, and Amortization). This would solidly place our company among an elite group of profitable companies generating significant cash flow.
To this point, in late 2018, we began to implement an aggressive growth strategy to drive accelerated long-term growth in 2019 and beyond. We are making additional investments in clinical studies, adding resources to better support our customers and partners, strengthening our distribution network, and making internal organizational changes that will better align the company for future rapid growth. Though this may result in some near-term fluctuations of our financial performance, we firmly believe these changes will result in solid 2019 year-over-year performance and a continued multi-year growth trajectory.
As we reflect upon the meaning of the holiday season and are energized by the New Year, on behalf of our Board of Directors and management team, let me once again thank the broader CytoSorbents family, including patients and their families, physicians and healthcare workers, hospitals and administrators, scientific and clinical researchers, our distributors and strategic partners, our service providers, our shareholders, and especially our employees and their families in Europe and in the U.S. for all of your hard work and dedication, and sharing our collective vision of saving lives, one person at a time. Best wishes to you and your families for a happy, healthy, and prosperous New Year!
Dr. Phillip Chan, MD, PhD
Chief Executive Officer
CytoSorbents Corporation
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in critical care immunotherapy, specializing in blood purification. Its flagship product, CytoSorb® is approved in the European Union with distributionin 53 countries around the world, as an extracorporeal cytokine adsorber designed to reduce the "cytokine storm" or "cytokine release syndrome" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. CytoSorbents is conducting its pivotal REFRESH 2-AKI trial - a multi-center, randomized controlled, clinical trial intended to support U.S. regulatory approval of CytoSorb for use in a heart-lung machine during complex cardiac surgery to reduce organ injury. CytoSorb® has been used in more than 56,000 human treatments to date.
CytoSorbents' purification technologies are 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. Its technologies have received non-dilutive grant, contract, and other funding of nearly $26 million from DARPA, the U.S. Army, the U.S. Department of Health and Human Services, the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), U.S. Special Operations Command (USSOCOM), and others. The Company has numerous products under development based upon this unique patented blood purification technology including CytoSorb-XL™, HemoDefend™, VetResQ™, K+ontrol™, ContrastSorb, DrugSorb, and others.
For more information, please visit the Company's websites:http://www.cytosorbents.com and http://www.cytosorb.com or follow us on Facebook and Twitter
Forward-Looking Statements
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. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 8, 2018 as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
If anyone took profits on the big gains, it is time to back up the truck and get back in long!
The video seems to be missing, but I was able to get this link to work:
https://player.vimeo.com/video/291283024
Definitely some good buying opportunities today!
For anyone considering watching this, at 3:20 someone asked about CTSO, but Jim had no clue.
http://video.cnbc.com/gallery/?video=7000023980
I had a friend who died of sepsis after I was long CTSO and it still makes me upset. I can't wait for it to be approved and I wish there weren't so many senseless casualties waiting for the FDA (FAILURE DRUG ADMINISTRATION) to keep dropping the ball.
I have been in this stock since MSBT and I am still adding as much as I can, but I wish I wasn't such a small fish. Anyway, this stock will go ridic status at some point. Make sure you are in deep when it happens.
CytoSorbents' CEO on flu epidemic-Yahoo Finance Video-February 13, 2018
The Center for Disease Control estimates that the most prominent strain could leave as many as fifty thousand Americans dead by the end of this year's flu season. Here to discuss this year's flu season and what hospitals can do to address this epidemic is Phil Chan CEO of CytoSorbents.
WATCH NOW!
Regards,
eColi
The video with Dr. Chan is also hosted here, if it helps?
http://video.roanoke.com/?ndn.trackingGroup=91597&ndn.siteSection=roanokestudio_hom_non_fro&ndn.videoId=33315035
http://www.lulegacy.com/2015/08/19/insider-selling-cytosorbents-corp-director-sells-62600-00-in-stock-ctso/584892/
Director Al Kraus sold 10,000 shares of the stock in a transaction dated Thursday, August 13th. The stock was sold at an average price of $6.26, for a total transaction of $62,600.00. Following the sale, the director now owns 55,746 shares in the company, valued at approximately $348,969.96. The transaction was disclosed in a filing with the Securities & Exchange Commission, which can be accessed through the SEC website.
Several equities research analysts have commented on CTSO shares. Brean Capital reiterated a “buy” rating and set a $25.00 price objective on shares of Cytosorbents Corp in a research note on Monday. MLV & Co. reduced their target price on shares of Cytosorbents Corp from $28.00 to $21.00 and set a “buy” rating for the company in a report on Tuesday, May 12th. One investment analyst has rated the stock with a hold rating and four have issued a buy rating to the company. The stock currently has a consensus rating of “Buy” and a consensus price target of $16.32.
Shares of Cytosorbents Corp (OTCMKTS:CTSO) traded down 3.51% during mid-day trading on Wednesday, reaching $7.43. 32,551 shares of the company were exchanged. The stock’s market capitalization is $186.09 million. Cytosorbents Corp has a 12 month low of $4.40 and a 12 month high of $15.24. The firm has a 50-day moving average price of $6.51 and a 200 day moving average price of $8.01.
Cytosorbents Corp (OTCMKTS:CTSO) last posted its quarterly earnings results on Thursday, August 13th. The company reported $0.05 earnings per share (EPS) for the quarter, topping the Thomson Reuters consensus estimate of ($0.11) by $0.16. The firm had revenue of $1.69 million for the quarter. Equities research analysts anticipate that Cytosorbents Corp will post ($0.40) EPS for the current fiscal year.
CytoSorbents Corporation is a development stage critical care focused company using blood purification to treat life-threatening illnesses. The technology is based upon biocompatible, highly porous polymer sorbent beads that are capable of extracting unwanted substances, such as drugs, dangerous chemicals, toxins, cytokines, free hemoglobin, and antibodies, from blood and other bodily fluids. Its CE Mark enables CytoSorb to be sold throughout the entire European Union. In addition to the sepsis indication, the Company continues to foster research in other critical care illnesses where CytoSorb could be used, such as ARDS, trauma, severe burn injury, acute pancreatitis, and in other acute conditions that may benefit by the reduction of cytokines in the bloodstream.
Coming in 3rd quarter/Near term?
-- Completion of, and near-term availability of clinical data from two randomized, controlled investigator-initiated studies from University of Hamburg-Eppendorf and Medical University of Vienna, evaluating the safety and ability of CytoSorb(R), when used intra-operatively during cardiac surgery, to reduce cytokines and post-operative inflammation
Seems like there are plenty of reasons to get in soon...
[from the CTSO release]
More recently, there have been a number of developments and near term catalysts that should begin to accelerate growth in the second half of this year. These include:
-- Expansion of the direct sales team in early Q3 to 7 people, including 2
new full-time sales people and a contract sales representative. With the
planned addition of 2 more sales people and a medical science liaison
before the end of the year, we believe we will be well-positioned to meet
the interest and demand for CytoSorb(R) in our direct sales territories
-- Recent approval of CytoSorb(R) in Saudi Arabia and signing of TekMed in
Australia and New Zealand, which immediately opened markets representing
57 million people
-- Nearing initial marketing with partner Fresenius Medical Care in France,
Poland, Denmark, Norway, Finland and Sweden, which would unlock
additional markets covering more than 127 million people
-- Completion of, and near-term availability of clinical data from two
randomized, controlled investigator-initiated studies from University of
Hamburg-Eppendorf and Medical University of Vienna, evaluating the safety
and ability of CytoSorb(R), when used intra-operatively during cardiac
surgery, to reduce cytokines and post-operative inflammation
-- The planned completion of an evaluation of CytoSorb(R) when used
intra-operatively during cardiac surgery by one of the leading global
cardiac surgery companies. CytoSorb(R) has now been used safely, without
complications, intra-operatively in more than 300 cardiac surgeries
to-date in Germany and Austria
-- Hosting the 2nd International CytoSorb(R) Users Meeting in Berlin,
Germany on October 2, 2015, just before our major presence at the 28th
European Society of Intensive Care Medicine Congress in Berlin (ESICM,
Oct 3-7) and the 29th European Association for Cardio-Thoracic Surgery
Meeting in Amsterdam, Netherlands (EACTS, October 3-7). These events
represent great exposure for the Company and CytoSorb(R), and put us
directly in the mindshare of our current and future customers."
Dr. Chan continued, "In addition to our commercialization efforts abroad, we are heavily focused on bringing CytoSorb(R) to the U.S. market through two main paths.
-- Cardiac Surgery: We are seeking approval to use CytoSorb(R)
intra-operatively during complex cardiac surgery and extended
cardiopulmonary bypass. These open heart surgeries are very common and
can result in the production of large amounts of toxic plasma free
hemoglobin, cytokines, activated complement and other factors that can
lead to post-operative complications such as kidney and respiratory
failure.
-- The FDA has approved an amendment to our REFRESH (REduction in
FREe Hemoglobin) trial, to convert it into a 40-patient, 8-center,
randomized controlled feasibility study. In doing so, we have
consolidated the original 20 patient, single arm, 3 center study
together with the larger non-interventional study that we had
previously discussed. Led by our Chief Medical Officer, Dr. Robert
Bartlett, MD, we are in the final contract negotiation and
Institutional Review Board (IRB) approval stage at 8 major U.S.
heart centers and are on schedule to begin the study in
September.
-- We welcome Steven Sisk, Director of Clinical Operations, from
Medtronic, who will oversee the day-to-day operations of this
trial and our other U.S. trials. He replaces Dr. Greg Di Russo,
who stepped down for personal reasons.
-- Sepsis and Critical Care: Sepsis is the overzealous immune response to a
severe infection and a top ten cause of death worldwide for which there
is no effective therapy. We are preparing an Expedited Access Pathway
(EAP) application, and look to submit the application to the FDA in the
coming weeks to seek EAP Designation, similar to "Breakthrough
Designation" for drugs and biologics. The EAP pathway was developed by
the FDA to help expedite market approval of safe medical devices that
address major unmet medical needs. We believe that CytoSorb(R) is
well-suited for the EAP program."
FYI - I couldn't sticky it since it is more than 48 hours old.
Sorry for my misunderstanding.
Correction to my last post: Fourth quarter revenues were lower than the prior quarter.
But they gave plenty of explanation for that in their 8-K report filing/presentation:
"After five consecutive months of quarter-over-quarter growth, the fourth quarter of 2014 product revenues were lower than the prior quarter. We point out that for the first time in third quarter of 2014, distributor sales accounted for the majority of CytoSorb sales as opposed to direct sales. As a result of the nature of sales to distributors, which can be lumpy, especially with initial orders and in new territories, sales may fluctuate from quarter to quarter. This decrease in sales for the quarter also reflects the restructuring of our direct sales team which Phil will provide more information about later."
Phil: "...growing a strong core sales team quickly is often a challenging task and we certainly faced our share of growing pains. In an effort to create an outstanding core sales team, we have been in the process of restructuring our direct sales force. First, we felt it necessary to support our dramatically expanding international distribution and partner network with someone who is very experienced with CytoSorb and can help teach our distributors and their sales teams about the advances in CytoSorb therapy that are happening elsewhere in the world. At the beginning of Q4, we promoted our Sales Director, who is one of our lead sales people and who was selling in northern Germany, to become International Sales Director. His replacement in Northern Germany joined us in Q1 and is excellent, but has not yet come up fully to speed, leaving a shortfall in sales in this territory.
In addition, despite a tremendous amount of time and effort in selecting, hiring and training our new sales people, during Q1 we let 4 existing sales people go in order to find stronger replacements who are better equipped to sell our therapy. The good part is that the remaining team, including recent additions to distributor support, product support and clinical support, is outstanding. However, this has created a significant gap in sales coverage in our direct sales territories (given that we divide Germany into multiple territories with 1 sales representative in each territory), which we believe has resulted temporarily in lower direct sales. We continue to see strong interest throughout Germany, but we still need representatives on the ground with a strong physician network that can properly detail the product and provide support and education at the reimbursement level, the hospital administration level, the physician level and the nursing level. This is similar to every other medical device company and is not unique to our company or product.
Although painful, we believe these changes are necessary and will have a significantly positive benefit in the second half of 2015. However, in the near term, taking into account this transition and adjusting for the approximately 22% drop in the Euro against the dollar in the first quarter versus a year ago, we anticipate that Q1 2015 sales will show approximately 45% year-over-year growth, but be slightly lower than Q4 2014.
Currently we expect that Q1 2015 CytoSorb® product revenue will be in the range of $700,000 to $725,000 on an unaudited basis. Adjusting for the impact in the change in the Euro, which has dropped 22 percent from a year ago, this is equivalent to an adjusted range of approximately $800,000 to $850,000. We expect restructuring of the sales force to be completed within the upcoming months. In the meantime, investors should expect that near-term growth will be driven predominantly by distributor and strategic partner sales. We expect to add several more international distributors in Q2 2014, and expect to see Fresenius begin selling in Q2 of this year and for certain key distributors such as the Middle East to come on-line as well. We believe that growth in direct sales will resume in the second half of 2015. Despite these short-term issues, because of the interest and usage that we see in the market, we remain very optimistic about achieving significant year-over-year growth in CytoSorb sales in 2015 vs. 2014."
Increasing quarterly sales revenue did occur - but not at the rate desired by investors. The problem was that their expenses went up more. Considering that they are building a sales team from the ground up and ran in to a snag, there could be some stagnancy from this; or it could be related to the products and only time will tell.
"Anticipated fast FDA progress"? Not many folks expect anything fast from a US government agency, so that would have been a stretch.
Shorts may be covering, but I think it was also WAY oversold.
Closed @ $12.89 after a new (7 year) high of $12.95 reached.
Way to go CTSO!
Today's close of $11.68 is the second highest since the split.
(Feb 25th @ $11.92 was the highest close since the split.)
You posted ECIG's chart, not CTSO :P
Yes ysung, there was a 25:1 R/S in December so that they could uplist to NASDAQ.
In agreement with you there, BMA.
Congratulations and good luck! I took advantage of the dip, too.
I scraped together all I could and added to my position at $7.90
CytoSorbents Submits IDE Application To FDA For U.S. CytoSorb(R) Cardiac Surgery Trial
MONMOUTH JUNCTION, N.J., Dec. 30, 2014 /PRNewswire/ -- CytoSorbents Corporation (NASDAQ CM: CTSO), a critical care immunotherapy company commercializing its CytoSorb® extracorporeal cytokine adsorber to reduce deadly inflammation in critically-ill and cardiac surgery patients, announced today that it has submitted an Investigational Device Exemption (IDE) application to the U.S. Food and Drug Administration (FDA) to conduct its proposed clinical trial using CytoSorb® intra-operatively in patients undergoing complex cardiac surgery requiring the use of a heart-lung machine. The goal of CytoSorb® treatment is to reduce inflammatory mediators and proteins such as cytokines and plasma free hemoglobin generated during surgery that can lead to serious post-operative complications.
Dr. Robert Bartlett, Chief Medical Officer of CytoSorbents, and Dr. Greg Di Russo, Senior Vice President of Clinical Development at CytoSorbents said in a joint statement, "Intra-operative use of CytoSorb® represents an innovative new strategy to improve the safety of complex cardiac surgical cases, and to reduce inflammation generated during the surgery. Currently, there are no practical alternatives approved in the U.S. or Europe to address this significant problem. We believe the proposed trial protocol, designed with significant input from our cardiac surgery advisory board, is well-designed to be effectively conducted by our clinical trial sites which include many of the leading cardiac surgery centers in the country. With approval, we will begin the clinical trial as soon as possible."
Mr. Vincent Capponi, Chief Operating Officer of CytoSorbents stated, "The submission of this IDE application represents a major milestone for the Company, initiating the clinical trial process needed to seek approval of CytoSorb® in the United States. With approximately half a million cardiac surgery procedures such as valve replacement and coronary artery bypass graft surgeries each year in the U.S. alone, and another one million in the rest of the world annually, we believe this represents a significant potential commercial opportunity for the Company."
All investigational medical devices require IDE approval before they can be used in U.S.-based clinical studies to evaluate safety and efficacy. This is a similar concept to the Investigational New Drug (IND) path for drug trials. CytoSorb® is currently approved in the European Union as an extra-corporeal cytokine adsorber, and installs easily and quickly into a bypass circuit in a standard heart-lung machine.
CytoSorb® has been used safely intra-operatively in well over 100 cardiac surgeries in Europe to date.
About CytoSorbents Corporation
CytoSorbents Corporation is a critical care focused immunotherapy company using blood purification to control severe inflammation -- with the goal of preventing or treating multiple organ failure in life-threatening illnesses. Organ failure is the cause of nearly half of all deaths in the intensive care unit, with little to improve clinical outcome. CytoSorb®, the Company's flagship product, is approved in the European Union and marketed in 28 countries around the world, as a safe and effective extracorporeal cytokine adsorber, designed to reduce the "cytokine storm" that could otherwise cause massive inflammation, organ failure and death in common critical illnesses such as sepsis, burn injury, trauma, lung injury, and pancreatitis. These are conditions where the risk of death is extremely high, yet no effective treatments exist. CytoSorb® is also being used during and after cardiac surgery to remove inflammatory mediators, such as cytokines and free hemoglobin, which can lead to post-operative complications, including multiple organ failure.
CytoSorbents' purification technologies are 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. CytoSorbents has numerous products under development based upon this unique blood purification technology, protected by 32 issued US patents and multiple applications pending, including HemoDefend™, ContrastSorb, DrugSorb, and others. Additional information is available for download on the Company's website: http://www.cytosorbents.com/.
Forward-Looking Statements
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. These forward-looking statements include, but are not limited to, statements about our plans, objectives, representations and contentions and are not historical facts and typically are identified by use of terms such as "may," "should," "could," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential," "continue" and similar words, although some forward-looking statements are expressed differently. You should be aware that the forward-looking statements in this press release represent management's current judgment and expectations, but our actual results, events and performance could differ materially from those in the forward-looking statements. Factors which could cause or contribute to such differences include, but are not limited to, the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2014, as updated by the risks reported in our Quarterly Reports on Form 10-Q, and in the press releases and other communications to shareholders issued by us from time to time which attempt to advise interested parties of the risks and factors which may affect our business. We caution you not to place undue reliance upon any such forward-looking statements. We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, other than as required under the Federal securities laws.
...and it has now left the stratosphere!
Thanks for the info! I'm trying to figure out how far this one might go - this is the biggest win I've ever had in a position and I've already made my original investments back. (I've been around since MSBT and I am not ready to leave now.)
23 cents before the split = $5.75
Congrats!
A correction should give us an idea of where support is going to be, so it won't be all bad.
GLTA - I know this has made my holidays brighter!
MODERATOR: Please change the symbol back to CTSO
Who would sell this down to $8?
+14.31% mmmmmmmmmmmmmmmm
I believe that means that the board has approved the shares to be listed, but now we have to wait for the NASDAQ approval.
RE: 2.2 [Stock Exchange Listing. The shares of Common Stock have been approved for listing on NASDAQ Capital Market (the “Exchange”), and the Company has taken no action designed to, or reasonably likely to have the effect of, delisting the shares of Common Stock from the Exchange, nor has the Company received any notification that the Exchange is contemplating terminating such listing except as described in the Registration Statement, the Pricing Disclosure Package and the Prospectus.]
Does anyone else in here own AEMD?
I can't tell if it is a Cytosorb competitor, but it has done ok in the past few years...
How small is your position now?