Category Archives: Press Release

CytoSorbents to Present at the Canaccord Genuity MedTech, Diagnostics and Digital Health & Services Forum and Jefferies London Healthcare Conference

MONMOUTH JUNCTION, N.J., Nov. 15, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announces its participation in two upcoming investor conferences.

CytoSorbents will present at the Canaccord Genuity Virtual MedTech, Diagnostics and Digital Health & Services Forum on Thursday, November 18, 2021. Dr. Phillip Chan, CytoSorbents’ Chief Executive Officer, will present a brief overview of the Company operations and outlook at 11:00 a.m. Eastern time accessible via the following Webcast Link. Company management will also meet with investors throughout the day.

Dr. Chan will also present at the 2021 Jefferies London Healthcare Conference. The presentation will be available for on-demand viewing via the following Webcast Link, starting Thursday, November 18, 2021 at 3:00 a.m. Eastern time. Management will also hold investor meetings on Friday, November 19, 2021.

An archived recording of CytoSorbents’ presentations at both investor conferences will be available under the Investor Relations portion of the Company’s website at Events & Presentations – Cytosorbents, and will be available for 30 days.

About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification. Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death. These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist. CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure. More than 152,000 cumulative CytoSorb devices have been utilized to date. CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber. Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure. The DrugSorb™-ATR Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. The Company is initiating two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR. The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery. The second is the 120-patient, 25 center STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others. The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb™-ATR, ContrastSorb, and others. For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us onFacebook 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 9, 2021, 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.

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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

SOURCE CytoSorbents Corporation

CytoSorbents Reports Full Third Quarter 2021 Financial and Operational Results

Third Quarter 2021 total revenue was $9.8 million, including product sales of $8.9 million. Core non-COVID-19 product sales increased 3% Y-Y to approximately $7.8 million.

MONMOUTH JUNCTION, N.J., Nov. 4, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, reports full financial and operating results for the quarter ended September 30, 2021.

CytoSorbents Reports Full Third Quarter 2021 Financial and Operational Results

Third Quarter 2021 Financial Results

  • Total revenue, including product sales and grant income, for Q3 2021 was $9.8 million, compared to $10.5 million in Q3 2020, a decrease of 7%.
  • Q3 2021 CytoSorb product sales were $8.9 million, down 13% compared to $10.2 million in Q3 2020.
  • Q3 2021 product sales in Germany were $3.7 million, a decrease of $1.1 million or 24% from product sales of $4.8 million in Germany in Q3 2020.
  • Core non-COVID-19 product sales for Q3 2021 were approximately $7.8 million, up 3% from approximately $7.5 million in Q3 2020.
  • Estimated Q3 2021 COVID-19 related sales were $1.1 million, compared to an estimated $2.7 million in Q3 2020.
  • Q3 2021 product gross margins were 82%, as compared to 74% in Q3 2020.
  • The Company maintains a healthy cash balance of $61.0 million at September 30, 2021 with no debt.

Recent Operating Highlights

  • In October, CytoSorbents enrolled the first patient in the pivotal U.S. STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) double-blind, randomized controlled trial in the United States to support FDA marketing approval of the DrugSorb-ATR™ antithrombotic removal system for intraoperative ticagrelor removal during urgent cardiothoracic surgery.
  • Following receipt of a second Breakthrough Designation attributed to DrugSorb-ATR for the removal of the market-leading Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban during urgent cardiothoracic surgery in August, the Company successfully filed an IDE application and received full FDA approval to begin the pivotal STAR-D ( Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants) double-blind, randomized controlled trial in the United States to support marketing approval for this additional indication.
  • In September, CytoSorbents presented topline results from the U.S. CTC Registry at the International Symposium on Intensive Care & Emergency Medicine conference in Belgium and hosted a dedicated webinar highlighting the associated findings.
  • Results from two investigator-initiated studies evaluating the use of CytoSorb in endocarditis, including the randomized, controlled REMOVE trial were presented at the European Association for Cardio-Thoracic Surgery conference in Spain in October.
  • In August, CytoSorbents and Aferetica announced the commercial launch in Italy of the PerSorb™ Adsorber (based on CytoSorbents’ ECOS-300CY™ sorbent technology) to remove inflammatory mediators during ex vivo perfusion via the PerLife™ Organ Perfusion System at the European Society of Organ Transplantation congress.
  • More than 152,000 cumulative CytoSorb devices have been utilized to date, an increase of 38% compared to more than 110,000 devices utilized as of Q3 2020, with more than 6,900 COVID-19 patients treated globally.
  • CytoSorb is now distributed in more than 70 countries, adding Thailand and the Ukraine during the quarter.

Fourth Quarter and Full Year 2021 Product Revenue Guidance

  • The Company maintains its revised 2021 product revenue guidance provided on October 12, 2021:
    • Q4 2021 product revenue is expected to be similar to Q3 2021 product revenue of $8.9 million.
    • Full year 2021 product revenue of at least $39.3 million, roughly flat compared to 2020 product revenue of $39.5 million. While difficult to predict, 2021 core non-COVID-19 product sales are expected to be approximately $33 to $34 million for the year versus $30.1 million in 2020.

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “As previously communicated in mid-October, third quarter product sales were negatively affected by a resurgence in COVID-19 cases in Germany in August and a reversal of initially encouraging trends that we saw at the beginning of the quarter.  Increased hospital restrictions led to lower-than-expected core non-COVID-19 sales of CytoSorb with fewer elective surgical procedures (where complications such as sepsis are often treated with CytoSorb), fewer ICU patients due to ICU capacity constraints from COVID-19 allocations and ICU staffing shortages caused by healthcare worker burnout, as well as decreased visitor access – impacting the ability of our sales force to generate sales. Meanwhile, during this historically seasonal quarter due to European vacation schedules, the severity of illness and deaths among hospitalized COVID-19 patients was unexpectedly low, resulting in fewer COVID-related CytoSorb sales.”

Dr. Chan continued, “As a result, product sales in the third quarter of 2021 were $8.9 million, reflecting lower sales in Germany and an expected decline in international COVID-related sales, taking into account the evolving and migrating pandemic and increasing global vaccinations.  Core non-COVID-19 product sales accounted for approximately 88% of our overall product sales.   Blended product gross margins were approximately 82% in the third quarter, a significant improvement from approximately 74% in the prior year quarter and a strong result driven by manufacturing efficiencies.  Today, the macro environment remains challenging in Germany, but we are proactively working within the current constraints to find creative ways to increase engagement with new and existing customers and to increase awareness of the benefits of CytoSorb in both COVID-19 and core applications.  We expect the macro environment to improve over time, though timing is difficult to predict.” 

Dr. Chan added, “Meanwhile, we are pleased by the latest successes of our U.S clinical development program in pursuit of U.S. commercialization.  We recently enrolled our first patient in the pivotal STAR-T trial evaluating the use of DrugSorb-ATR for intraoperative ticagrelor removal during urgent cardiothoracic surgery and are ramping up the number of active sites.  In addition, in the span of approximately three months we received a second FDA Breakthrough Device Designation for DrugSorb-ATR, this time to remove the direct oral anticoagulants apixaban and rivaroxaban during urgent cardiothoracic surgery, filed an associated IDE, and received full FDA approval to begin the pivotal STAR-D trial for this application.  The successful execution of these activities in such a short timeline is a testament to the strength of the clinical and regulatory talent we have hired over the past 18 months.  By the end of this year, we expect to have seven active Company-sponsored studies underway that are designed to generate robust clinical data to support our growth objectives.  We continue to have a healthy balance sheet, with approximately $61 million in cash and no debt, and we expect to continue funding activities to drive growth, including clinical development, sales and marketing infrastructure, and our new, expanded manufacturing facility, which is on track to come online by the end of 2022.”

Dr. Chan concluded, “Despite the complexities of COVID-19 on our business, we believe we are well-positioned for long-term growth with an outstanding therapy, CytoSorb, that when used on the right patients, at the right time, with the right dose, works to help save lives. We are boldly trying to solve some of the most complex medical problems in medicine today that claim the lives of millions each year.  It is not simple.  But with every study, we move closer to unlocking the key.  In addition, we believe we have an excellent business model bolstered by strong product gross margins, broad international physician and partner support, a growing body of clinical data, and a solid safety profile with now more than 152,000 treatments utilized across more than 70 countries.  We remain confident in our core business both in Germany and internationally and are excited about our pivotal trials in the U.S. that have the potential to open the significant U.S. market and make our therapies available to help even more people.”

Clinical Studies Update

  • In addition to prior commentary provided in this release, the U.S. STAR-T trial is now actively recruiting at multiple sites. Pending any COVID-19 related delays, we expect that the study will complete enrollment in 2022. In addition, study start-up activities have begun for the U.S. STAR-D trial, with first patient enrollment expected in the first quarter of 2022.
  • The REFRESH 2-AKI study in the United States has resumed enrollment at multiple trial centers. The goal of the study is to achieve the milestone of the interim analysis next year, however, the ongoing COVID-19 pandemic is causing enrollment delays associated with postponement or deferral of elective cardiac surgeries and shortage in research staff.
  • Primary results from the CytoSorb Therapy in COVID-19 (CTC) Registry demonstrating high 90-day survival in critically ill COVID-19 patients with acute respiratory distress syndrome (ARDS) treated with both extracorporeal membrane oxygenation (ECMO) and CytoSorb under FDA Emergency Use Authorization were presented at the International Symposium of Intensive Care Medicine (ISICEM) conference at the end of August 2021 in Brussels, Belgium, and have also been submitted for journal publication.
  • The CYTATION trial in patients on ticagrelor undergoing emergent cardiothoracic surgery in Germany is actively recruiting patients at all three sites plus a recently added clinical site in Luxembourg. Pending any uncertainty introduced by COVID-19 related delays, we expect that the study will complete enrollment in 2022.
  • The German PROCYSS multicenter, randomized controlled trial evaluating the ability of CytoSorb to restore hemodynamic stability in patients with refractory septic shock is now actively recruiting. The speed of enrollment remains uncertain due to COVID-19, however we currently estimate study completion by end of 2023.
  • The Hep-On-Fire single-arm, multi-center German trial evaluating CytoSorb in patients suffering from acute liver failure due to alcoholic hepatitis received Ethics Committee approval in October. Study start-up activities are ongoing, and we expect that the study will begin enrollment in the first quarter of 2022.
  • The Safe and Timely Antithrombotic Removal (STAR) Registry was designed to capture real world clinical and economic outcomes in the antithrombotic removal application. The registry is currently actively enrolling patients, and we estimate that first data readouts from the STAR Registry will begin in 2022.
  • The German government-sponsored and investigator-initiated REMOVE all-comer endocarditis study presented topline results at the European Association of Cardio–Thoracic Surgery (EACTS) annual meeting in Barcelona, Spain in October 2021. CytoSorbents is working collaboratively with the REMOVE investigators to conduct additional exploratory analyses to potentially identify subgroups that may have benefited from CytoSorb and to also inform potential future studies in this application.

Results of Operations for the Quarter ended September 30, 2021

Revenues
Revenue from product sales was approximately $8,902,000 in the three months ended September 30, 2021, as compared to approximately $10,246,000 in the three months ended September 30, 2020, a decrease of approximately $1,344,000, or 13%.  This decrease was driven by a decrease in direct sales of approximately $1,264,000 resulting primarily from lower sales in Germany due to COVID-19 pandemic-driven market conditions.  This was driven by a wave in new Delta variant-related COVID-19 cases in Germany, which accelerated through August and has continued to date.  This prompted many hospitals throughout Germany to reduce elective surgical procedures, to reserve ICU beds, and to either maintain or reinstitute restrictions such as visitation rights to non-essential visitors, in preparation of COVID-19 hospitalizations.  However, unlike prior waves in Germany, the rates of severe COVID-19 illness requiring ICU care, and death have been disproportionately very low.  This is being partly attributed to high rates of vaccinations that are associated with reduced severity of illness, reduced need for hospitalization, and risk of death.  These factors led to a decrease in both COVID-19 and core non-COVID-19 CytoSorb sales in Germany.  Sales to hospitals in the United States under the EUA granted by the FDA amounted to approximately $577,000 for the three months ended September 30, 2021.  Though difficult to quantitate, we estimate that approximately $1.1 million of total product sales in the third quarter of 2021 was due to the demand for CytoSorb to treat COVID-19 patients.  In addition, the change in the average exchange rate of the Euro to the U.S. dollar did not have a significant impact on product sales during the three months ended September 30, 2021, as compared to the three months ended September 30, 2020.

Grant income was approximately $859,000 for the three months ended September 30, 2021 as compared to approximately $301,000 for the three months ended September 30, 2020, an increase of approximately $558,000, or 185%.  This increase was a result of the easing of the COVID-19 pandemic in the United States during the three months ended September 30, 2021 and a corresponding increase in grant related work.  During the three months ended September 30, 2020, our research and development employees were either deployed to work-from-home status or reassigned to assist in activities related to increasing the production of CytoSorb.

Total revenues were approximately $9,760,000 for the three months ended September 30, 2021, as compared to total revenues of approximately $10,547,000 for the three months ended September 30, 2020, a decrease of approximately $787,000, or 7%.

Cost of Revenues
For the three months ended September 30, 2021, and 2020, cost of revenue was approximately $2,463,000 and $2,890,000, respectively, a decrease of approximately $427,000.  Product cost of revenue was approximately $1,642,000 and $2,622,000, respectively, for the three months ended September 30, 2021 and 2020, a decrease of approximately $980,000.  This decrease was due to lower sales and because certain costs associated with the rapid ramp-up of production during the three months ended September 30, 2020 that did not recur during the three months ended September 30, 2021.  Product gross margins were approximately 82% for the three months ended September 30, 2021 as compared to approximately 74% for the three months ended September 30, 2020.  The increase in the gross margin percentage in 2021 was due to manufacturing efficiencies achieved during the three months ended September 30, 2021 and the impact of the ramp-up costs incurred during the three months ended September 30, 2020 that did not recur in 2021.

Research and Development Expenses
For the three months ended September 30, 2021, research and development expenses were approximately $4,262,000, as compared to approximately $1,753,000 for the three months ended September 30, 2020, an increase of approximately $2,509,000.  This increase was due to an increase in costs associated with our clinical trial activities, including increased employee costs to build out our clinical team, as well as higher rent expense, among other items.

Selling, General and Administrative Expenses
Selling, general and administrative expenses were approximately $7,777,000 for the three months ended September 30, 2021, as compared to approximately $7,282,000 for the three months ending September 30, 2020, an increase of $495,000.  This increase is related to an increase in salaries, commissions and sales and marketing costs, increased travel and entertainment costs and an increase in non-cash restricted stock expense related to restricted stock units granted to the Company’s executive officers.  These increases were partially offset by a decrease in non-cash stock option compensation expense, lower royalty expense due to a decrease in sales, and a decrease in other general and administrative expenses.

Interest Income/(Expense), net
For the three months ended September 30, 2021, net interest income was approximately $13,000, as compared to net interest expense of approximately $261,000 for the three months ended September 30, 2020.  This decrease in net interest expense was the result of the payoff of our outstanding term loans with Bridge Bank in December of 2020.

Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the issuance of debt and equity securities.  As of September 30, 2021, we had current assets of approximately $72,752,000 including cash on hand of approximately $61,043,000 and current liabilities of approximately $11,070,000. During the period from January 1, 2020 through July 15, 2020, we raised approximately $26,427,000 by utilizing our ATM facility with co-agents Jefferies LLC and B. Riley FBR.  In addition, we received net proceeds of approximately $53,800,000 from our underwritten public offering that closed on July 24, 2020.  Also, we received approximately $1,127,000 in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey during the nine months ended September 30, 2021.

We believe that we have sufficient cash to fund our operations well into the future.

Fourth Quarter and Full Year 2021 Product Revenue Guidance

The macro environment of the global COVID-19 pandemic continues to add uncertainty to the Company’s sales outlook, especially since we are unable to predict the course of the pandemic or predict what impact, if any, the COVID-19 pandemic may have on global sales for the remainder of the year. 

The Company maintains its guidance that Q4 2021 product revenue will be similar to Q3 2021 product revenue of $8.9 million.

The Company maintains its guidance for expected full year 2021 product revenue of at least $39.3 million, roughly flat compared to 2020 product revenue of $39.5 million.  While difficult to predict, 2021 core non-COVID-19 product sales are expected to be approximately $33 to $34 million for the year versus $30.1 million in 2020.

For additional information, please see the Company’s Form 10-Q for the period ended September 30, 2021 filed on November 4, 2021 on http://www.sec.gov.

Conference Call

The company will conduct its third quarter operating and financial results call today at 4:30 p.m. Eastern time.  It will be archived for replay following the conference call.

Conference Call Details:
Toll free:  1-877-521-4127
International: 1- 212-231-2900
Conference ID:  21998483

It is recommended that participants dial in approximately 10 minutes prior to the start of the call.  There will be a simultaneous live webcast of the conference call that can be accessed through the following audio feed link: https://viavid.webcasts.com/starthere.jsp?ei=1505348&tp_key=fc4e9855a2

An archived recording of the conference call will be available under the Investor Relations section of the Company’s website at http://cytosorbents.com/investor-relations/financial-results/.

About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in more than 70 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 152,000 cumulative CytoSorb devices have been utilized to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.  The Company is initiating two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR.  The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery.  The second is the 120-patient, 25 center STAR–D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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 9, 2021, 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.

 

CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(amounts in thousands, except per share data)

Three months ended September 30,

Nine months ended September 30,

2021

2020

2021

2020

(Unaudited)

(Unaudited)

(Unaudited)

(Unaudited)

Revenue:

   CytoSorb sales

$

8,901

$

10,246

$

30,405

$

27,853

   Other sales

1

6

69

        Total product sales     

8,902

10,246

30,411

27,922

   Grant income

858

301

1,972

1,127

Total revenue

9,760

10,547

32,383

29,049

Cost of revenue

2,463

2,891

7,924

8,525

Gross profit

7,297

7,656

24,459

20,524

Other Expenses:

   Research and development

4,262

1,754

10,244

6,125

   Legal, financial and other consulting

665

580

2,090

1,945

   Selling, general and administrative

7,776

7,282

25,308

20,190

Total expenses

12,703

9,616

37,642

28,260

Loss from operations

(5,406)

(1,960)

(13,183)

(7,736)

Other income/(expense):

Interest income (expense), net

13

(261)

16

(840)

Gain (loss) on foreign currency transactions

(1,013)

1,381

(2,085)

1,417

Total other income (expense), net

(1,000)

1,120

(2,069)

577

Loss before benefit from income taxes

(6,406)

(840)

(15,252)

(7,159)

Benefit from income taxes

 

Net loss

$

(6,406)

$

(840)

$

(15,252)

$

(7,159)

Basic and diluted net loss per common share

$

(0.15)

$

(0.02)

$

(0.35)

$

(0.19)

Weighted average number of shares of common stock outstanding

43,396,464

41,593,218

43,319,507

37,350,564

Net loss

$

(6,406)

$

(840)

$

(15,252)

$

(7,159)

Other comprehensive income (loss):

 Currency translation adjustment

808

(1,047)

1,701

(1,044)

Comprehensive loss

$

(5,598)

$

(1,887)

$

(13,551)

$

(8,203)

 

CYTOSORBENTS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(amounts in thousands)

September 30,
2021

December 31, 2020

(unaudited)

ASSETS:

Current Assets:

Cash and cash equivalents

$

61,043

$

71,422

Grants and accounts receivable, net

5,241

5,159

Inventories

4,528

2,674

Prepaid expenses and other current assets

1,940

3,198

    Total current assets

72,752

82,453

Property and  equipment, net

3,799

2,120

Right of use asset

13,651

1,029

Other assets

4,865

4,348

    TOTAL ASSETS

$

95,067

$

89,950

LIABILITIES AND STOCKHOLDERS’ EQUITY:

Current Liabilities:

Accounts payable

$

3,358

$

1,835

Lease liability – current portion

265

447

Accrued expenses and other current liabilities

7,447

7,871

Total current liabilities

11,070

10,153

Lease liability, net of current portion

13,386

582

    TOTAL LIABILITIES

24,456

10,735

Total stockholders’ equity

70,611

79,215

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

$

95,067

$

89,950

 

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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

 

SOURCE CytoSorbents Corporation

CytoSorbents Comments on REMOVE Study Presentation

MONMOUTH JUNCTION, N.J., Oct. 20, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using CytoSorb®1 blood purification, makes additional comments on the investigator-initiated REMOVE study following the formal presentation of trial results on Saturday, October 16th at the European Association for Cardio-Thoracic Surgery (EACTS) annual meeting in Barcelona, Spain.

CytoSorbents Comments on REMOVE Study Presentation

This presentation adds to the information made publicly available by the preliminary data abstract at EACTS for the REMOVE (Revealing Mechanisms and Investigating Efficiency Of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients with Infective Endocarditis) investigator-initiated, randomized, controlled trial, and commented upon in a press release dated October 7, 2021.  The presentation by REMOVE Study Director, Dr. med. Mahmoud Diab, from University Hospital Jena, Germany included additional patient demographic and adverse event data from the study.  No study population subgroup analyses were reported.  Dr.  Diab commented on safety and concluded that there was “no signal for harm due to the use of CytoSorb® in patients undergoing surgery for infective endocarditis.”

Professor Dr. med. Torsten Doenst, Head of the Cardiothoracic Surgery Department, University Hospital Jena, Germany, and coordinating center of the REMOVE study stated, “The REMOVE topline results presented at the EACTS meeting contribute significant and valuable information on the intraoperative use of CytoSorb in patients undergoing valve replacement surgery for infective endocarditis.  Although the pre-specified primary outcome of the study was neutral, we demonstrated CytoSorb’s ability to reduce cytokines.  In addition, REMOVE also suggests that the use of CytoSorb in this setting is safe, with a similar adverse event profile to standard of care therapy.  Even though our data suggest that the intraoperative use of CytoSorb in a general endocarditis patient population may not be helpful, it is also not harmful, and it is conceivable that specific patient types may benefit from the therapy’s ability to lower cytokine levels.  We plan to work collaboratively with CytoSorbents to perform additional exploratory analyses of the REMOVE data to better characterize and identify the best populations to be included in future studies.  We are pleased with CytoSorbents’ continued commitment to high quality evidence generation in cardiac surgery.”

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “We want to congratulate the REMOVE investigators who executed this important trial.  We are encouraged that the intraoperative use of CytoSorb during cardiothoracic surgery had a favorable adverse event profile in this large randomized, controlled trial and that it reduced cytokines, validating CytoSorb’s mechanism of action.  Taking all evidence into account, we continue to believe that CytoSorb treatment of select endocarditis patients with high acuity of illness may provide clinical benefits, such as improved hemodynamic stabilization, especially when use of the therapy is extended postoperatively.  We look forward to our continued collaboration with Professor Doenst and his investigative team to better understand and analyze the results from the REMOVE trial to inform the design of future potential studies using CytoSorb in more specific infective endocarditis populations.  Importantly, the accumulating evidence of promising safety with intraoperative CytoSorb use during cardiothoracic surgery, including both studies presented at the recent EACTS conference, bodes very well for our U.S. FDA-approved clinical programs in cardiac surgery investigating intraoperative use of CytoSorbents’ technology in additional indications, specifically the REFRESH 2-AKI, STAR-T, and STAR-D pivotal studies.”

1 CytoSorb is approved in the European Union.  CAUTION: In the United States, CytoSorb is classified as an investigational device limited by United States law to investigational use.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 152,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.  The Company is initiating two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR.  The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery.  The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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, anticipated future results and performance, 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 9, 2021, 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.

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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com  

 

SOURCE CytoSorbents Corporation

First Patient Enrolled in U.S. STAR-T Pivotal Trial Evaluating the DrugSorb-ATR™ Antithrombotic Removal System to Remove Ticagrelor During Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., Oct. 14, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announced today that the first patient has been enrolled in the Safe and Timely Antithrombotic Removal-Ticagrelor (STAR–T) double-blind, randomized, controlled clinical trial designed to support FDA marketing approval of the DrugSorb-ATR™ Antithrombotic Removal System for intraoperative removal of ticagrelor during cardiothoracic surgery.  The STAR-T trial received full FDA IDE Approval in July 2021, and is being performed under the auspices of FDA Breakthrough Designation granted in April 2020.  The STAR-T trial is expected to enroll up to 120 patients across 20 sites and be completed by 2022.  The first patient was enrolled by Dr. Bradley S. Taylor, Chief of the Division of Cardiac Surgery and Director of Coronary Revascularization and site Principal Investigator at the University of Maryland Medical Center.

First Patient Enrolled in U.S. STAR-T Trial Evaluating DrugSorb-ATR™ to Remove Ticagrelor During Cardiothoracic Surgery

Dr. Bradley S. Taylor stated, “Ticagrelor is an antiplatelet agent routinely used in the management of patients with acute coronary syndrome to reduce the risk of death, myocardial infarction, and stroke.  However, when urgent surgery is required, patients on ticagrelor are at very high risk of serious and potentially fatal bleeding.  We are very pleased to enroll the first patient in the landmark STAR-T study that is investigating the ability of DrugSorb-ATR™ to remove ticagrelor during surgery and reduce the risk of bleeding in these patients. If positive, STAR-T could establish DrugSorb-ATR as an easily implemented solution that addresses a long-standing, frequent, and critical unmet medical need faced by cardiac surgery centers around the world.”

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated, “Removing antithrombotic agents intraoperatively with the DrugSorb-ATR system in patients requiring urgent cardiac surgery has the potential to save lives, reduce morbidity and provide substantial cost savings to heart centers around the world.  The FDA approved STAR-T trial has now left the station and we will work diligently to deliver on our stated goal to finish the trial in 2022.  Following the granting of a second Breakthrough Designation for the removal of apixaban and rivaroxaban, we recently received full FDA approval of our IDE application to conduct the Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants (STAR-D) trial, a second, very similar study that will leverage the existing infrastructure of STAR-T.  We anticipate fast study start-up and estimate that the first patient will be enrolled early in 2022.  The goal of both studies is to gain FDA marketing approval for the most widely prescribed next generation antiplatelet and anticoagulant agents and unlock an estimated $1 billion U.S. market opportunity.”

In April 2020, the FDA granted CytoSorbents Breakthrough Device Designation to remove ticagrelor during cardiothoracic surgery, recognizing this major unmet medical need.  Each year, ticagrelor is prescribed to millions of cardiovascular patients worldwide to reduce the risk of recurrent heart attack, stroke, or cardiovascular death.  Ticagrelor is frequently preferred as first-line therapy in patients presenting to hospitals with an acute coronary syndrome in preparation of percutaneous coronary intervention (PCI) and stent placement.  However, up to 10% of these patients will require coronary artery bypass graft (CABG) open heart surgery. As several clinical studies, such as the PLATO trial, have shown, these patients face a very high risk of severe or life-threatening perioperative bleeding.  CytoSorbents’ CytoSorb® therapy is the only treatment approved to remove ticagrelor during cardiopulmonary bypass in the E.U.  The DrugSorb-ATR™ Antithrombotic Removal system is based on the same polymer technology as CytoSorb®.  If FDA marketing approval is obtained by the FDA, DrugSorb-ATR™ would be marketed in the United States for ticagrelor removal during urgent cardiothoracic surgery, with the intention of reducing the risk of bleeding.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 152,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.  The Company is initiating two FDA approved pivotal trials designed to support U.S. marketing approval of DrugSorb-ATR.  The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery.  The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal-Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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, anticipated future results and performance, 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 9, 2021, 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.

Please Click to Follow Us on Facebook and Twitter

Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

 

SOURCE CytoSorbents Corporation

CytoSorbents Receives Full FDA Investigational Device Exemption (IDE) Approval to Begin U.S. STAR-D Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery

The U.S. STAR-D and already recruiting STAR-T randomized controlled pivotal trials are intended to establish DrugSorb-ATR as a single, easy-to-use solution for the reduction of perioperative bleeding in open heart surgery patients caused by the most widely prescribed next generation antiplatelet and anticoagulant drugs

MONMOUTH JUNCTION, N.J., Oct. 12, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the full approval of its Investigational Device Exemption (IDE) application by the FDA to conduct the pivotal STAR–D (Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants [DOAC]) double-blind, randomized, controlled trial in the United States to support FDA marketing approval.  This is being performed under the previously announced FDA Breakthrough Device Designation granted to the DrugSorb–ATR™ Antithrombotic Removal System for the removal of  apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Janssen/Bayer) in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.

Full FDA IDE Approval Received to Begin U.S. STAR-D Trial on DOAC Removal During Urgent Cardiothoracic Surgery

Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, “We are pleased to receive a second IDE approval for the antithrombotic removal application for the randomized, controlled, double-blind STAR-D trial designed to support FDA marketing approval of  DrugSorb–ATR™ for intraoperative apixaban and rivaroxaban removal during cardiothoracic surgery.  STAR–D is the next milestone of our STAR development program.  The STAR-D trial design and operational framework are identical to the actively screening STAR-T trial for ticagrelor removal, and are expected to yield extensive scientific, operational, and financial efficiencies.  STAR–D is expected to enroll up to 120 patients across 25 U.S. clinical sites – of which many are already actively participating in STAR-T, and will be led once again by Co-Principal Investigators Drs. Michael Mack and C. Michael Gibson and an Executive Committee comprised of world–renowned cardiac surgeons, interventional cardiologists, and thrombosis/hemostasis experts.  Trial start-up activities are underway and we expect the study to start in the first quarter of 2022.”

Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents, stated, “The full IDE approval of the STAR-D protocol now positions us to execute the next step in our DrugSorb-ATR market development strategy.  With this additional approval, we will have two U.S. randomized, controlled pivotal trials ongoing to support U.S. FDA marketing approval for the intraoperative removal of the key blockbuster antithrombotic drugs Brilinta®, Eliquis® and Xarelto® during open heart surgery to reduce the risk of perioperative bleeding.  If successful, we intend to establish DrugSorb-ATR as the go-to, easy-to-use, potential standard of care single treatment for this application in the U.S., targeting an estimated total addressable market in this country of approximately $1 billion.  In doing so, our goal is to address this major unmet medical need for patients and surgeons, while establishing a new, potentially significant driver of future company growth.”

In August 2021, the FDA granted CytoSorbents Breakthrough Device Designation to remove the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the risk of serious bleeding during urgent cardiothoracic surgery, recognizing this major unmet medical need.  Apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Janssen/Bayer) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients1 annually in the United States who are chronically on these medications to reduce the risk of deadly blood clots due to atrial fibrillation, prior history of heart attack or stroke, deep vein thrombosis, pulmonary embolism, and peripheral artery disease.  We expect the number of patients prescribed these drugs to continue to climb based on the superior performance of these agents compared to older alternatives, underlying demographic trends in the aging baby boomer population, improved disease detection rates, and other factors.  When patients on various “blood thinners”, like apixaban or rivaroxaban, require urgent cardiothoracic surgery, the risk of serious or life-threatening bleeding and complications is very high.  Based on our estimates, at least 1% of patients in the U.S. on apixaban or rivaroxaban may require urgent cardiothoracic surgery on an annual basis.  Today there are no approved or cleared alternatives in the U.S. to reduce bleeding risks during cardiothoracic surgery caused by direct oral anticoagulants.  With the appropriate U.S. marketing approvals for removal of ticagrelor and the two leading DOACs during cardiothoracic surgery, DrugSorb-ATR has the potential to address these major unmet medical needs, while targeting an estimated U.S. total addressable market of one billion dollars.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 152,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.  The Company is initiating two pivotal trials designed to support U.S. FDA marketing approval of DrugSorb-ATR.  The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery.  The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal of Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb–ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban.  

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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, anticipated future results and performance, 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 9, 2021, 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.

Please Click to Follow Us on Facebook and Twitter

Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@runbensteinpr.com 

1 Agency for Healthcare Research and Quality. Number of people with purchase in thousands by prescribed drug, United States, 1996-2018.  Medical Expenditure Panel Survey.  Generated interactively May 27, 2021.  CytoSorbents estimates.

SOURCE CytoSorbents Corporation

CytoSorbents Provides Preliminary Third Quarter Business Update and Revised 2021 Product Revenue Guidance

Preliminary third quarter 2021 total revenue was $9.7 million, including product sales of $8.9 million. Preliminary core non-COVID-19 product sales increased 4% Y-Y to approximately $7.8 million.

MONMOUTH JUNCTION, N.J., Oct. 12, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces preliminary third quarter financial results and revised second half and full year 2021 product revenue guidance, primarily reflecting pandemic-driven adverse market conditions in Germany.

Preliminary Third Quarter 2021 Financial Information

  • Total revenue, including product sales and grant income, for Q3 2021 was $9.7 million, down 8% compared to $10.5 million in Q3 2020.
  • Q3 2021 CytoSorb product sales were $8.9 million, down 13% compared to $10.2 million in Q3 2020.
  • Q3 2021 product sales in Germany are estimated to be $3.7 million, a decrease of $1.1 million or 24%, from product sales of $4.8 million in Germany in Q3 2020.
  • Core non-COVID-19 product sales for Q3 2021 were approximately $7.8 million, up 4% from approximately $7.5 million in Q3 2020.
  • Estimated product sales related to COVID-19 were $1.1 million in Q3 2021 versus approximately $2.7 million in Q3 2020.
  • The Company has a strong cash balance of $61.0 million at September 30, 2021 and no debt.
CytoSorbents Provides Preliminary Third Quarter Business Update and Revised 2021 Product Revenue Guidance

The third largest wave in new COVID-19 cases in Germany, driven by the Delta variant, accelerated through August and, after peaking in mid-September, has continued to date. This  prompted many hospitals throughout Germany to reduce elective surgical procedures, to reserve ICU beds, and to either maintain or reinstitute restrictions such as visitation rights to non-essential visitors, in preparation of COVID-19 hospitalizations.  However, unlike prior waves in Germany, the rates of severe COVID-19 illness requiring ICU care, and death have been disproportionately very low.  This is being partly attributed to high rates of vaccinations that are associated with reduced severity of illness, reduced need for hospitalization, and risk of death.  

These macro factors negatively impacted our critical care and cardiac surgery markets in Germany, resulting in lower-than-expected sales of CytoSorb during the third quarter.  Specifically, there were:

Quarterly results were further exacerbated by a greater-than-normal seasonal third quarter impact of European summer vacations.

A recent survey conducted by BVMed (Association of German Medtech Companies) of 110 Medtech companies in Germany published this month highlights that our experience is not unique.  Based on the most cited reasons presented in the chart entitled, “Biggest Sales Hurdles in Germany in the Second Coronavirus Year,” 62% of Medtech companies cite postponed elective interventions, 59% cite declines in patient numbers in hospitals, and 55% cite reduced contact to customers and/or patients.

Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents, stated, “At the time of our prior guidance in the first week of August, new COVID-19 infections from the Delta variant in Germany were still low.  Following strong results from the first half of this year, we believed our core non-COVID-19 sales would continue to increase, encouraged that German hospitals were continuing to lift restrictions and elective surgeries were increasing.  However, within the span of weeks, rates of new COVID-19 cases accelerated in Germany, and changed the macro business outlook significantly.  The convergence of the multiple challenges outlined above during a traditionally seasonal third quarter unexpectedly amplified the negative aspects of the pandemic on our business.  We believe many of these roadblocks are outside of our control, driven by the COVID-19 pandemic.  And while it is difficult to predict how fast the business environment will improve, we are diligently working in the background to improve the things we can control, to position our business for a return to sales growth.  Some examples include continuing to diversify our sources of revenue, maximizing existing clinical applications while launching new ones, executing on our clinical trial strategy, investing in and expanding our direct sales territories, and optimizing our sales force and access to physicians and hospitals.”

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “At the beginning of 2021, we highlighted that our challenge for the year was to replace COVID-19 revenue with core non-COVID-19 revenue.  We predicted that as vaccinations rose, the rates of COVID-19 and usage of CytoSorb to treat COVID-19 would drop, but this would allow us to resume our core non-COVID-19 business.  In the first half of 2021, we made good progress towards this goal, despite previously discussed challenges of this transition.  As we begin the traditionally strong fourth quarter and busy winter season for ICU admissions, we believe these macro factors will likely take some time to resolve, particularly ICU capacity issues, hospital restrictions, and the direction and impact of the COVID-19 pandemic, hence our revised guidance for the remainder of 2021.  We are fortunate to have a solid cash balance to weather the near-term uncertainty and are working to keep tight control of our expenses, while prioritizing generation of the next level of clinical data with seven Company-sponsored clinical studies, including four randomized controlled trials, expected to be active by the end of this year.  Meanwhile, we plan to make the most of our opportunities in Germany, while diversifying and augmenting our efforts in new and existing direct sales countries and distributor/partner channels.”

Dr. Chan concluded, “Meanwhile, we remain laser-focused on our U.S. regulatory program for the removal of antithrombotic drugs, or blood thinners, during cardiothoracic surgery.  We have already initiated our U.S. STAR-T pivotal randomized controlled trial (RCT) to remove ticagrelor during open heart surgery, and today have announced, that just two months after receiving FDA Breakthrough Device Designation for DrugSorb-ATR to remove apixaban (Eliquis®, Bristol-Myers Squibb/Pfizer), and rivaroxaban (Xarelto®, Janssen/Bayer) during urgent cardiothoracic surgery, the FDA has now fully approved the start of our STAR-D pivotal RCT to do the same.  These accomplishments highlight the sense of urgency and priority we have placed on these programs.  If both studies are successful, we believe they can be major catalysts for potential revenue growth as we seek FDA marketing approval for this approximately $1 billion total addressable U.S. market opportunity.”

Revised 2021 Product Revenue Guidance

The macro environment of the global COVID-19 pandemic continues to add uncertainty to the Company’s sales outlook, especially since we are unable to predict the course of the pandemic or predict what impact, if any, the COVID-19 pandemic may have on global sales for the remainder of the year.

We believe the revised guidance below is achievable, as in deriving the revised fourth quarter and full year product revenue outlook, we have assumed no improvement in the COVID-19 pandemic-related environment observed during the third quarter of 2021.  In addition, we do not have full visibility into the potential impact of the recently released data from the REMOVE study, as full study results are not yet available.  Though we believe that CytoSorb will continue to be used in selected infective endocarditis populations, we have included a potential negative impact to sales in our guidance.  As a result, the Company now expects:

  • Q4 2021 product revenue similar to Q3 2021 product revenue of $8.9 million, suggesting approximately $17.8 million in second half product sales, down 17% from first half 2021 products sales, as compared to previous expectations of higher second half 2021 product sales compared to first half 2021 product sales.
  • Full year 2021 product revenue of at least $39.3 million, roughly flat compared to 2020 product revenue of $39.5 million. While difficult to predict, 2021 core non-COVID-19 product sales are expected to be approximately $33 to $34 million for the year versus $30.1 million in 2020.

Third Quarter 2021 Results Call Information

CytoSorbents will report third quarter 2021 operating and financial results after the market close on November 4, 2021.  CytoSorbents’ management will host a live conference call and presentation webcast at 4:30 p.m. Eastern the same day.

Conference call details:
Date: Thursday, November 4, 2021
Time: 4:30 p.m. Eastern
Toll free: 1-877-521-4127
International: 1-212-231-2930
Conference ID: 21998483
Live presentation webcast: https://viavid.webcasts.com/starthere.jsp?ei=1505348&tp_key=fc4e9855a2

It is recommended that participants dial in approximately 10 minutes prior to the start of the call. 

A simultaneous live webcast can be accessed via the following audio feed: https://viavid.webcasts.com/starthere.jsp?ei=1505348&tp_key=fc4e9855a2

An archived recording of the conference call will be available under the Investor Relations portion of the company’s website at https://cytosorbents.com/investor-relations/financial-results/

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 152,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, apixaban and rivaroxaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery.  The Company is initiating two pivotal trials designed to support U.S. FDA marketing approval of DrugSorb-ATR.  The first is the 120-patient, 20 center STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial evaluating the ability of intraoperative DrugSorb-ATR use to reduce perioperative bleeding risk in patients on ticagrelor undergoing cardiothoracic surgery.  The second is the 120-patient, 25 center STAR-D (Safe and Timely Antithrombotic Removal of Direct Oral Anticoagulants) randomized, controlled trial, evaluating the intraoperative use of DrugSorb-ATR to reduce perioperative bleeding risk in patients undergoing cardiothoracic surgery on direct oral anticoagulants, including apixaban and rivaroxaban. 

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and www.cytosorb.com or follow us on Facebook and Twitter

Financial Disclosure Advisory

The Company reports its financial results in accordance with U.S. generally accepted accounting principles. The expected financial results discussed in this press release are preliminary, unaudited, and represent the most current information available to the Company’s management, as financial closing procedures for the quarter ended September 30, 2021 are not yet complete. These estimates are not a comprehensive statement of the Company’s financial results for the quarter ended September 30, 2021 and actual results may differ materially from these estimates as a result of the completion of normal quarter-end accounting procedures and adjustments, including the execution of the Company’s internal control over financial reporting, the completion of the preparation and review of the Company’s financial statements for the quarter ended September 30, 2021 and the subsequent occurrence or identification of events prior to the formal issuance of the third quarter financial results.

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, anticipated future results and performance, 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 9, 2021, 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.

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Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

SOURCE CytoSorbents Corporation

CytoSorbents Announces Availability of Preliminary Data Abstracts from Two Endocarditis Studies, including the REMOVE study, to be Presented at the EACTS Conference

MONMOUTH JUNCTION, N.J., Oct. 7, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification, announced the public availability of preliminary data abstracts from two separate endocarditis studies, including the REMOVE study, to be presented at the upcoming European Association for Cardio-Thoracic Surgery (EACTS) annual meeting taking place in Barcelona, Spain from October 13-16, 2021, where more extensive data are expected to be made available.  A summary of the abstracts are as follows:

The REMOVE (Revealing Mechanisms and Investigating Efficiency Of Hemoadsorption for Prevention of Vasodilatory Shock in Cardiac Surgery Patients with Infective Endocarditis) investigator initiated randomized, controlled trial enrolled 288 patients with documented infective endocarditis with a EuroSCORE II (European System for Cardiac Operative Risk Evaluation II) > 3, and who required open heart valve replacement surgery, and compared the intraoperative use of CytoSorb and standard of care with standard of care alone.  The investigators concluded that although intraoperative hemoadsorption reduced plasma cytokines at the end of cardiopulmonary bypass, it did not reduce the severity of post-operative organ dysfunction as observed by the change in mean SOFA (Sequential Organ Failure Assessment) score over nine days.  In addition, the investigators noted no statistical difference in secondary endpoints, including 30-day mortality and durations of post-operative hemodialysis, ventilation and vasopressor therapy.  

In a retrospective study entitled “Intraoperative Hemoadsorption Reduces Sepsis-related Death in All-comers Undergoing Surgery for Infective Left-sided Endocarditis,” investigators from Nuremberg, Germany report results from 195 consecutive patients with left-sided endocarditis (i.e. aortic and/or mitral valve involvement) who underwent valve replacement surgery at their institution with or without intraoperative treatment with CytoSorb.  A significant proportion of patients had endocarditis of a prosthetic valve (41% CytoSorb treated, 28% control).  The study analyses focused on the comparison of the control cohort (n=101) who were treated prior to CytoSorb introduction at the hospital and the CytoSorb cohort (n=94) who received intraoperative CytoSorb therapy during the operation.  The two groups had generally comparable baseline characteristics with a median age of 69 years, however CytoSorb treated patients had numerically higher baseline EuroSCORE II and were more frequently treated for prosthetic valve endocarditis.  The use of CytoSorb was associated with significantly lower post-operative sepsis-related mortality (7.5% vs. 20% control, p=0.021) and lower levels of C-Reactive Protein (8.8 vs. 9.8 mg/dl; p=0.019) and white blood cell counts (9.8 vs. 11.7 x10-6/mcL; p=0.033) on post-operative day 1.  The investigators stated that CytoSorb therapy was well-tolerated and safe and contributed to reduced sepsis-related mortality, CRP and leucocyte levels after surgery and concluded that “these data suggest that intraoperative hemoadsorption improves surgical outcomes in all-comers for left-sided infective endocarditis.”

Dr. Efthymios Deliargyris, Chief Medical Officer of CytoSorbents stated, “At the current time, the available data from both studies are preliminary and limited and do not allow for in-depth evaluation.  We plan to have a detailed statement once the full formal presentations are completed next week, and more complete data are made available.  From a high level, CytoSorb therapy tends to work best in carefully selected patients with a high acuity of illness who are treated with the device early and for an adequate duration of time.  In the case of these two endocarditis studies, important underlying differences may exist in the respective patient cohorts that could explain the reported differences in the observed benefits with the intraoperative use of CytoSorb during valve replacement surgery.  In addition, in both studies, CytoSorb was only used intra-operatively, where today in many centers, CytoSorb therapy in infective endocarditis patients has advanced to be used both intraoperatively and postoperatively during recovery with reported improved benefits.  Importantly, the investigators from Nuremberg reported that the intraoperative use of CytoSorb during cardiac surgery was well-tolerated and safe.  We view this as a positive development that provides added reassurances for our ongoing clinical programs on intraoperative device use and are looking forward to reviewing the safety data from the REMOVE trial that we anticipate will be released during the formal presentation.  We plan to work closely with the investigators of both studies to better understand the results and determine the direction for further analyses that could help identify the optimal endocarditis patient population for CytoSorb use and potentially inform the design of future endocarditis studies.”

Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “Today, infective endocarditis makes up a minor part of our overall usage and revenue in cardiac surgery and we believe that CytoSorb will continue to be used in selected infective endocarditis populations.  For example, prosthetic heart valve endocarditis is associated with very high mortality and is increasingly common due to the aging population with structural valvular disease and increased use of transcatheter aortic valve replacement (TAVR) and traditional open heart valve replacements. Overall, infective endocarditis is just one of many applications of our technology in cardiac surgery and is a much smaller opportunity than the removal of antithrombotic drugs during cardiothoracic surgery, for which we have specific approvals in the E.U., two U.S. FDA Breakthrough Device Designations, and is the core focus of our U.S. regulatory approval strategy.”

Infective endocarditis is a potentially life-threatening infection of one or more heart valves that is usually caused when bacteria enter the bloodstream due to a systemic infection, dental care, or intravenous drug abuse and the use of dirty needles. Treatment typically involves antibiotics, but for many patients, cardiac surgery and valve replacement is the only treatment option.  If left untreated, endocarditis can damage a patient’s heart valves and may be fatal. 

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 143,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, rivaroxaban and apixaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. 

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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, anticipated future results and performance, 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 9, 2021, 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.

Please Click to Follow Us on Facebook and Twitter

Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

SOURCE CytoSorbents Corporation

CytoSorbents to Host International Webinar on the Worldwide Experience Using CytoSorb® in Critically Ill Patients with COVID-19

Upcoming international webinar on September 16, 2021 will summarize published clinical data from around the world on the use of CytoSorb in critically ill COVID-19 patients

MONMOUTH JUNCTION, N.J., Sept. 14, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery announces an upcoming live webinar to provide a global perspective on CytoSorb® blood purification therapy in COVID-19 patients on Thursday September 16, 2021, at 11 a.m. EDT / 5:00 p.m. CET.  The webinar will highlight a growing body of data from seven recently published journal articles or presentations on the use of CytoSorb in more than 215 critically ill COVID-19 patients worldwide, including the recently announced topline results from the U.S. multicenter CTC Registry using CytoSorb with ECMO under U.S. FDA Emergency Use Authorization.  

CytoSorbents Corporation (NASDAQ: CTSO) is a leader in blood purification to treat cytokine storm and deadly inflammation in life-threatening illnesses and during cardiac surgery with its flagship product, CytoSorb.  CytoSorb is approved in the European Union and distributed in 67 countries worldwide.

Live Webinar details:
Update on CytoSorb Therapy in COVID-19 Patients
CytoSorbents’ International Experts Meeting in Intensive Care Series

Date: Thursday, September 16, 2021
Time: 11:00 a.m. Eastern / 5:00 p.m. CET
Registration Link: https://cyto.news/IEM-210916

Chairperson:

  • Dr. Manu Shakar-Hari, London/UK

Speakers:

  • Dr. Tae Song, Chicago/USA
    Topline results from the U.S. CTC multicenter registry
  • Dr. Zsolt Molnár, Budapest/Hungary
    Overview about current studies and experiences
  • Dr. Manu Shankar-Hari, London/UK
    Multisystem inflammatory syndrome

The session will conclude with a live, moderated Question and Answer session.

Highlighted data to be presented are expected to include:

  • Topline results from the U.S. CytoSorb Therapy in COVID-19 (CTC) Registry, reporting 73% 90-day survival in 52 critically-ill COVID-19 patients in refractory respiratory failure on ECMO and CytoSorb under FDA Emergency Use Authorization at 5 U.S. ECMO centers.1
  • Consistently reported key clinical parameters including:
    • Reductions of inflammatory marker levels, including IL-6, CRP and ferritin (Ruiz-Rodriguez2, Alharthy3, Nassiri4, Geraci5, Peng6, and Wunderlich-Sperl7
    • Improvements in hemodynamic stabilization and weaning of vasopressors (Ruiz-Rodriguez, Nassiri, Peng, Wunderlich-Sperl)
    • Improvements in the P/F ratio, considered to be one of the most clinically relevant measures of lung function in ventilated patients (Ruiz-Rodriguez, Alharthy, Peng, Wunderlich-Sperl)
  • The importance of starting CytoSorb therapy in COVID-19 patients with confirmed respiratory failure, before they develop irreversible organ injury.  Intervening before fulminant thrombotic ischemic injury has occurred, as evidenced by very high baseline D-dimer levels appears to be particularly important.  Multiple studies have identified high D-dimers as a significant risk factor for poor outcome and mortality in critically ill COVID-19 patients, regardless of whether cytokine adsorption is used or not.

Dr. Joerg Scheier, Vice President of Medical and Clinical Affairs of CytoSorbents, stated, “We are excited to see that the expanding numbers of positive clinical experiences with CytoSorb in COVID-19 patients are now being reflected by an increasing number of scientific peer review publications from many different geographies.  We believe the ability to reduce inflammatory mediators in these patients is a key reason that common clinical benefits are being reported in COVID-19 patients treated with CytoSorb.  Finally, clinicians routinely comment that CytoSorb is easy to use, irrespective of whether the device is set up within a renal replacement, an extracorporeal membrane oxygenation (ECMO), or a standalone circuit in hemoperfusion mode. This has given physicians greater flexibility in how and when they treat patients with CytoSorb.”

Overall, CytoSorb has been used in more than 6,500 critically ill COVID-19 patients in more than 30 countries worldwide to reduce cytokine storm and other circulating inflammatory mediators with the goals of reducing severe systemic hyper-inflammation and damage to vital organs like the lungs, heart, and kidneys, while improving the chances of survival.

References:

  1. Song, T et al., “CytoSorb Therapy in COVID-19 (CTC) Patients Requiring Extracorporeal Membrane Oxygenation:  A Multicenter, Retrospective Registry.” Intl Symposium on Intensive Care and Emergency Medicine Presentation – August 2021
  2. Ruiz-Rodriguez JC, et al., “The Use of CytoSorb Therapy in Critically Ill COVID-19 Patients: Review of the Rationale and Current Clinical Experiences.” Crit Care Res Pract. 2021
  3. Alharthy A, et al., “Continuous Renal Replacement Therapy with the Addition of CytoSorb Cartridge in Critically Ill Patients with COVID-19 Plus Acute Kidney Injury: A Case Series.” Artificial Organs. 2020
  4. Nassiri AA, et al., “Blood Purification with CytoSorb in Critically Ill COVID-19 Patients: A Case Series of 26 Patients.” Artif Organs. 2021
  5. Geraci T, et al., “Hemoadsorption for Management of Patients on Veno-Venous ECMO Support for Severe COVID-19 Acute Respiratory Distress Syndrome.”  J. Cardiac Surg. 2021
  6. Peng JY, et al., “Hemoperfusion with CytoSorb in Critically Ill COVID-19 Patients.” Blood Purif. 2021
  7. Wunderlich-Sperl F, et al., “Adjuvant Hemoadsorption Therapy in Patients with Severe COVID-19 and Related Organ Failure Requiring CRRT or ECMO Therapy: A Case Series. Int J Artif Organs. 2021

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 143,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs rivaroxaban and apixaban in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. 

CytoSorb has been granted U.S. FDA Emergency Use Authorization in the COVID-19 pandemic as an extracorporeal cytokine adsorber for use in adult, critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The CytoSorb device has neither been cleared nor approved for the indication to treat patients with COVID-19 infection. The CytoSorb device is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the CytoSorb device under Section 564(b)(l) of the Act, 21 U.S.C § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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, anticipated future results and performance, 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 9, 2021, 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.

Please Click to Follow Us on Facebook and Twitter

Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com

SOURCE CytoSorbents Corporation

CytoSorbents Commemorates World Sepsis Day and Sepsis Awareness Month with Key Sepsis-Related Events, Sponsorships and Studies

MONMOUTH JUNCTION, N.J., Sept. 13, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions, such as sepsis, in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces key sepsis-related events, sponsorships and studies in conjunction with World Sepsis Day today and Sepsis Awareness Month (September).

CytoSorbents Commemorates World Sepsis Day and Sepsis Awareness Month with Key Events, Sponsorships and Studies

Sepsis arises when the body’s immune response to a serious infection injures its own tissues and organs. Sepsis is often associated with excessive inflammation driven by a cytokine storm.  This in turn may lead to serious complications such as shock, failure of vital organs, and death – especially if not recognized early and treated promptly. Sepsis is the final common pathway to death from most infectious diseases worldwide, including viruses such as SARS-CoV-2, the virus that causes COVID-19. In aggregate, one in five deaths worldwide continue to be associated with sepsis, despite the broad use of antibiotics and other medications. CytoSorbents’ flagship product CytoSorb® has been used extensively in patients experiencing sepsis or septic shock to reduce cytokine storm and inflammation through blood purification, with the goals of reducing the severity and complications of sepsis, while helping to stabilize the patient.

Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents, stated, “Septic shock, or a life-threatening persistent drop in blood pressure, confers a high risk of mortality in sepsis.  In international clinical guidelines, its treatment is key to sepsis survival.  Historically, however, treatment options have been predominantly supportive.  CytoSorb has demonstrated the ability to reverse septic shock in multiple published studies.  We now look to extend our understanding of how best to use CytoSorb to treat refractory septic shock – one of the deadliest forms of sepsis – in the upcoming company-sponsored, randomized, controlled PROCYSS trial in Germany.  We expect the trial to start shortly, with the first patients enrolled before year-end.”

Last week, CytoSorbents proudly sponsored the 10th Annual Sepsis Update 2021 Congress, from September 8-10, 2021, hosted by the German Sepsis Society in Weimar, Germany.  As in years past, CytoSorbents once again was the corporate sponsor of the prestigious Roger Bone Prize for excellence in clinical sepsis research.  This year’s prize was awarded to Dr. Wolfgang Bauer from Charité University Medical Hospital in Berlin, Germany during the Opening Ceremony of the Congress for his work in comprehensive RNA diagnostics for viral and bacterial infections. 

Dr. Steiner added, “CytoSorbents has long funded and supported sepsis research and education, so it was a personal honor to present the Roger Bone Award to Dr. Bauer from Charité for his outstanding research and accomplishments in the sepsis field.  We believe it is important to recognize and support up-and-coming sepsis researchers who will one day help us end the sepsis scourge.”

The Company also hosted a lunch symposium at the Sepsis Update 2021 Congress entitled “Hemoadsorption with CytoSorb in Sepsis and COVID-19 Patients – an Update” on Friday September 10, 2021.

Chair:

  • M. Singer (London, U.K)

Speakers:

  • M. Shankar-Hari (London, U.K.)
    Immune System Alterations and Organ Disfunction in Sepsis
  • Z. Molnar (Budapest, Hungary)
    Effects of Hemoadsorption on Hemodynamic Stability in Septic Shock
  • R. Ferrer-Roca (Barcelona, Spain)
    Multisystem Inflammatory Syndrome Associated with COVID-19 – How to Master the Challenge?
  • A. Nierhaus (Hamburg, Germany)
    Use of Hemoadsorption in COVID-19 Patients – What Did We Learn So Far?

In the U.S., this symposia complements today’s previously announced webinar entitled, Presentation of Topline Results from CytoSorbents’ U.S. CTC Multicenter Registry which Demonstrate High Survival Using CytoSorb® in Critically Ill COVID-19 Patients on ECMO” presented by Dr. J.W. Awori Hayanga from West Virginia University School of Medicine, and hosted by Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. 

Dr. Chan commented, “The positive results of this multicenter registry study are important because it is generally underappreciated that those who die from COVID-19 pneumonia, often do so from complications of coronavirus-related sepsis and the hyperinflammatory response. Those on ECMO are often the sickest COVID-19 patients, and these data suggest that the combination of ECMO with CytoSorb potentially represents an enhanced lung rest and lung healing strategy to help these patients survive.”

In addition, in the United States, CytoSorbents has been a longtime sponsor of the Sepsis Alliance and is sponsoring this year’s Sepsis Alliance Summit, an event that explores an array of sepsis-related topics in healthcare, taking place virtually from September 14-16, 2021.

Dr. Chan concluded, “Sepsis is one of the most difficult and complicated diseases to treat, which is why there have been decades of failed trials and therapies.  With improved recognition, and new treatments like CytoSorb, we hope to change this. With every study, we continue to learn and gain valuable insights into how to beat sepsis, and move closer to more predictably helping to save lives.  We are proud to support World Sepsis Day and Sepsis Awareness Month and to be in a fortunate position to do our part and make a difference.”  

CytoSorbents supports Sepsis Awareness month.  To find out more about sepsis, including risks, causes, symptoms and how you can help raise awareness go here.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 143,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs rivaroxaban and apixaban in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. 

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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, anticipated future results and performance, 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 9, 2021, 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.

Please Click to Follow Us on Facebook and Twitter

Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@rubensteinpr.com  

SOURCE CytoSorbents Corporation

CytoSorbents Announces Filing of an Investigational Device Exemption (IDE) for the U.S. Clinical Trial on Apixaban and Rivaroxaban Removal by the DrugSorb-ATR™ Antithrombotic Removal System During Urgent Cardiothoracic Surgery

MONMOUTH JUNCTION, N.J., Sept. 10, 2021 /PRNewswire/ — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification via its proprietary polymer adsorption technology, announces the filing of an Investigational Device Exemption (IDE) application to gain FDA approval to conduct the clinical study, “Safe and Timely Antithrombotic Removal – Direct Oral Anticoagulants (STAR-D),” in the United States to support FDA marketing approval.  This is being performed under the previously announced FDA Breakthrough Device Designation granted to DrugSorb-ATR® for the removal of  apixaban and rivaroxaban in a cardiopulmonary bypass circuit to reduce the likelihood of serious perioperative bleeding in urgent cardiothoracic surgery.

CytoSorbents Files IDE for U.S. Clinical Trial on Apixaban and Rivaroxaban Removal During Urgent Cardiothoracic Surgery

Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents stated “The investigational plan set forth in this IDE filing comes approximately one month after the FDA granted Breakthrough Designation for this application, demonstrating the operational efficiencies of our clinical and regulatory teams and the leveraged synergies with the previously approved and currently active U.S. STAR-T pivotal trial to remove ticagrelor during urgent cardiothoracic surgery.  We expect discussions with FDA on the current IDE application to conclude in the fourth quarter of 2021 and if approved, plan to commence study initiation activities for this second DrugSorb-ATR trial immediately thereafter.  We plan to provide more details on the STAR-D trial, designed to support U.S. FDA marketing approval for this additional application, in the near future.”

In August 2021, the FDA granted CytoSorbents Breakthrough Device Designation to remove the Direct Oral Anticoagulants (DOACs) apixaban and rivaroxaban to reduce the risk of serious bleeding during urgent cardiothoracic surgery, recognizing this major unmet medical need.  Apixaban (Eliquis®, Bristol Myers Squibb/Pfizer) and rivaroxaban (Xarelto®, Jansen/Bayer) are two of the most commonly prescribed anticoagulants worldwide, including more than 5 million patients1 annually in the United States who are chronically on these medications to reduce the risk of deadly blood clots due to atrial fibrillation, prior history of heart attack or stroke, deep vein thrombosis, pulmonary embolism, and peripheral artery disease.  We expect the number of patients prescribed these drugs to continue to climb based on the superior performance of these agents compared to older alternatives, underlying demographic trends in the aging baby boomer population, improved disease detection rates, and other factors.  When patients on various “blood thinners”, like apixaban or rivaroxaban, require urgent cardiothoracic surgery, the risk of serious or life-threatening bleeding and complications is very high.  Based on our estimates, at least 1% of patients in the U.S. on apixaban or rivaroxaban may require urgent cardiothoracic surgery on an annual basis.  Today there are no approved or cleared alternatives in the U.S. to reduce bleeding risks during cardiothoracic surgery caused by direct oral anticoagulants.  With the appropriate U.S. marketing approvals for removal of ticagrelor and the two leading DOACs during cardiothoracic surgery, DrugSorb-ATR has the potential to address these major unmet medical needs, while targeting an estimated U.S. total addressable market of one billion dollars.

About CytoSorbents Corporation (NASDAQ: CTSO)

CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in intensive care and cardiac surgery using blood purification.  Its flagship product, CytoSorb®, is approved in the European Union with distribution in 68 countries around the world as an extracorporeal cytokine adsorber designed to reduce the “cytokine storm” or “cytokine release syndrome” seen in common critical illnesses that may result in massive inflammation, organ failure and patient death.  These are conditions where the risk of death can be extremely high, yet few to no effective treatments exist.  CytoSorb is also being used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to post-operative complications, including multiple organ failure.  More than 143,000 CytoSorb devices have been delivered to date.  CytoSorb was originally introduced into the European Union under CE-Mark as a first-in-kind cytokine adsorber.  Additional CE-Mark label expansions were received for the removal of bilirubin and myoglobin in clinical conditions such as liver disease and trauma, respectively, and both ticagrelor and rivaroxaban during cardiothoracic surgery.  CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with imminent or confirmed respiratory failure.  The DrugSorb-ATR™ Antithrombotic Removal System, which is based on the same polymer technology as CytoSorb, has also been granted FDA Breakthrough Designation for the removal of ticagrelor, as well as FDA Breakthrough Designation for the removal of the direct oral anticoagulant (DOAC) drugs, rivaroxaban and apixaban, in a cardiopulmonary bypass circuit during urgent cardiothoracic surgery. 

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 more than $39.5 million from DARPA, the U.S. Department of Health and Human Services (HHS), the National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), the U.S. Army, the U.S. Air Force, U.S. Special Operations Command (SOCOM), Air Force Material Command (USAF/AFMC), and others.  The Company has numerous marketed products and products under development based upon this unique blood purification technology protected by many issued U.S. and international patents and registered trademarks, and multiple patent applications pending, including ECOS-300CY®, CytoSorb-XL™, HemoDefend-RBC™, HemoDefend-BGA™, VetResQ®, K+ontrol™, DrugSorb™, DrugSorb-ATR™, ContrastSorb, and others.  For more information, please visit the Company’s websites at www.cytosorbents.com and 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, anticipated future results and performance, 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 9, 2021, 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.

Please Click to Follow Us on Facebook and Twitter

Investor Relations Contact:
Terri Anne Powers
Vice President, Investor Relations
and Corporate Communications
(732) 482-9984
tpowers@cytosorbents.com

U.S. Public Relations Contact:
Eric Kim
Rubenstein Public Relations
212-805-3052
ekim@runbensteinpr.com

1 Agency for Healthcare Research and Quality. Number of people with purchase in thousands by prescribed drug, United States, 1996-2018.  Medical Expenditure Panel Survey.  Generated interactively May 27, 2021.  CytoSorbents estimates.

 

SOURCE CytoSorbents Corporation