CytoSorbents Highlights New Clinical Data from Current Studies at the Live 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM)
PRINCETON, N.J., March 22, 2023 (GLOBE NEWSWIRE) — CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery using blood purification, announced its scientific program for the 42nd International Symposium on Intensive Care & Emergency Medicine (ISICEM 2023) Congress being held this week in Brussels, Belgium. Importantly, new data from some of the latest studies will be presented on Thursday, March 23, 2023, during a live streamed symposium entitled “Hemoadsorption with CytoSorb® – New evidence from current studies” from 12:30-1:30 PM CET (7:30-8:30AM EDT).
Symposium Chairs: Prof. Lui Forni (Surrey, UK) and Prof. Can Ince (Rotterdam, The Netherlands)
Topics:
Can hemoadsorption attenuate circulating cytokines during systemic inflammation? Prof. Peter Pickkers (Radboud University Nijmegen, The Netherlands) will focus on the ability of CytoSorb to reduce circulating cytokines during systemic inflammation in a robust controlled human study. The excessive production of cytokines, or cytokine storm, is common in critical illnesses and can trigger potentially life-threatening complications such as shock (a precipitous and dangerous drop in blood pressure) and lung failure in a host of deadly conditions treated in the intensive care unit, including sepsis
Is hemoadsorption able to prevent endothelial damage? Prof. Zsolt Molnar (Semmelweiss University, Budapest, Hungary and CytoSorbents Europe) will summarize the growing body of pre-clinical and clinical data supporting the use of CytoSorb to prevent endothelial damage to blood vessels, one of the main factors leading to failure of the vascular system and capillary leak syndrome – direct causes of shock, acute respiratory distress syndrome (ARDS), and tissue edema
Impact of CytoSorb on hemodynamics in patients with septic shock Dr. Gabriella Bottari (Bambino Gesù Children’s Hospital, Rome, Italy) will present data from the latest retrospective observational study from 7 pediatric intensive care units in Italy, highlighting the positive impact of CytoSorb in managing septic shock in pediatric patients
Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents stated, “ISICEM – the biggest scientific and clinical conference on Intensive Care Medicine outside the United States – is an excellent opportunity to unveil the latest research results on CytoSorb. CytoSorb is being increasingly used as a ‘go-to’ therapy option for critically ill patients suffering from a broad range of life-threatening illnesses, especially septic shock. Treating physicians and health care professionals around the world have directly experienced the beneficial impact of our therapy on their patients. With the important new data to be presented at our symposia, we now add to the significant body of evidence that helps to explain how our CytoSorb therapy works, underscoring the multiple mechanisms of action through which it has its biological and physiological effects. The contribution of CytoSorb in helping to effectively stabilize and manage critically ill patients is becoming clearer, particularly when patient selection, timing, and dosing are appropriate. We are grateful to the many international clinicians and scientists who have relentlessly contributed to the development of this therapy, and we are proud to have a role in helping to save patient lives.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents added, “We are pleased to actively participate in the ISICEM scientific congress, one of the most important critical care medicine conferences in the world. In addition to the above topics, there will be a number of exciting posters covering CytoSorb therapy in post-cardiac arrest syndrome, Eliquis® (apixaban, Pfizer, BMS) clearance, and others to round out the overall scientific program. We are excited to reconnect with key opinion leaders, customers, and partners from the global medical community to share our latest experiences and clinical studies with them. We encourage attendees to visit our exhibit booth and that of our global marketing partner, Fresenius Medical Care, where CytoSorb is on display on their blood purification machines. We look forward to your virtual or in-person participation at our educational symposium tomorrow. Please follow our activities on Facebook and Twitter.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, , statements about potential exposures resulting from our cash positions, 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, 2023, 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.
PRINCETON, N.J., March 14, 2023 (GLOBE NEWSWIRE) — 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, announced today that it does not have any direct financial exposure to Silicon Valley Bank or Signature Bank. CytoSorbents has diversified cash holdings in multiple financial institutions, both domestically and internationally. In the U.S., in cooperation with Bridge Bank, CytoSorbents currently holds the majority of its cash holdings at JP Morgan Chase and a minority at Bridge Bank.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, , statements about potential exposures resulting from our cash positions, 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, 2023, 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
U.S. Company Contact:
Kathleen Bloch, CFO 305 College Road East Princeton, NJ 08540 +1 (732) 398-5429
Pivotal U.S. and Canada STAR-T Trial enrollment passes halfway mark. Positive sales momentum from Q4 2022 continues in Q1 2023 to date, with expectation of sales growth in 2023
PRINCETON, N.J., March 09, 2023 (GLOBE NEWSWIRE) — 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, today reported financial and operating results for the quarter and year ended December 31, 2022 and provides its 2023 outlook.
Full Year 2022 Financial Results
2022 Total Revenue, which includes Product Sales and Grant Income, was $34.7 million versus $43.2 million in 2021, a decrease of 20%
2022 Product sales were $29.4 million versus $40.1 million in 2021, which included $0.3 million and $6.3 million in COVID-19 related Product Sales, respectively
2022 Core (non-COVID-19) Product Sales were approximately $29.1 million versus $33.8 million in 2021. This reflects an 11% drop in the average Euro to dollar exchange rate from 1.18 in 2021 to 1.05 in 2022. On a constant currency basis, Core Product Sales in 2022 would have been approximately $32.2 million versus $33.8 million in 2021, a decrease of 4.6%
The decrease in the average Euro to US dollar exchange rate negatively impacted 2022 product sales by approximately $3.1 million
2022 Product Gross Margin was approximately 70%, compared to 80% in 2021 due to manufacturing inefficiencies related to the relocation of our manufacturing operations to our new facility
We believe the Company remains well-capitalized with cash and cash equivalents of $23.8 million (which includes $1.7 million in restricted cash) at December 31, 2022
Fourth Quarter 2022 Financial Results
Q4 2022 Total Revenue, which includes Product Sales and Grant Income, was $9.4 million versus $10.8 million in Q4 2021, a decrease of 13%
Q4 2022 Product Sales were $7.6 million versus $9.7 million in Q4 2021. COVID-19 related sales were negligible in Q4 2022 and an estimated $1.7 million in Q4 2021.
Core Product Sales in Q4 2022 were $7.6 million compared to $8.0 million in Q4 2021. On a constant currency basis, core Q4 2022 Product Sales would have been $8.5 million, a 6% increase over $8.0 million in Q4 2021
The decrease in the average Euro to US dollar exchange rate lowed Q4 2022 product sales by approximately $0.9 million.
Q4 2022 product sales of $7.6 million rose 18% sequentially from $6.5 million in Q3 2022
Q4 2022 product gross margin was approximately 75%, compared to 78% in Q4 2021 due to manufacturing inefficiencies related to the relocation of our manufacturing operations to our new facility, and other factors
Recent Operating Highlights
Cumulative CytoSorb treatments delivered exceeded 195,000 at the end of 2022, up 20% from the end of 2021, and marking the 10th year of CytoSorb commercialization
The pivotal STAR-T randomized controlled trial achieved its first milestone of 40 patients enrolled, out of a target 120 patients, triggering a pre-specified Data and Safety Monitoring Board (DSMB) review
The STAR-T independent DSMB conducted a review of unblinded data from the first 40 patients in the study and recommended the trial continue as planned without any modifications
Welcomed Dr. Richard Whitlock, MD, PhD, Professor of Surgery at McMaster University Medical School, and Canada Research Chair in Cardiovascular Surgery for the Population Health Research Institute, as the Canada Principal Investigator of the STAR-T trial, bringing an outstanding track record of clinical trial execution and a superb network of Canadian clinical trial centers specializing in cardiac surgery studies to the program
Appointed Dr. Irina Kulinets as Senior Vice President of Global Regulatory and newest member of the senior management team. She will lead the DrugSorb-ATR regulatory submission for marketing approval to the U.S. FDA and Health Canada. She brings more than 30 years of experience in regulatory affairs and clinical research, where she has had an extensive track record of international regulatory success with the approval/clearance of medical products, including many Class II 510(k) and Class III Premarket Approval (PMA) medical devices
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, stated, “We are pleased to provide a brief update from our Stockholder Letter issued on January 31, 2023. If you have not already done so, we encourage you to review the letter, which highlights what we believe is our unique and compelling value proposition, and the proximity of major potential near-term catalysts, including the expected completion of the pivotal STAR-T RCT this year with the intent, with positive data, to submit for U.S. FDA and Health Canada marketing approval, and an expected return to Product Sales growth based on numerous growth initiatives.
STAR-T Update
The pivotal, U.S. and Canadian STAR-T (Safe and Timely Antithrombotic Removal – Ticagrelor) randomized controlled trial was designed to support FDA and Health Canada marketing approval for DrugSorb®-ATR to reduce the risk of perioperative bleeding in patients undergoing cardiothoracic surgery potentially caused by Brilinta® (ticagrelor, AstraZeneca). Our technology has received FDA Breakthrough Device Designation for this application, highlighting the major unmet medical need and lack of approved or cleared therapies for this problem. After achieving the first milestone of 40 patients enrolled in mid-November 2022, study enrollment is now past the halfway point and we believe we will achieve the second milestone of 80 patients enrolled this spring, which will trigger the second pre-specified DSMB review of unblinded data. Enrollment in the study has been accelerating, aided by broad participation of U.S. centers and multiple patients enrolled from initial Canadian centers as well. Because of the current fast pace of the study, we expect to complete enrollment at 120 patients this summer, with database lock, final data analysis, and DSMB closeout review to follow.
If the results of the study are positive, U.S. FDA and Health Canada regulatory submissions are planned following the completion of the study. This is a significant undertaking with preparatory work already in process, now led by our new SVP of Global Regulatory, Dr. Irina Kulinets. Meanwhile, we have developed a detailed launch and commercialization strategy for DrugSorb-ATR, led by COO and President, Vince Capponi, and our VP of US Sales and Marketing, Jim Komsa, and are pursuing our pre-commercial development in parallel to the study.
Other STAR Updates
Our decision to voluntarily pause the pivotal STAR-D (Safe and Timely Antithrombotic Removal – Direct oral anticoagulants) clinical trial has enabled us to focus our resources and those of our study centers on the STAR-T study and to save an anticipated $4M in clinical trial expense this year. That said, with the completion of the STAR-T trial, we intend to resume the STAR-D trial, and leverage the majority of clinical trial centers participating in STAR-T to complete that study quickly. If the results are positive, U.S. FDA and Health Canada marketing approval would double the total addressable market in the U.S. and Canada to more than $1 billion for DrugSorb-ATR as a “one-stop shop” for antithrombotic drug removal in cardiothoracic surgery, and spur sales internationally.
Meanwhile in Europe, the STAR registry that collects real-world evidence on the use of our technology to remove blood thinners during cardiothoracic surgery has now over 200 patients from 12 centers, well ahead of our projected enrollment. Data readouts from the registry commence at the large interventional cardiology conference, EuroPCR in Paris this May, with additional analyses submitted to the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) conferences later this year.
Finally, as we discussed in the press release earlier this week, we were pleased to see for the first time, the inclusion and recommendation of hemoadsorption in the European Guidelines to help manage perioperative bleeding risk in cardiovascular surgery in patients on blood thinning medications, based upon published studies with CytoSorb (a hemoadsorption cartridge). We believe this is a good validating next step in socializing our therapy to the broader surgery community. Positive randomized controlled data from STAR-T, STAR-D, and real-world evidence from the STAR registry are expected to establish our technologies as the primary standard-of-care therapy for these major unmet medical need in treatment guidelines worldwide.
Return to Product Sales Growth
In our Stockholder letter, we discuss at length the “perfect storm” of geopolitical, economic, post-pandemic, and company-specific factors that we had to navigate in 2022. Yet despite these challenges, we sill managed to achieve $29.1M in core product sales, that when adjusted for the 11% drop in the Euro, would have been approximately $32.2M, within 5% of 2021 core sales of $33.8M – our highest annual core sales to date, and greater than 30% higher than pre-pandemic product sales of $22.8M in 2019.
We were encouraged by progress in our sales momentum in Q4 2022, which was 18% sequentially higher than Q3 2022, and actually 6% higher than core product sale in Q4 2021 on a constant currency basis. Importantly, we are seeing a continuation of this strength in Q1 2023 to date, which we believe is being driven by strong support, enthusiasm, and receptiveness to new clinical data, of CytoSorb at the customer level – which we believe is a direct result of the long history of positive usage of the therapy in the market. We also believe this has been augmented by our increased ability to meet in-person with customers in hospitals and our focused sales and marketing activities last year. Although many of the macro factors we faced in 2022 still remain, we believe a number of these have abated, and believe our own situation has improved significantly, with many initiatives underway that are expected to contribute to sales growth in 2023.
We expect gains from key programs such as our therapy area focus and leaderhsip in critical care, cardiac surgery, and liver & kidney diseases, our “Right patient, right dose, right time” marketing campaign, our standalone blood pump initiative, our global marketing agreement with Fresenius Medical Care, and our preferred supplier agreements with the top two largest private hospital networks in Germany, Asklepios and Helios. Also, we expect a positive impact of new clinical data and publications in the treatment of numerous illnesses, including:
Positive clinical results of the final analysis of the International CytoSorb Registry (precursor to the new COSMOS registry)
We also expect a restoration of product gross margins back to more historic levels of 75-80+% as current demand has worked down finished goods inventory and begun to drive volume manufacturing out of the new manufacturing facility. As evidence of this, our Q4 2022 product gross margins were 75%, up from a recent low of 64% in Q3 2022 (55% with one time charges) primarily related to manufacturing inefficiencies related to the relocation of our manufacturing operations to our new facility. This improved gross margin is expected to significantly reduce our cash flow needs. Meanwhile, we expect to report more normalized year-over-year comparisons in 2023, given that the Euro likely bottomed in Q3 2022, and going forward, we will not need to distinguish core versus COVID-19 related product sales, as COVID-19 sales in 2022 were nominal.
Finally, we expect more government-led economic relief for hospitals throughout Europe to help avert a healthcare crisis, and a gradual improvement in staffing shortages, which will help hospitals generate more procedure-based revenue and open up more hospital ward and ICU beds, which would help us as well. In addition, we expect consolidation of smaller hospitals into the larger hospitals where we conduct the majority of our business.
Reduced Cash Burn with Tight Control Over Expenses
We ended the year with $23.8M in cash, including restricted cash and $5M in debt at attractive terms. In 2023, we expect to significantly reduce our cash burn through a combination of:
Improved sales
Restoration of product gross margins to 75-80+%
No major capital expenditures
Reduced fixed overhead following consolidation of all U.S. operations to our new Princeton, NJ headquarters and manufacturing facility last year
Expected realization of annualized cost savings from the impact of our 10% workforce reduction in 2022
Monetizing our New Jersey net operating losses
Executing on our $11.5M grant backlog to reduce R&D overhead, and
Significantly reduced operating and clinical trial expenses
Because of this, we believe our current cash position is more than sufficient to drive our 2023 operating plan.”
Dr. Chan concluded, “2023 is a very different year from last year, and believe we are now well-positioned to get to the two most important objectives we have as a company: Successful and timely completion of the STAR-T RCT in the U.S. and Canada and the potential to commercially open the vital U.S. and Canadian markets, and a return to growth of our main commercial CytoSorb business internationally. We thank you for your support and look forward to the next update.”
Results of Operations
Comparison of the year ended December 31, 2022 and 2021
Revenues:
For the year ended December 31, 2022, we generated total revenue, which includes product revenue and grant income, of approximately $34,689,000 as compared to revenues of approximately $43,166,000 for the year ended December 31, 2021, a decrease of approximately $8,477,000, or 20%. Revenue from product sales was approximately $29,360,000 for the year ended December 31, 2022, as compared to approximately $40,109,000 in the year ended December 31, 2021, a decrease of approximately $10,749,000 or 27%. Direct sales decreased by approximately $8,983,000 and distributor sales decreased by approximately $1,766,000 during the year ended December 31, 2022 as compared to the year ended December 31, 2021. Sales to hospitals in the United States under the EUA granted by the FDA amounted to approximately $300,000 for the year ended December 31, 2022, as compared to approximately $1,690,000 in 2021. Though difficult to quantify, we estimate that approximately $300,000 and approximately $6,300,000 of total product sales during the years ended December 31, 2022 and 2021 was due to the demand for CytoSorb to treat COVID-19 patients. In addition, as a result of the decrease in the average exchange rate of the Euro to the U.S. dollar, 2022 product sales were negatively impacted by approximately $3,127,000. For the year ended December 31, 2022, the average exchange rate of the Euro to the U.S. dollar was $1.05 as compared to an average exchange rate of $1.18 for the year ended December 31, 2021.
Grant income was approximately $5,329,000 for the year ended December 31, 2022 as compared to approximately $3,057,000 for the year ended December 31, 2021, an increase of approximately $2,272,000, or 74%. During the year ended December 31, 2021, 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. In 2022, research and development employees were assigned primarily to grant related activities.
Cost of Revenue:
For the years ended December 31, 2022 and 2021, cost of revenue was approximately $13,956,000 and $11,047,000, respectively, an increase of approximately $2,909,000. This increase was due to an increase in grant cost of revenue of approximately $2,210,000 due to the increase in billable hours charged to our grant related projects. Product cost of revenues increased approximately $698,000 during the year ended December 31, 2022 as compared to the year ended December 31, 2021. This increase was primarily due to an equipment failure of a refrigeration unit at our new manufacturing facility that caused a net write-off (after insurance proceeds) of approximately $300,000 of work-in-process inventory (see Note 2 to the financial statements) and inefficiencies associated with lower production due to a decrease in production volume and inefficiencies associated with relocating our production activities to the new facility. Product gross margins were approximately 70% for the year ended December 31, 2022 and approximately 80% for the year ended December 31, 2021.
Gross Profit:
Gross profit was approximately $20,733,000 for the year ended December 31, 2022, a decrease of approximately $11,385,000 or 35%, versus gross profit of $32,118,000 in 2021. This decrease is attributed to lower sales, the inventory write-off related to an equipment failure and inefficiencies associated with the process of relocating our production activities to the new facility as discussed above.
Research and Development Expenses:
Our research and development costs were approximately $15,119,000 and $16,381,000 for the years ended December 31, 2022 and 2021, respectively, a decrease of approximately $1,262,000, or 8%. This decrease was due to a decrease in clinical trial related costs of approximately $2,448,000, due primarily to the temporary pause of our STAR-D clinical trial in the U.S. and the discontinuation of the Hep-On-Fire clinical trial in Germany, a decrease in rent expense to research and development of approximately $685,000 related to our new facility and a decrease in non-grant related research and development costs of approximately $187,000. These decreases were offset by an increase in salaries related to our clinical trial activities of approximately $1,694,000 due to the hiring of additional clinical expertise and an increase in other research and development labor costs of approximately $364,000 related to the hiring of additional scientific expertise.
Legal, Financial and Other Consulting Expenses:
Our legal, financial and other consulting costs were approximately $2,848,000 and $2,732,000 for the years ended December 31, 2022 and 2021, respectively, an increase of approximately $116,000, or 4%. This increase was due to an increase in legal fees of approximately $685,000 due to the abandonment of certain issued patents and patent applications and an increase in accounting fees of approximately $169,000. These increases were offset by a decrease in consulting fees of approximately $396,000 and a decrease in hiring fees of approximately $342,000.
Selling, General and Administrative Expenses:
Our selling, general and administrative expenses were approximately $34,288,000 and $35,750,000 for the years ended December 31, 2022 and 2021, respectively, a decrease of approximately $1,462,000, or 4%. This decrease was due to a decrease of salary and commission costs of approximately $594,000 due to a reduction in commissions due to lower sales, a decrease in royalty expense of approximately $915,000 due to lower sales, a decrease in non-cash restricted stock expense of approximately $1,771,000 related to restricted stock units granted to the Company’s executive officers, a decrease in non-cash stock compensation expense of approximately $597,000 and a decrease in other general and administrative expenses of approximately $324,000. These decreases were offset by an increase sales and marketing costs, which include advertising and conference attendance, of approximately $797,000, an increase in travel and entertainment costs of approximately $530,000 and an increase in occupancy costs of approximately $1,412,000 related to the rent expense on our new manufacturing facility.
Gain (Loss) on Foreign Currency Transactions:
For the year ended December 31, 2022, the loss on foreign currency transactions was approximately $2,449,000, as compared to a loss on foreign currency transactions of approximately $2,578,000 for the year ended December 31, 2021. The 2022 loss is directly related to the decrease of the exchange rate of the Euro as of December 31, 2022 as compared to December 31, 2021. The exchange rate of the Euro to the U.S. dollar was $1.07 per Euro at December 31, 2022 as compared to $1.14 per Euro at December 31, 2021. The 2021 loss is directly related to the decrease in the exchange rate of the Euro as of December 31, 2021, as compared to December 31, 2020. The exchange rate of the Euro to the U.S. dollar was $1.14 per Euro at December 31, 2021 as compared to $1.22 per Euro at December 31, 2020.
Benefit from Income Taxes:
Our benefit from income taxes was approximately $1,093,000 and $736,000 for the years ended December 31, 2022 and 2021, respectively. These benefits were realized by utilizing the New Jersey Technology Business Tax Certificate Transfer Program whereby the State of New Jersey allows us to sell a portion of our state net operating losses to a third party.
Comparison of the year ended December 31, 2021 and 2020
Revenues:
For the year ended December 31, 2021, we generated total revenue, which includes product revenue and grant income, of approximately $43,166,000 as compared to revenues of approximately $41,005,000 for the year ended December 31, 2020, an increase of approximately $2,161,000, or 5%. Revenue from product sales was approximately $40,109,000 for the year ended December 31, 2021, as compared to approximately $39,453,000 in the year ended December 31, 2020, an increase of approximately $656,000 or 2%. Direct sales increased by approximately $361,000 and distributor sales increased by approximately $295,000 during the year ended December 31, 2021 as compared to the year ended December 31, 2020. Sales to hospitals in the United States under the EUA granted by the FDA amounted to approximately $1,690,000 for the year ended December 31, 2021, as compared to approximately $1,341,000 in 2020. Though difficult to quantify, we estimate that approximately $6.3 million and $9.4 million of total product sales during the years ended December 31, 2021 and 2020 was due to the demand for CytoSorb to treat COVID-19 patients. In addition, as a result of the increase in the average exchange rate of the Euro to the U.S. dollar, sales were positively impacted by approximately $1,207,000. For the year ended December 31, 2021, the average exchange rate of the Euro to the U.S. dollar was $1.18 as compared to an average exchange rate of $1.14 for the year ended December 31, 2020.
Cost of Revenue:
For the years ended December 31, 2021 and 2020, cost of revenue was approximately $11,047,000 and $11,052,000, respectively, a decrease of approximately $5,000. Product cost of revenues decreased approximately $1,447,000 during the year ended December 31, 2021 as compared to the year ended December 31, 2020. This decrease was related to certain costs associated with the rapid ramp-up of production during the year ended December 31, 2020 that did not recur during the year ended December 31, 2021. These decreases were offset by the negative impact of non-recurring costs related to prior years tariffs as a result of an audit by the German Customs Authorities of approximately $732,000 and the offsetting non-recurring positive impact of the Employee Retention Tax Credit of approximately $388,000, both of which were recorded in the first quarter of 2021. Product gross margins were approximately 80% for the year ended December 31, 2021 and approximately 76% for the year ended December 31, 2020.
Gross Profit:
Gross profit was approximately $32,118,000 for the year ended December 31, 2021, an increase of approximately $2,166,000 or 7%, over gross profit of $29,952,000 in 2020. This increase is attributed to the reasons discussed above.
Research and Development Expenses:
Our research and development costs were approximately $16,381,000 and $8,811,000 for the years ended December 31, 2021 and 2020, respectively, an increase of approximately $7,570,000, or 86%. This increase was due to an increase in clinical trial and related costs of approximately $4,670,000, due primarily to the start-up of our STAR-T and STAR-D clinical trials in the U.S. and our PROCYSS and Hep-On-Fire clinical trials in Germany, an increase in salaries related to our clinical trial activities of approximately $1,620,000 due to the hiring of additional clinical expertise, an increase in rent expense of approximately $943,000 related to rent expense on our new facility, an increase in other research and development labor costs of approximately $294,000 related to the hiring of additional scientific expertise and an increase in other research and development costs of approximately $43,000.
Legal, Financial and Other Consulting Expenses:
Our legal, financial and other consulting costs were approximately $2,732,000 and $3,048,000 for the years ended December 31, 2021 and 2020, respectively, a decrease of approximately $316,000, or 10%. This decrease was due to due to a decrease in hiring fees of approximately $319,000, a decrease in legal fees of approximately $263,000, and a decrease in accounting fees of approximately $28,000. These increases were offset by an increase in consulting fees of approximately $294,000 related to certain corporate initiatives.
Selling, General and Administrative Expenses:
Our selling, general and administrative expenses were approximately $35,750,000 and $28,464,000 for the years ended December 31, 2021 and 2020, respectively, an increase of approximately $7,286,000, or 26%. This increase is related to an increase in salaries, commissions and related costs of approximately $4,476,000, an increase in non-cash restricted stock expense of approximately $989,000 related to restricted stock units granted to the Company’s executive officers, an increase in non-cash stock option compensation expense of approximately $507,000, an increase in commercial insurance of approximately $280,000, an increase in sales and marketing costs, which include advertising and conference attendance of approximately $1,152,000 and an increase in travel and entertainment costs of approximately $121,000. These increases were offset by a decrease in contracted public relations costs of approximately $210,000 and a decrease in other general and administrative expenses of approximately $29,000.
Interest Expense, Net:
For the year ended December 31, 2021, interest income, net was approximately $28,000, as compared to interest expense, net of approximately $1,201,000 for the year ended December 31, 2020. This decrease in net interest expense of approximately $1,229,000 was the result of the payoff of our outstanding term loans with Bridge Bank in December of 2020.
Gain (Loss) on Foreign Currency Transactions:
For the year ended December 31, 2021, the loss on foreign currency transactions was approximately $2,578,000, as compared to a gain on foreign currency transactions of approximately $2,607,000 for the year ended December 31, 2020. The 2021 loss is directly related to the decrease of the exchange rate of the Euro at December 31, 2021 as compared to December 31, 2020. The exchange rate of the Euro to the U.S. dollar was $1.14 per Euro at December 31, 2021 as compared to $1.22 per Euro at December 31, 2020. The 2020 gain is directly related to the increase in the exchange rate of the Euro at December 31, 2020, as compared to December 31, 2019. The exchange rate of the Euro to the U.S. dollar was $1.22 per Euro at December 31, 2019 as compared to $1.12 per Euro at December 31, 2019.
Benefit from Income Taxes:
Our benefit from income taxes was approximately $736,000 and $1,127,000 for the years ended December 31, 2021 and 2020, respectively. These benefits were realized by utilizing the New Jersey Technology Business Tax Certificate Transfer Program whereby the State of New Jersey allows us to sell a portion of our state net operating losses to a third party.
Liquidity and Capital Resources
Since inception, our operations have been primarily financed through the private and public placement of our debt and equity securities. At December 31, 2022, we had current assets of approximately $33,760,000 including cash, cash equivalents and restricted cash on hand of approximately $23,832,000 and had current liabilities of approximately $9,715,000. All of the $25 million of our total shelf amount allocated to our ATM facility was available as of December 31, 2022. On December 27, 2022, we drew down the first $5 million tranche of the Term C loans available under the terms of our Amended Loan and Security Agreement with Bridge Bank. Also, we expect to receive approximately $1,093,000 in cash from the approved sale of our net operating losses and research and development credits from the State of New Jersey in the first half of 2023.
As of December 31, 2022, cash, cash equivalents and restricted cash were $23.8 million compared to $53.8 million as of December 31, 2021. After taking into account the $5 million related to our debt drawdown, our 2022 cash burn was approximately $35.0 million. This cash burn was due to lower-than-expected sales volumes, product gross margins that were lower due to decreased production volumes and operating efficiencies associated with the move to our new manufacturing facility, capital expenditures of approximately $6.3 million related to our new facility and other factors (e.g. a delay in realizing savings from cost cutting due to notice periods and labor laws in Europe). A reduction in product gross margins from 80% in 2021 to 70% in 2022, unfavorably impacted our cash burn by approximately $2.9 million. We expect product gross margins to return to previous levels as we transition production fully to the new facility by the end of this year, end the lease at our Deer Park Drive facility, and begin to capture anticipated manufacturing efficiencies driven by expected improvement in market conditions and increased product demand.
We are also managing our resources proactively, continuing to invest in key areas such as our U.S. clinical program. while driving cost-cutting throughout our Company. At the beginning of Q2 2022, we began instituting tighter cost controls and have reduced our headcount (including full and part-time employees and consultants) internationally by 10%, with the goal of reducing our cash burn. In addition, we have shifted our R&D headcount to funded grant programs, where we have an $11.5 million backlog as of December 31, 2022. Some of our costs savings of our headcount reduction are not yet visible in our results due to notice periods and labor laws in Europe but will be reflected in our 2023 operating budget. Meanwhile, we are working diligently to prioritize activities that we believe have a near-term return on investment and advance our strategic priorities, which cutting non-core or non-essential activities and spend. Our goal is, through a combination of driving an increase in sales and gross margin, and cutting costs, to significantly reduce our cash burn and to extend our operating runway with the resources we have.
Based upon the foregoing, we believe that we have sufficient cash to fund the Company’s operations beyond twelve months from the issuance of the consolidated financial statements included elsewhere in this Annual Report on Form 10-K
Conference Call Details:
Date: Thursday, March 9, 2023 Time: 4:30 PM Eastern Time Participant Dial-In: 1-201-389-0879 Conference ID: 13736064
It is recommended that participants dial in approximately 10 minutes prior to the start of the call. There will also 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=1596520&tp_key=3635996201
For additional information, please see the Company’s Form 10-K for the period ended December 31, 2022, filed on March 9, 2023, on http://www.sec.gov.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, including our future sales goals and targets, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, statements about our growth opportunities, statements regarding the expected impacts of our cost cutting measures, statements about the anticipated timing for completion of our STAR-T clinical trial and regulatory submissions, 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, 2023, 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
(amounts in thousands, except per share data)
Year ended December 31,
2022
2021
2020
Revenue:
CytoSorb sales
$
28,573
$
39,997
$
39,342
Other sales
787
112
110
Total product sales
29,360
40,109
39,452
Grant income
5,329
3,057
1,552
Total revenue
34,689
43,166
41,004
Cost of revenue
13,956
11,048
11,052
Gross profit
20,733
32,118
29,952
Other Expenses:
Research and development
15,119
16,381
8,810
Legal, financial and other consulting
2,848
2,732
3,048
Selling, general and administrative
34,288
35,750
28,464
Total expenses
52,255
54,863
40,322
Loss from operations
(31,522
)
(22,745
)
(10,370
)
Other income (expense):
Interest income (expense), net
133
28
(1,201
)
Gain (loss) on foreign currency transactions
(2,449
)
(2,578
)
2,607
Miscellaneous income
(67
)
—
—
Total other income (expense), net
(2,383
)
(2,550
)
1,406
Loss before benefit from income taxes
(33,905
)
(25,295
)
(8,964
)
Benefit from income taxes
1,092
736
1,127
Net loss
$
(32,813
)
$
(24,559
)
$
(7,837
)
Basic and diluted net loss per common share
$
(0.75
)
$
(0.57
)
$
(0.20
)
Weighted average number of shares of common stock outstanding
43,573,215
43,359,186
38,818,990
Net loss
$
(32,813
)
$
(24,559
)
$
(7,837
)
Other comprehensive income (loss):
Currency translation adjustment
1,804
2,260
(2,260
)
Comprehensive loss
$
(31,009
)
$
(22,299
)
$
(10,097
)
CYTOSORBENTS CORPORATION CONDENSED CONSOLIDATED BALANCE SHEETS (amounts in thousands)
PRINCETON, N.J., March 07, 2023 (GLOBE NEWSWIRE) — 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 that hemoadsorption of antithrombotic drugs in cardiothoracic surgery has made its way into the new “2022 Guidelines for the Management of Severe Perioperative Bleeding” by the European Society of Anaesthesiology and Intensive Care (ESAIC) and was published in the European Journal of Anaesthesiology last week.
The aim of this second update to the guidelines previously published in 2017, was to provide an evidence-based set of recommendations to aid in the clinical management of patients at risk of surgical bleeding in a variety of clinical situations. The ESAIC Guideline Committee and Task Force worked with 20 expert affiliate co-authors to conduct a systematic literature search from 2015 – 2021, ultimately identifying approximately 138,000 articles that were assessed and, where appropriate, were used as new evidence to support the new guidelines.
In Section 2.1, “How Should Intra-operative and Postoperative Bleeding be Stopped and Anaemia be Managed” in patients undergoing cardiovascular surgery, the committee reviewed published studies using CytoSorb® to reduce bleeding complications in patients undergoing cardiac surgery on antithrombotic agents and made the following recommendation:
“In patients on ticagrelor or rivaroxaban undergoing emergency cardiac/aortic surgery on CPB [cardiopulmonary bypass], haemoadsorption may be considered as an adjuvant therapy to reduce bleeding complications.”
Dr. Christian Steiner, Executive VP Sales & Marketing of CytoSorbents, stated, “This is another step forward in helping to establish our blood purification technologies as the preferred way to prevent severe bleeding in patients on blood thinning medications undergoing cardiac surgery today, and potentially other surgeries in the future. CytoSorb® is already CE mark approved in the European Union to remove the blood thinners Brilinta®/Brilique® (ticagrelor, AstraZeneca) and Xarelto® (rivaroxaban, Bayer, Janssen/Johnson & Johnson) during cardiothoracic surgery, and is being used for these indications in many hospitals throughout the world. We are excited that hemoadsorption of blood thinning medications has been considered in these updated European guidelines for the first time and that the concept is being highlighted to a broad and relevant audience.”
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents, added, “The recognition of hemoadsorption of blood thinning drugs in these guidelines is a nice validation of our DrugSorb-ATR® clinical program in the U.S. and Canada. Should the ongoing STAR-T pivotal randomized controlled trial demonstrate that the DrugSorb-ATR system, which uses an equivalent polymer technology as CytoSorb, can safely reduce bleeding complications in cardiothoracic surgery patients on Brilinta®, we expect the data to not only support U.S. FDA and Health Canada marketing approval, but to also help establish our technologies as the standard of care therapy for this major unmet medical need in treatment guidelines worldwide.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, including our future sales goals and targets, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, statements about our growth opportunities, statements regarding the expected impacts of our cost cutting measures, statements about the anticipated timing for completion of our STAR-T clinical trial and regulatory submissions, 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 10, 2022, 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.
PRINCETON, N.J., Feb. 27, 2023 /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 that Dr. Phillip Chan, Chief Executive Officer, will present at the Cowen 43rd Annual Health Care Conference at the Boston Marriott Copley Place, in Boston, MA on Tuesday, March 7, 2023. Company management will also meet in-person with investors in 1×1 meetings during the conference. To schedule a meeting with management, please contact your Cowen representative.
When: Tuesday, March 7, 2023 from 1:30PM-2:00PM EST Where: Boston Marriott Copley Place, Arlington Room (3rd floor) Webcast: Cowen Presentation Webcast Link
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, including our future sales goals and targets, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, statements about our growth opportunities, statements regarding the expected impacts of our cost cutting measures, statements about the anticipated timing for completion of our STAR-T clinical trial and regulatory submissions, 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 10, 2022, 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.
MONMOUTH JUNCTION, N.J., Feb. 24, 2023 /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, will report fiscal 2022 financial results on Thursday, March 9, 2023 at 4:30PM EST.
CytoSorbents’ management will host a live conference call and presentation webcast that will recount both operational and financial progress during Q4 2022 and fiscal year ending December 31, 2022 followed by a question and answer session.
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support U.S. FDA and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, including our future sales goals and targets, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, statements about our growth opportunities, statements regarding the expected impacts of our cost cutting measures, statements about the anticipated timing for completion of our STAR-T clinical trial and regulatory submissions, 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 10, 2022, 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.
Cumulative CytoSorb treatments surpassed 195,000. Q4 2022 product sales rebounded from Q3 2022 low. Adjusted for constant currency, Core non-COVID 2022 product sales were within 5% of that achieved in 2021 and greater than 30% increased from pre-pandemic 2019
PRINCETON, N.J., Jan. 31, 2023 /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, issues a stockholder letter from its Chief Executive Officer, Dr. Phillip Chan, and announces preliminary unaudited fourth quarter 2022 and full year 2022 results ahead of filing its Form 10-K.
Preliminary Unaudited Full Year 2022 Results
Cumulative CytoSorb treatments delivered exceeded 195,000 at the end of 2022, up 20% from the end of 2021, and marking the 10th year of CytoSorb commercialization
Preliminary unaudited 2022 Total Revenue, which includes Product Sales and Grant Revenue, was approximately $34.7 million versus $43.2 million in 2021, and $24.9 million in pre-pandemic 2019
Overall preliminary unaudited 2022 Product Sales were approximately $29.4 million versus $40.1 million in 2021, which included $0.3 million and $6.3 million in COVID-19 related Product Sales, respectively, and versus $22.8 million in pre-pandemic 2019
2022 Core (non-COVID-19) Product Sales were approximately $29.1 million versus $33.8 million in 2021. This reflects an 11% drop in the average Euro to dollar exchange rate from 1.18 in 2021 to 1.05 in 2022. On a constant currency basis, Core Product Sales would have been approximately $32.2 million versus $33.8 million in 2021, a decrease of 4.6%
Solid cash balance at the end of 2022 of approximately $23.8 million
Preliminary Unaudited Q4 2022 Results
Q4 2022 Total Revenue was approximately $9.4 million versus $10.8 million in Q4 2021, and versus $7.4 million in pre-pandemic Q4 2019
Q4 2022 Product Sales were approximately $7.6 million, which rose 18% sequentially from $6.5 million in Q3 2022, but were lower than the $9.7 million in Q4 2021, which benefitted from $1.7 million in COVID-related sales. Pre-pandemic Q4 2019 Product Sales were $6.6 million.
Core (non-COVID-19) Product Sales in Q4 2022 were approximately $7.6 million, compared to approximately $8.0 million in Q4 2021. On a constant currency basis, core Q4 2022 product sales would have been $8.5 million, a 6% increase over $8.0 million in Q4 2021
CytoSorbents targets pivotal STAR-T trial completion this year, with massive U.S. & Canadian markets in its sights
The Company expects to report fully-audited financial results for Q4 2022 and full year 2022 on Thursday, March 9, 2023, with a conference call held at 4:30PM ET. Further details for the earnings call will be provided at a later date.
CytoSorbents 2023: Eyes on the Prize
Dear Stockholders and Friends,
Before I begin, I thought it would be helpful to pause and take stock of where CytoSorbents stands today. In short, we are a NASDAQ-traded medical device company that generated total revenue of approximately $34.7M in 2022, primarily from international sales of our flagship product, CytoSorb®, a unique therapy that is E.U. approved for many life-saving applications in the multi-billion dollar markets of critical care and cardiac surgery. CytoSorb has demonstrated its clinical value through 10 years of commercialization and nearly 200,000 treatments administered across 75 countries around the world. In addition, we are working to enter the U.S. and Canadian markets for the first time with a second product, DrugSorb™-ATR, intended to reduce serious bleeding complications from cardiothoracic surgery associated with the blockbuster blood thinning drug, Brilinta® (AstraZeneca). We anticipate completing enrollment of our pivotal STAR-T registration trial this summer and if positive, intend to file for FDA and Health Canada marketing authorization of DrugSorb-ATR following study completion. We closed 2022 with a strong cash balance of $23.8M, and a grant contract backlog of approximately $11.5M, primarily to fund the development of HemoDefend-BGA for Universal Plasma, another potentially major product in the queue.
We believe our value proposition is unique and compelling, particularly in light of the major unmet medical needs that our products address globally, our high margin “razorblade” business model, the validation of our technology by our customers, strategic partners, and government funding agencies, and the potential proximity of opening and driving sales in the U.S., the largest medical device market in the world, with the potential to significantly accelerate our sales growth and profitability.
1. Opening the U.S. and Canadian Markets with DrugSorb-ATR
Antithrombotic, or “blood thinning,” medications are among the most widely prescribed drugs in the world, with millions of people on these agents to reduce the risk of heart attack and stroke. However, patients taking these medications have a higher tendency to bleed, sometimes fatally, particularly when undergoing urgent surgery, suffering an acute injury, or developing a spontaneous bleeding event such as a hemorrhagic stroke or gastrointestinal bleed.
We are in the midst of the pivotal U.S. and Canadian STAR-T (Safe and Timely Antithrombotic Removal of Ticagrelor) randomized, controlled trial, designed to support FDA and Health Canada marketing approval for DrugSorb®-ATR to reduce the risk of perioperative bleeding in patients undergoing cardiothoracic surgery potentially caused by Brilinta® (ticagrelor). DrugSorb-ATR has already received two FDA Breakthrough Device Designations, one to remove Brilinta, and the other to remove direct oral anticoagulants such as Xarelto® (Bayer, Janssen) and Eliquis® (Pfizer, BMS), highlighting the lack of effective approved or cleared therapies in the U.S. to deal with the bleeding risk in surgical patients. Based on actual data on numbers of U.S. and Canadian patients on Brilinta® needing urgent cardiothoracic surgery each year, we estimate the immediate combined total addressable market for DrugSorb-ATR in these two countries is approximately $300–350M currently, and expected to potentially double as Brilinta® becomes generic in 2024. We are already working with many of the leading cardiac surgery centers and surgeons in both the U.S. and Canada that have historically been instrumental in driving innovation in the cardiac surgery field.
In 2023, our goal is to successfully complete the STAR-T trial, finalize our data analysis, and file for U.S. FDA and Health Canada regulatory approval. We believe this would be a game changing win for our company and have been working to put the pieces in place to achieve this. Most recently, we have:
Enrolled the first third of a total of 120 patients in the STAR-T trial in November 2022, achieving the first of three major milestones in the study
Received the recommendation by the independent Data and Safety Monitoring Board (DSMB) to continue the trial without modification in December 2022, following an unblinded data review of the first 40 patients
Obtained Health Canada approval of our STAR-T protocol this month, clearing the way for us to initiate new high volume Brilinta-using centers in the country, which is expected to speed enrollment and completion of the study, while also supporting a Health Canada regulatory submission
Welcomed Dr. Irina Kulinets, PhD as Senior Vice President of Global Regulatory Affairs and the newest member of the executive management team, to lead the regulatory approval of DrugSorb-ATR for anti-thrombotic removal. Previously, she was the SVP of Regulatory Affairs, Clinical Research, and Quality at Microvention, a global leader in advanced neuroendovascular surgical products. Irina is highly experienced in all aspects of U.S. and international medical device regulatory affairs and has an outstanding track record of successful device approvals across the gamut of low to high-risk medical devices.
Patient enrollment in STAR-T continues to meet expectations. We expect to reach the second milestone of 80 patients enrolled this spring, which will trigger the next unblinded data review by the DSMB, and to complete enrollment of all 120 patients this summer, with database lock and topline data expected shortly thereafter. If positive, FDA and Health Canada regulatory submissions are planned upon the completion of the trial.
Preparing for Commercialization of DrugSorb-ATR
Meanwhile, we have developed a detailed launch and commercialization strategy for DrugSorb-ATR and are pursuing our pre-commercial development in parallel to the clinical study. A key area of focus is how DrugSorb-ATR will be funded. Based upon a number of health economic analyses done in the U.K., Germany, and here in the U.S., the value proposition of DrugSorb-ATR to reduce bleeding complications and their associated costs is dominant, even in the absence of dedicated reimbursement. With approval, we expect rapid adoption under current cardiac surgery payment bundles. That said, the STAR-T randomized, controlled trial is designed to provide valuable health economics data to support market pricing and standard reimbursement of DrugSorb-ATR from both private and government insurers such as Centers for Medicare and Medicaid Services (CMS), where we believe the cost-benefit message is very compelling.
Although we feel very comfortable with the conventional path to obtain reimbursement for DrugSorb-ATR, interestingly, there may soon be another alternative avenue to obtain CMS reimbursement that will only be available to a select group of FDA-approved Breakthrough Devices. We have previously discussed how in January 2021, CMS announced the “Medicare Coverage for Innovative Technologies (MCIT)” rule, that was designed to spur innovation in the medical device industry by offering up to four years of automatic reimbursement for approved or cleared FDA Breakthrough Devices. This would have been very relevant to DrugSorb-ATR as a Breakthrough Device, as many patients on blood thinners who require cardiothoracic surgery are in the targeted Medicare population. Unfortunately, CMS rescinded the rule in late 2021, citing needed improvements to ensure safety, efficacy, and relevance in Medicare patients. In the wake of this disappointing news, leading researchers at Stanford University, including Dr. Joshua Makower, published a paper entitled “The Need for Accelerated Medicare Coverage of Innovative Technologies: Impact on Patient Access and the Innovation Ecosystem.” In the paper, CytoSorbents and DrugSorb-ATR were selected as one of four highlighted Breakthrough technologies, among all other FDA Breakthrough Devices, that exemplified the importance of the MCIT rule to the Medicare population.
Thankfully, there is broad bipartisan support of the MCIT rule, and a modified version of it is included in the proposed CURES 2.0 Act legislation. In addition, in early 2022, CMS announced a new initiative called “Transitional Coverage for Emerging Technologies (TCET)” as a potential replacement for MCIT. TCET is supported by AdvaMed (Advanced Medical Technology Association) – the world’s largest medical technology association representing device, diagnostics, and digital technology manufacturers who issued a similar letter supporting a proposed TCET rule in August 2022.
In an article entitled, “A Vision of Medicare Coverage for New and Emerging Technologies – A Consistent Process to Foster Innovation and Promote Value” published in the October 13, 2022 edition of the Journal of the American Medical Association (JAMA), Dr. Lee Fleisher and Jonathan Blum, Centers for Medicare & Medicaid Services (CMS), said that CMS is “committed to making sure Medicare beneficiaries are able to access emerging technologies” and announced plans to develop a new expedited Medicare reimbursement coverage pathway for new and innovative medical devices that are relevant to the Medicare population.
At a Medtech Conference panel in October 2022, Tamara Syrek Jensen, director of the CMS Coverage and Analysis Group, stated that CMS plans to issue a proposed TCET policy by April 2023 and stated “We will have a proposed [rule] out by April of 2023, that is a big priority for my crew.” This was reiterated at the November 9-10, 2022 Medical Device Manufacturers Association (MDMA) meeting featuring CMS officials where in a meeting synopsis, a key takeaway was that “TCET is still a CMS priority and policy development is ongoing, expected timeline for the proposed rule is early 2023.”
In a press release and open letter to CMS Administrator Chiquita Brooks-LaSure on December 16, 2022, members of Congress urged CMS to issue a proposed rule to streamline Medicare beneficiaries’ access to innovative medical devices” and stated, “We firmly believe a successful implementation of a TCET rule should include an independent transitional coverage pathway for breakthrough devices that have been proved safe and effective by the FDA.”
Again, we believe DrugSorb-ATR, as an FDA Breakthrough Device whose target population comprises many patients 65 years of age and older in the Medicare population, could be well-suited to a proposed CMS TCET policy. We are encouraged by the continued prioritization of this program by CMS and will continue to follow the progress closely. If it becomes a reality, we will investigate this as an alternate path for CMS coverage. Meanwhile, we continue to be laser-focused on driving DrugSorb-ATR to the finish line.
2. Return to Sales Growth
CytoSorb is a European Union-approved blood purification technology used primarily to treat deadly inflammation that is the key common factor that drives illness severity and risk of death in a wide range of life-threatening conditions in the intensive care unit and cardiothoracic surgery. These are major unmet medical needs that include, for example, sepsis, trauma, shock, lung injury, liver failure, and complications of cardiothoracic surgery, where outside of antibiotics, there is little more than supportive care therapy (e.g. mechanical ventilation, dialysis, vasopressors) to treat them. The number of afflicted patients is being driven by many key trends in healthcare, particularly the aging demographic. Collectively, these conditions afflict tens of millions of people each year, typically killing 20-40% of patients despite the best medical treatment, and often severely debilitating survivors such that many are not alive or back in the ICU in the next year. Sepsis alone is estimated to be responsible for 1 in every 5 deaths worldwide. CytoSorb celebrated its 10th year of commercialization last year, accumulating nearly 200,000 human treatments and hundreds of publications to date, and helping to save many, many lives across 75 countries.
CytoSorb targets a global multi-billion dollar total addressable market each year. To date, among dozens of different applications, nearly half of all CytoSorb treatments were related to sepsis and septic shock. But other applications are expected to gain momentum, particularly:
Treatment of severe ARDS (acute respiratory distress syndrome) with new exciting survival data in 100 patients from 5 major U.S. ECMO centers, combining CytoSorb with ECMO (extracorporeal membrane oxygenation) in the setting of COVID-19 to achieve “enhanced lung rest” under FDA Emergency Use Authorization
Antithrombotic drug removal with strong adoption by cardiothoracic surgeons in Europe and the pending completion of the STAR-T randomized controlled trial
Staph aureus endocarditis, driven by the risk of infection of aging implanted prosthetic heart valves as well as the opiate crisis and use of dirty needles
CytoSorbents sells CytoSorb with a direct sales force in 15 countries, and through distributors and partners in 60 other countries. We leverage an attractive “razorblade” disposables business model, where we believe the historic blended product gross margins (mixing higher direct sales margins with lower distributor margins) for CytoSorb are in the top tier for the medical device industry and are more comparable to those seen in the biotechnology and pharmaceutical industries. We are also partnered with some of the leading providers of the blood pump machine “razors”, that include industry leaders Fresenius Medical Care (FMC), B Braun, Terumo Cardiovascular, Biocon, and Nikkiso. Late last year, CytoSorb became the “featured solution for cytokine, bilirubin, and myoglobin removal” on FMC’s blood pump platforms, helping to “expand the dimension of blood purification” beyond the approximately 10% of ICU patients who require kidney replacement therapy, to the estimated 30-40% of patients in the ICU who suffer from severe, damaging inflammation.
CytoSorb, DrugSorb-ATR, ECOS-300CY® and VetResQ® are now being manufactured at our new, certified, state-of-the-art production facility and headquarters in Princeton, New Jersey. With capacity to support up to $400M in global product sales, the new plant was designed to streamline production, drive manufacturing efficiencies, and ultimately drive down costs of goods sold, and conversely help to expand product gross margins.
We believe the fundamentals of our business and sales model are sound. However, in 2022, we experienced a perfect storm of many geopolitical, economic, post-pandemic, and company-specific factors that contributed to lower-than-expected sales and product gross margins, and higher capital expenditures and operating costs, that made it a challenging year. Some of these factors included:
Significant weakness in the acute care hospital segment worldwide. As widely reported, the toll of the protracted pandemic led to an exodus of healthcare professionals, particularly nurses, and a shortfall in revenues due to fewer hospital beds, patients, and procedures, coupled with the additional financial strain from inflation and energy costs. Many hospitals in many countries are experiencing major deficits and are facing significant financial hardship
The 11% drop of the Euro against the U.S. dollar resulting in major currency exchange headwinds as a majority of our sales are based in Euros and converted into dollars
The impact of high inflation and rapidly rising interest rates that threatened global recession, cascading down into all aspects of our business
The Russia–Ukraine war that drove both political and economic instability, and fueled skyrocketing energy costs throughout Europe
The plunge of the stock market that triggered a bear market in many sectors, impacted our stock, and iced new investments and funding
“Pandemic inflation” resulting in higher-than-expected construction costs to open our new manufacturing facility
A temporary decline in product gross margin due to the transition to our new Princeton, New Jersey manufacturing facility
The unusually competitive labor market, resulting in higher labor costs and employee turnover, and
The simultaneous launch of the two pivotal STAR-T and STAR-D trials that increased our clinical spend
Given these challenges, we still managed to achieve approximately $29.2 million in core product sales last year, that when adjusted for the 11% drop in the Euro, would have been at approximately $32.2M, within 5% of 2021 core sales of $33.8M, and greater than 30% higher than pre-pandemic product sales of $22.8M in 2019.
As we look ahead to 2023, many of the factors that we faced last year still remain, but importantly, we believe a number of these have abated, and we believe our own situation has improved significantly. This year, we expect:
Increased Visibility on the Likelihood of DrugSorb-ATR Contributing to Future Sales As we discussed above, every month that goes by, we get closer to the completion of the STAR-T randomized controlled trial, expected this year. High quality clinical efficacy and health economics data from this study, if positive, are expected to support FDA and Health Canada regulatory approval, demonstrate cost savings to the healthcare system to justify reimbursement, and support consideration for inclusion into patient care guidelines. Should these come to pass, we believe DrugSorb-ATR adoption could be swift with it becoming a significant contributor to overall product sales, capturing a portion of the estimated initial total addressable U.S. and Canadian markets of $300–350M annually
Rebound of International Product Sales Growth Core product sales for the year, when adjusted for currency exchange differences, were within 5% of that achieved in 2021. In addition, Q4 2022 core product sales were 18% sequentially higher than Q3 2022, and actually 6% higher than core product sales in Q4 2021 on a constant currency basis. We believe this was primarily related to our efforts and ability as a company to get back to selling and marketing our products in person, rather than any significant improvement of the hospital markets. Although too early to draw broad conclusions, we are encouraged by the continued market enthusiasm for our therapy and are projecting stronger product sales this year based upon numerous growth opportunities and initiatives. We expect gains from key programs such as our standalone blood pump initiative, our global marketing agreement with Fresenius Medical Care, our therapy area focus in critical care, cardiac surgery, and liver & kidney diseases, and our preferred supplier agreements with the top two largest private hospital networks in Germany, Asklepios and Helios. We also expect to launch several new sales and marketing initiatives in 2023 that we believe have the potential to drive increased sales of CytoSorb throughout the world. We will have more detail on these programs as the year progresses. Our goal is to more than double our annual ex-U.S. product sales to at least $80M in the next three years
Restoration of Product Gross Margins – In 2022, product gross margins were lower due to scheduled pauses in device production, the combined overhead of two manufacturing facilities, one-time manufacturing issues, and decreased production due to inventory and lower than expected product sales. As most of these issues were non-recurring, we believe product gross margins will return to historic ranges between 75-80% in 2023
Full CytoSorb Production from Princeton Facility In December 2022, we consolidated all of our U.S. operations to our Princeton, New Jersey headquarters. The transition was smooth and we are currently beginning full production of CytoSorb out of the new manufacturing facility
More Normalized Year-over-Year Comparisons In the past several years, our results have been skewed by two major items: large COVID-19 related product revenue from the first two years of the pandemic, and currency exchange volatility. Going forward, we expect more normalized year-over-year comparisons, with nominal COVID-19 related revenue to compare to last year, and what was a likely bottoming of the Euro in 2022
Reduced Cash Burn with Tight Control Over Expenses, and No Major Capital Expenditures In December, we strengthened our cash balance to $23.8M with a non-dilutive $5M term-loan from Bridge Bank. Meanwhile in Q4 2022, we reduced our cash burn significantly and expect our quarterly cash burn to be even lower in 2023 with achievement of budgeted sales. Many of the cost cutting efforts that we took in 2022 will become more apparent. For example, consolidation of our U.S. facilities, where we exited our prior lease at the end of 2022, will save approximately $0.8M this year. The postponement of STAR-D is expected to save $4M in 2023. And annualized savings from the 10% headcount reduction made last year will begin to be realized, particularly in Europe now that mandatory employment notice periods have expired. In addition, we do not expect any major capital expenditures this year, after completing the build out of our manufacturing facility last year
Finally, We Expect More Economic Relief for Hospitals Throughout Europe Healthcare is often cited as recession resistant, as there are always people getting sick. However, the pandemic initiated a global healthcare crisis, and eroded the infrastructure and buffer that protected hospitals as the backbone of the healthcare industry. This will likely result in a wave of hospital consolidations with weaker ones being assimilated or closed. But overall, we believe hospitals are such a core part of the economy and provide such a fundamental, basic human right that governments cannot afford, both economically and politically, to let them fail despite occasional rhetoric to the contrary. This is particularly true in most European countries where governments regulate and fund, or heavily subsidize, universal healthcare. For example, Germanypledged financial support for German hospitals to offset the cost of energy in October 2022. In the same month, France announced a 150M Euro relief fund for pediatric services, and earlier this month announced an overhaul to the French health system. At the same time, the U.K. Prime Minister called an emergency meeting in early January 2023 on how to shore up the struggling National Health System (NHS). Although not enough, it highlights the motivation of governments to address this crisis, which ultimately we believe would be good for us
Eyes on the Prize
With everything going on in the world today, it is easy to get distracted by short-term events and uninformed speculation, and to lose sight of the significant value that we have created in this Company, the expected proximity of some potentially game-changing events such as the completion of the STAR-T trial and submission for FDA and Health Canada marketing approval for DrugSorb-ATR, and the long game goal of becoming a highly profitable leader in acute care blood purification.
Despite the significant challenges that we have faced this past year and their impact on our business, we believe we have successfully navigated through some of the most challenging times in our Company’s history and believe we are in excellent shape and well-positioned to take the next step in our evolution. We believe we have been able to do so because of our strong fundamentals.
An outstanding and passionate team of nearly 200 employees worldwide
A strong network of dedicated users and healthcare professionals in 75 countries globally
A portfolio of compelling products, including CytoSorb, DrugSorb-ATR, ECOS-300CY, VetResQ, HemoDefend-BGA, and others under commercialization and development that address pressing unmet medical needs, massive markets, and are driven by major trends in healthcare
An attractive high margin “razorblade” business model
World-class industry partners
A solid balance sheet to fund our initiatives
A new manufacturing facility that is expected to drive further product gross margin expansion while supplying product for years to come, and finally,
The expected successful completion of the STAR-T trial this year, and if positive, submission for FDA and Health Canada marketing approval, potentially opening up the massive U.S. and Canadian markets – a potential watershed event for our Company
We are grateful to all of you who continue to support CytoSorbents, see the tremendous value we have created, and share our vision of success in the future. Best wishes to you and your families for a happy, healthy, and prosperous New Year!
Dr. Phillip Chan, MD, PhD Chief Executive Officer CytoSorbents Corporation
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. At the end of 2022, more than 195,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support FDA marketing approval in the United States and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, including our future sales goals and targets, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, statements about our growth opportunities, statements regarding the expected impacts of our cost cutting measures, statements about the anticipated timing for completion of our STAR-T clinical trial and regulatory submissions, 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 10, 2022, 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.
PRINCETON, N.J., Jan. 23, 2023 /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, announced that it has received regulatory approval from Health Canada allowing inclusion of Canadian sites into the pivotal Safe and Timely Antithrombotic Removal – Ticagrelor (STAR-T) randomized, controlled trial.
Health Canada Approval to Expand STAR-T Pivotal Trial to Canadian Sites Expected to Accelerate Completion of Study
Richard Whitlock, M.D., Ph.D., FRCSC, Professor of Surgery at McMaster University Medical School and the Population Health Research Institute, Canada Research Chair in Cardiovascular Surgery and Canada Principal Investigator for the STAR-T trial stated, “Canadian cardiac surgery centers are excited to join the STAR-T trial. Ticagrelor is a potent antiplatelet agent with strong evidence of clinical benefit in acute coronary syndromes and is commonly used in the Canadian system. However, managing patients on ticagrelor when they need urgent cardiac surgery is challenging because of the increased bleeding risk. STAR-T will provide definitive evidence whether the DrugSorb-ATR system can effectively remove ticagrelor during surgery and improve clinical outcomes by reducing bleeding. The Population Health Research Institute has successfully completed several of the largest randomized trials in cardiac surgery and will coordinate the STAR-T trial in several of their most successful collaborating sites in Canada. These centers will provide high volume recruitment with high quality data to help answer this important question in a timely manner. Canada is excited to begin recruitment in the pivotal STAR-T trial.”
Dr. Efthymios N. Deliargyris, Chief Medical Officer of CytoSorbents commented, “We are very pleased to receive regulatory approval to expand STAR-T into Canada and are now working closely with our partners at the Population Health Research Institute to onboard up to 7 Canadian sites as soon as possible. We anticipate these high performing sites will contribute meaningfully to study enrollment and help us execute on our stated goals of reaching the next milestones of 80 enrolled patients this Spring and full enrollment of 120 patients by Summer 2023.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove inflammatory mediators that can lead to postoperative complications, including multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support FDA and Health Canada marketing approval in the United States and Canada, respectively, for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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.
Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents’ executive management team to lead FDA marketing approval of DrugSorb®-ATR and other global regulatory priorities
PRINCETON, N.J., Jan. 17, 2023 /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, announced that it has appointed Irina B. Kulinets, Ph.D., as Senior Vice President of Global Regulatory Affairs. Dr. Kulinets brings more than 30 years of experience in regulatory affairs and clinical research of medical devices, biologics, and combination products in multiple therapeutic areas, including cardiovascular, neurovascular, oncology, orthopedics, biologic implants, and others. She will serve as a member of CytoSorbents’ executive management team and will report to Vincent Capponi, President and Chief Operating Officer of CytoSorbents.
Dr. Irina Kulinets, seasoned U.S. and international medical device regulatory expert, joins CytoSorbents
Dr. Kulinets was most recently the SVP of Regulatory Affairs, Clinical Research, and Quality at MicroVention, Inc., a division of Terumo Corporation and a global manufacturer of neuroendovascular medical devices. She has also worked for major U.S. and international life science corporations such as Johnson & Johnson, Boston Scientific, CynoSure, Anika Therapeutics, and BioSphere Medical. She has an extensive track record of international regulatory success with the approval/clearance of medical products in numerous therapeutic areas, including many Class II 510(k) and Class III Premarket Approval (PMA) medical devices. Dr. Kulinets has also provided executive strategic and operational leadership to help launch new products in the U.S., E.U., China, Japan, and many other Asian and Latin American markets.
Dr. Kulinets also has extensive experience as a regulator and worked for TUV America, Product Service – Medical Division and was appointed as a third-party FDA Inspector and 510(k) reviewer on behalf of the FDA to review, assess and approve new technologies.
Dr. Kulinets stated, “I am excited to join CytoSorbents at such an important time in the Company’s history as it nears the completion of the STAR-T pivotal trial, evaluating the ability of the DrugSorb®-ATR system to reduce the risk of perioperative bleeding in cardiothoracic surgery caused by the antithrombotic drug, Brilinta®. During my career I have led the regulatory approval of many cardiovascular and neurovascular medical devices. I believe the DrugSorb®-ATR system is a unique breakthrough therapy that can reduce bleeding complications in this setting and we will be working diligently to bring this product to help clinicians and patients as the Company’s first commercialized product in the U.S. and Canada. Meanwhile, CytoSorbents has so many other compelling technologies, such as CytoSorb® and HemoDefend®-BGA. I look forward to leveraging my U.S. and international regulatory and clinical expertise to help rapidly advance these programs around the world.”
Mr. Vincent Capponi remarked, “I am excited that Irina is joining the CytoSorbents team to lead Global Regulatory Affairs. She comes to us with a wealth of regulatory experience in medical devices, tissue products, and drugs and has received numerous FDA approvals. In addition to U.S. approvals, Irina has led international approvals in Europe, China, Japan, South Korea, Latin America, Australia, and Canada.”
Mr. Capponi continued, “First and foremost, Irina’s focus will be to help drive FDA marketing approval of DrugSorb-ATR for our initial indication of Brilinta® removal, currently under study in the STAR-T trial, and then later for direct oral anticoagulant (DOAC) removal under the STAR-D trial. Irina’s regulatory experience with cardiovascular devices aligns well with this intended use. Meanwhile, her background will no doubt be useful in expanding the DrugSorb-ATR market to hospital-wide applications where preoperative removal of antithrombotics could be helpful, as before emergency orthopedic or neurologic surgeries. At the same time, Irina is well-suited to help refine our global regulatory strategy for CytoSorb, HemoDefend-BGA (universal plasma), and other technologies currently under development. We are fortunate to have a regulatory professional of Irina’s caliber to join our team and look forward to her future success.”
Dr. Kulinets holds an M.S. in Mechanical Engineering from Belarus Polytechnic Academy, M.S. in Quality Systems from California State University, and a Ph.D. in Health Science from Trident University. She is RAPS (Regulatory Affairs Professionals Society) certified RAC (Regulatory Affairs Certification) and Board Certified in Medical Affairs. Irina also has strong ties to Academia. She served as a Faculty Director and lecturer for the Master of Science in Regulatory and Clinical Affairs Program at Northeastern University, Boston, and designed a Master of Science in Regulatory Science and Clinical Research program in Georgetown University, Washington DC. She has authored or co-authored 3 books and has multiple peer-reviewed publications in areas of her expertise.
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support FDA marketing approval in the United States and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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.
Non-dilutive debt capital at market favorable terms strengthens the balance sheet and provides additional working capital to fund key clinical and commercial initiatives
PRINCETON, N.J., Dec. 29, 2022 /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, announced that it has received $5 million in non-dilutive debt financing under the terms of the Fourth Amendment to its Amended and Restated Loan and Security Agreement with Bridge Bank, which provided for a term loan commitment of up to $15 million in aggregate, available for drawdown in tranches of $5 million each at the discretion of CytoSorbents and subject to certain financial requirements. Separately, on December 29, 2022, the two parties entered into the Fifth Amendment to the Amended and Restated Loan and Security Agreement, extending the drawdown period on the remaining $10 million loan commitment from December 31, 2022 to March 1, 2023, subject to certain requirements.
Non-dilutive debt at market favorable terms strengthens balance sheet & helps fund key clinical & commercial initiatives
The initial $5 million tranche of the term loan has no associated financial or other covenants and bears interest at the Index Rate (defined in the Loan Agreement as the greater of 3.25% or the Prime Rate as published by the Wall Street Journal on the last business date of the month immediately preceding the month in which the interest will accrue) plus 1.25%, subject to an interest rate cap of 8.00%. Subject to certain financial requirements, interest-only payments are due until January 1, 2024, followed by equal monthly payments of principal and interest until the maturity of the loan on December 1, 2025.
Kathleen P. Bloch, CPA, MBA, Chief Financial Officer of CytoSorbents, stated, “We believe that debt capital represents an attractive alternative to equity at the current time and that this non-dilutive financing strengthens our balance sheet at favorable terms, providing us with additional capital that we anticipate using for three of our major goals as we enter 2023. The first is to successfully complete our U.S. STAR-T pivotal trial and to file for potential U.S. FDA and Health Canada marketing approvals for DrugSorb-ATR™ in the second half of 2023. The second is to support a number of important commercial initiatives and to steer our Company back to product sales growth. The third goal is to ensure tight control of expenses designed to make our cash go farther. Bridge Bank has been an excellent partner for more than six years and we greatly appreciate their continuing confidence and support of our business.”
Bill Wickline, Head of Life Sciences at Bridge Bank, stated, “Over the years of working with CytoSorbents, we have witnessed the significant revenue growth of the Company and the validation of its scalable, high margin business model. We are pleased to contribute to the capital needs of CytoSorbents at this next stage of their evolution and to support their important mission of working to save lives worldwide.”
About CytoSorbents Corporation (NASDAQ: CTSO)
CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and in cardiac surgery through blood purification. Its lead product, CytoSorb®, is approved in the European Union and distributed in 75 countries worldwide. It is an extracorporeal cytokine adsorber that reduces “cytokine storm” or “cytokine release syndrome” in common critical illnesses that can lead to massive inflammation, organ failure and patient death. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorb is also used during and after cardiothoracic surgery to remove antithrombotic drugs and inflammatory mediators that can lead to postoperative complications, including severe bleeding and multiple organ failure. As of September 30, 2022, more than 186,000 CytoSorb devices have been used cumulatively. CytoSorb was originally launched in the European Union under CE mark as the first cytokine adsorber. Additional CE mark extensions were granted for bilirubin and myoglobin removal in clinical conditions such as liver disease and trauma, respectively, and for ticagrelor and rivaroxaban removal in cardiothoracic surgery procedures. CytoSorb has also received FDA Emergency Use Authorization in the United States for use in adult critically ill COVID-19 patients with impending or confirmed respiratory failure. The DrugSorb™-ATR antithrombotic removal system, based on the same polymer technology as CytoSorb, also received two FDA Breakthrough Device Designations, one for the removal of ticagrelor and another for the removal of the direct oral anticoagulants (DOAC) apixaban and rivaroxaban in a cardiopulmonary bypass circuit during urgent cardiothoracic procedures. The Company is currently conducting the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 120 patients at approximately 30 centers in U.S. and Canada to evaluate whether intraoperative use of DrugSorb-ATR can reduce the perioperative risk of bleeding in patients receiving ticagrelor and undergoing cardiothoracic surgery. This pivotal study is intended to support FDA marketing approval in the United States and Health Canada marketing approval for DrugSorb-ATR in this application.
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 approximately $48 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.
About Bridge Bank
Bridge Bank, a division of Western Alliance Bank, Member FDIC, delivers relationship banking that puts clients at the center of everything. Founded in 2001 in Silicon Valley, Bridge Bank offers a full spectrum of tailored business banking solutions throughout the Bay Area and has specialized expertise, focused on life sciences and technology and innovation companies, at every stage in their life cycle, through its offices in major tech hubs across the country. Bridge Bank also serves the private equity and venture capital communities and provides business escrow services. As part of $65 billion Western Alliance Bancorporation — ranked #1 top-performing large bank with assets greater than $50 billion in 2021 by both American Banker and Bank Director — Bridge Bank has the reach, resources and deep industry knowledge that make a difference for customers. For more information, visit Bridge Bank.
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, future targets and outlooks for our business, expectations regarding the future impacts of COVID-19 or the ongoing conflict between Russia and the Ukraine, 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 10, 2022, 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 is a leader in critical care immunotherapy. The company is committed to serving the best interests of our patients and their families, our customers, our employees, and our shareholders.
CytoSorb® is a unique blood purification therapy.The product is currently approved in the European Union and distributed in 58 countries around the world
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U.S. FDA Grants CytoSorb® Emergency Use Authorization for Use in Patients with COVID-19 Infection. Call 848-667-8990 to Order.
