Latest news with #DrugSorb-ATR
Associated Press
14-04-2025
- Business
- Associated Press
CytoSorbents Appoints Thomas Shannon as Vice President of Marketing for North America
PRINCETON, N.J., April 14, 2025 /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, today announced the appointment of Thomas Shannon as Vice President of Marketing for North America. With anticipated marketing approval, Mr. Shannon will lead the marketing strategy and execution for DrugSorb™-ATR in the U.S. and Canada. 'We are thrilled to welcome Tom to the CytoSorbents team as we prepare for the potential launch of DrugSorb-ATR in the U.S. and Canada,' stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. 'Tom brings outstanding leadership and a proven track record of commercial success in introducing groundbreaking cardiovascular and critical care technologies to stakeholders across the U.S. and globally. His expertise will be invaluable in driving the successful commercialization of DrugSorb-ATR, as we work to reduce the risk of serious perioperative bleeding in patients undergoing coronary artery bypass graft (CABG) surgery while on the blood thinner Brilinta®.' Mr. Shannon is a global strategic marketing executive who brings over 25 years of experience commercializing life-saving technologies for high growth cardiovascular surgery and extracorporeal therapy-focused medical device companies. Previously, Mr. Shannon served as Vice President of Sales and Marketing at Genesee Biomedical, an innovator in cardiac heart valve repair, and Director of Marketing at Fresenius Medical Care, where he established their Heart and Lung Acute Care division and launched the first ever FDA-cleared long-term extracorporeal membrane oxygenation (ECMO) life support device. At Getinge (formerly Maquet), Mr. Shannon commercialized 20 new products across the Americas, including the successful launch of the market-leading CardioHelp® ECMO platform, managed a $450 million cardiac and vascular surgery portfolio, and consistently delivered double digit growth year-over-year. During his tenure at Medtronic, Tom led initiatives in sales, therapy development and marketing, and product launches including anti-coagulation monitoring devices, blood pumps, and autotransfusion technologies. Earlier in his career, Tom spent 17 years as a healthcare practitioner, including 12 years as a cardiovascular perfusionist, supporting complex cardiothoracic surgeries. 'I have had the good fortune to help lead the launch and commercialization of some major innovations in critical care and cardiac surgery during my career,' commented Tom Shannon. 'Of them all, I am impressed by the straight-forward and compelling value proposition that DrugSorb-ATR can represent for patients, surgeons, and hospital systems. In particular, intraoperative and postoperative bleeding in CABG patients due to blood thinning medications such as Brilinta® is a major problem for cardiac surgeons that only continues to get worse. As a former cardiovascular perfusionist, I cannot overstate the importance of intraoperative stability and low bleeding to the cardiovascular surgeon and surgical team. They want a smooth operation without complications. I am excited to have this new opportunity to collaborate closely with the dedicated and passionate team at CytoSorbents to ensure that patients have access to this innovative breakthrough technology.' DrugSorb-ATR is a U.S. FDA Breakthrough medical device which we believe is uniquely positioned to address the critical issue of perioperative bleeding caused by blood thinners like Brilinta® in patients undergoing CABG surgery. The Company's marketing applications for DrugSorb-ATR continue to be in substantive and interactive review with the U.S. FDA and Health Canada, and the Company continues to expect regulatory decisions from both agencies in 2025. Until then, DrugSorb-ATR is an investigational device that is neither cleared nor approved in the United States and Canada, respectively. Brilinta® and Cardiohelp® are registered trademarks of AstraZeneca and Getinge, respectively. About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood 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. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, continuous renal replacement therapy or CRRT, extracorporeal membrane oxygenation or ECMO, and heart-lung machines), where blood is repeatedly recirculated outside the body, through our cartridges where toxic substances are removed, and then back into the body. CytoSorbents' technologies are used in a number of broad applications. Specifically, two important applications are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding, and 2) the removal of inflammatory agents and toxins in common critical illnesses that can lead to massive inflammation, organ failure and patient death. The breadth of these critical illnesses includes, for example, sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis as well as the removal of liver toxins that accumulate in acute liver dysfunction or failure, and the removal of myoglobin in severe rhabdomyolysis that can otherwise lead to renal failure. In these diseases, the risk of death can be extremely high, and there are few, if any, effective treatments. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in over 70 countries worldwide, with more than a quarter million devices used cumulatively to date. 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. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has 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. In September 2024, the Company submitted a De Novo medical device application to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its MDSAP certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. 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™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. 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, representations and contentions, and the outcome of our regulatory submissions, 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, our restructuring of our direct sales team and strategy in Germany and the risks discussed in our Annual Report on Form 10-K, filed with the SEC on March 31, 2025, 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 X U.S. Company Contact: Peter J. Mariani, Chief Financial Officer 305 College Road East Princeton, NJ 08540 [email protected] Investor Relations Contact: Aman Patel, CFA & Adanna G. Alexander, PhD ICR Healthcare [email protected] View original content to download multimedia: SOURCE Cytosorbents Corp
Yahoo
01-04-2025
- Business
- Yahoo
CytoSorbents Corp (CTSO) Q4 2024 Earnings Call Highlights: Strong Revenue Growth and Strategic ...
Fourth Quarter Product Revenue: $9.2 million, a 25% increase compared to the prior year. Full Year Product Revenue: $35.6 million, representing 15% year-over-year growth. Core Product Sales: $35.6 million in 2024. Gross Margin: 71% for both the quarter and the full year. Operating Expenses: Decreased 30% year-over-year to $10.2 million in Q4. Operating Loss: Improved 61% year-over-year to $3.7 million in Q4. Adjusted EBITDA Loss: Improved by 70% to $2.4 million in Q4. Net Loss: $7.5 million or $0.14 per share in Q4. Adjusted Net Loss: Improved to $1.7 million or $0.03 per share in Q4. Cash and Cash Equivalents: $9.8 million as of December 31, 2024; pro forma cash position approximately $17 million. Debt Facility: $20 million with Avenue Capital Group, consummated in June 2024. Shareholder Rights Offering: Raised total net proceeds of $7.3 million. Warning! GuruFocus has detected 5 Warning Signs with CTSO. Release Date: March 31, 2025 For the complete transcript of the earnings call, please refer to the full earnings call transcript. CytoSorbents Corp (NASDAQ:CTSO) reported a 25% increase in fourth-quarter product revenue, reaching $9.2 million, and a 15% year-over-year growth in full-year product revenue for 2024. The company's core product, CytoSorb, has been utilized in over 270,000 devices across more than 70 countries, driving significant international sales. CytoSorbents Corp (NASDAQ:CTSO) maintained a healthy product gross margin of 71%, reflecting the strength of their business model. The company strengthened its financial position with a $20 million debt facility and a successful shareholder rights offering, increasing liquidity by $12.3 million. CytoSorbents Corp (NASDAQ:CTSO) is actively preparing for the potential commercial launch of DrugSorb-ATR in the US and Canada, with a total addressable market opportunity of $300 million, potentially growing to over a billion dollars. CytoSorbents Corp (NASDAQ:CTSO) experienced flat growth in direct sales in Germany, which is their largest market, for the second consecutive year. The company identified misstatements in inventory and non-cash stock compensation, leading to a restatement of their 2023 and 2024 financial reports. There is a material weakness in CytoSorbents Corp (NASDAQ:CTSO)'s internal controls over financial reporting, which they aim to remediate during the current calendar year. The reorganization of the sales team in Germany is expected to cause short-term disruption, resulting in modestly lower product sales in the first quarter of 2025. CytoSorbents Corp (NASDAQ:CTSO) anticipates that the DrugSorb-ATR business will not be immediately profitable upon launch due to initial investments in commercial capabilities. Q: Have you seen any impacts from the new US administration on the regulatory process for DrugSorb, and what gives you confidence in clearance by year-end? A: Although there have been cuts to HHS, including the FDA, these cuts are not targeting review personnel. This gives us confidence in the timeline for clearance by year-end. - Phillip Chan, CEO Q: What are the key things you'll be looking for during the controlled launch of DrugSorb before a full commercial launch? A: We aim to learn how to get into hospitals, get onto their lists, and get ordered. We want to understand how quickly we can get through VA committees and how surgeons integrate the product into their usage patterns. This will help us titrate the launch effectively. - Peter Mariani, CFO Q: What kind of commercial organization size might you need to fully commercialize in the US? A: We anticipate a sales force of 15 to 25, potentially larger over time. We aim to establish sticky accounts early and grow usage across multiple surgeons. We may also use distributors in certain regions. - Peter Mariani, CFO Q: What were the main growth drivers for sales outside Germany, and why did they not apply to the German market? A: Growth outside Germany was driven by strong adoption in specific applications and successful reimbursement strategies. In Germany, issues like post-COVID challenges and hospital reforms have impacted growth. We are reorganizing our sales approach to address these challenges. - Phillip Chan, CEO Q: What metrics do you need to hit to reach near cash break-even in the core business by the end of the year? A: We need continued revenue growth and maintaining 70%+ gross margins. Driving efficiencies and reducing cash burn are also crucial to achieving cash flow break-even in the core business, allowing investment in DrugSorb's launch. - Peter Mariani, CFO For the complete transcript of the earnings call, please refer to the full earnings call transcript. This article first appeared on GuruFocus.
Yahoo
04-03-2025
- Business
- Yahoo
CytoSorbents Postpones Earnings Release to Allow More Time to Complete Annual Audit Following the Passing of Corporate Controller
The Company reaffirms previously provided preliminary financial results for the quarter and full year ended December 31, 2024, and continues to expect regulatory decisions on DrugSorb™-ATR marketing applications in 2025 PRINCETON, N.J., March 04, 2025 (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, today announced that it is postponing its previously announced earnings call scheduled for March 6, 2025 to allow more time to complete the annual financial audit following the recent passing of the Company's Vice President and Corporate Controller from natural causes. The Company now expects to report fourth quarter and full year 2024 financial results after the market close on Tuesday, March 25, 2025. Management will host a live conference call, presentation webcast, and a question-and-answer session starting at 4:30PM ET the same day, and expects to file its Form 10-K in that timeframe. The delay follows the unexpected passing of the Company's Vice President and Corporate Controller, James E. Cason, Jr. Mr. Cason had a long and successful career and worked with the Company for the past 10 years. 'We are deeply saddened by the loss of our dear colleague, Jim,' said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. 'Over the past decade, Jim was an exceptional leader, talented colleague, and trusted friend who contributed greatly to the growth and success of CytoSorbents, and was dedicated to our mission to help save lives around the world. We extend our deepest condolences to his family and many friends.' Dr. Chan continued, 'Though we will miss Jim, we are fortunate to have a strong financial team whose immediate focus has been to support one another and to ensure an effective transition of Jim's important responsibilities during this difficult time. We believe this extension of time is a prudent decision to ensure the thorough completion of the year-end audit.' The Company reiterates previously provided preliminary expectations, including: Fourth quarter product revenue (excluding grant income) in the range of $9.0 million to $9.2 million, representing 22% to 25% growth versus $7.35 million in the fourth quarter of 2023 Full-year product revenue (excluding grant income) in the range of $35.4 million to $35.6 million, representing approximately 14% growth versus $31.1 million for the full-year 2023 Fourth quarter product gross margin of approximately 70%, compared to 61% in the prior quarter and 72% in the fourth quarter of 2023 DrugSorb-ATR Marketing ApplicationsThe Company's marketing applications for DrugSorb-ATR continue to be in substantive and interactive review with the U.S. FDA and Health Canada, and the Company continues to expect regulatory decisions from both agencies in 2025. Estimated Pro-Forma December 31, 2024, Cash Balance and Q4 2024 Cash BurnAs previously disclosed, the Company has raised a total of $7.85 million of aggregate gross proceeds in the first quarter of 2025 inclusive of $6.25 million from the January 10, 2025, Rights Offering, and $1.6 million from the related February 24, 2025, exercise of Series A Right Warrants. Proceeds net of related fees is approximately $7.3 million. The pro forma balance of cash, cash equivalents, and restricted cash on December 31, 2024, after giving effect to the Rights Offering and the exercise of Series A Right Warrants as if they had occurred on December 31, 2024, would have been approximately $17.0 million, including unrestricted cash of approximately $15.5 million. These amounts reflect $7.3 million in net proceeds raised and net cash used in the fourth quarter of 2024 of approximately $2.5 million. The estimated financial results, proforma cash balance and estimate of cash utilized in the fourth quarter remain preliminary and unaudited. Conference Call and Webcast Details:Date: Tuesday, March 25, 2025Time: 4:30 PM ETNorth American toll-free: 1-800-836-8184International toll: 1-646-357-8785Live webcast link: It is recommended that participants dial in approximately 10 minutes prior to the start of the call. An archived recording of the conference call will be available under the Investor Relations section of the Company's website at About CytoSorbents Corporation (NASDAQ: CTSO) CytoSorbents Corporation is a leader in the treatment of life-threatening conditions in the intensive care unit and cardiac surgery through blood purification. CytoSorbents' proprietary blood 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. Cartridges filled with these beads can be used with standard blood pumps already in the hospital (e.g. dialysis, ECMO, heart-lung machines). CytoSorbents' technologies are used in a number of broad applications. Two important ones are 1) the removal of blood thinners during and after cardiothoracic surgery to reduce the risk of severe bleeding and 2) the removal of inflammatory agents in common critical illnesses such as sepsis, burn injury, trauma, lung injury, liver failure, cytokine release syndrome, and pancreatitis 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. CytoSorbents' lead product, CytoSorb®, is approved in the European Union and distributed in 76 countries worldwide, with more than 250,000 devices used cumulatively to date. 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. CytoSorb is not yet approved or cleared in the United States. In the U.S. and Canada, CytoSorbents is developing the DrugSorb™-ATR antithrombotic removal system, an investigational device based on an equivalent polymer technology to CytoSorb, to reduce the severity of perioperative bleeding in high-risk surgery due to blood thinning drugs. It has 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. In September 2024, the Company submitted a De Novo medical device application to the U.S. FDA requesting marketing approval to reduce the severity of perioperative bleeding in CABG patients on the antithrombotic drug ticagrelor, which was accepted for substantive review in October 2024. In November 2024, the Company received its Medical Device Single Audit Program (MDSAP) certification and submitted its Medical Device License (MDL) application to Health Canada. DrugSorb-ATR is not yet granted or approved in the United States and Canada, respectively. 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™, ContrastSorb, and others. For more information, please visit the Company's website at or follow us on Facebook and X. 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, representations and contentions, and the outcome of our regulatory submissions, 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 14, 2024, 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. U.S. Company Contact:Peter J. Mariani, Chief Financial Officer305 College Road EastPrinceton, NJ 08540pmariani@ Investor Relations Contact:Aman Patel, CFA & Adanna G. Alexander, PhDICR Healthcare ir@ in to access your portfolio
