Good Sport
1 month ago
CytoSorbents Expands Global Footprint with Opening of New Regional Sales Subsidiary in Dubai
Mon, January 6, 2025 at 7:00 AM EST 6 min read
PRINCETON, N.J., Jan. 06, 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 the opening of a new regional sales subsidiary in Dubai, United Arab Emirates (UAE). The new subsidiary provides a gateway into the Middle East and Africa - regions with increasing demand for advanced medical technologies and high-quality therapies in critical care and cardiac surgery.
“Establishing a central commercial presence in Dubai represents a major milestone in our regional expansion strategy, reflecting our commitment to accelerating sales growth in this critical international market," said Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “Our business in the region has been growing over the past several years, and this new subsidiary is expected to be a key international sales center that will help us strengthen and better support existing partnerships, foster closer on-the-ground interactions with customers to augment sales, forge new alliances, and drive long-term value creation.”
CytoSorbents has established its new commercial office in the heart of Dubai’s Science Park, a commercial, healthcare-focused, “free zone” with special economic benefits, that will serve as a hub for regional sales and business development, training, customer support, and regulatory affairs. The UAE is the regional home of many multinational medical device companies and was selected because of its strategic location, strong economy and favorable tax policies, advanced infrastructure, well-developed healthcare system, and supportive economic and regulatory policies.
Dr. Chan continued, “The Middle East and Africa continue to experience rapid growth in the demand for cutting-edge healthcare technologies such as CytoSorb® and we are thrilled to be at the forefront of this transformation. We look forward to working closely with healthcare providers, regulators, and key stakeholders to establish CytoSorbents as a leader in critical care and cardiac surgery across this dynamic region.”
https://finance.yahoo.com/news/cytosorbents-expands-global-footprint-opening-120000074.html
Paulness
5 months ago
NEWS -- CytoSorbents Submits DrugSorb-ATR Marketing Application to U.S. FDA to Reduce the Severity of Bleeding in Heart Bypass Surgery Patients on the Blood Thinner Ticagrelor and Provides Business Update
The De Novo medical device application for DrugSorb™-ATR is eligible for FDA priority review as an FDA Breakthrough Designated Device for this indicationThe Health Canada Medical Device License application is ready for submission, pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near futureExpecting FDA and Health Canada decisions in 2025PRINCETON, N.J., Oct. 01, 2024 (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 the submission of its DrugSorb™-ATR medical device De Novo marketing application to the U.S. Food and Drug Administration (FDA) on September 27, 2024, to reduce the severity of perioperative bleeding in patients on ticagrelor (Brilinta®, AstraZeneca) undergoing coronary artery bypass graft (CABG) surgery. The FDA has previously granted Breakthrough Device Designation to DrugSorb-ATR to address this major unmet medical need, making it eligible for priority review.
“The DrugSorb-ATR De Novo submission to FDA is the culmination of multiple years of significant clinical, regulatory, and manufacturing accomplishments company-wide, centered on the execution and data analysis from the U.S. and Canadian pivotal STAR-T randomized controlled trial and the product development of DrugSorb-ATR,” stated Dr. Phillip Chan, Chief Executive Officer of CytoSorbents. “We are very proud of our dedicated CytoSorbents team and external clinicians, collaborators, and consultants who helped to achieve this major milestone. We look forward to interactions with FDA and the timely review of our application. Meanwhile, we have also completed our DrugSorb-ATR Health Canada Medical Device License (MDL) application, which will be submitted with the expected near-term receipt of MDSAP certification.”
Ticagrelor is a blood thinning drug frequently administered in the hospital to patients suffering from a heart attack. If patients are not eligible for a coronary stent, they will often require CABG surgery to restore blood flow to heart muscle. Current guidelines recommend the delay of surgery by three to five days to allow “washout” or natural elimination of the drug to reduce the high risk of serious and potentially fatal perioperative bleeding from the use of the blood thinner. The 140-patient North American pivotal STAR-T randomized, double-blind, sham-controlled trial evaluated the safety and efficacy of DrugSorb-ATR in patients undergoing urgent CABG surgery on ticagrelor to remove the drug and reduce the severity of perioperative bleeding complications compared with patients operated without the device. These safety and efficacy data from STAR-T form the basis of our marketing approval submissions.
About the U.S. and Canadian Regulatory Pathways
The U.S. FDA De Novo process for medical devices provides a marketing pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. Following application acceptance by FDA, De Novo submissions enter the substantive review phase where FDA Breakthrough Device designation and an associated interactive priority review, called “sprint discussions,” can accelerate the process.
The Health Canada Medical Device License (MDL) authorizes manufacturers to import or sell Class II, III, and IV medical devices in Canada. The license ensures that these devices meet the necessary safety, quality, and efficacy standards as per the Medical Devices Regulations. MDL requires MDSAP certification, which the Company expects to receive shortly, at which point it will file its MDL application.
Final regulatory decisions on DrugSorb-ATR are expected from FDA and Health Canada in 2025. DrugSorb-ATR is not yet approved or cleared in the U.S. or Canada.
Preliminary, Selected Third Quarter 2024 Financial Results and Business Update
We estimate that our Q3 2024 Product Sales (excluding grant income) will be in the range of approximately $8.3 million to $8.5 million, representing growth of 7% to 10%, versus $7.8 million in Q3 2023.A planned temporary slowdown in production to rebalance inventory levels coupled with a short-term manufacturing issue resulted in a significantly lower number of CytoSorb devices produced in the quarter. Because of this, we estimate that our product gross margins for Q3 2024 will be in the range of approximately 50% - 60%, compared to 71% in Q3 2023. The Company believes the short-term manufacturing issue has been resolved and expects a return to more normalized production levels and product gross margins in Q4 2024. The Company continues to have sufficient inventory to meet demand.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 remove ticagrelor and reduce the severity of perioperative bleeding in CABG patients on the drug. The Company expects to submit its completed Health Canada Medical Device License (MDL) application, pending the expected receipt of Medical Device Single Audit Program (MDSAP) certification in the near future. DrugSorb-ATR is not yet approved or cleared in the United States and Canada.
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 https://www.cytosorbents.com 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.
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
mailto://pmariani@cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA
Investor Relations, ICR-Westwicke
(443) 450-4191
mailto://ir@cytosorbents.com
Paulness
7 months ago
NEWS -- CytoSorbents Unveils Newly Redesigned, Unified Company and Product Website
“Working to Save Lives Together” Theme Highlights Two Decades of Successful Collaboration with the International Medical and Research Communities to Help Patients Survive Life-Threatening Illnesses
PRINCETON, N.J., July 29, 2024 (GLOBE NEWSWIRE) -- CytoSorbents Corporation (NASDAQ: CTSO), a leader in the treatment of deadly conditions in the intensive care unit and cardiac surgery using blood purification via its proprietary polymer adsorption technology, is proud to announce the launch of its newly redesigned and consolidated website at https://www.cytosorbents.com. The theme of “Working to Save Lives Together” highlights two decades of successful collaboration with the international medical and research communities to continuously refine how our therapies, such as CytoSorb®, ECOS-300CY®, and VetResQ® are being used to help patients survive life-threatening illnesses.
A Modern, Unified Online Presence
The new website, built from the ground up, unifies our corporate and product information into a single, cohesive and comprehensive information hub for healthcare professionals, investors, and other key stakeholders. Visitors will find a streamlined modern design, intuitive navigation, and extensive content on our company, technology, therapies, pipeline that includes DrugSorb™-ATR and HemoDefend-BGA™, clinical studies, investor conferences, and much more.
Key Features of the New Website:
User-Friendly Layout and Intuitive Navigation - with easy access to essential information and optimized for both desktop and mobile browsing.Enhanced Easy-to-Understand Content - tailored for different stakeholders.News and Updates - dedicated to the latest developments and events.Comprehensive and Searchable Resource Library - from a collection of 1,000+ peer-reviewed publications, poster presentations, abstracts, white papers and case reports highlighting the use of our therapies in many applications.Introduction to Our Experts - who are there to provide guidance and support.Voices Around the World - with insights and feedback from users worldwide.Dedicated Investor Relations site - for quick access to investor materials.Improved Contact Forms - facilitating faster communications and interactions.Dr. Christian Steiner, Executive Vice President of Sales and Marketing of CytoSorbents, stated, “We are grateful to all of the pioneering physicians, nurses, perfusionists, researchers, and other healthcare professionals who use our therapies in daily clinical practice or who have contributed to the many studies and the more than 1,000 references that can be found in our CytoSorb literature database on our new website. Your dedication and insights have been instrumental in shaping the success of our technology and improving patient outcomes worldwide. Likewise, as we have in the past, it is our commitment to you to be a trusted and dependable partner who will be there to support you whenever you need us.”
Dr. Steiner added, “We invite everyone to explore the new CytoSorbents website which is a celebration of all that we have accomplished together, and to learn how CytoSorbents is helping to save lives and ‘Expand the Dimension of Blood Purification™’ with our products around the world.”
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 March 31, 2024, more than 237,000 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. CytoSorb is not yet approved in the United States.
The DrugSorb™-ATR antithrombotic removal system, an investigational device based on the same polymer technology as CytoSorb, 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. The Company has completed the FDA-approved, randomized, controlled STAR-T (Safe and Timely Antithrombotic Removal-Ticagrelor) study of 140 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 $50 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™, ContrastSorb, and others. For more information, please visit the Company’s websites at https://www.cytosorbents.com and https://www.cytosorb.com 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, 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 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.
Please Click to Follow Us on Facebook and X
U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
mailto://kbloch@cytosorbents.com
Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
mailto://ir@cytosorbents.com
Level up your trading with our powerful tools and real-time insights all in one place.
fung_derf
6 months ago
Monksdream
8 months ago
Hot Features
Premium
