Full Press Release Details
PRINCETON, N.J., June 13, 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 via its proprietary polymer adsorption technology, announces the launch and immediate availability of its PuriFi™ hemoperfusion machine in the E.U., following approval and certification under the E.U. Medical Device Regulation (MDR).
The PuriFi peristaltic blood pump features a number of differentiating innovations that separate it from other standard hemoperfusion pumps including a pre-assembled adult and pediatric blood line kit, auto-priming, an auto-leveling bubble catcher, an intuitive touchscreen graphical user interface with a step-by-step user-friendly set-up guide, optional blood warming, and a rapid 10-minute set-up time. Together, these unique features enable an easy and rapid way to administer CytoSorbents’ leading CytoSorb® blood purification cartridge for critically ill and cardiac surgery patients. For more information, please visit www.cytosorbents-purifi.com
Mr. Vincent Capponi, President and Chief Operating Officer of CytoSorbents said: “We are excited to launch the PuriFi pump, the result of a 2-year development program with our original equipment manufacturer (OEM) partner, the Medica Group. Innovation is a key growth driver for us and the feature-rich, easy-to-use PuriFi pump exemplifies this. During the past year, we have been diligently preparing for this product launch, including extensive beta testing of the pumps, sales and technical training for both direct sales teams and select distributors, developing new marketing collateral, establishing a hardware and service maintenance program, prioritizing key sales targets, and working with Medica to ensure availability of machines and bloodlines under MDR. We are pleased to finally begin commercialization.”
Ms. Bettina Sabisch, Vice President of International Distributor Sales stated, “PuriFi represents a significant advancement in our product portfolio. Its introduction comes at a critical time as the end-user demand for more efficient and effective blood purification solutions is growing in the E.U. and worldwide. In particular, many of our distributor partners are eager to fill this need with Purifi and CytoSorb. The potential for adoption across various medical fields and geographies is expected to drive sales of CytoSorb and PuriFi, substantially increase our market footprint, while helping to improve patient outcomes and to reinforce our leadership in changing medicine through advanced technology.”
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.
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.
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.
U.S. Company Contact:
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Investor Relations Contact:
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A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cc9c138d-416e-49b6-81d0-88b90befa6e4
CytoSorbents PuriFi Hemoperfusion Pump
CytoSorbents Launches PuriFi Hemoperfusion Pump in the European Union