CytoSorbents Announces the Launch and Immediate Availability of the PuriFi™ Blood Pump in the European Union
CytoSorbents (NASDAQ: CTSO) has launched the PuriFi™ blood pump in the European Union following approval under the E.U. Medical Device Regulation (MDR). This peristaltic blood pump features innovative elements such as pre-assembled blood line kits, auto-priming, an auto-leveling bubble catcher, an intuitive touchscreen interface, optional blood warming, and a rapid 10-minute set-up time. These advancements facilitate the use of CytoSorbents’ CytoSorb® blood purification cartridge for critically ill and cardiac surgery patients. The launch, a result of a 2-year development program with Medica Group, aims to meet growing demand for efficient blood purification solutions.
- Immediate availability of PuriFi pump in the E.U. post MDR approval.
- Innovative features like pre-assembled kits, auto-priming, and intuitive interface.
- Expected increase in demand and sales for CytoSorb blood purification cartridges.
- Potential for adoption in various medical fields across different geographies.
- Launch backed by extensive beta testing and comprehensive sales prep.
- Partnership with Medica Group ensures availability and supply chain stability.
- Risk of reliance on new product adoption to drive sales.
- Potential competition and differentiation challenges in the hemoperfusion market.
Insights
The launch of the PuriFi™ blood pump signifies a substantial development for CytoSorbents Corporation. This product introduction is particularly relevant due to its immediate availability in the European Union following regulatory approval under the E.U. Medical Device Regulation (MDR).
Key innovations in the PuriFi pump, such as the pre-assembled blood line kit and rapid set-up time, enhance its usability. These features could lead to increased adoption among healthcare providers, potentially resulting in
Given the stringent MDR requirements, CytoSorbents' ability to secure approval and launch the PuriFi pump suggests a high degree of regulatory compliance and quality. This could bolster investor confidence in both the company’s operational capabilities and its product pipeline.
From a market perspective, the PuriFi pump's introduction is well-timed as demand for advanced blood purification solutions is growing. This could lead to strong and sustained sales, enhancing CytoSorbents' market position and driving long-term growth.
In terms of investment impact, the PuriFi launch represents a positive development, signaling potential revenue growth and market expansion.
This product launch taps into a important market need for faster and more efficient blood purification technologies. The PuriFi™ pump’s unique features, such as auto-priming and an intuitive user interface, set it apart from other hemoperfusion devices, potentially giving CytoSorbents a competitive edge.
For retail investors, it's essential to note that the PuriFi pump could significantly boost sales of the CytoSorb® cartridge as it simplifies and expedites the treatment process. The
The partnership with Medica Group and the extensive preparatory work, including beta testing and technical training, underline strategic execution and preparedness, which are positive indicators of future success.
However, investors should also consider potential challenges such as market competition and the need for continuous innovation to maintain market leadership. The long-term success will depend on how well CytoSorbents can continue to innovate and meet evolving market demands.
Overall, this launch looks promising for CytoSorbents, with potential for both immediate and enduring positive impacts on the company’s financial health.
By enabling more rapid and easy treatment, PuriFi is expected to increase the demand and sales of CytoSorbents’ leading CytoSorb® blood purification cartridge for critically ill patients in the European Union (E.U.)
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.
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
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.
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U.S. Company Contact:
Kathleen Bloch, CFO
305 College Road East
Princeton, NJ 08540
+1 (732) 398-5429
kbloch@cytosorbents.com
Investor Relations Contact:
Eric Ribner
LifeSci Advisors, LLC
250 W 55th St, #3401
New York, NY 10019
+1 (646) 751-4363
ir@cytosorbents.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/cc9c138d-416e-49b6-81d0-88b90befa6e4
FAQ
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