CytoSorbents Expands Global Footprint With Opening of New Regional Sales Subsidiary in Dubai
CytoSorbents Expands Global Footprint With Opening of New Regional Sales Subsidiary in Dubai
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.
新澤西州普林斯頓,2025年1月6日(環球新聞) -- Cytosorbents公司 (納斯達克:CTSO),在重症監護和心臟手術中使用血液淨化治療危及生命病症的領導者,今天宣佈在阿聯酋迪拜開設新的區域銷售子公司。新子公司爲進入中東和非洲市場提供了通道 - 這些地區對先進醫療科技和高質量危重護理及心臟手術療法的需求日益增加。
"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."
「在迪拜建立中央商業存在標誌着我們區域擴展策略的一個重要里程碑,反映了我們加速在這個關鍵國際市場銷售增長的承諾,」Cytosorbents首席執行官PHILLIP Chan博士表示。「我們在該地區的業務在過去幾年中一直在增長,預計這家新子公司將成爲一個關鍵的國際銷售中心,幫助我們鞏固並更好地支持現有合作伙伴關係,促進與客戶的緊密互動以增加銷售,建立新聯盟,並推動長期價值創造。」
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.
Cytosorbents已在迪拜科學園的中心建立了新的商業辦公室,這是一個關注商業和醫療保健的「自由區」,擁有特殊的經濟利益,將作爲區域銷售和業務發展、培訓、客戶支持和法規事務的中心。阿聯酋是許多跨國醫療器械公司的區域總部,因其戰略位置、強大的經濟實力和有利的稅收政策、先進的基礎設施、發達的醫療系統和支持性的經濟和監管政策而被選中。
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."
陳博士繼續說道:"中東和非洲在對前沿醫療科技(如Cytosorb)的需求上持續快速增長,我們很高興能夠處於這一轉型的前沿。我們期待與醫療提供者、監管機構和關鍵利益相關者密切合作,以確立Cytosorbents在該活躍地區的重症監護和心臟手術領域的領導地位。"
About CytoSorbents Corporation (NASDAQ: CTSO)
關於Cytosorbents公司(納斯達克代碼: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. 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 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公司是重症監護室和心臟外科領域治療危急狀況的領導者,採用血液淨化技術。Cytosorbents的專有血液淨化技術基於生物相容性、高孔隙率的聚合物顆粒,能夠通過孔捕獲和表面吸附有效去除血液和其他體液中的毒素。這些顆粒填充的濾器可以與醫院中已有的標準血液泵(例如透析、ECMO、心肺機)一起使用。Cytosorbents的技術已應用於多個廣泛的領域。具體而言,兩個重要應用是1)在心胸外科手術期間及之後去除抗凝血藥物,以減少嚴重出血的風險,以及2)去除常見重症疾病(如膿毒症、燒傷、創傷、肺損傷、肝衰竭、細胞因數釋放綜合症和胰腺炎)中的炎症介質,這些疾病可導致大規模炎症、臟器衰竭和病人死亡。在這些疾病中,死亡的風險非常高,且幾乎沒有有效的治療方法。
CytoSorbents' lead product, CytoSorb, is approved in the European Union and distributed in 76 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, to reduce pro-inflammatory cytokine levels. CytoSorb is not yet approved in the United States.
Cytosorbents的領先產品Cytosorb已在歐盟獲得批准,並在全球76個國家分銷,至今累計使用超過25萬個設備。Cytosorb最初在歐盟以CE標誌作爲首個細胞因數吸附器上市。之後針對臨牀狀況如肝病和創傷,分別獲得了用於膽紅素和肌紅蛋白去除的CE標誌擴展許可,並用於心胸外科手術中去除ticagrelor和rivaroxaban。Cytosorb還獲得了美國FDA緊急使用授權,用於即將或確診的呼吸衰竭的成人重症COVID-19患者,以降低促炎性細胞因數水平。Cytosorb尚未在美國獲得批准。
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.
在美國和加拿大,Cytosorbents正在開發DrugSorb-ATR抗凝藥物去除系統,這是一種基於與Cytosorb等效聚合物技術的研究設備,用於減少由於抗凝藥物導致的高風險手術中的圍手術期出血嚴重性。它獲得了兩項FDA突破性醫療設備認證:一項用於去除ticagrelor,另一項用於在緊急心胸手術中,使用心肺旁路迴路去除直接口服抗凝劑(DOAC)apixaban和rivaroxaban。2024年9月,公司向美國FDA提交了一份De Novo醫療設備申請,以請求批准降低使用抗凝藥物ticagrelor的CABG患者的圍手術期出血嚴重性,該申請於2024年10月被接受進行實質性審查。2024年11月,公司獲得了醫療設備單一審計計劃(MDSAP)認證,並向加拿大健康部提交了醫療設備許可證(MDL)申請。DrugSorb-ATR尚未在美國和加拿大獲得批准。
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.
公司擁有多種市場化產品和基於這一獨特血液淨化技術的在開發產品,該技術受許多已頒發的美國和國際專利及註冊商標的保護,並有多個專利申請正在等待中,包括ECOS-300CY、CytoSorb-XL、HemoDefend-RBC、HemoDefend-BGA、VetResQ、K+ontrol、DrugSorb、ContrastSorb等。有關更多信息,請訪問公司網站或關注我們的Facebook和X。
Forward-Looking Statements
前瞻性聲明
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.
本新聞稿包含旨在符合1995年私人證券訴訟改革法案規定的安全港負責任的前瞻性陳述。這些前瞻性陳述包括但不限於關於我們計劃、目標、未來目標及業務前景的陳述,陳述和主張,以及我們監管申請結果的內容,這些並非歷史事實,通常通過使用諸如「可能」、「應該」、「能夠」、「期望」、「計劃」、「預期」、「相信」、「估計」、「預測」、「潛在」、「繼續」等類似詞彙加以識別,儘管一些前瞻性陳述的表達方式有所不同。您應該意識到本新聞稿中的前瞻性陳述代表管理層的當前判斷和預期,但我們的實際結果、事件和表現可能與這些前瞻性陳述中的內容有重大差異。可能導致或促成此類差異的因素包括但不限於在我們於2024年3月14日向SEC提交的10-k表年度報告中討論的風險,以及我們不時向股東發佈的季度報告10-Q中的風險更新,在這些報告和新聞稿中嘗試告知相關方可能影響我們業務的風險和因素。我們提醒您不要對任何此類前瞻性陳述過度依賴。我們沒有義務公開更新或修訂任何前瞻性陳述,無論是由於新信息、未來事件,還是其他原因,除非根據聯邦證券法的要求。
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U.S. Company Contact:
Peter J. Mariani
Chief Financial Officer
pmariani@cytosorbents.com
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美國公司聯繫:
彼得·J·馬里亞尼
財務長
pmariani@Cytosorbents.com
Investor Relations Contact:
Aman Patel, CFA
Investor Relations, ICR Healthcare
(443) 450-4191
ir@cytosorbents.com
投資者關係聯繫:
阿曼·帕特爾,CFA
投資者關係,ICR醫療保健
(443) 450-4191
ir@Cytosorbents.com
譯文內容由第三人軟體翻譯。