CytoSorbents Announces Compliance with Nasdaq Minimum Bid Price Requirement
CytoSorbents (NASDAQ: CTSO) has regained compliance with Nasdaq's minimum bid price requirement of $1.00 per share. The company received notification from Nasdaq on July 26, 2024, confirming that its common stock had closed at or above $1.00 for 10 consecutive trading sessions ending July 25, 2024. This development strengthens CytoSorbents' market position as it approaches expected regulatory submissions for DrugSorb®-ATR marketing approval to the U.S. FDA and Health Canada in the coming months.
Dr. Phillip Chan, CEO of CytoSorbents, highlighted recent operational progress in clinical, regulatory, commercial, manufacturing, and financing areas, along with continued aggressive cost-cutting measures. These efforts are aimed at establishing a foundation for what the company believes will be an exciting new phase of its business.
CytoSorbents (NASDAQ: CTSO) ha recuperato la conformità con il requisito del prezzo minimo di offerta di Nasdaq di $1.00 per azione. L'azienda ha ricevuto una notifica da Nasdaq il 26 luglio 2024, confermando che le sue azioni ordinarie si erano chiuse a $1.00 o oltre per 10 sessioni di trading consecutive fino al 25 luglio 2024. Questo sviluppo rafforza la posizione di mercato di CytoSorbents mentre si avvicina a presentazioni normative attese per l'approvazione commerciale di DrugSorb®-ATR all'U.S. FDA e a Health Canada nei prossimi mesi.
Il Dr. Phillip Chan, CEO di CytoSorbents, ha evidenziato i recenti progressi operativi nelle aree cliniche, regolatorie, commerciali, di produzione e finanziamento, insieme a continue misure di riduzione dei costi. Questi sforzi mirano a stabilire le basi per quella che l'azienda ritiene sarà una nuova fase entusiasmante del suo business.
CytoSorbents (NASDAQ: CTSO) ha recuperado el cumplimiento con el requisito de precio mínimo de oferta de Nasdaq de $1.00 por acción. La compañía recibió una notificación de Nasdaq el 26 de julio de 2024, confirmando que sus acciones comunes habían cerrado a $1.00 o más durante 10 sesiones de negociación consecutivas que terminaron el 25 de julio de 2024. Este desarrollo fortalece la posición de mercado de CytoSorbents a medida que se acerca a las presentaciones regulatorias esperadas para la aprobación de comercialización de DrugSorb®-ATR ante la FDA de EE. UU. y Health Canada en los próximos meses.
El Dr. Phillip Chan, CEO de CytoSorbents, destacó los recientes avances operativos en áreas clínicas, regulatorias, comerciales, de fabricación y financiamiento, junto con medidas agresivas de reducción de costos. Estos esfuerzos están destinados a establecer una base para lo que la compañía cree que será una emocionante nueva fase de su negocio.
CytoSorbents (NASDAQ: CTSO)는 나스닥의 최소 매도 가격 요구 사항인 주당 $1.00을 다시 충족했습니다. 이 회사는 2024년 7월 26일 나스닥으로부터 통지를 받았으며, 그 통지 내용은 2024년 7월 25일까지 10회 연속 거래 회의에서 보통주가 $1.00 이상에 마감되었다는 것이었습니다. 이번 발전은 CytoSorbents의 시장 입지를 강화하며, 다가오는 몇 달 안에 미국 FDA 및 Health Canada에 DrugSorb®-ATR 마케팅 승인에 대한 예상 규제 제출에 접근하고 있습니다.
CytoSorbents의 CEO인 Phillip Chan 박사는 임상, 규제, 상업, 제조 및 금융 분야에서의 최근 운영 성과와 함께 지속적인 비용 절감 조치를 강조했습니다. 이러한 노력은 회사가 흥미로운 새로운 비즈니스 단계로 나아가기 위한 토대를 마련하는 것을 목표로 하고 있습니다.
CytoSorbents (NASDAQ: CTSO) a retrouvé le respect de l'exigence de prix minimal de Nasdaq de 1,00 $ par action. L'entreprise a reçu une notification de Nasdaq le 26 juillet 2024, confirmant que ses actions ordinaires s'étaient clôturées à 1,00 $ ou plus pendant 10 séances de négociation consécutives se terminant le 25 juillet 2024. Ce développement renforce la position de marché de CytoSorbents alors qu'elle se prépare à des soumissions réglementaires attendues pour l'approbation de commercialisation de DrugSorb®-ATR auprès de la FDA des États-Unis et de Santé Canada dans les mois à venir.
Le Dr. Phillip Chan, PDG de CytoSorbents, a souligné les récents progrès opérationnels dans les domaines clinique, réglementaire, commercial, de fabrication et de financement, ainsi que les mesures de réduction des coûts continues et agressives. Ces efforts visent à établir une base pour ce que l’entreprise considère comme une nouvelle phase passionnante de son activité.
CytoSorbents (NASDAQ: CTSO) hat die Einhaltung der Nasdaq-Anforderungen für den Mindestgebotspreis von $1,00 pro Aktie wiedererlangt. Das Unternehmen erhielt am 26. Juli 2024 eine Mitteilung von Nasdaq, die bestätigte, dass seine Stammaktien während 10 aufeinanderfolgender Handelstage bis zum 25. Juli 2024 bei oder über $1,00 geschlossen hatten. Diese Entwicklung stärkt die Marktposition von CytoSorbents, während sich das Unternehmen erwarteten regulatorischen Einreichungen zur Marktgenehmigung von DrugSorb®-ATR an die U.S. FDA und Health Canada in den kommenden Monaten nähert.
Dr. Phillip Chan, CEO von CytoSorbents, hob die aktuellen operationellen Fortschritte in den Bereichen Klinik, Regulierung, Kommerz, Fertigung und Finanzierung hervor, sowie die anhaltenden aggressiven Kostensenkungsmaßnahmen. Diese Bemühungen zielen darauf ab, eine Grundlage zu schaffen für das, was das Unternehmen für eine aufregende neue Phase seines Geschäfts hält.
- Regained compliance with Nasdaq's minimum bid price requirement
- Approaching regulatory submissions for DrugSorb®-ATR marketing approval in the U.S. and Canada
- Recent operational progress in multiple areas
- Implementing aggressive cost-cutting measures
- None.
CytoSorbents' compliance with Nasdaq's minimum bid price requirement is a positive development, but it's important to view this in context. While it removes the immediate threat of delisting, it doesn't fundamentally change the company's financial position or market prospects.
The $1.00 per share threshold is a basic requirement for Nasdaq listing and maintaining it suggests a minimal level of investor confidence. However, it's important to note that this compliance was achieved just at the threshold, indicating the stock's fragility.
Dr. Chan's statement about approaching regulatory submissions for DrugSorb®-ATR is more significant from a business perspective. FDA and Health Canada approvals could potentially open new revenue streams, but investors should be cautious. Regulatory processes are unpredictable and even if approved, market adoption can be slow.
The mention of "aggressive cost cutting" is a double-edged sword. While it may improve short-term financial metrics, it could also hinder long-term growth if it affects R&D or marketing capabilities. Investors should look for detailed financials in upcoming reports to assess the balance between cost control and growth investments.
Overall, while compliance is positive, it's a low bar. The company's future hinges more on regulatory approvals, market adoption of its products and its ability to manage costs without sacrificing growth potential. Investors should closely monitor these factors in the coming months.
From a medical research perspective, CytoSorbents' focus on blood purification technology for critical care and cardiac surgery is noteworthy. The company's proprietary polymer adsorption technology addresses a important need in managing life-threatening conditions in intensive care units.
The upcoming regulatory submissions for DrugSorb®-ATR to the FDA and Health Canada are particularly interesting. This product, if approved, could potentially address the significant clinical challenge of managing perioperative bleeding in patients on antithrombotic medications. The ability to rapidly remove these drugs from a patient's bloodstream could revolutionize perioperative care in certain high-risk surgeries.
However, it's important to note that regulatory approval is just the first step. The real test will be in clinical adoption and real-world effectiveness. Healthcare providers will need to see clear evidence of improved patient outcomes and cost-effectiveness to widely adopt this technology.
The company's mention of "recent operational progress on the clinical, regulatory, commercial, manufacturing and financing fronts" suggests a comprehensive approach to bringing their technology to market. However, without specific details, it's difficult to assess the true impact of these developments.
Investors should keep a close eye on upcoming clinical data, post-market surveillance results (for products already in use) and any partnerships with major healthcare institutions or companies. These factors will be important in determining the long-term success and adoption of CytoSorbents' technology in the medical field.
PRINCETON, N.J., Aug. 01, 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, announces that it has regained compliance with the Nasdaq Stock Market’s minimum bid price requirement of
On July 26, 2024, CytoSorbents received notification from the Listing Qualifications Department of the Nasdaq Stock Market (“Nasdaq”) that it has regained compliance with the minimum bid price requirement in Nasdaq Listing Rule 5550(a)(2) as a result of the closing bid price of CytoSorbents’ common stock being
Dr. Phillip Chan, Chief Executive Officer of CytoSorbents stated, “We are pleased to confirm that CytoSorbents is now back in full compliance with Nasdaq’s listing requirements, strengthening our market position as we approach our expected regulatory submissions for DrugSorb®-ATR marketing approval to U.S. FDA and Health Canada in the next several months. With recent operational progress on the clinical, regulatory, commercial, manufacturing, and financing fronts, coupled with continued aggressive cost cutting, we have been systematically putting into place the foundation of what we believe will be an exciting new phase of our business.”
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
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 timing of our expected 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.
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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
FAQ
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