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Nasdaq Panel Grants Nuwellis Continued Listing on the Nasdaq Stock Market, Subject to Conditions

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Nuwellis, Inc. (Nasdaq: NUWE) has been granted continued listing on the Nasdaq Stock Market by the Nasdaq Hearings Panel, subject to specific conditions. The decision follows a hearing on July 23, 2024. The company must meet the following requirements by November 19, 2024:

  • File a Form 10-Q for Q3 2024, detailing transactions to achieve compliance with the minimum stockholder Equity Rule
  • Provide 12-month income projections with clear assumptions
  • Demonstrate compliance with the minimum Bid Price Rule

Nuwellis must promptly notify Nasdaq of any significant events affecting compliance during the exception period. The Panel reserves the right to reconsider the terms of the exception based on any developments that may make continued listing inadvisable or unwarranted.

Nuwellis, Inc. (Nasdaq: NUWE) ha ottenuto il mantenimento della quotazione nel Nasdaq Stock Market dal Nasdaq Hearings Panel, soggetto a condizioni specifiche. La decisione segue un'udienza tenutasi il 23 luglio 2024. L'azienda deve soddisfare i seguenti requisiti entro il 19 novembre 2024:

  • Presentare un Modulo 10-Q per il terzo trimestre 2024, dettagliando le transazioni per raggiungere la conformità con il Regolamento sul Capitale Minimo degli Azionisti
  • Fornire previsioni di reddito per 12 mesi con assunzioni chiare
  • Dimostrare la conformità con il Regolamento sul Prezzo Minimo di Offerta

Nuwellis deve informare prontamente il Nasdaq di eventuali eventi significativi che influenzano la conformità durante il periodo di eccezione. Il Panel si riserva il diritto di riconsiderare i termini dell'eccezione in base a eventuali sviluppi che possano rendere inopportuna o ingiustificata la continuazione della quotazione.

Nuwellis, Inc. (Nasdaq: NUWE) ha recibido la aprobación para continuar su listado en el Nasdaq Stock Market por parte del Nasdaq Hearings Panel, sujeto a condiciones específicas. La decisión sigue a una audiencia celebrada el 23 de julio de 2024. La compañía debe cumplir con los siguientes requisitos antes del 19 de noviembre de 2024:

  • Presentar un Formulario 10-Q para el tercer trimestre de 2024, detallando las transacciones para lograr el cumplimiento de la Regla de Capital Mínimo de Accionistas
  • Proporcionar proyecciones de ingresos para 12 meses con supuestos claros
  • Demostrar el cumplimiento de la Regla de Precio Mínimo de Oferta

Nuwellis deberá notificar a Nasdaq de inmediato sobre cualquier evento significativo que afecte el cumplimiento durante el período de excepción. El Panel se reserva el derecho de reconsiderar los términos de la excepción con base en cualquier desarrollo que pueda hacer que la continuidad del listado sea desaconsejable o injustificada.

Nuwellis, Inc. (Nasdaq: NUWE)는 Nasdaq Hearings Panel로부터 특정 조건을 충족하는 한 Nasdaq Stock Market에서 계속 상장될 수 있는 승인을 받았습니다. 이 결정은 2024년 7월 23일에 열린 청문회에 따릅니다. 회사는 2024년 11월 19일까지 다음 요구 사항을 충족해야 합니다:

  • 최소 주주 자본 규정 준수를 달성하기 위한 거래를 상세히 설명하는 2024년 3분기 10-Q 양식 제출
  • 명확한 가정을 포함한 12개월 수입 예측 제공
  • 최소 입찰 가격 규정 준수 입증

Nuwellis는 예외 기간 동안 준수에 영향을 미치는 중요한 사건에 대해 Nasdaq에 즉시 통지해야 합니다. 패널은 지속적인 상장의 정당성이 떨어지는 발전에 따라 예외 조건을 재고할 권리를 보유합니다.

Nuwellis, Inc. (Nasdaq: NUWE) a obtenu l'autorisation de maintenir son inscription sur le Nasdaq Stock Market de la part du Nasdaq Hearings Panel, sous réserve de conditions spécifiques. Cette décision fait suite à une audience qui s'est tenue le 23 juillet 2024. L'entreprise doit satisfaire aux exigences suivantes d'ici le 19 novembre 2024 :

  • Déposer un formulaire 10-Q pour le 3ème trimestre 2024, détaillant les transactions pour garantir la conformité avec la règle du capital minimum des actionnaires
  • Fournir des prévisions de revenus sur 12 mois avec des hypothèses claires
  • Démontrer la conformité avec la règle du prix d'offre minimum

Nuwellis doit informer rapidement le Nasdaq de tout événement significatif affectant la conformité pendant la période d'exception. Le Panel se réserve le droit de reconsidérer les termes de l'exception en fonction des développements qui pourraient rendre le maintien de l'inscription inapproprié ou injustifié.

Nuwellis, Inc. (Nasdaq: NUWE) hat vom Nasdaq Hearings Panel die Genehmigung für die Fortsetzung des Listings an der Nasdaq Stock Market erhalten, vorbehaltlich bestimmter Bedingungen. Diese Entscheidung folgt auf eine Anhörung am 23. Juli 2024. Das Unternehmen muss bis zum 19. November 2024 die folgenden Anforderungen erfüllen:

  • Einreichen eines Formulars 10-Q für das 3. Quartal 2024, in dem die Transaktionen zur Erreichung der Einhaltung der Mindestkapitalanforderung für Aktionäre detailliert sind
  • Bereitstellung von 12-monatigen Einkommensprognosen mit klaren Annahmen
  • Nachweis der Einhaltung der Mindestgebotspreisregel

Nuwellis muss Nasdaq umgehend über wesentliche Ereignisse informieren, die die Einhaltung während der Ausnahmepolitik beeinflussen können. Das Panel behält sich das Recht vor, die Bedingungen der Ausnahme auf Grundlage von Entwicklungen zu überprüfen, die die Fortsetzung des Listings in Frage stellen könnten.

Positive
  • Granted continued listing on Nasdaq Stock Market
  • Given until November 19, 2024 to meet compliance requirements
Negative
  • Must demonstrate compliance with minimum stockholder Equity Rule
  • Required to show compliance with minimum Bid Price Rule
  • Continued listing subject to meeting specific conditions
  • Risk of delisting if conditions are not met

The Nasdaq Panel's decision to grant Nuwellis continued listing is a double-edged sword for investors. While it provides a temporary reprieve, it also highlights significant challenges:

  • The company must file its Q3 2024 10-Q by November 19, 2024, demonstrating compliance with the minimum stockholder Equity Rule.
  • Income projections for the next 12 months are required, indicating potential scrutiny of the company's financial health.
  • Nuwellis must meet the minimum Bid Price Rule by the same deadline, which may necessitate a reverse stock split or other capital actions.

These conditions suggest underlying financial instability. Investors should closely monitor Nuwellis's ability to meet these requirements, as failure could result in delisting. The tight deadline and multiple conditions indicate a high-risk situation for the company and its shareholders.

The Nasdaq Panel's decision carries significant legal and regulatory implications for Nuwellis:

  • The company is now under heightened scrutiny, with an obligation to promptly report any events affecting Nasdaq compliance.
  • Failure to meet the specified conditions by November 19, 2024, could result in immediate delisting proceedings.
  • The Panel's reservation of rights to reconsider the exception terms adds an element of uncertainty to Nuwellis's listing status.

This situation places Nuwellis in a precarious legal position, potentially exposing it to shareholder litigation if it fails to meet the conditions or if material information is not disclosed promptly. The company's management must navigate these requirements carefully to avoid legal repercussions and maintain market trust.

Nuwellis's listing challenges reflect broader market trends for small-cap medical technology companies:

  • The fluid overload treatment market, while promising, faces intense competition and regulatory hurdles.
  • Investor sentiment towards small-cap biotech and medtech firms has been cautious, impacting stock prices and capital raising abilities.
  • The company's struggle to maintain Nasdaq compliance may indicate underlying market positioning issues.

To regain investor confidence, Nuwellis must demonstrate a clear path to profitability and market share growth. The next few months are critical for the company to prove its viability in a challenging market landscape. Investors should watch for signs of improved financial health and market traction in Nuwellis's upcoming disclosures.

MINNEAPOLIS, Aug. 08, 2024 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on transforming the lives of people with fluid overload (the “Company”), today announced The Nasdaq Hearings Panel (“Panel”) granted its request to continue its listing on the Nasdaq Stock Market, subject to certain conditions. The decision was based on information the Company presented to the Panel during a hearing on July 23, 2024.

The letter received from the Panel stated that the continued listing was subject to the following: 1) on or before November 19, 2024, the Company shall file a Form 10-Q for the period ending September 30, 2024, describing the transactions undertaken by the Company to achieve compliance and demonstrate long-term compliance with the minimum stockholder Equity Rule and provide an indication of its equity following those transactions, 2) on or before November 19, 2024, the Company must provide the Panel with income projections for the next 12 months, with all underlying assumptions clearly stated, and 3) on or before November 19, 2024, the Company shall demonstrate compliance with the minimum Bid Price Rule.

The letter also stated that it is a requirement during the exception period that the Company provide prompt notification of any significant events that occur during this time that may affect the Company’s compliance with Nasdaq requirements. This includes, but is not limited to, any event that may call into question the Company’s ability to meet the terms of the exception granted. The Panel reserves the right to reconsider the terms of this exception based on any event, condition or circumstance that exists or develops that would, in the opinion of the Panel, make continued listing of the Company’s securities on the Exchange inadvisable or unwarranted.

About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X.

About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically proven therapy using a simple, flexible and smart method of removing excess fluid from patients suffering from hypervolemia (fluid overload). The Aquadex SmartFlow system is indicated for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kg or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a health care provider, within an outpatient or inpatient clinical setting, under physician prescription, both having received training in extracorporeal therapies.

Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2024 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.

CONTACTS

Investors:
Vivian Cervantes
Gilmartin Group
ir@nuwellis.com


FAQ

What conditions must Nuwellis (NUWE) meet to maintain its Nasdaq listing?

Nuwellis must file a Q3 2024 Form 10-Q, provide 12-month income projections, and demonstrate compliance with the minimum Bid Price Rule by November 19, 2024.

When did the Nasdaq Hearings Panel grant Nuwellis (NUWE) continued listing?

The Nasdaq Hearings Panel granted Nuwellis continued listing following a hearing on July 23, 2024.

What is the deadline for Nuwellis (NUWE) to meet Nasdaq's compliance requirements?

Nuwellis must meet Nasdaq's compliance requirements by November 19, 2024.

What happens if Nuwellis (NUWE) fails to meet the Nasdaq listing conditions?

If Nuwellis fails to meet the conditions, the Nasdaq Panel reserves the right to reconsider the terms of the exception, potentially leading to delisting from the Nasdaq Stock Market.

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