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Nuwellis Signs Letter of Intent to Explore Acquisition of Rendiatech Ltd., A AG真人官方-Time Fluid Monitoring Company

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Nuwellis (Nasdaq: NUWE) has signed a non-binding letter of intent to acquire Rendiatech Ltd., an Israeli medical device company specializing in real-time urine flow and acute kidney injury monitoring technologies. The proposed acquisition would add Rendiatech's FDA-cleared Clarity RMS monitoring system and its next-generation Clarity Prime system to Nuwellis' portfolio.

The strategic acquisition aims to expand Nuwellis' technology platform beyond ultrafiltration into continuous renal health monitoring. The deal targets improved patient outcomes in acute kidney injury (AKI) management, which affects 20-50% of ICU patients with over 50% mortality rate. The transaction is expected to close in Q4 2025, following a 45-day due diligence period and subject to final approvals.

Nuwellis (Nasdaq: NUWE) ha firmato una lettera d'intenti non vincolante per acquisire Rendiatech Ltd., una societ脿 israeliana di dispositivi medici specializzata in tecnologie di monitoraggio del flusso urinario in tempo reale e dell'insufficienza renale acuta. La proposta di acquisizione integrerebbe nel portafoglio di Nuwellis il sistema di monitoraggio Clarity RMS, gi脿 autorizzato dalla FDA, e la sua generazione successiva, il Clarity Prime.

Questa operazione strategica mira a estendere la piattaforma tecnologica di Nuwellis oltre l'ultrafiltrazione, verso il monitoraggio continuo della salute renale. L'obiettivo 猫 migliorare gli esiti clinici nella gestione dell'insufficienza renale acuta (AKI), condizione che colpisce il 20-50% dei pazienti in terapia intensiva con oltre il 50% di mortalit脿. La transazione 猫 prevista per la Q4 2025, dopo un periodo di due diligence di 45 giorni e soggetta alle approvazioni finali.

Nuwellis (Nasdaq: NUWE) ha firmado una carta de intenciones no vinculante para adquirir Rendiatech Ltd., una empresa israel铆 de dispositivos m茅dicos especializada en tecnolog铆as de monitorizaci贸n en tiempo real del flujo urinario y de la lesi贸n renal aguda. La adquisici贸n propuesta a帽adir铆a al portafolio de Nuwellis el sistema de monitorizaci贸n Clarity RMS autorizado por la FDA y su nueva generaci贸n, el Clarity Prime.

La operaci贸n estrat茅gica busca ampliar la plataforma tecnol贸gica de Nuwellis m谩s all谩 de la ultrafiltraci贸n, hacia el monitorizado continuo de la salud renal. El objetivo es mejorar los resultados de los pacientes en la gesti贸n de la lesi贸n renal aguda (AKI), que afecta al 20-50% de los pacientes en UCI y presenta una mortalidad superior al 50%. Se espera que la transacci贸n se cierre en el Q4 de 2025, tras un periodo de diligencia debida de 45 d铆as y sujeta a las aprobaciones finales.

Nuwellis (Nasdaq: NUWE)電� 鞁れ嫓臧� 靻岆硛 鞙犽焿 氚� 旮夓劚 鞁犾啇靸�(AKI) 氇媹韯半 旮办垹鞚� 鞝勲鞙茧 頃橂姅 鞚挫姢霛检棙 鞚橂旮瓣赴 須岇偓 Rendiatech Ltd. 鞚胳垬毳� 鞙勴暅 甑啀霠� 鞐嗠姅 鞚橅枼靹滌棎 靹滊獏頄堨姷雼堧嫟. 鞝滌晥霅� 鞚胳垬搿� Nuwellis 韽姼韽措Μ鞓れ棎電� FDA 鞀轨澑霅� Clarity RMS 氇媹韯半 鞁滌姢韰滉臣 彀劯雽 Clarity Prime 鞁滌姢韰滌澊 於旉皜霅� 鞓堨爼鞛呺媹雼�.

鞚措矆 鞝勲灥鞝� 鞚胳垬電� Nuwellis鞚� 旮办垹 頂岆灚韽检潉 齑堨棳瓿�(ultrafiltration) 鞓侅棴鞚� 雱橃柎 歆靻嶌爜鞚� 鞁犾灔 瓯搓皶 氇媹韯半鞙茧 頇曥灔頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�. 瓯半灅電� 欷戫櫂鞛愳嫟 頇橃瀽鞚� 20鈥�50%鞐� 鞓來枼鞚� 氙胳箻瓿� 靷毳犾澊 50% 鞚挫儊鞐� 雼晿電� 旮夓劚 鞁犾啇靸� 甏毽棎靹� 頇橃瀽 瓴瓣臣毳� 臧滌劆頃橂姅 瓴冹潉 氇╉憸搿� 頃╇媹雼�. 瓯半灅電� 45鞚缄皠鞚� 鞁れ偓 旮瓣皠瓿� 斓滌 鞀轨澑 臁瓣贝鞚� 瓯办硱 2025雲� 4攵勱赴鞐� 鞕勲霅� 瓴冹溂搿� 鞓堨儊霅╇媹雼�.

Nuwellis (Nasdaq: NUWE) a sign茅 une lettre d'intention non contraignante visant l'acquisition de Rendiatech Ltd., une soci茅t茅 isra茅lienne de dispositifs m茅dicaux sp茅cialis茅e dans les technologies de surveillance en temps r茅el du d茅bit urinaire et des l茅sions r茅nales aigu毛s. L'acquisition propos茅e int茅grera au portefeuille de Nuwellis le syst猫me de surveillance Clarity RMS, approuv茅 par la FDA, ainsi que sa g茅n茅ration suivante, le Clarity Prime.

Cette op茅ration strat茅gique vise 脿 茅tendre la plateforme technologique de Nuwellis au-del脿 de l'ultrafiltration, vers la surveillance continue de la sant茅 r茅nale. L'objectif est d'am茅liorer les r茅sultats des patients dans la prise en charge de la l茅sion r茅nale aigu毛 (AKI), qui touche 20 脿 50 % des patients en r茅animation et affiche une mortalit茅 sup茅rieure 脿 50 %. La transaction devrait 锚tre finalis茅e au 4e trimestre 2025, apr猫s une p茅riode de diligence raisonnable de 45 jours et sous r茅serve des approbations finales.

Nuwellis (Nasdaq: NUWE) hat eine unverbindliche Absichtserkl盲rung zur 脺bernahme von Rendiatech Ltd. unterzeichnet, einem israelischen Medizintechnikunternehmen, das sich auf die Echtzeit眉berwachung des Harnflusses und Technologien zur Erkennung akuter Nierensch盲den spezialisiert hat. Durch den geplanten Erwerb w眉rde Nuwellis das von der FDA zugelassene 脺berwachungssystem Clarity RMS sowie das n盲chste Produkt Clarity Prime in sein Portfolio aufnehmen.

Die strategische Transaktion zielt darauf ab, die Technologieplattform von Nuwellis 眉ber die Ultrafiltration hinaus auf die kontinuierliche 脺berwachung der Nierengesundheit auszuweiten. Damit sollen die Patientenergebnisse bei der Behandlung der akuten Nierensch盲digung (AKI) verbessert werden, die 20鈥�50 % der Intensivpatienten betrifft und eine Sterblichkeitsrate von 眉ber 50 % aufweist. Der Abschluss der Transaktion wird nach einer 45-t盲gigen Due-Diligence-Phase und vorbehaltlich der endg眉ltigen Genehmigungen f眉r das 4. Quartal 2025 erwartet.

Positive
  • Strategic expansion into continuous renal health monitoring technology
  • Addition of FDA-cleared Clarity RMS system to product portfolio
  • Access to next-generation Clarity Prime system in development
  • Alignment with existing critical care call points, leveraging current commercial infrastructure
  • Potential for earlier detection of AKI and improved patient outcomes
Negative
  • Non-binding letter of intent subject to 45-day due diligence and final approvals
  • Company not yet cash flow positive
  • Integration risks with Israeli-based technology company
  • Financial terms of acquisition not disclosed

Insights

Nuwellis' potential acquisition of Rendiatech could strengthen its fluid management portfolio with real-time kidney monitoring technology, addressing critical clinical needs.

Nuwellis (NUWE) has signed a non-binding letter of intent to acquire Rendiatech, an Israeli medical device company specializing in real-time urine flow and kidney monitoring technologies. This potential acquisition aligns with Nuwellis' strategy to expand beyond ultrafiltration into continuous renal health monitoring, potentially creating a more comprehensive fluid management platform.

The deal would add Rendiatech's FDA-cleared Clarity RMS system to Nuwellis' portfolio. This technology continuously measures urine flow and automatically alerts medical staff to fluctuations in real-time. Rendiatech is also developing Clarity Prime, a next-generation system to advance urine monitoring capabilities for renal and cardiovascular health insights.

This strategic move targets the acute kidney injury (AKI) market, a significant clinical challenge affecting 10-20% of emergency hospital admissions with over 20% inpatient mortality. In ICU settings, AKI incidence rises to 20-50% with mortality exceeding 50%. Earlier detection through continuous monitoring could potentially improve these outcomes.

The acquisition appears synergistic as both companies target the same critical care call points, potentially streamlining sales efforts. Nuwellis' CEO John Erb framed the move as part of a "transformational growth strategy to accelerate our path to cash flow positive."

The companies have entered a 45-day due diligence period, with potential closing in Q4 2025 pending board approval and closing conditions. While promising, investors should note this remains a non-binding agreement with no financial terms disclosed, and the transaction may not ultimately materialize.

Proposed acquisition supports strategy to drive technology expansion of fluid management offering to include continuous renal health monitoring technologies supporting the full patient journey, from early risk assessment to targeted fluid removal

MINNEAPOLIS, Aug. 19, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company focused on improving patient outcomes through advanced fluid management, today announced it has signed a non-binding letter of intent (LOI) to acquire Rendiatech, Ltd., an Israeli-based medical device company specializing in real-time urine flow and acute kidney injury monitoring technologies. The proposed acquisition is expected to support Nuwellis鈥� strategy to expand its current technology platform beyond ultrafiltration by potentially adding continuous renal health monitoring technologies that provide clinicians with earlier insight into fluid status and kidney function.

As part of the proposed transaction, Nuwellis would add to its product portfolio Rendiatech鈥檚 Clarity RMS, an FDA-cleared critical care monitoring system that continuously measures urine flow and automatically sends data and alerts of fluctuations to medical staff in real-time. Rendiatech鈥檚 next-generation system, Clarity Prime, is currently in development to advance urine monitoring capabilities, offering clinicians critical insights into renal and cardiovascular health.

鈥淲e have embarked on a transformational growth strategy to accelerate our path to cash flow positive. We believe this LOI marks an important synergistic step that has the potential to be a leap forward in realizing our strategic vision. Rendiatech鈥檚 technologies align with our deliberate focus on comprehensive fluid management, complementing our current offering and reaching the same critical care call points we already serve, all of which we believe will unlock value for all stakeholders,鈥� said John Erb, CEO of Nuwellis.

鈥淲e鈥檙e excited by the possibility of partnering with Nuwellis to expand access to our next-generation technology,鈥� said Avi Kleiman, CEO of Rendiatech. 鈥淭heir commercial reach and commitment to advancing fluid management make them an ideal strategic fit as we look to scale clinical adoption.鈥�

AG真人官方-time urine output monitoring is increasingly recognized as a critical indicator for acute kidney injury (AKI), fluid responsiveness, and treatment efficacy鈥攁reas where actionable insights may significantly improve outcomes, particularly in complex ICU patients. AKI is seen in 10% to 20% of people admitted to hospital as emergencies, with an inpatient mortality over 20%1. The overall incidence of AKI in the ICU is higher at 20% to 50% and it is associated with mortality over 50%1. The Company believes that this technology has the potential to change the current pathway and may lead to improved outcomes through earlier detection of AKI and dehydration.

A 45-day due diligence period has commenced. Should both parties agree to proceed, the transaction is anticipated to close in the fourth quarter of 2025, pending final Board approval and closing conditions.

鈥淭his is a potential milestone in our continued evolution,鈥� Erb added. 鈥淲e believe that adding real-time monitoring technologies to our portfolio could strengthen our ability to deliver precise, proactive fluid management across a range of critical conditions.鈥�

For more information, visit .

About Rendiatech, Ltd. Rendiatech, Ltd., an Israeli-based medical device company specializing in real-time urine flow and acute kidney injury monitoring technologies. The company鈥檚 key product, Rendiatech鈥檚 Clarity RMS, an FDA-cleared critical care monitoring system that continuously measures urine flow and automatically sends data and alerts of fluctuations to medical staff in real-time and its next-generation system, Clarity Prime, currently in development.

About Nuwellis Nuwellis, Inc. (Nasdaq: NUWE) is a medical device 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, formerly known as Twitter.

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 2025 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.

Citation Source: 1: RenalSense Clarity RMS for acute kidney injury ()

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Investor Relations:
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Jenene Thomas
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Media Contact:
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Director of Communications


FAQ

What is the strategic rationale behind Nuwellis (NUWE) acquisition of Rendiatech?

The acquisition aims to expand Nuwellis' technology platform beyond ultrafiltration by adding continuous renal health monitoring technologies, enhancing their comprehensive fluid management offering and leveraging existing critical care sales channels.

What products will Nuwellis acquire from Rendiatech?

Nuwellis will acquire the FDA-cleared Clarity RMS critical care monitoring system and rights to the next-generation Clarity Prime system currently in development.

When is the Nuwellis-Rendiatech acquisition expected to close?

The acquisition is anticipated to close in the fourth quarter of 2025, following a 45-day due diligence period and subject to final Board approval and closing conditions.

What is the market opportunity for acute kidney injury (AKI) monitoring?

AKI affects 20-50% of ICU patients with mortality rates over 50%, and 10-20% of emergency hospital admissions with over 20% inpatient mortality.

Who will lead the combined company after the Nuwellis-Rendiatech acquisition?

The press release indicates that John Erb will continue as CEO of Nuwellis, while specific post-merger management structure details were not disclosed.
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