Nuwellis Signs Letter of Intent to Explore Acquisition of Rendiatech Ltd., A Real-Time Fluid Monitoring Company
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 società 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, già 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 è 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 mortalità. La transazione è 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 israelí de dispositivos médicos especializada en tecnologías de monitorización en tiempo real del flujo urinario y de la lesión renal aguda. La adquisición propuesta añadiría al portafolio de Nuwellis el sistema de monitorización Clarity RMS autorizado por la FDA y su nueva generación, el Clarity Prime.
La operación estratégica busca ampliar la plataforma tecnológica de Nuwellis más allá de la ultrafiltración, hacia el monitorizado continuo de la salud renal. El objetivo es mejorar los resultados de los pacientes en la gestión de la lesión renal aguda (AKI), que afecta al 20-50% de los pacientes en UCI y presenta una mortalidad superior al 50%. Se espera que la transacción se cierre en el Q4 de 2025, tras un periodo de diligencia debida de 45 días y sujeta a las aprobaciones finales.
Nuwellis (Nasdaq: NUWE)는 실시간 소변 유량 및 급성 신손상(AKI) 모니터링 기술을 전문으로 하는 이스라엘 의료기기 회사 Rendiatech Ltd. 인수를 위한 구속력 없는 의향서에 서명했습니다. 제안된 인수로 Nuwellis 포트폴리오에는 FDA 승인된 Clarity RMS 모니터링 시스템과 차세대 Clarity Prime 시스템이 추가될 예정입니다.
이번 전략적 인수는 Nuwellis의 기술 플랫폼을 초여과(ultrafiltration) 영역을 넘어 지속적인 신장 건강 모니터링으로 확장하는 것을 목표로 합니다. 거래는 중환자실 환자의 20–50%에 영향을 미치고 사망률이 50% 이상에 달하는 급성 신손상 관리에서 환자 결과를 개선하는 것을 목표로 합니다. 거래는 45일간의 실사 기간과 최종 승인 조건을 거쳐 2025년 4분기에 완료될 것으로 예상됩니다.
Nuwellis (Nasdaq: NUWE) a signé une lettre d'intention non contraignante visant l'acquisition de Rendiatech Ltd., une société israélienne de dispositifs médicaux spécialisée dans les technologies de surveillance en temps réel du débit urinaire et des lésions rénales aiguës. L'acquisition proposée intégrera au portefeuille de Nuwellis le système de surveillance Clarity RMS, approuvé par la FDA, ainsi que sa génération suivante, le Clarity Prime.
Cette opération stratégique vise à étendre la plateforme technologique de Nuwellis au-delà de l'ultrafiltration, vers la surveillance continue de la santé rénale. L'objectif est d'améliorer les résultats des patients dans la prise en charge de la lésion rénale aiguë (AKI), qui touche 20 à 50 % des patients en réanimation et affiche une mortalité supérieure à 50 %. La transaction devrait être finalisée au 4e trimestre 2025, après une période de diligence raisonnable de 45 jours et sous réserve des approbations finales.
Nuwellis (Nasdaq: NUWE) hat eine unverbindliche Absichtserklärung zur Übernahme von Rendiatech Ltd. unterzeichnet, einem israelischen Medizintechnikunternehmen, das sich auf die Echtzeitüberwachung des Harnflusses und Technologien zur Erkennung akuter Nierenschäden spezialisiert hat. Durch den geplanten Erwerb würde Nuwellis das von der FDA zugelassene Überwachungssystem Clarity RMS sowie das nächste Produkt Clarity Prime in sein Portfolio aufnehmen.
Die strategische Transaktion zielt darauf ab, die Technologieplattform von Nuwellis über die Ultrafiltration hinaus auf die kontinuierliche Überwachung der Nierengesundheit auszuweiten. Damit sollen die Patientenergebnisse bei der Behandlung der akuten Nierenschädigung (AKI) verbessert werden, die 20–50 % der Intensivpatienten betrifft und eine Sterblichkeitsrate von über 50 % aufweist. Der Abschluss der Transaktion wird nach einer 45-tägigen Due-Diligence-Phase und vorbehaltlich der endgültigen Genehmigungen für das 4. Quartal 2025 erwartet.
- 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
- 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’ 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’s 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’s next-generation system, Clarity Prime, is currently in development to advance urine monitoring capabilities, offering clinicians critical insights into renal and cardiovascular health.
“We 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’s 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,” said John Erb, CEO of Nuwellis.
“We’re excited by the possibility of partnering with Nuwellis to expand access to our next-generation technology,” said Avi Kleiman, CEO of Rendiatech. “Their commercial reach and commitment to advancing fluid management make them an ideal strategic fit as we look to scale clinical adoption.”
Real-time urine output monitoring is increasingly recognized as a critical indicator for acute kidney injury (AKI), fluid responsiveness, and treatment efficacy—areas where actionable insights may significantly improve outcomes, particularly in complex ICU patients. AKI is seen in
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.
“This is a potential milestone in our continued evolution,” Erb added. “We 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.”
For more information, visit www.nuwellis.com.
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’s key product, Rendiatech’s 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 (https://www.nice.org.uk/advice/mib256)
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Investor Relations:
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FAQ
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