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Nuwellis Contracts with KDI Precision Manufacturing to Strengthen Production and Improve Operational Efficiency

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Nuwellis (NUWE) has finalized a strategic manufacturing agreement with KDI Precision Manufacturing to outsource the assembly of key Aquadex product components. Under the agreement, KDI will take over assembly responsibilities for the Aquadex SmartFlow® Console, AquaFlexFlow® Blood Circuits, and dELC® Catheters. The partnership aims to enhance operational efficiency and reduce costs while maintaining product quality.

KDI, an ISO 13485 certified and FDA registered company founded in 1982, specializes in medical manufacturing with over 80% of its business in healthcare products. To ensure continuity, current Nuwellis assembly employees will be hired by KDI. Notably, KDI's CEO Vitaliy Epshteyn previously served as Nuwellis' SVP of Operations, Engineering, and QA/RA for 6 years.

Nuwellis (NUWE) ha finalizzato un accordo strategico di produzione con KDI Precision Manufacturing per esternalizzare l'assemblaggio di componenti chiave dei prodotti Aquadex. Secondo l'accordo, KDI si occuperà dell'assemblaggio della Console Aquadex SmartFlow®, dei Circuiti Sanguigni AquaFlexFlow® e dei Cateteri dELC®. Questa collaborazione mira a migliorare l'efficienza operativa e ridurre i costi, mantenendo al contempo la qualità del prodotto.

KDI, azienda certificata ISO 13485 e registrata presso la FDA, fondata nel 1982, è specializzata nella produzione medicale con oltre l'80% del suo fatturato dedicato a prodotti sanitari. Per garantire continuità, gli attuali dipendenti di assemblaggio di Nuwellis saranno assunti da KDI. Da notare che il CEO di KDI, Vitaliy Epshteyn, ha precedentemente ricoperto per 6 anni il ruolo di SVP Operations, Engineering, e QA/RA presso Nuwellis.

Nuwellis (NUWE) ha finalizado un acuerdo estratégico de fabricación con KDI Precision Manufacturing para externalizar el ensamblaje de componentes clave de los productos Aquadex. Según el acuerdo, KDI asumirá la responsabilidad del ensamblaje de la Consola Aquadex SmartFlow®, los Circuitos Sanguíneos AquaFlexFlow® y los Catéteres dELC®. La asociación busca mejorar la eficiencia operativa y reducir costos, manteniendo la calidad del producto.

KDI, una empresa certificada ISO 13485 y registrada en la FDA, fundada en 1982, se especializa en fabricación médica, con más del 80% de su negocio en productos de salud. Para asegurar la continuidad, los empleados actuales de ensamblaje de Nuwellis serán contratados por KDI. Cabe destacar que el CEO de KDI, Vitaliy Epshteyn, fue anteriormente SVP de Operaciones, Ingeniería y QA/RA en Nuwellis durante 6 años.

Nuwellis (NUWE)KDI Precision Manufacturing과 전략적 제조 계약을 체결하여 Aquadex 주요 제품 부품의 조립을 외주화하기로 했습니다. 이 계약에 따라 KDI는 Aquadex SmartFlow® 콘솔, AquaFlexFlow® 혈액 회로, dELC® 카테터의 조립 책임을 맡게 됩니다. 이번 협력은 운영 효율성을 높이고 비용을 절감하는 동시에 제품 품질을 유지하는 것을 목표로 합니다.

KDI는 1982년에 설립된 ISO 13485 인증 및 FDA 등록 기업으로, 의료 제조를 전문으로 하며 전체 사업의 80% 이상을 의료 제품에 집중하고 있습니다. 연속성을 보장하기 위해 현재 Nuwellis 조립 직원들은 KDI에 고용될 예정입니다. 특히 KDI의 CEO Vitaliy Epshteyn은 이전에 6년간 Nuwellis에서 운영, 엔지니어링, QA/RA 부문 부사장을 역임했습니다.

Nuwellis (NUWE) a conclu un accord stratégique de fabrication avec KDI Precision Manufacturing afin de sous-traiter l'assemblage des composants clés des produits Aquadex. Selon cet accord, KDI prendra en charge l'assemblage de la console Aquadex SmartFlow®, des circuits sanguins AquaFlexFlow® et des cathéters dELC®. Ce partenariat vise à améliorer l'efficacité opérationnelle et à réduire les coûts tout en maintenant la qualité des produits.

KDI, une entreprise certifiée ISO 13485 et enregistrée auprès de la FDA, fondée en 1982, est spécialisée dans la fabrication médicale, avec plus de 80 % de son activité consacrée aux produits de santé. Pour assurer la continuité, les employés actuels de l'assemblage chez Nuwellis seront recrutés par KDI. Il est à noter que le PDG de KDI, Vitaliy Epshteyn, a auparavant occupé pendant 6 ans le poste de SVP des opérations, de l'ingénierie et de l'assurance qualité/réglementation chez Nuwellis.

Nuwellis (NUWE) hat eine strategische Fertigungsvereinbarung mit KDI Precision Manufacturing abgeschlossen, um die Montage wichtiger Aquadex-Produktkomponenten auszulagern. Im Rahmen der Vereinbarung übernimmt KDI die Montage der Aquadex SmartFlow® Konsole, AquaFlexFlow® Blutkreisläufe und dELC® Katheter. Die Partnerschaft zielt darauf ab, die betriebliche Effizienz zu steigern und Kosten zu senken, während die Produktqualität erhalten bleibt.

KDI, ein nach ISO 13485 zertifiziertes und bei der FDA registriertes Unternehmen, wurde 1982 gegründet und ist auf die medizinische Fertigung spezialisiert, wobei über 80 % des Geschäfts im Gesundheitsbereich liegen. Um Kontinuität zu gewährleisten, werden die derzeitigen Montage-Mitarbeiter von Nuwellis von KDI übernommen. Bemerkenswert ist, dass KDI-CEO Vitaliy Epshteyn zuvor sechs Jahre lang als SVP für Operations, Engineering sowie QA/RA bei Nuwellis tätig war.

Positive
  • Cost reduction through manufacturing outsourcing
  • Preservation of product expertise by transferring assembly employees to KDI
  • Partnership with an experienced medical manufacturer (ISO 13485 certified, FDA registered)
  • KDI's CEO has deep knowledge of Nuwellis' operations from previous role
Negative
  • Potential operational risks during manufacturing transition
  • Loss of direct control over manufacturing operations

Insights

Nuwellis' manufacturing outsourcing to KDI should reduce costs while maintaining quality through employee retention and leadership familiarity with Aquadex products.

This manufacturing outsourcing agreement represents a significant operational restructuring for Nuwellis that addresses several critical business challenges simultaneously. By transitioning assembly of their Aquadex SmartFlow Console and related components to KDI, Nuwellis is implementing a classic vertical de-integration strategy that should reduce fixed operating costs while maintaining product quality.

The deal structure includes three particularly noteworthy elements that mitigate typical outsourcing risks:

  • KDI will hire Nuwellis' existing assembly employees, preserving institutional knowledge and expertise
  • KDI's CEO (Vitaliy Epshteyn) previously served as Nuwellis' SVP of Operations for 6 years
  • KDI is already ISO 13485 certified and FDA registered, critical qualifications for medical device manufacturing

From an operational perspective, this arrangement allows Nuwellis to transform fixed manufacturing costs into variable ones, potentially improving gross margins while retaining core competencies in R&D, sales, and customer service. The geographic proximity (Rogers, MN to Minneapolis) also minimizes supply chain disruption risk.

This move aligns with broader medical device industry trends where smaller companies focus on innovation and market development while leveraging specialized contract manufacturers for production. The specific mention of "next phase of growth" suggests this restructuring is part of a broader strategic plan to scale operations more efficiently.

Strategic agreement is expected to reduce costs, preserve expertise, and streamline operations.

WHOWHATWHEREWHENWHY
Nuwellis, Inc. (Nasdaq: NUWE) and KDI Precision ManufacturingOutsourcing manufacturing and assembly of key Aquadex product components.Manufacturing operations will transition to KDI’s facility.May 9, 2025To strengthen operational efficiency, preserve product expertise, and reduce costs.

MINNEAPOLIS, May 12, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company dedicated to transforming fluid management care, today announced it has finalized an agreement with KDI Precision Manufacturing to support the next phase of Nuwellis’ growth. This strategic relationship is expected to expand Nuwellis' manufacturing capabilities, streamline operations, and enhance the company's ability to deliver high-quality products to healthcare providers and patients.

Under the agreement, KDI will assume assembly responsibilities for the Aquadex SmartFlow® Console, AquaFlexFlow® Blood Circuits, and dELC® Catheters.

KDI, founded in 1982 and ISO 13485 certified and FDA registered, brings decades of medical manufacturing experience, with over 80% of its business focused on healthcare products. KDI is located in Rogers, MN and serves a variety of customers from Fortune 500 to start-up companies.

To ensure a seamless transition and protect product expertise, current Nuwellis assembly employees will be hired by KDI. Sales, customer service, product design, and post-market surveillance will continue to reside within Nuwellis.

“Our outsourcing agreement with KDI Precision Manufacturing marks an important milestone in our ongoing effort to operate more efficiently and responsibly,” said John Erb, Interim CEO of Nuwellis. “KDI’s expertise, operational rigor, and deep familiarity with the Aquadex system made them the clear choice to help us maintain our commitment to quality while reducing costs.”

“We are proud to collaborate with the Nuwellis team and are committed to supporting their growth,” said Vitaliy Epshteyn, CEO of KDI Precision Manufacturing. Epshteyn, current KDI CEO, is the former Nuwellis SVP of Operations, Engineering, and QA/RA, where he served for 6 years. “Our team’s specialized understanding of the Aquadex console and consumable circuits positions us to deliver manufacturing excellence and uphold the trust that physicians and patients place in Nuwellis products.”

Transition activities are set to begin shortly to support this next phase of growth.

For more information, visit www.nuwellis.com.

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.

About KDI Manufacturing Since 1982, KDI has been bringing creativity and intelligence to complex challenges in product development, contract manufacturing and precision machining for mechanical and electro-mechanical systems for medical applications. KDI builds complete medical devices, handles the entire supply chain, and provides finished good storage, order fulfillment, and complaint handling/repair services. KDI is currently in the process of adding a clean room to its facility. For more information visit www.kdimfg.com.

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.

For further information, please contact:

Investor Relations:
Louisa Smith
Gilmartin Group
ir@nuwellis.com

Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com


FAQ

What is the purpose of Nuwellis (NUWE) outsourcing manufacturing to KDI?

Nuwellis is outsourcing manufacturing to KDI to reduce costs, strengthen operational efficiency, and preserve product expertise while maintaining product quality.

What products will KDI manufacture for Nuwellis (NUWE)?

KDI will handle assembly for the Aquadex SmartFlow Console, AquaFlexFlow Blood Circuits, and dELC Catheters.

How will Nuwellis (NUWE) ensure quality control with KDI manufacturing?

KDI is ISO 13485 certified and FDA registered, with over 80% focus on healthcare products. Current Nuwellis assembly employees will be hired by KDI to maintain expertise.

What operations will remain with Nuwellis (NUWE) after the KDI agreement?

Nuwellis will retain control of sales, customer service, product design, and post-market surveillance operations.

Who is KDI's CEO and what is their connection to Nuwellis (NUWE)?

KDI's CEO is Vitaliy Epshteyn, who previously served as Nuwellis' SVP of Operations, Engineering, and QA/RA for 6 years.
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