Strategic agreement is expected to reduce costs, preserve expertise, and streamline operations.
| WHO | WHAT | WHERE | WHEN | WHY |
| Nuwellis, Inc. (Nasdaq: NUWE) and KDI Precision Manufacturing | Outsourcing manufacturing and assembly of key Aquadex product components. | Manufacturing operations will transition to KDI's facility. | May 9, 2025 | To 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
