Core Viewpoint - Nuwellis, Inc. has finalized a strategic agreement with KDI Precision Manufacturing to outsource the manufacturing and assembly of key components of its Aquadex product line, aiming to enhance operational efficiency, preserve expertise, and reduce costs [1][2][5]. Company Overview - Nuwellis, Inc. is a medical technology company focused on transforming fluid management care, particularly through the commercialization of the Aquadex SmartFlow system for ultrafiltration therapy [7]. - KDI Precision Manufacturing, established in 1982, specializes in medical manufacturing with over 80% of its business dedicated to healthcare products and is ISO 13485 certified and FDA registered [3][9]. Agreement Details - Under the agreement, KDI will take over assembly responsibilities for the Aquadex SmartFlow® Console, AquaFlexFlow Blood Circuits, and dELC Catheters [3]. - Current assembly employees from Nuwellis will be hired by KDI to ensure a seamless transition and protect product expertise, while sales, customer service, product design, and post-market surveillance will remain with Nuwellis [4]. Strategic Importance - The outsourcing agreement is seen as a significant milestone for Nuwellis, aimed at improving operational efficiency and maintaining product quality while reducing costs [5]. - KDI's CEO, who has prior experience with Nuwellis, emphasizes the company's specialized understanding of the Aquadex system, positioning them to deliver manufacturing excellence [5]. Future Outlook - Transition activities are set to begin shortly to support Nuwellis' next phase of growth, indicating a proactive approach to enhancing manufacturing capabilities [5].