Nuwellis' Vivian Receives $3 Million NIH Grant to Accelerate Pediatric Platform and Strengthen Fluid-Management Portfolio
MWN-AI** Summary
Nuwellis Inc. (NASDAQ: NUWE) announced a significant milestone with the award of an approximately $3 million multi-year grant from the National Institutes of Health (NIH) to its development partner, Koronis Biomedical Technologies Corporation (KBT). This funding aims to accelerate the development of Vivian™, a dedicated pediatric continuous renal replacement therapy (CRRT) device designed for patients weighing between 2.5 and 20 kg, a demographic with limited therapeutic options for kidney support.
Vivian is intended to provide precise and gentle fluid management tailored specifically for neonates and young children suffering from kidney failure. As current clinical practices often adapt adult technologies for pediatric use, Vivian represents a much-needed innovation, focusing on safety and efficacy for the most vulnerable patients. The device builds upon Nuwellis’ existing Aquadex SmartFlow® technology, which is currently approved for use in adults and larger pediatric patients (20 kg and above).
Nuwellis' CEO, John Erb, emphasized the importance of offering solutions that are specifically designed for children rather than adaptations from adult treatments. The grant will support the critical development of core software and firmware as well as the initiation of an investigational device study expected to enroll around 15 patients. Notably, while KBT will manage the program and allocate funds, Nuwellis maintains full rights to the technology and its intellectual property.
With this grant, Nuwellis aims to enhance Vivian’s readiness for commercial use while also strengthening its broader fluid-management portfolio, potentially opening new avenues for growth as it continues to address the pressing needs of pediatric care in the renal space.
MWN-AI** Analysis
Nuwellis Inc. (Nasdaq: NUWE) has recently received a significant boost in momentum with a $3 million grant from the National Institutes of Health (NIH) meant to accelerate the development of its pediatric continuous renal replacement therapy (CRRT) device, Vivian™. This funding not only emphasizes the potential of Vivian in a niche yet critical market but also reflects growing institutional support for innovative medical solutions tailored for pediatric patients.
With options for treating kidney failure in children weighing between 2.5 kg and 20 kg severely limited, the introduction of a dedicated device like Vivian represents an important advancement. Nuwellis' strategy appears well-aligned with market needs, as it builds upon existing technology—the Aquadex SmartFlow® system—expanding its applications to a previously underserved patient population.
From a market analysis perspective, this development is poised to enhance Nuwellis’ growth potential. The company is working towards an investigational device study that will support its case for FDA approval. Successful commercialization of Vivian would not only diversify Nuwellis' product offerings but also solidify its position in the pediatric market, providing significant competitive advantages.
Investors should monitor the upcoming phases of the investigational study and the market's response to the device. The company’s retention of full rights to technology developed under this NIH grant adds another layer of financial security, positioning it well for potential licensing deals, partnerships, or equity investments in the years ahead.
Overall, the market sentiment surrounding Nuwellis should be cautiously optimistic. While challenges remain, particularly around regulatory pathways and market acceptance, this grant could act as a catalyst for Nuwellis, providing necessary funding and validating its innovations toward improving pediatric healthcare. Investors may find value in this growth-oriented narrative as Nuwellis continues on its regulatory journey.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Awarded grant supports dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients between 2.5 and 20 kg where therapeutic options are scarce
Company working to advance Vivian™ towards an investigational device study to support the path to US regulatory clearance
MINNEAPOLIS, Sept. 09, 2025 (GLOBE NEWSWIRE) -- Nuwellis Inc. (Nasdaq: NUWE), announced today that the National Institutes of Health (NIH) has awarded an approximately $3 million multi-year grant to its development partner, Koronis Biomedical Technologies Corporation (KBT). The NIH-supported program will accelerate Vivian™, Nuwellis’ dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients under 20 kilograms, and advance core software and firmware that strengthen the company’s broader portfolio.
For babies and small children with kidney failure or who require artificial kidney support, therapeutic options remain limited. Clinicians often adapt technologies built for adults, which can create challenges for the smallest patients. Vivian is being designed to meet these needs head-on with a pediatric-specific approach to precise, gentle fluid management. The program builds on the company’s Aquadex SmartFlow ® technology, which is currently indicated for adults and pediatric patients 20 kg and above, and aims to extend support to children under 20 kg.
“Every conversation with a pediatric ICU team brings us back to the same truth — families need options that were built for their child, not borrowed from adult care,” said John Erb, Chief Executive Officer of Nuwellis. “This grant helps us finish critical software and firmware development, run the initial investigational study, and move Vivian toward commercial readiness. Just as important, the technology we’re building for these kids strengthens our entire platform and opens real avenues for growth for Nuwellis.”
The award will fund firmware and software development and support an FDA investigational device study expected to enroll approximately 15 patients. KBT will administer the program and disburse funds to Nuwellis under the collaboration, and Nuwellis retains full rights to the technology and intellectual property created.
For more information, visit www.nuwellis.com .
About Vivian Vivian is a purpose-built pediatric CRRT system designed from the ground up for neonates and children. The platform targets an extracorporeal blood volume of 29–67 mL and features integrated hematocrit and SvO? sensors for real-time monitoring. Vivian brings three therapies—UF, CVVH, and CVVHD—onto a single platform with closed-loop ultrafiltration control tailored to patient weight. A guided, clinician-informed interface with on-screen prompts streamlines setup and reduces training burden, while a 6-port circuit provides flexible vascular-access options. Intended for patients 2.5–20 kg, Vivian was developed with direct input from pediatric ICU and nephrology teams to prioritize safety, precision, and simplicity for the most fragile patients.
Disclaimer: Vivian is an investigational device, under development, and not available for sale. Features and specifications are subject to change.
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 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.
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:
Jenene Thomas
JTC
NUWE@jtc.com
Media Contact:
Leah McMullen
Director of Communications
Leah.mcmullen@nuwellis.com
FAQ**
How does the NIH grant awarded to Nuwellis Inc. (NUWE) enhance the development and clinical potential of the Vivian™ CRRT device for pediatric patients under 20 kg, considering the current lack of therapeutic options?
What specific advancements in firmware and software does Nuwellis Inc. (NUWE) anticipate achieving with the support of the NIH grant, and how will these impact patient care in pediatric nephrology?
Can you elaborate on the collaboration between Nuwellis Inc. (NUWE) and Koronis Biomedical Technologies Corporation in administering the NIH-funded program, particularly regarding project milestones?
What are the projected timelines and key steps for Nuwellis Inc. (NUWE) to move Vivian™ through the FDA investigational device study and towards potential commercialization for pediatric patients?
**MWN-AI FAQ is based on asking OpenAI questions about Nuwellis Inc. (NASDAQ: NUWE).
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