Nuwellis’ Vivian Receives $3 Million NIH Grant to Accelerate Pediatric Platform and Strengthen Fluid-Management Portfolio

Rhea-AI Summary

Nuwellis (Nasdaq: NUWE) has secured a significant $3 million multi-year NIH grant through its development partner Koronis Biomedical Technologies Corporation. The funding will accelerate the development of Vivian™, a dedicated pediatric continuous renal replacement therapy (CRRT) device designed for patients weighing between 2.5 and 20 kg.

The grant will support firmware and software development and fund an FDA investigational device study targeting approximately 15 patients. Vivian builds upon Nuwellis' Aquadex SmartFlow® technology, currently approved for patients 20 kg and above, addressing a critical gap in pediatric renal care where therapeutic options are limited.

Positive

• Secured $3 million NIH grant funding for pediatric device development
• Expanding addressable market to include patients under 20 kg
• Technology development will strengthen entire product platform
• Company retains full rights to technology and intellectual property

Negative

• FDA approval still pending with clinical trials yet to begin
• Limited initial study size of only 15 patients

Insights

Biomedical Engineering Expert

NIH's $3M grant accelerates Nuwellis' pediatric renal device development, addressing crucial treatment gaps for small children with kidney failure.

The $3 million NIH grant awarded to Nuwellis' development partner represents a significant advancement for their pediatric continuous renal replacement therapy (CRRT) platform. The Vivian device targets a critical treatment gap for patients weighing between 2.5 and 20 kg - precisely where current therapeutic options are most limited. This development builds upon their existing Aquadex SmartFlow technology by extending support to smaller children who currently face treatment with adapted adult devices.

From an engineering perspective, designing specialized fluid management systems for pediatric patients presents unique challenges requiring precise control systems. Small children have significantly lower blood volumes and reduced physiological reserves compared to adults, making fluid removal tolerance margins extremely narrow. The grant funding for firmware and software development suggests Nuwellis is focusing on creating sophisticated control algorithms capable of the gentle, precise fluid management these vulnerable patients require.

The upcoming investigational device study with approximately 15 patients will be crucial for validating the technology's safety profile and efficacy parameters. What's particularly noteworthy is that the technology developed specifically for pediatric applications will strengthen Nuwellis' entire platform - the control systems and software refinements needed for the extreme precision in pediatric applications will likely enhance their adult offerings as well, creating technological synergies across their product portfolio.

Healthcare Investment Analyst

This NIH grant brings substantial strategic value beyond the immediate $3 million funding. For Nuwellis, a company focused on fluid management technologies, the grant addresses two critical business objectives: expanding their addressable market to include smaller pediatric patients and strengthening their core technology platform.

The pediatric CRRT market represents a specialized niche with limited competition due to technical challenges in treating patients under 20 kg. By developing Vivian, Nuwellis is targeting an underserved segment where clinicians currently resort to adapting adult technologies - a suboptimal approach that creates demand for purpose-built solutions. This strategic expansion extends their Aquadex technology into smaller patient populations, potentially capturing additional institutional contracts.

Beyond the immediate pediatric application, the grant supports development of core software and firmware that will benefit Nuwellis' broader product portfolio. This technology transfer effect multiplies the grant's value by enhancing their competitive position across multiple product lines. The collaboration structure with Koronis Biomedical Technologies (KBT) is particularly advantageous - while KBT administers the grant, Nuwellis retains full intellectual property rights, ensuring complete commercialization control.

The planned FDA investigational study with approximately 15 patients creates a clear regulatory pathway, establishing milestones investors can track. While full commercialization remains distant, this grant significantly de-risks the development process by providing non-dilutive capital for a technology that could meaningfully expand their addressable market.

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 SvO₂ 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

What is the purpose of Nuwellis' $3 million NIH grant for the Vivian device?

The grant will accelerate the development of Vivian™, a pediatric CRRT device for patients under 20 kg, supporting software development and an FDA investigational device study.

What patient population will Nuwellis' Vivian CRRT device target?

Vivian is designed specifically for pediatric patients weighing between 2.5 and 20 kg who require continuous renal replacement therapy.

How many patients will be enrolled in Nuwellis' Vivian device clinical study?

The FDA investigational device study is expected to enroll approximately 15 patients.

How does Vivian differ from Nuwellis' existing Aquadex SmartFlow technology?

While Aquadex SmartFlow is approved for patients 20 kg and above, Vivian is specifically designed for smaller pediatric patients under 20 kg, addressing an unmet need in pediatric renal care.

Who owns the intellectual property rights for Nuwellis' Vivian technology?

Nuwellis retains full rights to the technology and intellectual property created, despite the grant being administered through their development partner KBT.