Nuwellis Announces Peer Reviewed Data Demonstrating 71% Survival with Kidney Replacement Therapy Using a Modified Aquadex in Low-Birth-Weight Preterm Neonates

Rhea-AI Summary

Nuwellis, Inc. (NUWE) announced promising clinical data demonstrating the efficacy of kidney replacement therapy using ultrafiltration for preterm neonates with end-stage kidney disease. A retrospective study revealed that 71% of the seven neonates studied survived to hospital discharge. The company aims to address unmet needs in neonatal fluid management and is developing a new pediatric CRRT device with partial funding from a $1.7 million NIH grant, collaborating with Koronis Biomedical Technologies Corporation.

Positive

• 71% survival rate for preterm neonates in the study.
• Development of a new pediatric continuous renal replacement therapy device funded by a $1.7 million NIH grant.
• Partnership with Koronis Biomedical Technologies Corporation to enhance neonatal care.

Negative

• The Aquadex SmartFlow system is currently only FDA-cleared for patients weighing 20 kg or more, limiting its use in smaller neonates.
• No sponsorship of the study may raise concerns about the reliability of the findings.

Findings Demonstrate Encouraging Results for Pediatrics with Kidney Failure Treated with Kidney Replacement Therapy

MINNEAPOLIS, Nov. 03, 2022 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (NasdaqCM: NUWE), a medical technology company focused on transforming the lives of people with fluid overload, today announced the publication of promising clinical data supporting the use of kidney replacement therapy with ultrafiltration to treat preterm, low weight neonates with end-stage kidney disease in Pediatrics.

The investigator-led, retrospective study examined seven preterm neonates with end-stage kidney disease who were successfully managed using an innovative approach to kidney replacement therapy using a physician modified Aquadex SmartFlow ultrafiltration system, which is cleared by the U.S. Food and Drug Administration only for use in adults and pediatric patients weighing 20 kg (44 lbs.) or more. Five of the seven newborns (71%) survived to hospital discharge.

Managing neonates with kidney failure can be challenging, as dialysis and other therapies used to treat kidney failure are typically designed for adults or larger pediatric patients. These challenges are especially pronounced in preterm neonates. Interventions are sometimes not available for these small patients, who are typically transitioned to palliative care, or a medical caregiving approach aimed at optimizing quality of life and mitigating suffering among neonates with serious, complex, and often terminal illnesses. However, many of these patients are otherwise healthy and would be considered survivable if kidney replacement therapy were available.¹

“Physicians continue to express the urgent need for neonatal fluid management therapies designed to support small children and infants,” said Nestor Jaramillo, Jr., President and CEO of Nuwellis. “We remain committed to developing safe innovations and bringing them to market as quickly as possible to address this critical unmet need. This patient population continues to be an important and fast-growing segment of our business.”

Nuwellis, which did not sponsor the study that is the subject of the publication, is currently developing a new, fully integrated pediatric continuous renal replacement therapy (CRRT) device designed to provide care for small babies and children under 20 kg. This device is funded in part by a $1.7 million grant from the National Institutes of Health (NIH). Nuwellis has partnered with Minneapolis-based research and development firm Koronis Biomedical Technologies Corporation (KBT), the grant recipient, to design and develop a custom pediatric product that will enable clinicians to better care for babies with limited kidney function.

About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The Company is focused on developing, manufacturing and commercializing the Aquadex SmartFlow® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, MN, with a wholly owned subsidiary in Ireland.

About the Aquadex SmartFlow® System
The Aquadex SmartFlow system delivers clinically superior 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.

Forward-Looking Statements
Certain statements in this release are 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 2022 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 impact of the COVID-19 pandemic, 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 as a result of new information, future events or otherwise.

---

¹ Sutherland SM, Davis AS, Powell D, Tanaka J, Woo M, Josephs S, Wong CJ. Kidney Replacement Therapy in Low Birth Weight Preterm Newborns. Pediatrics. 2022 Sep 1;150(3):e2022056570. doi: 10.1542/peds.2022-056570. PMID: 35945293.

FAQ

What clinical results did Nuwellis announce regarding kidney replacement therapy for neonates?

Nuwellis reported a 71% survival rate among preterm neonates with end-stage kidney disease treated with ultrafiltration.

What is the significance of the $1.7 million NIH grant for Nuwellis?

The NIH grant supports the development of a new pediatric CRRT device aimed at improving care for neonates under 20 kg.

How does Nuwellis plan to address the needs of neonates with kidney failure?

Nuwellis is developing innovative kidney replacement therapies tailored for small patients, emphasizing their commitment to this market.

What are the limitations of the Aquadex SmartFlow system?

The system is FDA-cleared only for patients weighing 20 kg or more, which restricts its application in smaller neonates.

Who partnered with Nuwellis for the development of the pediatric CRRT device?

Nuwellis has partnered with Koronis Biomedical Technologies Corporation for the design and development of the pediatric device.