Nuwellis Secures Exclusive U.S. Distribution Rights For Zorro-Flow® Pediatric Urine Collection System Supporting Non-Invasive Urine Collection And Earlier Identification Of Acute Kidney Injury In Neonates And Small Children
MINNEAPOLIS, Nov. 10, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced that it has secured exclusive U.S. distribution rights for the pediatric Zorro-Flow® urine collection system. Under the agreement, Nuwellis will serve as the commercial arm for the product in the U.S., further expanding its presence across neonatal and pediatric critical care.
Zorro-Flow is a non-invasive urine collection system designed for neonates and small children, offering clinicians an easy-to-use, safe, effective non-invasive alternative to traditional methods that do not work well.
“Accurately understanding urine output in our most vulnerable pediatric patients can provide clinicians with critical information about kidney function; yet, the tools traditionally available to collect and measure urine have significant limitations,” said Mike McCormick, Nuwellis President and Chief Executive Officer.“Zorro-Flow addresses an important unmet need with a non-invasive solution designed specifically for neonates and small children. With Nuwellis already deeply engaged with pediatric care teams across the country, we are well positioned to bring this technology to hospitals to ensure that babies and small children have the products they need.”
The exclusive distribution agreement builds on Nuwellis' established position in pediatric critical care. Aquadex SmartFlow®, the Company's ultrafiltration platform, is integrated into PICUs and CVICUs and has been adopted by 47 of the top U.S. children's hospitals as ranked by U.S. News & World Report. Nuwellis is also advancing development of VivianTM, its dedicated pediatric renal replacement therapy system currently intended for patients as small as 2.5 kg.
“Multiple observational studies show that a decrease in urine output is common and associated with mortality, so quantifying urine output in critically ill babies is essential. I have seen firsthand how challenging it is to collect urine in small baby girls whose urethra can be as small as a human hair,” said Dr. David Askenazi, MD, MSPH, Professor of Pediatrics and Founder and Chief Scientific Officer at Zorro-Flow Inc.“I started Zorro-Flow because babies and small children deserve safe and effective devices designed specifically for them. Partnering with Nuwellis allows us to bring this technology to babies and small children because Nuwellis has strong relationships with pediatric critical care teams across the country.”
In August 2026, Nuwellis entered into a co-promotion and distribution agreement with Atrility Medical for the FDA-cleared AtriAmp® device for pediatric and adult patients, which gives ICU clinicians continuous atrial electrograms at the bedside using existing monitoring and pacing equipment, beginning with a six-month pilot in select U.S. territories. The addition of Zorro-Flow with AtriAmp, is expected to broaden the Company's relationships with pediatric care teams and strengthen its commercial footprint within children's hospitals. By leveraging an established sales infrastructure and existing relationships with many of the hospitals and clinical specialists that represent potential Zorro-Flow customers, Nuwellis plans to move directly into full U.S. commercialization under the agreement beginning in the first quarter of 2027.
“Pediatrics has become an increasingly important part of Nuwellis' business and long-term strategy,” McCormick added.“Adding Zorro-Flow to our portfolio allows us to address another critical point in the care pathway by providing clinicians with a better way to assess urine output, adding to the technologies we offer to help manage complex fluid and cardiorenal conditions. Along with Aquadex and Atrility, Zorro-Flow further strengthens our ability to serve pediatric care teams with a broader portfolio of purpose-built technologies.”
With a patented ergonomic design, Zorro-Flow collects and measures urine safely and effectively. The devices are sterile and made of silicone materials designed for babies' sensitive skin. The system enables accurate urine collection and quantification without bladder catheterization, which is extremely difficult in small babies. By avoiding bladder catheterization and suprapubic needle puncture, it avoids pain and trauma, the agony of failed attempts, and eliminates the risk of catheter-associated urinary tract infection (CAUTI). Furthermore, because the urine doesn't contact absorbents (e.g. cotton balls), it provides reliable results of non-invasive urine biomarkers.
About the Zorro-Flow ® Urine Collection Device
The Zorro-Flow® Urine Collection Device is a patented, sterile, non-invasive system designed to collect and measure urine in newborns, infants, and young children. Available in four female sizes, the device accommodates patients ranging from extremely premature neonates to children aged years. The infant male products are expected in the second quarter of 2027. Made with soft, medical-grade silicone materials and adhesives, Zorro-Flow enables urine collection without bladder catheterization or suprapubic needle puncture. The device collects urine directly, helping preserve sample integrity for diagnostic testing while supporting urine output monitoring and early recognition of kidney dysfunction. Designed for use for up to 24 hours, Zorro-Flow products are registered and listed with the U.S. Food and Drug Administration (FDA) as Class II exempt medical devices.
About Zorro-Flow Inc.
Founded in 2022 by pediatric nephrologist Dr. David Askenazi, Zorro-Flow Inc. is a pediatric medical device company focused on addressing longstanding challenges in neonatal and pediatric care. Combining clinical, engineering, and manufacturing expertise, the company develops purpose-built solutions for newborns, infants, and young children. Its flagship technology is the patented infant Zorro-Flow® external urine collection system. For more information, visit .
About Aquadex
The Aquadex SmartFlow® System is currently indicated for the continuous ultrafiltration therapy 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 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis' strategy includes expanding its portfolio through internally developed technologies and strategic commercial partnerships that broaden its presence across acute and chronic critical care. For more information, visit .
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 2026 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.
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