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

Nuwellis plans to use its existing sales infrastructure and hospital relationships for full U.S. commercialization beginning in the first quarter of 2027.

Rhea-AI Summary

Nuwellis (Nasdaq: NUWE) has secured exclusive U.S. distribution rights for Zorro-Flow, a non-invasive urine collection system for neonates and small children. Nuwellis will serve as the product’s U.S. commercial arm and plans to begin full U.S. commercialization in the first quarter of 2027, using its existing sales infrastructure and hospital relationships.

The agreement expands its pediatric portfolio alongside Aquadex and its AtriAmp distribution arrangement. Zorro-Flow products are registered and listed with the FDA as Class II exempt medical devices. Infant male products are expected in the second quarter of 2027.

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Positive

• Moderate pointExclusive U.S. distribution rights for Zorro-Flow expand Nuwellis’ pediatric commercial portfolio.
• Minor point. Forward-looking: it has not happened yet and may not happen.Full U.S. commercialization is planned beginning in the first quarter of 2027.
• Minor pointZorro-Flow products are registered and listed with the FDA as Class II exempt medical devices.
• Minor point. Forward-looking: it has not happened yet and may not happen.Infant male products are expected in the second quarter of 2027.

Negative

• None.

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On Nov 10, the day this news came out, the latest delayed price for NUWE is 0.19% above the previous close. Our momentum scanner has recorded 6 alerts for this stock so far that day. The latest delayed price is $5.25.

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Key Figures

U.S. commercialization start: Q1 2027 Infant male products: Q2 2027 Designed use duration: Up to 24 hours

U.S. commercialization start

Q1 2027

Planned start under the distribution agreement

Infant male products

Q2 2027

Expected availability

Designed use duration

Up to 24 hours

Zorro-Flow product use

Key Terms

catheter-associated urinary tract infection, suprapubic needle puncture, ultrafiltration, class ii exempt

4 terms

catheter-associated urinary tract infection medical

"eliminates the risk of catheter-associated urinary tract infection (CAUTI)"

An infection of the urinary tract that occurs in a person who had an indwelling urinary catheter at the time of, or within 48 hours before, onset of urinary symptoms; public health agencies (for example the US CDC) use that time window when classifying catheter-associated urinary tract infections (CAUTIs). Catheters provide a direct route for bacteria to enter the bladder and encourage formation of bacterial biofilms on catheter surfaces, which increases the likelihood of bacteriuria progressing to symptomatic infection such as fever, urinary urgency, pain, or systemic signs.

suprapubic needle puncture medical

"avoiding bladder catheterization and suprapubic needle puncture"

A suprapubic needle puncture is a medical procedure that uses a needle inserted through the lower abdominal wall, just above the pubic bone, to enter the urinary bladder. It is used to obtain urine samples, aspirate urine, or provide temporary bladder drainage when access through the urethra is unsuitable; the procedure is performed with local anesthesia and often imaging guidance, and it carries risks such as bleeding, infection, or injury to nearby organs if the bladder is not adequately distended or anatomy is altered.

ultrafiltration medical

"the Company’s ultrafiltration platform"

Ultrafiltration is a process that separates small particles and liquids from larger molecules or substances using a filter with tiny pores. It is often used in water treatment and medical applications to remove impurities or excess fluids. For investors, understanding ultrafiltration is important because innovations or changes in this technology can impact industries focused on clean water, healthcare, and filtration products.

class ii exempt regulatory

"listed with the U.S. Food and Drug Administration (FDA) as Class II exempt medical devices"

A Class II exempt device is a medical device that the U.S. Food and Drug Administration (FDA) classifies as moderate risk but has been given an exemption from the agency’s premarket notification (510(k)) requirement. The exemption means the manufacturer does not need to submit a 510(k) to demonstrate substantial equivalence before marketing, but the device remains subject to other applicable FDA requirements such as general controls (registration and listing, labeling, medical device reporting, and, when applicable, quality system (GMP) and certain special controls); some devices have partial or conditional exemptions that still require specific submissions or compliance steps.

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Agreement expands Nuwellis’ pediatric portfolio with a non-invasive solution designed to improve urine output collection and monitoring

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 Vivian™, 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 www.zorro-flow.com.

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 www.nuwellis.com.

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.

For further information, please contact:

Investor Relations:
CORE IR
ir@nuwellis.com

Media Contact:
CORE PR
media@nuwellis.com

FAQ

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What rights did Nuwellis secure for Zorro-Flow?

Nuwellis secured exclusive U.S. distribution rights for the pediatric Zorro-Flow urine collection system. It will serve as the product’s commercial arm in the U.S. The system is designed for non-invasive urine collection in neonates and small children.

When does Nuwellis plan to commercialize Zorro-Flow in the U.S.?

Nuwellis plans to begin full U.S. commercialization in the first quarter of 2027. The company intends to use its established sales infrastructure and existing relationships with hospitals and clinical specialists that represent potential Zorro-Flow customers.