A new UAB startup is working to improve care for neonates.
In July, Dr. David Askenazi, medical director of the Pediatric and Infant Center for Acute Nephrology at Children’s of Alabama, and his team launched Zorro-Flow, a neonatal external urine-collection device, which has been designed to collect urine more safely and effectively in critically ill female neonates and children.
Askenazi, a professor and W. Charles Mayer Endowed Chair in Pediatric Nephrology at the University of Alabama at Birmingham, was inspired to "bring innovation to the bedside" when he heard a colleague speak about how important medical innovation is and how academics should devote time and effort to inventing devices and products to aid patients’ health, rather than only focusing on observing and reporting.
“After all, we have a front row seat in understanding where the gaps in optimal care exist," Askenazi said in a news release.
Askenazi gathered a business team, including James Wilkie and Bruce and Eva Ovitt. Wilkie has 35 years of experience in the life sciences industry developing both drugs and devices. Bruce and Eva Ovitt brought experience in various healthcare business startups, branding, marketing and sales. The Harbert Institute for Innovation and Entrepreneurship assisted them in disseminating management duties and helped give Askenazi a basic foundation in entrepreneurship.
To bring Zorro-Flow from paper sketches to a physical device, the team also enlisted the help of Martin Holland, then a graduate student in the UAB School of Engineering. Two nurses from Children’s, Elizabeth Dechant and Shelby Leverett, advised on the design of the device. As ostomy nurses, they provided insight on how to adapt the device to provide the most comfort for young patients.
Among neonates, collection and recognition of whether urine is being produced is essential, but current urine-collection methods used in neonates are often can vary in effectiveness. Due to the lack of accurate tools, current clinical practices vary among institutions.
“In every critically ill patient at our institution, we can reliably collect urine. The exception happens to be some of the most vulnerable patients: premature neonates and children,” Askenazi said. “As a world leader in the field of neonatal nephrology, I am convinced that providers will care for these vulnerable children better if we have the right tool.”
The goal is to bring the device to bedside by 2023.
Askenazi said the Harbert team provided framework and guidance for forming a team, developing a plan, applying for internal seed funds and the steps needed to file an international patent.
In 2020, the HIIE split $300,000 among 11 UAB early-stage projects – including Zorro-Flow – as part of the U.S. Economic Development Administration’s Regional Innovation Strategies program, now known as the Build to Scale program. The initial pilot funding for Zorro-Flow prototypes came from the Tolwani Innovation Fund in Nephrology.
Within the next year, Askenazi hopes to file the female version of Zorro-Flow as an FDA class 2 device, which will require manufacturing systems, regulatory documents and quality evaluations. Such evaluations have already begun, he said. He also hopes to solidify the business framework, complete the Series A funding round and launch the devices for beta testing at several large academic centers focused on neonatal nephrology.
Within three years, Askenazi looks to complete the Series B funding round, file the male version as an FDA class 2 device and scale up the manufacturing of the Zorro-Flow devices.
