In 2022, Dr. David Askenazi founded Zorro-Flow after years of struggling to find tools needed to care for critically ill babies with kidney disease. Zorro-Flow exists because babies and small children deserve safe and effective devices to assess kidney health.

Dr. Stuart Goldstein (aka Superman and founder of acute care nephrology Hall of Justice). The first part of the name credits Dr. Askenazi aka Zorro. The second part is to remind us that when we "Go With the Flow" everything is better.

All skin-contact materials (cup) are silicone-based. The tubing, luers and bag are NOT made with natural rubber latex.

The Instructions for use specifies use only up to 24 hours.

Make sure to wait for 3 -5 minutes for the liquid adhesive to dry. Make sure that the ridge at the bottom of the cup is placed first such that it enters into the introitus. Press for 20 seconds to secure. Use adhesive tape to secure in place.

Always use a a silicone-based adhesive removal pads. Remove the device slowly.

The instructions for use specify product is for single use only.

The diameter of the tubing is around 2 mm. The length is around 3 feet and the volume of the entire tube is 2.5 mL.

To assure that the urine doesn't back up, make sure that the bag is below the level of the bladder.

Yes, the cup, tubing, and urine collection bag are sterile.

You should not need to in most situations, but you can unscrew the male and female leurs to position the tubing.

You can; however, we designed the device so that the syringe will only fit the distal port (the one connected to the collection bag). The syringe can not be connected to the proximal luer due to a concern that suction can damage the skin with a well-adhered cup.

Only a percutaneous bladder cauterization has very low rates of contamination. Other procedures to collect a urine culture (indwelling catheter, collection bag) are at risk of contamination. Current tests are underway to determine the rate of contamination with Zorro-Flow compared to bladder catheterization and bags. We expect results in 2025.

Yes, we anticipate a medium and large version in 2025.

Yes, we anticipate a male version being available in 2025.

Physicians, nurses, engineers, and wound experts from the University of Alabama at Birmingham, and Children's of Alabama.

Through an IRB-approved study, we designed, 3-D printed, and tested devices until we found an ergonomic cup designed to fit comfortably and minimize leaking.

Under an IRB with approved protocol and parental consent, 86 neonates and infant females, <10 kg who did NOT require strict intake/output, did not have any skin breakdown or urogenital abnormalities. (Median gestational age = 35.2 (range 22.9 - 40.6) weeks; median post-menstrual age = 40.1 (range = 24.6 - 103 weeks); Median weight = 3.1 kg (range = 0.6 = 9.2 kg).

Through an iterative approach we designed and printed 11 different product designs. Each design was tested on at least 2 babies until we achieved optimal fit and clinical outcomes.

We tested multiple silicone-based, FDA-approved products. We chose 'Skinister' adhesive liquid and 'DermaHug' tape because of optimized ease-of-use, with adequate (but not excessive) adherence properties.

We evaluated the skin using a 5-point skin assessment tool. If any of the 5 elements were abnormal, it was determined that there was a skin issue. We evaluated the skin before placement, immediately after removal and 24 hours after removal.

Only 3 patients out of 86 had mild redness after removal of the device. All 3 improved in less than one hour and no skin issues were evident at 24 hours. Importantly, 2 of the 3 that had transient redness incorporated low pressure wall suction, which was NOT included in the final design.

As of November 2024, the device received patent designation from Japan. Patent is pending in United States, Canada, Australia, European Union, and Brazil.

Yes. All documentation and registration procedures have been completed. Zorro-Flow female urine collection devices are listed as FDA - Class 2 exempt (i.e., exempt from FDA review of a premarket notification [510k]).

All tests required by the FDA were passed including: bioburden, stability, sterilization, residuals, transportation, physical properties, and biocompatibility (skin irritation, mucosal irritation, cytotoxicity, and sensitization).

Contact us at info@zorro-flow.com and we will work with your hospital to become a vendor.

Yes, please contact us at info@zorro-flow.com and we will work with your hospital to organize a product trial.

No. Zorro-Flow is only available through direct purchase. Please contact us at info@zorro-flow.com for more information.

No. Zorro-Flow is only available through direct purchase from a clinic or hospital. Please contact us at info@zorro-flow.com for more information.

Not at this time. Although we recognize that Zorro-Flow has potential applications in adults, we are currently focused on neonates and small children as the population with the biggest need. We anticipate adult sized devices being available in 2026.

Not at this time. We are currently focused in the US. We do have plans for expansion outside of the US market in 2026.