Innovative patient-developed technology improves comfort, data accuracy, ease of use

Bright Uro, a medical device company with a mission to transform care for lower urinary tract dysfunction (LUTD) through innovations in urodynamics, today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Glean™ Urodynamics System, a comprehensive system that enables wireless, catheter-free ambulatory urodynamics designed to support clinical decision making for patients with LUTD and other urological conditions.

An estimated 80 million Americans suffer from voiding problems, including overactive bladder, urinary incontinence, enlarged prostate (BPH) and neurogenic bladder^1-4. Urodynamics is the science of testing how well the bladder, sphincters, and urethra hold and release urine to determine the source of leaks or blockages.

The Glean System moves beyond current catheter-based urethral pressure testing, which is uncomfortable for patients and often generates imprecise data. Glean is easier for clinicians to use⁵, delivers more accurate data⁵ to enable better-informed treatment plans, and offers a more comfortable experience for the patient⁵.

Bright Uro was founded by Derek Herrera in 2021 with the goal of developing the most advanced diagnostic sensors and machine learning for Urology. As a Marine Raider Special Operations Officer, Derek was paralyzed from the chest down by a sniper’s bullet in Afghanistan. After recovering, Derek was inspired to develop products to address unmet clinical needs that he personally experienced. He began his career as a medical device entrepreneur in 2015.

“I consider Glean to be the kind of diagnostic technology advance that the urology community has awaited for decades,” said Dr. Alan Wein of University of Miami. “The system produces information that is closer to a real-life situation than that generated in a urodynamics laboratory. New norms may have to be worked out, but ultimately, I think this has great potential for deciphering lower urinary tract symptomatology and thereby improving patient care.”

“Today, some providers forego urodynamics due to a paucity of equipment and trained nurses to administer the test,” said Dr. Melissa Kaufman of Vanderbilt University. “Given the simple and versatile nature of how Glean is delivered, we’ll be able to accelerate access so more patients can benefit from this important diagnostic information.”

“The majority of urologists, including myself, believe that current urodynamics testing is lacking," said Dr. Bilal Chughtai of Northwell Health. “With artificial filling and voiding with catheters in place, patients are often unable to replicate symptoms during the test. Urodynamics is uncomfortable for patients, sometimes even traumatic. Glean will enable patients to void naturally, without catheters in place. I believe this advance will yield a better test that mimics actual symptoms.”

“FDA clearance of the Glean Urodynamics System represents a historic milestone for our company,” said Derek Herrera, founder and CEO of Bright Uro. “This achievement is a direct result of the tremendous passion and dedication of our team, and we are excited to tackle our next great challenge – bringing this product to clinicians across the country to help them improve outcomes for millions of patients in need.”

About Glean

The Glean™ Urodynamics System is a urodynamic analyzer system that is intended to quantify the pressure and flow characteristics of the lower urinary tract. The system can be used in adult patients only to perform standard urodynamic tests such as uroflow, cystometrogram, urethral pressure profile, and micturition studies. The major application of urodynamics is the diagnosis of uncontrolled loss of urine (incontinence), abnormal urinary retention, or neurological cases of micturition disorder. The device is intended to be used as medical diagnostic equipment.

Bright Uro has obtained an exclusive licensing agreement from Cleveland Clinic for technology Cleveland Clinic developed in collaboration with the Department of Veterans Affairs, Case Western Reserve University, and Parker Hannifin Corporation.

About Bright Uro

Based in Irvine, Calif., Bright Uro’s mission is to transform care of lower urinary tract dysfunction (LUTD) with its innovative technology that is poised to disrupt outdated urodynamics approaches. The Company’s FDA-approved Glean™ Urodynamics System is designed to enable wireless, catheter-free ambulatory urodynamics monitoring, with the goal of improving patient comfort and clinical outcomes. For more information, visit www.GleanUDS.com.

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