Irvine’s Bright Uro Receives FDA Approval for Glean System

News Summary

Bright Uro Inc. from Irvine, California, has achieved a pivotal milestone by receiving FDA approval for the Glean Urodynamics System. This innovative, wires-free and catheter-free solution is poised to revolutionize bladder testing, making it less invasive and more patient-friendly. The company is set to roll out the Glean system across U.S. clinics later this year, serving a market that impacts 80 million Americans. Backed by $32 million in funding, Bright Uro aims to expand its team and develop further urological technologies.

Irvine: Innovation in Bladder Health Takes a Major Leap Forward!

Exciting news is making waves in the world of medical technology from sunny Irvine, California. Bright Uro Inc. has achieved a groundbreaking milestone by receiving FDA approval for its first product, the Glean Urodynamics System. This marks a significant achievement for the innovative company, which has spent three long years developing a system that could transform bladder testing for millions.

The Glean System: A Game Changer in Urodynamics

The Glean Urodynamics System is not your typical bladder testing solution. With its unique design, the system features three sophisticated components that work together seamlessly to improve the accuracy and comfort of bladder assessments. What sets the Glean apart is that it is the first wires-free and catheter-free method specifically designed to measure bladder pressure. This advancement promises to make bladder testing less invasive and more patient-friendly.

Looking Ahead: Commercial Rollout and Target Audience

With the green light from the FDA, Bright Uro is ready to hit the ground running. They plan to roll out the Glean system gradually to clinics across the country during the third and fourth quarters of this year. Bladder health issues impact an estimated 80 million Americans, making the United States the largest market for urodynamic procedures. Bright Uro is poised to meet a substantial need, providing a solution that can significantly enhance patient care.

Financial Backing Fuels Development

In preparation for this commercial launch, Bright Uro successfully raised an impressive $32 million in an oversubscribed Series A funding round last October. This substantial financial backing will not only support the rollout of the Glean system but also aid in the development of additional urology products. As the company gears up for growth, they anticipate expanding their team from the current staff of over 30 employees to more than 100 by the end of the year. They are looking to hire manufacturing technicians and operations specialists to boost production capabilities.

What’s Inside the Glean System?

The Glean system features a small sensor that is inserted into a silicone tube to measure bladder pressure before being safely removed after the testing is complete. The device is designed for single-use and will come packaged with a disposable insertion tool for added convenience. In addition to the pressure measurement tool, the system includes a reusable digital Uroflowmeter that will measure urine flow and a web application tailored for clinicians, along with a mobile app optimized for patients.

Bright Uro’s Remarkable Growth

Since its inception, Bright Uro has rapidly expanded its operations and expertise. To augment its production capabilities, the company doubled the size of its manufacturing facility from 8,000 to 16,000 square feet. The leadership team has also seen significant growth, with the recent appointment of a Chief Medical Officer and a new commercial leadership group. Together, they bring over 20 years of experience in the urology field, ensuring that Bright Uro is in capable hands as it ventures into the market.

A Personal Journey of Innovation

The founder of Bright Uro, who deeply understands the challenges of bladder health, was inspired to create this innovative technology after experiencing firsthand the difficulties associated with bladder testing due to a spinal injury sustained in combat. The successful FDA clearance of the Glean Urodynamics System marks a significant turnaround from an earlier venture that did not come to fruition. A collaborative effort involving esteemed institutions like the Cleveland Clinic, the Department of Veterans Affairs, and Case Western Reserve University has helped bring the Glean system to life, making it a promising tool for transforming and improving patient care in urology.

In short, with the Glean Urodynamics System, the future of bladder health looks brighter than ever, and Bright Uro is ready to lead the charge into this vital field.

Deeper Dive: News & Info About This Topic

HERE Resources

Additional Resources

• Orange County Business Journal
• Business Wire
• MassDevice
• Urology Times
• MedCity News
• Wikipedia: Urodynamics
• Google Search: Glean Urodynamics System
• Google Scholar: Glean Urodynamics System FDA
• Encyclopedia Britannica: Urodynamics
• Google News: Bright Uro FDA