Bright Uro, an Irvine-based medical device company focused on urology, has completed a new 1,500-square-foot clean room at its headquarters. This expansion is set to boost the in-house manufacturing capabilities for the company’s Glean Urodynamics System, a diagnostic device designed to test bladder function. The new facility will allow Bright Uro to produce nearly every part of its bladder testing system locally in Orange County.
The clean room is the latest addition to Bright Uro's approximately 16,000-square-foot Irvine headquarters, located within the city. The company recently signed a full lease for this space, having previously subleased it. At this location, Bright Uro already handles electronics assembly, research and development, and product packaging. The company states it only outsources lower-level components and specialized sterilization processes that require hazardous chemicals.
The Glean Urodynamics System features a small, flexible sensor that is inserted into the bladder through a sheath. This design frees patients from being physically tethered to a machine during testing. The system measures bladder pressure to help diagnose issues such as urinary incontinence and frequent urination. Bright Uro received FDA clearance for the Glean system last April. In May, the company obtained a second FDA clearance for a new sensor that expands the system's capabilities to measure abdominal pressure in conjunction with bladder pressure.
Following the initial FDA clearance, Bright Uro has increased its sales efforts and expanded its sales force to 12 representatives operating nationwide. Chief Executive Officer Derek Herrera reported that the company experienced a 'very successful release' after a limited soft launch of the device. Herrera, who founded Bright Uro in 2021 with personal insight into patient challenges from traditional bladder testing, projects continued growth.
Bright Uro currently employs about 75 individuals. The company plans to double its headcount over the next 12 to 18 months, a goal contingent on securing additional financing. To support this growth, Bright Uro expects to raise a Series C funding round, which would fund further hiring, including more sales representatives. The company previously raised $15 million in a Series B round and $32 million in an oversubscribed Series A round.
The core technology for the Glean system was licensed from the Cleveland Clinic. Bright Uro then developed the sensor concept further by adding a reusable digital scale, named the 'Uroflowmeter,' which measures the flow of urine. The company also created software applications for both clinicians and patients to download and access the collected data. Derek Herrera indicated that the next phase of product development will focus more heavily on software than on new devices, with a dozen new features planned for launch over the next year.
Herrera indicated that the algorithms developed would be impactful, citing the high quality data obtained from their sensors. Looking ahead, Herrera anticipates Bright Uro will need more space within the next one to two years. He stated that while he values Orange County, the permitting process for the clean room addition, which took approximately nine months longer than expected, was a deterrent for local expansion. Potential future locations outside Irvine include sites in Texas, Tennessee, or Mexico.
