Bright Uro, an Irvine-based medical device startup, has significantly expanded its local production capabilities with the completion of a new 1,500-square-foot clean room at its Orange County headquarters. The company, which specializes in urology-focused medical devices, is now equipped to manufacture nearly every part of its bladder testing system within the facility.
This new clean room is a key addition to Bright Uro’s approximately 16,000-square-foot Irvine headquarters, where the company already conducts electronics assembly, research and development, and product packaging. The expansion is intended to support increased production of its flagship bladder diagnostic device, the Glean Urodynamics System. This system features a small, flexible sensor inserted into the bladder through a sheath, allowing patients greater freedom by not being tethered to a machine.
Chief Executive Officer Derek Herrera, who founded Bright Uro in 2021, brings a personal understanding to the challenges patients face during traditional bladder testing, having become paralyzed while in combat as a former Marine. Herrera indicated that as demand continues to grow, Bright Uro expects to add more production lines and technicians over the next year.
The company has ramped up its operations since receiving FDA clearance for Glean last April. Following a limited soft launch, Herrera described the product’s release as “very successful,” and the company has since increased its sales force to 12 representatives nationwide.
Bright Uro further bolstered its product line with a second FDA clearance in May for a new sensor that adds the capability to measure abdominal pressure alongside bladder pressure. The company currently employs about 75 individuals and plans to double its headcount over the next 12 to 18 months, contingent on securing financing. To support this growth, Bright Uro expects to raise a Series C funding round, which will help fund additional hiring, including more sales representatives. The company has previously secured $15 million in a Series B round and $32 million in an oversubscribed Series A round.
Bright Uro recently signed a full lease for its Irvine headquarters, having previously subleased the space. The company handles most of its operations in-house, only outsourcing lower-level components and sterilization due to the hazardous chemicals involved. Looking ahead, Herrera expressed an ambition for Bright Uro to “outgrow this facility” within the next one to two years, potentially requiring more space at its current site or in other locations such as Texas, Tennessee, or Mexico.
Herrera noted that while he “loves Orange County,” the permitting process for the clean room addition, which took approximately nine months longer than anticipated, could be a factor in future expansion decisions. This extended timeline highlights the practical costs and complexities businesses can face with local regulations.
The core technology for the Glean system was licensed from the Cleveland Clinic. Bright Uro enhanced this technology by adding a reusable digital scale, known as the “Uroflowmeter,” which measures urine flow, and developed software applications for clinicians and patients to access data. This system measures bladder pressure for urodynamic monitoring, aiding in the diagnosis of bladder issues like urinary incontinence and frequent urination.
Future product development at Bright Uro is expected to focus more heavily on software, with a dozen new features slated for launch over the next year. In April, the company launched a patient registry to collect de-identified data for future device development and clinical research, with enrollment currently underway for existing Glean users. Herrera believes the algorithms developed from this high-quality data will be “incredibly impactful.”
