Inside Bright Uro’s newly completed clean room, the urology-focused medical device startup is preparing to manufacture nearly every part of its bladder testing system in Orange County.
The 1,500-square-foot clean room is the latest addition to the company’s roughly 16,000-square-foot Irvine headquarters, where Bright Uro already handles electronics assembly, research and development and product packaging.
The clean room will support increased production of its bladder diagnostic device, the Glean Urodynamics System — a small, flexible sensor inserted into the bladder through a sheath, freeing patients from being tethered to a machine.
Over the next year, we expect as demand
“Over the next year, we expect as demand continues to grow, we’ll add more lines and more technicians,” Chief Executive Officer Derek Herrera told the Business Journal during a tour of the company’s facilities.
Herrera, a former Marine who became paralyzed while in combat, founded Bright Uro in 2021 with a personal understanding of the challenges patients faced during traditional bladder testing.
Since receiving FDA clearance for Glean last April, Herrera said the company has stepped up sales efforts and increased its sales force to 12 representatives nationwide.
Herrera did not disclose exact revenue, but said
Herrera did not disclose exact revenue, but said Bright Uro had a “very successful release” following a limited soft launch.
The company expects to raise a Series C round to fund additional hiring, including more sales representatives. It previously raised $15 million in a Series B and $32 million in an oversubscribed Series A.
Bright Uro employs about 75, Herrera said, with plans to double its headcount over the next 12 to 18 months, contingent on financing.
Obtains Second FDA Clearance Bright Uro is ramping
Obtains Second FDA Clearance
Bright Uro is ramping up production following its second FDA clearance in May for a new sensor, adding the ability to measure abdominal pressure alongside bladder pressure.
The company recently signed a full lease for its roughly 16,000-square-foot headquarters in Irvine after previously subleasing the space.
Bright Uro handles electronics assembly, R&D and packaging in-house at its facility. The company outres hazardous chemicals
“At a certain point, we hope to outgrow this facility,” Herrera said.
Herrera expects Bright Uro will need more room
Herrera expects Bright Uro will need more room within the next year or two, potentially at its current site or elsewhere in Texas, Tennessee or Mexico.
While he said he “loves Orange County,” Herrera pointed to the lengthy, complex permitting process for the clean room addition, which took about nine months longer than expected, as a deterring factor.
Licensed Tech From Cleveland Clinic
Bright Uro licensed the technology for the Glean system from renowned academic medical center Cleveland Clinic in Ohio.
The technology measures bladder pressure for urodynamic monitoring,
The technology measures bladder pressure for urodynamic monitoring, which helps pinpoint the cause of bladder issues including urinary incontinence and frequent urination.
Bright Uro then took the idea for the sensor and added a reusable digital scale named the “Uroflowmeter,” which measures the flow of urine going into it, as well as software apps for clinicians and patients to download the data.
Bright Uro’s next phase of product development will lean more heavily on software than devices, with a dozen new features scheduled to launch over the next year
In April, the company launched a patient registry
In April, the company launched a patient registry to collect de-identified data for future device development and clinical research.
“The algorithms that we’ll be able to develop will be incredibly impactful because we have the highest quality data coming off of our sensors,” Herrera said.
Enrollment is underway for current Glean users.
