Bright Uro Inc. this month received Food and Drug Administration approval for its first product, the Glean Urodynamics System.
It’s the biggest milestone to date for the Irvine medical device maker that for three years has worked on the three components making up the diagnostic system designed to improve bladder testing.
“The clearance enables us to now sell the product that we’ve been working so hard to develop, so that’s meaningful for the company from a business perspective,” Chief Executive Derek Herrera told the Business Journal.
Herrera said the Glean system is the first wireless, catheter-free method to measure bladder pressure for urodynamic monitoring.
The company plans to gradually roll out Glean to clinics throughout the third and fourth quarters of this year.
Funds from an oversubscribed $32 million Series A round, raised last October, will support the anticipated commercial launch in the U.S., as well as the development of additional products in its pipeline.
Scaling for Launch
The company estimates that 80 million Americans suffer from bladder issues.
“The biggest market for these types of procedures is the U.S. currently,” Herrera said.
Bright Uro’s Glean system replaces the need for patients to be hooked up to a machine.
There is a small sensor in a silicone tube that’s inserted into the bladder to measure pressure, then pulled out once the test is over. The single-use device will come in a disposable package with an insertion tool.
The Glean system will also consist of a reusable digital scale called the Uroflowmeter that measures the flow of urine going into it, as well as a web application for clinicians and mobile app for patients to download the data.
Bright Uro hasn’t disclosed how much Glean will cost yet.
Herrera said they will be sold directly to urologists and urogynecologists for in-clinic use.
Bright Uro has grown from Herrerra as its only employee to a full-time staff of over 30.
The company will “continue to grow much more rapidly this year,” he said.
Two months ago, the company added two new executives in preparation for Glean’s expected launch.
It announced the appointment of Dr. Scott MacDiarmid as chief medical officer and a four-person commercial leadership team to be led by Chief Commercial Officer Casey Kanel. The four leaders have worked at Medtronic, and each has more than 20 years of experience in sales and marketing in the urology field.
Herrera expects the company to have more than 100 employees by the end of this year with plans to hire manufacturing technicians and operations specialists.
Bright Uro manufactures and assembles Glean in Irvine and has “invested significantly” on its facility, doubling in size from 8,000 square feet to 16,000 square feet, according to Herrera.
“This will be the only facility that we have here for the foreseeable future, and we’re happy to have it here in Orange County,” Herrera said.
Former Marine Turned Entrepreneur
Herrera founded Bright Uro in 2021, understanding firsthand the unpleasantries of undergoing bladder testing.
A sniper’s bullet left the former Marine paralyzed from the chest down in 2012 while stationed in Afghanistan.
It was after the recovery process that Herrera became inspired to develop products to address unmet clinical needs that he experienced.
Herrera said that he’s “relatively young” to the urology space.
“I had a previous company that was unsuccessful in achieving this, so this is the first time I had a device I helped work on that’s achieved FDA clearance,” Herrera said. “It’s an incredible feeling.”
Prior to Bright Uro, Herrera founded UroDev Medical.
The San Clemente company was developing the IntelliFlow bladder management device for people suffering from urinary retention. UroDev ended up changing headquarters from San Clemente to Minneapolis and still hasn’t commercialized IntelliFlow yet.
