December 5, 2023 Source: drugdu 76
Bright Uro raised $23 million in Series A funds to help achieve FDA clearance for its urodynamics system and launch the product in the U.S. Should it be cleared, the system will become the first product on the market able perform urodynamic monitoring wirelessly and without a catheter, the company's CEO said.
By KATIE ADAMS
Bright Uro, a Irvine, California-based startup founded in 2021, is on a mission to make urodynamic testing more accurate for clinicians, more comfortable for patients, and more efficient for clinics.
On Thursday, the company announced it has raised $23 million to help it get closer to achieving those goals — the Series A funding round was led by Laborie Medical Technologies, a provider of urology diagnostic and therapeutic products.
The round reflects the total amount of equity investment Bright Uro has raised since its founding, said CEO Derek Herrera. The startup also received a $2 million grant from the National Institutes of Health to support product development and clinical research, he added.
The company plans to use its new funding to achieve FDA clearance for its urodynamics system and launch the product in the U.S.
Urodynamics — a set of tests that measure lower urinary tract function — is “the gold standard of care” for patients with people with complex lower urinary tract symptoms (LUTS), Herrea explained. The umbrella term LUTS is used to refer to many urinary issues in men and women, including urine flow complications, overactive bladder, stress urinary incontinence and benign prostatic hyperplasia.
The field of urodynamics is in need of innovation, Herrera declared. For starters, these tests often fail to accurately characterize patients’ symptoms, he noted.
“Due to the time, cost and space requirement of current urodynamics equipment, clinicians experience challenges with practice efficiency and scheduling, which often negatively impacts revenue and profitability. The current test is also very invasive and embarrassing because it requires patients to urinate in front of multiple clinicians with catheters in their bladder and rectum or vagina,” Herrera said.
Bright Uro’s system enables wireless, catheter-free urodynamics. The system consists of three main components: a single-use disposable sensor, a reusable meter that measures urinary flow and volume, and software apps for patients and clinicians.
The sensor is a miniature computing platform that is inserted wholly into the bladder. Once inside the bladder, it measures and records pressure data while the patient goes about their daily life. After the patient has urinated into the digital flow meter, the sensor is removed, and data is wirelessly transmitted to the cloud through the apps. Once in the cloud, all data is synchronized for review and analysis by the patient’s physician.
“[The system] enables patients to walk around and urinate in privacy, replicating more natural bladder function conditions. In addition, there is potential for increased accuracy through the collection of ambulatory data with natural filling/emptying that is more relevant due to physiologic accuracy,” Herrera explained.
In addition, Bright Uro’s solution could provide clinicians with important information before they decide on treatments such as surgeries or other invasive therapeutic options, he added.
Herrera said he expects Bright Uro’s system to be cleared by the FDA in 2024, with the U.S. product launch beginning in the same year. Once commercially available, the startup will sell three components of the system to urology and uro-gynecology clinics.
There are existing CPT codes for urodynamic monitoring that may be acceptable for clinicians to utilize, Herrera noted.
“From the earliest days of Bright Uro, we built our product development strategy around creating a device that could utilize existing CPT codes to help support adoption and access to the technology,” he said.
Should it be cleared by the FDA, Bright Uro’s system will become the first product on the market able perform urodynamic monitoring wirelessly and without a catheter, Herrera declared.
There are multiple companies that offer urodynamic testing equipment — such as Medtronic, Laborie and Albyn Medical — but all of them require providers to buy expensive and bulky equipment that is difficult to operate, he pointed out. These companies’ equipment also requires the use of catheters in the bladder and rectum or vagina during use, Herrera added.
Photo: Topp_Yimgrimm, Getty Images
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