Vivid Uro, a Irvine, California-based startup based in 2021, is on a mission to make urodynamic testing extra correct for clinicians, extra comfy for sufferers, and extra environment friendly for clinics. 

On Thursday, the corporate introduced it has raised $23 million to assist it get nearer to attaining these objectives — the Sequence A funding spherical was led by Laborie Medical Applied sciences, a supplier of urology diagnostic and therapeutic merchandise.

The spherical displays the full quantity of fairness funding Vivid Uro has raised since its founding, stated CEO Derek Herrera. The startup additionally acquired a $2 million grant from the Nationwide Institutes of Well being to assist product growth and medical analysis, he added.

The corporate plans to make use of its new funding to realize FDA clearance for its urodynamics system and launch the product within the U.S.

Urodynamics — a set of checks that measure decrease urinary tract perform — is “the gold normal of care” for sufferers with individuals with complicated decrease urinary tract signs (LUTS), Herrea defined. The umbrella time period LUTS is used to seek advice from many urinary points in women and men, together with urine stream issues, overactive bladder, stress urinary incontinence and benign prostatic hyperplasia.

The sphere of urodynamics is in want of innovation, Herrera declared. For starters, these checks usually fail to precisely characterize sufferers’ signs, he famous.

“As a result of time, price and area requirement of present urodynamics tools, clinicians expertise challenges with follow effectivity and scheduling, which frequently negatively impacts income and profitability. The present take a look at can also be very invasive and embarrassing as a result of it requires sufferers to urinate in entrance of a number of clinicians with catheters of their bladder and rectum or vagina,” Herrera stated.

Vivid Uro’s system permits wi-fi, catheter-free urodynamics. The system consists of three primary elements: a single-use disposable sensor, a reusable meter that measures urinary stream and quantity, and software program apps for sufferers and clinicians. 

The sensor is a miniature computing platform that’s inserted wholly into the bladder. As soon as contained in the bladder, it measures and data stress information whereas the affected person goes about their day by day life. After the affected person has urinated into the digital stream meter, the sensor is eliminated, and information is wirelessly transmitted to the cloud by the apps. As soon as within the cloud, all information is synchronized for evaluation and evaluation by the affected person’s doctor.

“[The system] permits sufferers to stroll round and urinate in privateness, replicating extra pure bladder perform situations. As well as, there may be potential for elevated accuracy by the gathering of ambulatory information with pure filling/emptying that’s extra related resulting from physiologic accuracy,” Herrera defined.

As well as, Vivid Uro’s resolution may present clinicians with vital data earlier than they determine on therapies corresponding to surgical procedures or different invasive therapeutic choices, he added.

Herrera stated he expects Vivid Uro’s system to be cleared by the FDA in 2024, with the U.S. product launch starting in the identical 12 months. As soon as commercially accessible, the startup will promote three elements of the system to urology and uro-gynecology clinics.

There are present CPT codes for urodynamic monitoring that could be acceptable for clinicians to make the most of, Herrera famous. 

“From the earliest days of Vivid Uro, we constructed our product growth technique round creating a tool that would make the most of present CPT codes to assist assist adoption and entry to the expertise,” he stated.

Ought to or not it’s cleared by the FDA, Vivid Uro’s system will turn out to be the primary product in the marketplace in a position carry out urodynamic monitoring wirelessly and with no catheter, Herrera declared.

There are a number of firms that supply urodynamic testing tools — corresponding to Medtronic, Laborie and Albyn Medical — however all of them require suppliers to purchase costly and ponderous tools that’s troublesome to function, he identified. These firms’ tools additionally requires the usage of catheters within the bladder and rectum or vagina throughout use, Herrera added.

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