HealthMatters
Vivid Uro, a Irvine, California-based startup based in 2021, is on a mission to make urodynamic testing extra correct for clinicians, extra snug for sufferers, and extra environment friendly for clinics.
On Thursday, the corporate introduced it has raised $23 million to assist it get nearer to reaching these objectives — the Collection 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 scientific analysis, he added.
The corporate plans to make use of its new funding to attain FDA clearance for its urodynamics system and launch the product within the U.S.
Urodynamics — a set of exams that measure decrease urinary tract operate — is “the gold commonplace of care” for sufferers with individuals with complicated decrease urinary tract signs (LUTS), Herrea defined. The umbrella time period LUTS is used to discuss with many urinary points in women and men, together with urine movement issues, overactive bladder, stress urinary incontinence and benign prostatic hyperplasia.
The sector of urodynamics is in want of innovation, Herrera declared. For starters, these exams typically fail to precisely characterize sufferers’ signs, he famous.
“As a result of time, value and area requirement of present urodynamics gear, clinicians expertise challenges with observe effectivity and scheduling, which regularly negatively impacts income and profitability. The present check 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 movement 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 each day life. After the affected person has urinated into the digital movement meter, the sensor is eliminated, and information is wirelessly transmitted to the cloud via 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 operate situations. As well as, there’s potential for elevated accuracy via the gathering of ambulatory information with pure filling/emptying that’s extra related on account of physiologic accuracy,” Herrera defined.
As well as, Vivid Uro’s answer might present clinicians with essential data earlier than they resolve on remedies comparable 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 obtainable, the startup will promote three elements of the system to urology and uro-gynecology clinics.
There are current 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 might make the most of current CPT codes to assist assist adoption and entry to the expertise,” he stated.
Ought to it’s cleared by the FDA, Vivid Uro’s system will change into the primary product available on the market in a position carry out urodynamic monitoring wirelessly and and not using a catheter, Herrera declared.
There are a number of firms that provide urodynamic testing gear — comparable to Medtronic, Laborie and Albyn Medical — however all of them require suppliers to purchase costly and hulking gear that’s tough to function, he identified. These firms’ gear additionally requires the usage of catheters within the bladder and rectum or vagina throughout use, Herrera added.
Photograph: Topp_Yimgrimm, Getty Photographs
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