Bright Uro, a medtech company based in California, has created the Glean Urodynamics System, a catheter-free urodynamics testing system. At present, urodynamics testing can help clinicians to diagnose and assess patients with lower urinary tract symptoms, including a frequent urge to urinate and incontinence. The procedure typically involves inserting a catheter into the bladder and another into the vagina or rectum. The test can provide information on how well the bladder can store and empty urine. However, the need for two catheters means that a patient must lie in place as the test is ongoing, and does not allow clinicians to obtain valuable data when a patient is ambulatory and performing everyday activities. These issues inspired Bright Uro to develop the Glean Urodynamics System, a catheter-free system that lets patients move about during testing. The technology includes a small sensor that is advanced into the bladder, where it records pressure data and then transmits it wirelessly. Bright Uro recently announced that it has received $6 million in seed financing to assist in developing the technology. See a video about the system below. Medgadget had the opportunity to speak with Derek Herrera, CEO at Bright Uro, about the technology. Conn Hastings, Medgadget: Please give us an overview of lower urinary tract symptoms, the conditions that contribute to these, and their consequences for patients. Derek Herrera, Bright Uro: Lower urinary tract symptoms (LUTS) often include urgency (feeling like you have to pee all the time), frequency (actually peeing all the time), and incontinence (leaking). The unfortunate reality is that tens of millions of Americans have to deal with these issues every year. For many people, these symptoms may be caused by conditions like Overactive Bladder (OAB), Urinary Incontinence (SUI), and/or Benign Prostate Hyperplasia (BPH). The consequences for people dealing with LUTS can be severe. If left unchecked, these conditions can be debilitating, and may lead to severe anxiety, depression, and social isolation. For some, the symptoms are so impactful that every time they go to a new place, they start searching for the bathroom just to make sure they know how close it is in the event they suffer from the onset of symptoms. For others, they may avoid new social encounters altogether and withdraw from work, travel, and other activities. In many cases, these patients will report that these symptoms are truly life-changing and have a negative impact on their overall quality of life. Medgadget: Please give us an overview of urodynamics testing and its purpose. Derek Herrera: Urodynamics testing is a diagnostic evaluation that clinicians can perform to help diagnose the underlying conditions which may contribute to lower urinary tract symptoms. A urodynamics evaluation provides the clinician with data to evaluate the relationship of pressure and volume in the bladder, and, with this data, they have more information about how well the bladder can store and empty urine. Medgadget: How is such testing conducted currently? Derek Herrera: Currently, to perform urodynamics a patient must come into a clinic. The patient gets undressed, lays down on an exam table, and is prepared for catheter insertion. The clinician will insert one catheter into the bladder and another catheter into the rectum or vagina. These catheters are connected to a machine that will record the pressure of the bladder and abdomen. Once the catheters are in place, the bladder is emptied and then filled quickly using an infusion pump. When the patient’s bladder feels full the clinician asks them to urinate. Once the patient is done urinating, the catheters are removed, and the evaluation is complete. At this point the clinician can analyze the pressure data from the catheters and the flow of urine from a digital scale called a uroflowmeter. This data helps to inform the clinician and better understand the relationship of pressure and volume in the bladder. Medgadget: Please give us an overview of the Glean Urodynamics System and how it works. Derek Herrera: Bright Uro’s Glean Urodynamics System is the first wireless, catheter-free method for urodynamics evaluation. Instead of using catheters that hang from the bladder and rectum/vagina, Glean uses a small sensor that can be inserted completely into the bladder where it records pressure data. Glean uses advanced data science techniques so that urodynamics evaluations can be conducted with just one sensor in the bladder and no catheters hanging from the bladder and rectum/vagina. This means patients can stand, walk, and go about their normal routines while the device collects data. The bladder can fill naturally, and patients can urinate in privacy. Once the period of monitoring is complete, the sensor can be removed easily using the removal string. The clinician uses an app to wirelessly download and analyze the data. So many clinicians are excited about Glean because they think it could provide more physiologically relevant data and offer better insights to help inform their treatment decisions. If successful, Glean could improve outcomes and reduce the time to successful treatment by helping to ensure the optimal treatment is prescribed for the patient. As a company, our goal is to provide actionable insight for clinicians to improve patient outcomes. What this means for patients is that they are able to find effective therapies faster and regain control over their lives. Medgadget: What inspired you to develop this technology? Derek Herrera: Glean originated from decades of research conducted by world-leading experts at the Cleveland Clinic. Bright Uro has licensed this IP and we are working to bring the product to market as quickly as possible. Personally, I was inspired to become a medical device entrepreneur after I sustained a Spinal Cord Injury and was paralyzed from the chest down while serving in Afghanistan as a Marine Raider. After my injury, I quickly found bladder management to be the biggest challenge I faced on a daily basis. I decided to take action and worked to develop innovative technologies that could improve the quality of life for myself and millions of others dealing with similar issues. For the past eight years, I have worked in early-stage medical device development with a focus on urology. Every day I am inspired because we can see how impactful the technology we develop will be for so many people. Medgadget: Congratulations on securing seed funding recently. How do you intend to spend the money? Derek Herrera: Thank you! The funds secured will be used to complete product development, establish manufacturing, conduct clinical studies, and achieve FDA regulatory clearance. We have been fortunate to have found amazing investors and team members who all believe in the vision of our company. They are excited about the future we are working to create, and I am so grateful for their continued support! Source
