BOCA RATON, Fla., June 30, 2022 /PRNewswire/ -- Uro Medical Corporation, a privately-held urology-focused medical device company engaged in the development, manufacture, and commercialization of innovative, minimally invasive neurostimulation solutions leveraging nanotechnology creating the smallest stimulators in existence, today announced the Center for Medicare and Medicaid Services (CMS) coverage for participants in the GUARDIAN™ clinical trial, a multi-center randomized controlled clinical study evaluating the safety and efficacy of the Protect PNS neurostimulator medical device, as compared to traditional pharmaceutical medical management for the treatment for overactive bladder (OAB).
"CMS support of the Guardian clinical trial furthers our goal of establishing Protect PNS as a viable treatment option for patients suffering from refractory OAB", said Shanice Saunders, Executive Vice President of Clinical Affairs for Uro Medical. This study is expected to enroll approximately 600 subjects with refractory OAB across multiple clinical sites in the United States. The results of this study, which is the second randomized clinical trial conducted for the Protect PNS device, will be used to support long term, nationwide payor reimbursement coverage as a mainline therapy option post FDA market authorization.
"Our on-going Protect randomized controlled trial supporting registration, combined with Guardian creates a unique opportunity to examine Protect PNS clinical utility in both third and second-line applications", said Shanice Saunders, Vice President of Clinical. "As a clinician seeing patients routinely fail medical management of OAB, I'm excited to learn how Protect PNS may play an earlier role as an alternative to pharmaceuticals", said Dr. Larry Sirls, investigator in the Guardian clinical trial. Learn more about Uro Medical Corporation at www.uromedical.com.
About Protect PNS
Protect PNS is a wirelessly powered, minimally invasive, microtechnology neurostimulator intended to treat overactive bladder (OAB). Protect PNS is currently being studied for the treatment of OAB and is under regulatory review for market approval by the FDA.
About Uro Medical
Uro Medical is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, microtechnology neurostimulators, providing patients with convenient, safe, minimally invasive, and highly cost-effective urological solutions that are easily incorporated into their daily lives. Uro Medical's goal is to evolve its patented, cutting-edge platform for neuromodulation to standard of care, increasing the accessibility for patients worldwide while lowering the economic impact of urology care management. www.uromedical.com.
BOCA RATON, Fla., April 14, 2020 — StimGuard LLC, a privately-held medical device company engaged in the development, manufacture and pre-commercialization of innovative wireless, percutaneously placed electroceutical device solutions for urological conditions, today announced that it will host a webinar entitled “The Protect PNS for OAB: A Wireless Uro-Stimulation Technology,” on Wednesday, April 29, 2020 at 5pm Eastern Time.
Larry Sirls, MD, and Ken Peters, MD, both from Beaumont Health, will discuss the Protect PNS wireless uro-stimulation technology and the current treatment landscape and unmet medical need to treat patients with over-active bladder syndrome (OAB). The Protect PNS for OAB is an investigational device based on wireless neuromodulation technology and is implanted using a minimally invasive procedure percutaneously through a needle. This technology includes a tiny 0.1 cc device, called a stimulator, and an external transmitter for power that is a fabric antenna placed in clothing. The Protect PNS provides therapy for the relief of OAB symptoms by delivering small controlled electrical pulses to the tibial nerve that travel to the sacral nerve plexus, the group of nerves near the pelvis that control bladder function.
Date: Wednesday, April 29th
Time: 5pm Eastern Time
Larry Sirls, MD graduated from the University of Michigan Medical School and completed urology residency training at Henry Ford Hospital. He completed specialty fellowship training in Male and Female Pelvic Reconstructive Surgery, Urodynamics, Female Urology, and Neurourology at Kaiser Permanente Medical Center in Los Angeles. He returned to Detroit in 1993 and has practiced exclusively at Beaumont Hospital Royal Oak since 1996. Dr. Sirls is the Director of Female Pelvic Medicine and Reconstructive Surgery at Beaumont Hospital Royal Oak, is a Professor at the Oakland University William Beaumont Medical School and is the Primary Investigator for the Beaumont Site of the National
Institutes of Health Urinary Incontinence Treatment Network, one of only 9 centers in the country selected to perform research on treatment options for urinary incontinence. His areas of interest include reconstructive urology, male and female incontinence and voiding difficulty. He is widely published and is a national thought leader in the evaluation and treatment of male and female pelvic floor disorders. He travels to Sub-Saharan Africa yearly to perform complicated fistula and other reconstructive procedures.
Kenneth Peters, MD, is Chair of Urology at Beaumont Health System in Royal Oak, Michigan, and Medical Director of the Beaumont Women’s Urology Center in Royal Oak, a unique multidisciplinary center dedicated to women with chronic pelvic pain and voiding dysfunction. Dr. Peters is also Professor and Chair of Urology at the Oakland University William Beaumont School of Medicine in Rochester, Michigan. He graduated with honors from the University of Michigan in Ann Arbor and earned his medical degree from Case Western Reserve University School of Medicine in Cleveland, Ohio. Dr Peters subsequently completed his training in surgery and urology at William Beaumont Hospital, where he also completed a fellowship in female urology and urodynamics. A specialist in the treatment of voiding dysfunction and female urology, Dr Peters is a well-respected clinician, educator, and researcher. He is internationally known for his work on interstitial cystitis, neuromodulation for voiding dysfunction,
nerve rerouting surgery to restore voiding in patients with spina bifida, and adult human stem cell injection for stress urinary incontinence. He has published over 100 peer-reviewed articles and book chapters. He has twice won the Society for Urodynamics and Female Urology (SUFU) clinical research award. An active member of many professional organizations, Dr Peters has served on the Research Council of the American Urological Association. At the 2012 annual meeting of the International Pelvic Pain Society, he was a keynote speaker on the management of chronic pelvic pain. He maintains a private practice in Royal Oak.
MIAMI BEACH, Fla. (May 17, 2018) - StimGuard LLC, a privately-held, pre-commercial medical device company headquartered in South Florida, today announced it received CE Mark approval for the world’s first wireless programmable neuromodulation device that can be introduced through a needle without surgery for treating chronic, intractable symptoms of overactive bladder. The device will be available in Europe beginning Summer 2018.
Representing a life-changing technological breakthrough for the more than 100 million people worldwide who have an overactive bladder, the StimGuard Sacral Nerve Stimulation (SNS) System is the most versatile system available in the industry. The CE Marked StimGuard SNS System can provide European patients with the same traditional SNS currently available, but the implant is 95 percent smaller than anything on the market. The StimGuard SNS System utilizes the Apple iPad as its programmer, allowing for advanced programming and widespread availability for all markets.
“A wireless system that enables urologists to inject such a clinically proven therapy represents a shift in the field where there has only been one option for over 15 years,” said Karl-Dietrich Sievert MD, PhD, professor and co-chairman of urology, University of Rocstock, Germany. “The ability of the CE Marked StimGuard SNS System to offer the same level of stimulation at the micro-wireless level will give patients an alternative to a bulky battery or excessive invasive surgeries, but still provide the same control.”
The major advantage of the StimGuard SNS system is the elimination of the implanted battery source (a pacemaker-like device), called an IPG, required by the other SNS device on the market. With the StimGuard technology, only a small device, five percent of the size of the other option, with electrode contacts and an embedded chip is placed within the body through a needle mated with a wire receiver, enabling a potentially lower-cost option. The StimGuard SNS System allows a European patient to experience the same stimulation parameters that have been clinically proven to relieve overactive bladder for over 15 years. With other systems, the patient undergoes an invasive surgery to have a battery pack surgically implanted under their skin. The battery pack would have to be replaced every three to five years, which is eliminated with the StimGuard SNS System.
“Prior to the StimGuard system, we would need to make a large incision to implant a battery-powered generator, and complications, such as pain at the generator site, infection, erosion and reoperation, were common,” said Kenneth M. Peters, M.D., a recognized leader in neuromodulation. “The battery typically lasted four to five years and replacement resulted in additional surgery and substantial cost to the healthcare system. Finally, this technology is an option for patients that makes sacral neuromodulation a minimally-invasive procedure.”
The CE Marked StimGuard SNS System is well positioned to revolutionize the urology industry in Europe. With the StimGuard SNS System, all programming is wireless, and, most importantly, upgradeable externally without any additional surgery. Please visit stimguard.com for more information on the availability of the StimGuard SNS System in Europe.
StimGuard is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective overactive bladder therapy solution that is easily incorporated into their daily lives. StimGuard’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of overactive bladder therapy. www.StimGuard.com
MIAMI, Fla., (May 28, 2015) – StimGuard LLC, a medical device manufacturer and independent research institute headquartered in Miami Beach, Florida, today announced positive results for long-term patients using the world’s first wireless micro-technology injectable tibial stimulator for the relief of overactive bladder (OAB). The device was placed last year in Zurich, Switzerland by leading urology pioneer Karl-Dietrich Sievert, M.D., chairman of Urology at the University of Salzburg. Patient outcomes show ongoing reduction of voiding episodes and more than 80 percent relief with a therapy that is administered only at night.
These preliminary results represent a life-changing technological breakthrough for the more than 200 million people worldwide that are afflicted with incontinence. To date, patients have had to make office visits routinely or undergo a surgery in the OR to utilize neuromodulation for relief of their OAB symptoms. The StimGuard technology, developed by scientists and engineers led by co-inventor and StimGuard Chairman Laura Tyler Perryman, uses a tiny injectable microchip device placed through a small needle that delivers small pulses of energy to electrodes near surrounding nerves, triggering a reaction that enables the brain to remap specific urge signals.
“The therapy is utilized for just eight hours a day, so it can be conveniently administered using only a sock worn during the evening or overnight,” said industry veteran and StimGuard Director James McGivern. “Chronic tibial stimulation affects multiple afferent paths to the micturition centers, possibly better serving patients than classic sacral neurostimulation over the long term.”
Dr. Sievert conducted the procedures live at the 2014 Swiss Continence Foundation Conference in Zurich last August. “I am pleased to report that our two patients who presented with OAB and a variety of other medical complications had long term positive outcomes and a reduction in incontinence episodes of greater than 80 percent on average, positively affecting their quality of life,” said Sievert. “The procedure was simple to perform, and I look forward to treating many patients with this novel therapy, which can be administered in a less costly way than other neuromodulation options.”
“I am extremely excited about this new technology developed by StimGuard. Now people with overactive bladder will have additional options, including the ability to receive a permanent implant with a far less invasive and complicated surgery in an office setting,” said Chris Winters, M.D., chairman of the Department of Urology, Louisiana State University. “The StimGuard Tibial System is well positioned to revolutionize the urology industry with an interventional method that most urologists will be able to easily integrate into their practices.”
While neuromodulation has been used for the treatment of OAB since 1997 with expensive systems and numerous large implanted parts and batteries, StimGuard’s novel tibial placement procedure requires just one implanted component: a microsize neurostimulator that can be implanted non-surgically by using only a needle and without the need for imaging equipment. This treatment offers a minimally-invasive, outpatient office procedure resulting in a lower cost option for the industry and a patient option that is widely accepted since it is similar to acupuncture, but permanent.
StimGuard conducted short-term pilot studies in 2013 with encouraging results for the chronic tibial neurostimulation concept. The company plans to complete regulatory studies for CE Mark in 2015 and to seek FDA approval in 2016. For more information about the StimGuard clinical trials, please visit www.stimguard.com or www.clinicaltrials.gov.
StimGuard is a privately held medical device company engaged in the development, manufacture, and commercialization of wirelessly powered, injectable, microtechnology neurostimulators, providing patients with a convenient, safe, minimally invasive, and highly cost-effective urological solution for incontinence that is easily incorporated into their daily lives. StimGuard’s goal is to evolve its patented, cutting-edge platform into the default for neuromodulation, increasing the accessibility for patients worldwide while lowering the economic impact of urinary management. www.stimguard.com.
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