Robb Lee 6127010608
Plymouth, MN ( November 28, 2017 )- University of Minnesota researchers are helping launch a clinical study of a new medical solution that could dramatically change the way urethral strictures are treated today for millions of men around the world.
The Optilume™ drug-coated balloon (DCB), developed by Urotronic, based in Plymouth, MN, represents the first substantial investment in urology in a medtech field often dominated by advancements in cardiology and oncology.
The trial includes patients at the University of Minnesota where Dr. Sean Elliott practices as a reconstructive urologist. The results could ultimately help more of his patients to avoid painful surgery.
“It’s exciting to see investment to treat this disease and to see a new product being offered for really the first time in history,” says Dr. Sean Elliott, who directs the program in reconstructive urological surgery at the University of Minnesota and is the principal investigator of the FDA-approved clinical trial of Optilume.
The U.S. based trial, known as ROBUST II, recently received FDA approval for an Investigational Device Exemption (IDE). In addition to the University of Minnesota, the early feasibility study will be conducted at 4 other medical centers around the country including the Eastern Virginia Medical Center, University of Utah, University of Iowa and Metro Urology in Minneapolis, MN.
There are roughly 1.5 million doctors’ office visits in the U.S. to treat urethral strictures, which block the pathway for urine to exit the body from the bladder and can result in a painful, frustrating slowing of the urinary stream. Urethral strictures are often caused by infections, trauma and other medical procedures that injure the lining of injure the urethra. The number of urological procedures is expected to grow rapidly as Baby Boomers age and are more susceptible to urinary tract problems, according to doctors involved in the clinical trial.
The most common treatments, balloon dilation and another endoscopic intervention known as an urethrotomy, both have high rates of recurrence. An open surgical procedure called urethroplasty, another treatment option for urethral stricture, has a much better success rate however, it may require a longer recovery and includes painful side effects.
“What we’re looking for is something that is minimally invasive and also curative. This has the potential to decrease the number of urethroplastys that are performed,” says Dr. Brad Erickson, a reconstructive urologist at the University of Iowa.
“Men, in general, cringe at the idea of an open urethroplasty and much prefer something that can be done without cutting open the genital area,” says Dr. Elliott. “The numbers speak for themselves. Close to 95-98% of urethral strictures in the United States are treated with endoscopic means, meaning with a dilation or urethrotomy.”
Elliott and Erickson are founding members of the Trauma and Urologic Reconstructive Network of Surgeons (TURNS) which is working in Minnesota and elsewhere to advance urethral stricture treatments. For them, and millions of men around the world, the drug-coated balloon solution represents an option that could be more effective in treating strictures without painful, surgical side effects.
As with other medtech advancements, it is the drug-coated balloon that could be a difference maker. Scar tissue quickly develops after any medical intervention. The Optilume DCB combines balloon dilation with an anti-proliferative drug which has already been proven effective at limiting scar tissue generation in cardiovascular applications.
Urotronic’s solution may also be a response to changes underway in healthcare delivery where the emphasis is shifting to outcomes as opposed to fee-for- service models.
The American Urological Association recently updated its treatment guidelines to include a discussion of the most effective treatments for men with recurrent urethral strictures. The field of urology has not seen the same level of research and product offerings. Dr. Elliott says treatments have undergone very few changes in centuries.
“If the drug-coated balloon proves to be effective, that would really change the game in how I am counseling patients,” he said.
Dr. Elliott and other investigators will monitor the progress of the ROBOUST II clinical trials, which get underway shortly and will follow the patients for a period of five years. The FDA will monitor the progress as well.
The Optilume DCB is an investigational device, not available for sale. CAUTION- Investigational Device. Limited by Federal (or United States) law to investigational use.
About Urotronic, Inc.
Urotronic, Inc., headquartered in Plymouth, Minnesota, is an early stage medical device company currently conducting clinical trials to support global commercialization of their products. The Optilume™ drug-coated balloon technology provides a low cost, minimally-invasive treatment option for men suffering from urinary track conditions like benign prostatic hyperplasia (BPH), urethral and ureteral strictures, and bladder neck contractures (BNC). The prevalence of BPH and lower urinary tract issues rises markedly with increased age. BPH affects 70% of men 60-69 years of age and 80% of those 70 years of age or older. The drug-coated balloon technology under development creates a paradigm change from the methods currently used by urologists to treat these conditions. For more information on Urotronic and our products, please visit us at urotronic.com