Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Bluetooth-operated Bionic Sphincter Controller Close to Human Trial Phase
Most of us don’t have to give much thought to the mechanics of going to the bathroom. Our bodies tell our brains when we have to go, and our brains tell our bodies when it’s acceptable to do so. But millions of people with incontinence have to cope numerous times a day with the reality that the brain-to-body messaging they once took for granted will never operate normally again. In a small office building in Fort Lauderdale, inventor Peter H. Sayet says he’s close to marketing a device that will enable incontinence sufferers to regain control of their urinary functions. Sayet is president and CEO of Precision Medical Devices Inc., which he founded in 1998. In the past two decades, the company has secured nine patents and spent $5 million raised from about 200 investors through private-placement stock offerings to develop a Bluetooth-operated bionic sphincter controller, which he calls the Flow Control Device. Read more.
Source: Sun Sentinel, April 9, 2018
Charting an Underexplored Landscape: The Genitourinary Microbiome
More sensitive cultivation methods and precise 16S rRNA gene sequencing techniques have revealed that the human bladder hosts a significant microbiome and those diverse bacteria inside the bladder impact pediatric urologic diseases. As recently as one decade ago, the human bladder was thought to be a sterile landscape. In recent years that view has shifted radically, opening brand-new fields of research aimed at clarifying the role the microbiome plays in common urologic diseases that affect children, according to a review article published online Feb. 22, 2018, by Current Urology Reports. “There is a growing appreciation for the role of diverse bacteria in contributing to improved health as well as triggering disease processes or exacerbating illness,” says Michael H. Hsieh, M.D., Ph.D., director of the Clinic for Adolescent and Adult Pediatric Onset Urology (CAPITUL) at Children’s National Health System and study senior author. Read more.
Source: Medical Xpress, APril 5, 2018
Stress Incontinence – A Hidden Disease Finds Some Light
While many of us have seen the ads for Attends, the problem being treated, urinary stress incontinence in women, is rarely mentioned [1]; and that is odd for a problem that by some reports effects 25% of women over age 25. (The incidence of breast cancer is about 12%). A recent article in the American Journal of Obstetrics and Gynecology sheds light on this somewhat unmentioned disease. Urinary incontinence is the involuntary passing of urine, frequently associated with coughing, laughing or any activity that causes a person to bear down. It is a result of the loss of support for the bladder, rectum, and vagina – all the structures of the pelvis and is most often seen in women after childbirth. For all the beauty and miracles of birth, passing an eight-pound object through the vagina causes some wear and tear. But physicians know little about the natural history and progression of this loss of pelvic support (clinically termed prolapse). The study provides a better understanding of the course of the disease and some possible milestones. Read more.
Source: American Council on Science and Health, April 3, 2018
Urovant Starts Pursuit of Astellas’ Overactive Bladder Drug Myrbetriq with New Phase 3 Trial
A little later than expected, Roivant group company Urovant has started its confirmatory phase 3 program for overactive bladder (OAB) drug vibegron, originally licensed from Merck & Co. The pivotal trial—which was originally expected to get underway last year—will involve around 1,400 adults with symptoms of OAB such as urge urinary incontinence, urgency, and urinary frequency, according to Urovant. The drug already has positive phase 2b and phase 3 data in hand, so if the latest trial is positive Urovant should be able to move ahead with regulatory filings. If approved, it could become a direct competitor to Astellas’ Myrbetriq (mirabegron), the first beta3-adrenergic agonist to reach the market for OAB. And that could present a big commercial opportunity: Astellas reported sales of its drug rose 30% to 93.1 billion yen ($876 million) in the nine months to end-January 2018 with take-up driven by greater tolerability than the widely used antimuscarinic OAB drug class. Read more.
Source: Fierce Biotech, March 28, 2018
Dignity In Incontinence? This Philly-area Start-up Thinks It Has the (Secret) Formula
Loss of Control: Exploring the Links Between Falls and Incontinence
It might seem odd to some that resident falls and incontinence would be mentioned in the same breath. It actually can be difficult to estimate the extent to which one causes the other. Yet, as clinical detectives have discovered, both subjects have a way of winding up in the same discussions. It all relates to the dangers for those residents who have lost control of their bodies in one or more ways. Emerging research and technology are growing closer to uncovering major underlying issues that could lead to reductions of incontinence and falls. As a result, they’re instilling hope for a better quality of life for millions of seniors. Read more.
Source: McKnight’s Long-Term Care News, March 8, 2018
LABORIE Medical Technologies to Acquire Cogentix Medical Inc., for $214 million
LABORIE Medical Technologies, a leading global developer and manufacturer of medical diagnostics and devices in the pelvic health and gastroenterology market, today announces the execution of a definitive agreement to acquire Cogentix Medical Inc., (NASDAQ: CGNT) for $3.85 per Cogentix share in cash, and an enterprise value of $214 million. Cogentix is a global medical company that provides proprietary, innovative technologies to a number of specialty markets including urology. “The acquisition of Cogentix advances our strategy to invest in leading technologies that provide product and channel scale to LABORIE’S existing Urology Strategic Business Unit (SBU) diagnostic and therapeutic portfolio, particularly in the areas of OAB (overactive bladder) and SUI (stress urinary incontinence),” commented Michael Frazzette, President & CEO of LABORIE Medical Technologies. “The addition of Cogentix’s suite of technology will significantly expand LABORIE’S therapeutic offering, thereby providing customers and their patients with comprehensive, clinically-relevant solutions along the disease treatment continuum.” Read more.
Source: Market Insider, March 12, 2018