StimGuard Announces Corporate Name Change to Micron Medical and Appointment of CEO as part of Expansive Executive Management Team

StimGuard LLC, a privately-held medical device company engaged in the development, manufacture and pre-commercialization of innovative wireless, injectable electroceutical device solutions for urological conditions, today announced that it is changing its corporate name to Micron Medical Corporation. In addition, effective immediately, Stephen Deitsch has been appointed as Chief Executive Officer (CEO) and will join the Company’s board of directors. Co-founder Laura Tyler Perryman will now assume the role of Chief Operating Officer (COO) in order to focus on product development, regulatory and clinical affairs efforts. Read more.

Source: StreetInsider, April 3, 2020

Essity Acquires Smart Ultrasound Technology for Incontinence Care

Hygiene and health company Essity is strengthening its offering in incontinence products through the acquisition of the Dutch company Novioscan. The company develops a wearable ultrasound technology that monitors the bladder and enables continence control. The purchase price is approximately SEK 70m (EUR 6.5m) on a debt-free basis. The SENS-U innovation is a wearable ultrasound sensor that measures the level in the bladder. It sends a discrete notification that allows the user to empty their bladder in time. A version of SENS-U for children is already available in the market and an adult version is under development. Read more.

Source: PRNewswire, April 1, 2020

Urovant Sciences Announces U.S. FDA Acceptance of New Drug Application for Vibegron for the Treatment of Overactive Bladder

Urovant Sciences (Nasdaq: UROV) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company’s New Drug Application (NDA) for once-daily 75 mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA has been assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 26, 2020. In addition, the FDA has communicated that they are not currently planning to hold an Advisory Committee meeting to discuss the application. Read more.

Source: Businesswire, March 5, 2020

Viveve Completes Enrollment in Short-Term Feasibility Study for Stress Urinary Incontinence

Viveve Medical, Inc. (VIVE), a medical technology company focused on women’s intimate health, announced today that it has completed enrollment in its three-arm, three-month feasibility study to compare Viveve’s Cryogen-cooled Monopolar Radiofrequency (CMRF) treatment and a cryogen-only sham treatment to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. The Investigational Testing Application (ITA) study, approved by the Canadian Ministry of Health, was initiated in January 2020. Read more.

Source: Yahoo Finance!, March 4, 2020

New Research Takes P*** Out of Incontinence

Millions of people might eventually be spared the embarrassment and extreme isolation caused by wetting themselves, thanks to new research. One in every five people has a lower urinary tract disorder called overactive bladder which, for some, means not being able to hold in urine, needing to go to the toilet often, or waking in the night to empty their bladder. Some wear sanitary towels or disposable underwear, while others worry that even with absorbent underwear, they’ll smell of urine, so they choose instead to stay at home. Now, scientists at the University of Portsmouth have identified chemicals in urine that are specific to overactive bladder. The next step is to develop a gadget similar to a pregnancy test, to see if these chemical markers are present. Such a device is 12-24 months from clinical trials, but the early signs are encouraging. Read more.

Source: EurekAlert,, February 20, 2020

Incontinence in MS Affects Walking Ability, Negatively Impacts Patients’ Quality of Life, Study Finds

Urinary incontinence, associated with poor functioning of the muscles in the pelvic area, was found to have a negative impact on daily activities like walking and overall quality of life in people with multiple sclerosis (MS), a study shows. Adding pelvic floor muscle training to an MS treatment program may help to improve overall function, the researchers suggest, which could improve patient performance of daily life activities, especially in those with moderate or severe dependence on others. The study, “Pelvic floor dysfunction negatively impacts general functional performance in patients with multiple sclerosis,” was published in the journal Neurology and Urodynamics. Read more.

Source: Multiple Sclerosis News Today, February 18, 2020

Atlantic Therapeutics Announces FDA Clearance for Over-the-Counter Use of INNOVO®

Atlantic Therapeutics today announced that the U.S. Food and Drug Administration (FDA) has granted over-the-counter (OTC) clearance to INNOVO^®, a non-invasive, clinically proven and wearable device that treats the root cause of bladder weakness, known clinically as stress urinary incontinence (SUI). INNOVO^® was previously available in the U.S. by prescription, with more than 3.5 million safe and successful therapy sessions delivered worldwide. Read more.

Source: Yahoo! Finance, February 6, 2020

Contura Nabs FDA Nod for Female Incontinence Device

Contura has earned FDA approval for an injectable hydrogel [Bulkamid] to treat stress urinary incontinence in women, according to a premarket approval order posted by the agency Monday. The permanently implanted device acts as a scaffold for cells to grow through, supporting the closing mechanism of the urethra for better control of urine. Approval of the Bulkamid implant was based on a study of 228 women that showed 75% of those who got the device reported dryness or improvement in their symptoms. Read more.

Source: MedTechDive, February 4, 2020

InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control

Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention. The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but it is a rechargeable device with an expected longevity of about 15 years. This is made possible partially thanks to so-called Overdrive technology that lets the battery maintain almost its full capacity to recharge throughout its working life. Read more.

Source: Medgadget, January 13, 2020

Smartphone Camera Test for Urinary Tract Infections

Researchers at the University of Bath have developed a simple point-of-care test for urinary tract infections that uses a smartphone camera. The system can rapidly detect the presence of E. coli in urine samples and could guide doctors in their decision to prescribe antibiotics, ensuring appropriate patient care and avoiding the overuse of antimicrobial medication. It can sometimes be difficult for clinicians to know whether to prescribe antibiotics. Unnecessary use of antibiotics is resulting in antimicrobial resistance, which will pose significant challenges to healthcare in the coming years. However, if a patient has an infection, such as a urinary tract infection (UTI), then antibiotics are undoubtedly warranted, but it can sometimes be difficult for a clinician to know for sure if a patient’s symptoms are caused by an infection. Read more.

Source: Medgadget, January 9, 2020