Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”). The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia. The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted. Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term. Read more.

Source: Business Wire, September 9, 2019

elderly underactive bladder symptoms needed to be reported

Survey: Seniors Choose to Endure Discomfort Instead of Asking Their Children for Assistance

Aeroflow Healthcare, an Inc. 5000 fastest growing company, announced the results of a proprietary survey designed to stress the importance of communication between seniors and their friends and family as they age. The third-party administered survey polled 1,003 adults aged 60 or older living in the United States and was completed over a span of three days in July 2019. To view the full survey results, please click here.

Notable survey results include:
64% of seniors would prefer assisted living to having their adult children care for them
46% of seniors are concerned they may become a burden on their family
54% of seniors would feel embarrassed discussing incontinence issues with friends or family
52% of seniors would try to hide incontinence or lie about it rather than ask for help

The survey results suggest that seniors are more worried about inconveniencing their adult children than receiving the care they need, and are willing to take considerable measures to avoid asking for help. Read more.

Source: PRNewswire, August 22, 2019

Elidah Announces the Launch of ELITONE® – A New Non-Invasive Treatment for Women’s Incontinence

Elidah, Inc (https://elitone.com/), a woman-owned medical device company, today announced the launch of ELITONE®, the first and only patented medical device providing non-invasive treatment for stress urinary incontinence in women. ELITONE is the first product of its kind launched under a newly created FDA product category for non-invasive incontinence therapy. Stress urinary incontinence is the loss of bladder control when activities such as exercising, coughing, laughing or sneezing increase the internal pressure placed on the abdominal cavity and pelvic floor muscles. Read more.

Source: PRNewswire, August 20, 2019

Axonics® Announces Publication of ARTISAN Clinical Study Results in the Journal of Urology

Axonics Modulation Technologies, Inc. (AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the results from its ARTISAN-SNM study were published online in the peer-reviewed Journal of Urology (https://doi.org/10.1097/JU.0000000000000458). This is the first journal publication to detail outcomes for patients in the United States treated with a rechargeable sacral neuromodulation system. The study, conducted under a U.S. Food & Drug Administration (FDA) Investigational Device Exemption (“IDE”), found that 90% of all implanted patients with the Axonics r-SNM® System had successful therapy outcomes. Read more.

Source: Business Wire, July 29, 2019

TARIS Announces Presentation of Clinical Data for TAR-302 for Overactive Bladder

TARIS Bio™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today that results of the company’s Phase 1b study of TAR-302 for the treatment of overactive bladder (OAB) will be presented in a podium session on Wednesday, September 4^th at the Annual Meeting of the International Continence Society (ICS) in Gothenburg, Sweden. The presentation will detail the safety, tolerability, pharmacokinetics and preliminary efficacy data including a durable benefit of TAR-302, which was administered to 11 OAB patients for six weeks. The abstract is available on the ICS website. Read more.

Source: PRNewswire, July 25, 2019

FemTech – Making strides for women

While EU Member States discuss the Health Technology Assessment proposal, an EU-wide research tool to support decision-making on health technologies and innovation in the “FemTech” sector (encompassing fertility, pregnancy and nursing care, women’s sexual wellness and e-health technologies) promises to revolutionise the treatment of pelvic floor dysfunctions for women across Europe and beyond. Over 50 percent of women worldwide suffer from at least one of the following three pelvic floor dysfunctions: Stress urinary incontinence, faecal incontinence, and pelvic organ prolapse (POP). Read more.

Source: The Parliament, July 23, 2019

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Study Shows Advantages for Stress Urinary Incontinence Surgery

One of the most commonly performed surgeries to treat stress urinary incontinence in women may have better long-term results than another common surgical technique, according to a study led by Mayo Clinic researchers. The retrospective study of more than 1,800 cases at Mayo Clinic from 2002 to 2012 found that the need for additional surgery was twice as high after a transobturator sling surgery compared with a retropubic sling procedure. Reoperation rates within eight years after surgery were 11.2 percent for patients in the transobturator group compared with 5.2 percent in the retropubic group, according to the study, which will be published in the journal Obstetrics and Gynecology in August. Read more.

Source: Austin Daily Herald, July 16, 2019

Urinary Tract Infections Affect Millions. The Cures Are Faltering

For generations, urinary tract infections, one of the world’s most common ailments, have been easily and quickly cured with a simple course of antibiotics. But there is growing evidence that the infections, which afflict millions of Americans a year, mostly women, are increasingly resistant to these medicines, turning a once-routine diagnosis into one that is leading to more hospitalizations, graver illnesses and prolonged discomfort from the excruciating burning sensation that the infection brings. The New York City Department of Health has become so concerned about drug-resistant U.T.I.s, as they are widely known, that it introduced a new mobile phone app this month that gives doctors and nurses access to a list of strains of urinary tract infections and which drugs they are resistant to. Read more.

Source: New York Times, July 13, 2019

Deep Brain Stimulation May Ease Some of Common Urinary Problems in Parkinson’s Patients, Study Reports

Deep brain stimulation (DBS) can help to alleviate some urinary symptoms — such as urinary frequency, urgency, and incontinence — in Parkinson’s patients, and is particularly helpful to women, a large study reports. The study, “Clinical study of the effects of deep brain stimulation on urinary dysfunctions in patients with Parkinson’s disease,” was published in Clinical Intervention in Aging. DBS involves a surgical procedure in which very fine wires are inserted into the brain to electrically stimulate areas responsible for movement control and, in this way, adjust neuronal activity within those brain regions. This treatment approach is indicated for Parkinson’s patients whose motor symptoms do not respond well to commonly used parkinsonian medications. Read more.

Source: Parkinson’s News Today, July 2, 2019

Smart Diaper Detects Urinary Tract Infections

Urinary tract infections (UTIs) are dangerous for infants and the elderly. While the onset of UTIs generally involves pain and other symptoms, young children are not able to describe how they’re feeling, while the elderly may suffer from neurodegenerative conditions that reduce sensation in the affected area. Moreover, it’s difficult to obtain a sample for testing from those that wear diapers. Now, engineers at Purdue University have developed a sensor-embedded diaper that can accurately point to the presence of a bacterial infection in the urinary tract. Read more.

Source: Medgadget, June 25, 2019