business buildings

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

ELITONE

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

business buildings

Rinovum Women’s Health Debuts Revolutionary Reusable Over-the-Counter Product Clinically Proven To Treat Light Bladder Leaks and Boost Women’s Confidence

Rinovum Women’s Health, the makers of the successful Stork® products for at-home conception has debuted a breakthrough reusable device, clinically proven to treat light bladder leaks that does not require a prescription, impacting the more than 15 million women in the U.S. who suffer from the embarrassing issue. The revolutionary product Revive™ is an FDA-cleared urethral support device designed to empower women and help them to take charge of their health by kicking stress urinary incontinence (SUI) to the curb. After successfully growing The Stork ®OTC, the first conception aid sold over-the-counter, Rinovum Women’s Health has made Revive available in nearly 5,000 retail locations nationwide and growing. Read more.

Source: BioSpace, June 24, 2019

INNOVO

1-In-3 Women In America Can Now Proudly Declare “I Just Free’d Myself With INNOVO®” Thanks To Revolutionary New Device To Treat Root Cause Of Bladder Weakness

“OMG. I just free’d myself!” Today, 20 million women in America will rewrite that whispered, uncomfortable admission of bladder weaknessinto a declarative, celebratory shout thanks to INNOVO®. As the first-in-class wearable, non-invasive solution for Stress Urinary Incontinence (SUI), INNOVO has the potential to positively impact the lives of one in three women.These women will now be able to laugh louder, exercise harder and even sneeze with ease. The INNOVO thigh-length, elasticized therapeutic shorts are outfitted with eight electrodes sewn in a crisscross formation across the pelvic region. When activated via its attached hand-held controller, INNOVO delivers a series of pelvic stimulations equivalent to Kegel exercises for strengthening the pelvic floor. Read more.

Source: PRNewswire, June 5, 2019

business buildings

INNOVO Transcutaneous Electrical Stimulator for Urinary Incontinence Coming to U.S.

Atlantic Therapeutics, a company out of Galway, Ireland, will soon be releasing its INNOVO transcutaneous electrical stimulator to treat stress urinary incontinence in women. The device was FDA approved late last year as the first transcutaneous stimulator with such an indication. It delivers electric current through the body toward muscles that control the pelvic floor, which in turn can help maintain continence.  The technology provides women a non-invasive option that, in a clinical trial, demonstrated that 87% of women were dry or nearly so after a three month treatment. 80% of the women studied had results after only a month or therapy.  Read more.

Medgadget, April 11, 2019

product approval introduction

InControl Medical Wins FDA Clearance for Attain: The First Over-the-Counter, At-Home Device for the Treatment of Urinary and/or Fecal Incontinence in Women

InControl Medical wins FDA clearance for new Attain, the first over-the-counter (OTC) non-implantable muscle stimulator designed for at-home use to help treat the approximately 60 million women in the U.S. suffering with stress, urge, mixed urinary incontinence and/or bowel incontinence.  This is good news for all those affected by urinary and/or involuntary bowel leakage that can increase with age: 20% -30% of young women, 30%-40% of middle-aged women, and up to 50% of older women suffer from incontinence.  It’s time to talk about this taboo topic before diapers become the newest accessory in the Nike store. So, strengthen your calves and abs, but don’t forget to strengthen your pelvic floor muscles too, says Lauren Streicher, M.D., Medical Director of the Northwestern Medicine Center for Sexual Health and Menopause and Clinical Professor of Obstetrics and Gynecology at Northwestern University. All kidding aside, many of my patients who suffer with urinary incontinence, can also have leaky bowel, and truly suffer in silence and embarrassment. Post-partum, anal or rectal cancer, and the natural aging process can cause incontinence. Thankfully, many patients respond well to pelvic-floor electrical stimulation and biofeedback as a first-line treatment, before considering surgery or medication. Attain is a small, painless, easy to use medical device for women to self-treat in the privacy of their own home, reducing or eliminating the need for pads or diapers. Read more.

Source: Global Banking & Finance Review, March 26, 2019

women friends

Behavioral Therapy Superior to Drugs Alone for Urinary Incontinence

Behavioral therapies relieve stress, urgency, and mixed urinary incontinence (UI) more effectively than drug monotherapies in nonpregnant women.  In a new systematic review and network meta-analysis (NMA) of 84 randomized trials published in theAnnals of Internal Medicine, most interventions including combination therapies improved or resolved women’s symptoms better than no treatment, whether sham or watchful waiting, Ethan Balk, MD, MPH, of Brown University in Providence, Rhode Island, and colleagues reported. Hormones and periurethral bulking agents appeared less than effective, however. Read more.

Source: Renal & Urology News, March 20, 2019

older woman elderly

Common Problems Still Challenge Caregivers When It Comes to Incontinence Treatment

Skilled nursing educators worth their mettle today will strongly warn bedside caregivers to throw out any preconceived notions they may have about incontinence. A big one is the widely disproved notion that incontinence is an “old person’s disease.” Another one is that “incontinence cannot be cured.” In a recent study, in fact, significant numbers of professional nurses and a vast majority of nurse assistants told Indiana University researchers they believed bladder disorders are a normal part of aging. Time and again, researchers have refuted incontinence mythology. Along the way, their efforts all too often show how frail elderly individuals can quickly tumble down a path of declining health, endless indignities and painful bed sores. That is, if open minds and a thorough assessment had not prevailed before a resident’s head hit the pillow for the first time. Read more.

Source: McKnight’s Long-term Care News, March 7, 2019

doctor and patient

Axonics® Submits Pivotal Clinical Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System

Axonics Modulation Technologies, Inc. (NASDAQ: 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 submission of pivotal clinical data from the ARTISAN-SNM pivotal clinical study designed to gain marketing approval from the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System1.  The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption (“IDE”) to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction.  Read more.

Source: Business Wire, February 26, 2019

business buildings

InControl Medical Introduces Attain at CES 2019

InControl Medical is proud to announce that Attain, the most advanced over-the-counter device available to treat male and female incontinence and the logical first choice for treatment, will be shown at the 2019 Consumer Electronics Show (CES, January 8-11, Las Vegas Sands, Halls A-D – 43569). According to Herschel “Buzz” Peddicord, InControl’s founder and CEO, “This revolutionary medical device is designed to help treat the approximately 87 million people in the U.S. suffering with stress, urge, or mixed urinary incontinence, and/or bowel incontinence. Attain provides muscle stimulation, visual biofeedback, and a guided exercise program to solve incontinence at the source — the muscle level. Attain’s regular self-treatment program, in the privacy of one’s home, eliminates the need for pads, meds, surgery or diapers.” Read more.

Source: Business Wire, January 8, 2019