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FDA Authorizes Study Exploring Novel Device for Bladder Incontinence

The FDA has approved the launch of an investigational device exemption trial exploring a novel implantable tibial neuromodulation (TNM) device designed to relieve symptoms of bladder incontinence.  The trial, known as the TITAN 1 Feasibility Study, is a multicenter, prospective trial aiming to enroll 20 patients at 8 clinical sites in the United States. The patients will have the device implanted in the posterior tibial nerve near the ankle. They will be followed for 12 months to assess the feasibility of the product. Enrollment for the trial is expected to commence in May. Medtronic currently offers several products for bladder control, including the InterStim sacral neuromodulation systems and the NURO percutaneous tibial neuromodulation (PTNM). Read more.

Source: Urology Times, April 27, 2021

Urovant Sciences Announces U.S. Commercial Launch of GEMTESA® (vibegron) 75 mg Tablets for Patients with Overactive Bladder

Urovant Sciences, a biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today announced the commercial launch of GEMTESA® (vibegron) 75 mg tablets, a beta-3 (β3) adrenergic receptor agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: Business Wire, April 12, 2021

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First Patients Enrolled in Uromedica’s Adjustable Continence Therapy (ACT®) for Female Stress Urinary Incontinence (SUI) Trial

Uromedica, Inc. announces the initiation of its FDA Investigational Device Exemption trial for ACT® to evaluate its safety and efficacy for treatment of female SUI.  Stress urinary incontinence is the accidental leakage of urine that can occur when sneezing, coughing, or performing physical activity. The investigational intent of the ACT trial, a post-operatively adjustable, minimally invasive outpatient procedure, is to assess safety and efficacy for women who suffer from moderate or severe SUI. Read more.

Source: Business Wire, March 10, 2021

Isolated and Alone: Nonprofits See Explosion of Need for Adult Incontinence Products

Before the pandemic and when she had the extra money, Lucy Jackson would sometimes go out to buy the adult incontinence products she needed to get through the day and night. But now, worried about catching the coronavirus, she rarely leaves her Newark, New Jersey, boarding house. To get supplies, she relies more on friends, family and the Modestly Cover Diaper Bank of Essex County, New Jersey. “During this pandemic, it’s been very, very difficult,” Jackson, 72, said. Read more.

Source: NBC Universal, March 8, 2021

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Principle Business Enterprises Celebrates 60 Years

Principle Business Enterprises, Inc. (PBE) celebrates 60 years of manufacturing safety and absorbent products for the healthcare industry by announcing the evolution of its Tranquility brand of incontinence products and ongoing commitment to being an employer of choice. Since welcoming the company’s third generation of family leadership with the appointment of Andrew Stocking as president and CEO, PBE has continued to focus on product innovation and its mission to uplift, enlighten, and enrich the lives of its customers and associates. Read more.

Source: Nonwovens Industry, March 3, 2021

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Stewartville Medical Device Maker Lands big European Deal

A Stewartville firm, which makes medical devices to control fecal incontinence, took a major step forward this week with a deal to bring its products to European markets. Minnesota Medical Technologies, founded in 2015 under the leadership of Jim and Philip Conway, has signed an agreement with Sweden-based Wellspect Healthcare to distribute Minnesota Medical’s fecal incontinence insert throughout Europe. The myMiracle device is made of soft silicone, with a bulb that encapsulates liquid, so the insert conforms to the patient’s body for comfort and to create a seal. A typical patient might use about 500 of the one-time-use products a year. Read more.

Source: Post Bulletin, February 25, 2021