Santex SPA Announces Acquisition of U.S. E-commerce Retailer Parentgiving, Inc.

Santex SPA, a global leader in premier incontinence products and surgical dressing and orthopedic products, announced the acquisition of Parentgiving, Inc., the country’s premier retailer of caregiving products for the aging. The agreement was finalized in June 2020, and the companies have spent the past year integrating operations and developing an expanded portfolio of Parentgiving’s signature Dry Direct incontinence products for expansion in the United States. Read more.

Source: PR Newswire, June 22, 2021

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

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

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

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

Axonics® Expands into Stress Urinary Incontinence with the Acquisition of Bulkamid®

Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced that it has acquired privately-held Contura Ltd. and its flagship product, Bulkamid, a best-in-class urethral bulking agent for women with stress urinary incontinence (SUI). Read more.

Source: Business Wire, February 25, 2021

Urovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)

Urovant Sciences, Inc (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. Read more.

Source: BioSpace, December 23, 2020

Vibegron Update Shared as FDA Weighs Approval in OAB

The FDA is considering an application for vibegron for the treatment of patients with OAB with symptoms of urge urinary incontinence, urgency, and urinary frequency. Vibegron continued to demonstrate improved clinical outcomes versus tolterodine in patients with overactive bladder (OAB), according to findings from an extension study of the phase 3 EMPOWUR trial presented during the 2020 International Continence Society (ICS) online meeting. The extension results showed that at week 52, 61% of patients receiving vibegron had a 75% or higher reduction in urge urinary incontinence (UUI) episodes compared with 54.5% of patients who received tolterodine. Additionally, 40.8% versus 34.2% of patients, respectively, had a 100% reduction in UUI episodes and experienced no incontinence episodes over a 7-day diary. Read more.

Source: Urology Times, November 20, 2020