Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
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
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, 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
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 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, 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
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