Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Bioness, a Valencia, California firm, won European regulatory approval for its StimRouter neuromodulation system to treat fecal incontinence. Previously cleared in the EU as a tool for managing chronic pain and overactive bladder, the new indication significantly expands the stated capabilities of this novel neuromodulation system. For the management of fecal incontinence, the StimRouter system targets the tibial nerve near the ankle. This is achieved thanks to a tiny implant and an external pulse transmitter patch that’s stuck to the skin over where the electronic lead implant is positioned. The entire outpatient procedure takes about thirty minutes to complete and relies on local anesthesia. Read more.
Source: Medgadget, January 8, 2020
NorthShore Care Supply, the company behind NorthShore brand premium adult diapers, will be moving to a new 173,000 square foot facility in Green Oaks, IL, in March 2020. The new building more than doubles the current space and will include NorthShore’s headquarters, U.S. fulfillment center, contact center, research & development as well as quality control lab. “It’s going to be an exciting year for our company as we complete our relocation and bring online our new fulfillment center with heavy investments in automation & robotics,” says Adam Greenberg, founder and president. “We also have planned investments in new products, advertising campaigns and an educational campaign designed to help end the blame, shame & stigma that exists around incontinence.” Read more.
Source: Nonwovens Industry, January 6, 2020
Urovant Sciences has submitted a New Drug Application (NDA) to the Food and Drug Administration (FDA) for vibegron, a beta-3 adrenergic agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The NDA submission includes data from an extensive clinical development program involving over 4000 patients with OAB. Results from the pivotal 12-week phase 3 EMPOWUR study support the efficacy and safety of vibegron in 1518 patients randomized to receive either vibegron 75mg once daily, placebo, or tolterodine extended-release 4mg once daily. Read more.
Source: MPR, January 2, 2020
Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women’s intimate health, announced today that it has received approval of its Investigational Testing Application (ITA) from the Canadian Ministry of Health to conduct a three-arm, three-month feasibility study to compare Viveve’s cryogen-cooled monopolar radiofrequency (CMRF) treatment and a cryogen-only sham to an inert sham treatment for the improvement of stress urinary incontinence (SUI) in women. Read more.
Source: Street Insider, December 18, 2019
November 2019 proved to be a fruitful month for urology-specific FDA approvals, with the agency giving the green light to a new drug for complicated urinary tract infection, an implantable device for the treatment of overactive bladder/retention, and a digital product for strengthening of pelvic floor muscles and treatment of urinary incontinence in women. The FDA approved cefiderocol (FETROJA) in patients 18 years of age or older who have limited or no alternative treatment options, for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, caused by the following: susceptible Gram-negative microorganisms: Escherichia coli, Klebsiella pneumoniae, Proteus mirabilis, Pseudomonas aeruginosa, and Enterobacter cloacae complex. Read more.
Source: Urology Times, December 4, 2019
Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention. The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting with urinary urge incontinence. Read more.
Source: Business Wire, November 14 2019
Since 1989, the American College of Surgeons (ACS) has acknowledged individuals who have distinguished themselves through their exemplary investments in the mission of the College and in philanthropy with the Distinguished Philanthropist Award. The Board of Directors of the ACS Foundation will present the 2019 Distinguished Philanthropist Award to Christopher K. Payne, MD, FACS, at its annual Donor Recognition Luncheon Monday. The award recognizes Dr. Payne for his philanthropic endeavors, service to the surgical profession, and long-lasting contributions to the medical community and the ACS. Read more.
Source: American College of Surgeons Clinical Congress News, October 31, 2019