Latest Research, Industry, Medical and Scientific News
Axonics Receives FDA Approval for Fourth-Generation Rechargeable Sacral Neuromodulation System
Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today announced that the U.S. Food and Drug Administration has approved the company’s fourth-generation rechargeable sacral neuromodulation system. The newly approved Axonics R20™ neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to just once every 6 to 10 months for only one hour. Read more.
Source: BusinessWire, January 31, 2023
Amber Therapeutics Announces Successful First-in-human Implants of Amber-UI: An Intelligent, Closed-loop Bioelectrical Therapy for Urge and Mixed Urinary Incontinence
Amber Therapeutics (‘Amber’ or the ‘Company’), a University of Oxford spinout developing next-generation, intelligent bioelectrical therapies to transform clinical outcomes in patients with functional disorders of the peripheral nervous system, announces that the first participants have been implanted with Amber-UI, the Company’s proprietary therapy for urge and mixed urinary incontinence (UI). Amber-UI is the first fully implantable closed-loop bioelectrical therapy in clinical development for UI, which is made possible by being able to access and target the pudendal nerve – the nerve that directly controls continence – through a novel, minimally invasive surgical procedure. Read more.
Source: PRNewswire, January 24, 2023
Incontinence Due to Pelvic Floor Issues Affects Women With DM1
Pelvic floor disorders, including urinary and anal incontinence, are common in women with myotonic dystrophy type 1 (DM1) and a cause of significant distress, according to a recent study in Canada. “This study highlights the importance of screening these symptoms in a clinical setting and will help develop interventions to adequately treat these symptoms, taking into account the characteristics of the disease,” its researchers wrote. Ways of addressing urinary incontinence — reported by 60% of the women in this study — “should be explored due to the high prevalence of this disorder,” the team added. The study, “Prevalence of urinary incontinence and other pelvic floor disorders in women with myotonic dystrophy type 1,” was published in the journal Neuromuscular Disorders. Read more.
Source: Bionews, January 17, 2023
Viveve Announces Topline Results from Pivotal U.S. PURSUIT Trial for Treating Female Stress Urinary Incontinence
Viveve Medical, Inc. , a medical technology company focused on women’s health and the treatment of female stress urinary incontinence (SUI), today announced topline result from the U.S. Pivotal PURSUIT clinical trial. PURSUIT was a multicenter, randomized, double-blinded, sham-controlled U.S. study to evaluate the safety and efficacy of the Viveve treatment for SUI in women. The results were obtained by the company on Friday evening, January 13, 2023. The PURSUIT study did not meet its primary endpoint of achieving a statistically significant higher proportion of patients who experienced greater than a 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment in the active treatment group versus the sham control group. Read more.
Source: Accesswire, January 17, 2023
Zida LLC Recently Launched The Zida Control Sock to Help People Fight Against Incontinence
Zida has recently launched “The Zida Control Sock” to help individuals suffering from overactive bladder and incontinence reduce their symptoms. The Zida Control Sock is an FDA-cleared neuromodulation device that uses transcutaneous tibial nerve stimulation to treat overactive bladder and incontinence. Read more.
Source: Newsfile Corp., January 11, 2023
Cellf BIO Begins Phase 1 Clinical Trial of BioSphincter™ Implant for Fecal Incontinence
Cellf BIO, a biotechnology company that manufactures bioengineered sphincters using autologous progenitor cells, announced today that it has begun its Phase 1 clinical trial for its BioSphincter™ Implant for the treatment of severe passive fecal incontinence (FI). The FDA cleared the company’s Investigational New Drug (IND) application, and the Institutional Review Board (IRB) approved the trial to begin enrolling participants. Read more.
Source: Globe Newswire, January 5, 2023