Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
Nov. 25-30 acknowledges Nocturia Awareness Week, part of Bladder Health Month, which encourages people to take control of their urinary health. Nocturia, a treatable medical condition that forces you to wake up multiple times a night to urinate, affects nearly 50 million Americans and is a leading cause of sleep disruption.1, Nocturia can have mental and physical consequences, including: impaired memory3 and concentration, moodiness, depression, obesity, diabetes and a weakened immune system. However, most Americans have never heard of nocturia and think waking multiple times at night to urinate is normal. To help inform Americans so they do not unknowingly endure the consequences of nocturia, Avadel Pharmaceuticals, a leader in urological health and education, has brought together the most influential patient advocacy groups across specialty areas to form the Nocturia Council: American Alliance for Healthy Sleep, Caregiver Action Network, Healthy Women, Men’s Health Education Council, Men’s Health Network, Multiple Sclerosis Association of America, National Association for Continence, National Sleep Foundation, Simon Foundation for Continence and ZERO – The End of Prostate Cancer. Over the next few months, the Nocturia Council, with support from Avadel Pharmaceuticals, will kick off several educational initiatives to lessen the stigma of night-time urination and promote conversations with a healthcare professional about managing nocturia. Read more.
Source: Globe Newswire: November 29, 2018
Astellas has made another deal in the gene therapy category, licensing a candidate for treating faecal incontinence from US biotech Juventas Therapeutics. Terms of the deal haven’t been disclosed, but Astellas says it has taken an exclusive option on the non-viral gene therapy – called JVS-100 and in early-stage clinical development – in all world markets except China. It’s paying an upfront fee and will also fund preclinical and clinical studies of the therapy. JVS-100 is Ohio-based Juventas’ lead product candidate and delivers the gene sequence for stromal cell-derived factor-1 (SDF-1), a naturally occurring signalling protein that is thought to activate the body’s tissue repair pathways, using a plasmid vector. The agreement grants Astellas a licence to develop JVS-100 through phase 2a clinical studies, with an option to acquire the therapy for further development and commercialisation if all goes according to plan. Juventas has already tested the candidate in early-stage trials involving more than 180 patients in other indications, including repeat administrations, and says it has no significant side effects. Read more.
Source: PMLiVE, November 23, 2018
SOME men with prostate cancer are willing to accept lower survival odds to avoid incontinence, impotence and repeat treatments, according to researchers. Prostate cancer is one of the most common forms of cancer in men but in many cases it is a slow growing disease with relatively good survival, even if left untreated. Treatment can include surgery or radiotherapy, but both can cause urinary incontinence and a loss of sexual function. Some patients will spend weeks or months recovering from treatments and some may need a second round of treatment. A new British study suggests that while patients value a longer life, they also value quality of life and may be willing to choose less treatment on that basis. Read more.
Source: The Senior, November 13, 2018
Atlantic Therapeutics, a global manufacturer of innovative, garment-based pelvic floor muscle strengthening and nerve stimulation products, announced today (13.11.18) that the U.S. Food and Drug Administration (FDA) has granted a DeNovo clearance for its INNOVO® therapy device, an externally worn electrical muscle stimulator for the treatment of stress urinary incontinence in adult females. INNOVO® is the first transcutaneous electrical stimulation continence device to be cleared by the FDA, following results of two randomized controlled trials (RCTs) demonstrating it to be an effective and low-risk device for the treatment for stress urinary incontinence (SUI) in adult females. Read more.
Source: Business Wire, November 13, 2018
Renovia Inc. (“Renovia”), a company dedicated to discovering and delivering first-line digital therapeutic and diagnostic devices for women with pelvic floor disorders, today announced it has launched a large, multi-center randomized controlled trial (RCT) to study the efficacy of a first-line non-surgical digital therapeutic for the treatment of stress-dominant urinary incontinence (UI). Pelvic floor muscle exercises (PFME), also known as Kegel exercises, are the widely accepted first-line conservative treatment for pelvic floor disorders including stress, urgency, and mixed UI within the urogynecology, urology and physical therapy communities. However, many women have trouble identifying and contracting the correct muscles when performing these exercises, and remembering to perform the exercises regularly can be challenging. Read more.
Source: Business Wire, November 12, 2018
According to the American Urological Association, approximately 40% of women and 30% of men live with overactive bladder or OAB. Many people with OAB find it difficult to talk to their doctor or loved ones about their condition because of the stigma associated with it. Pro-ficiency, a leading provider of interactive online patient education tools, announces its collaboration with the Academy for Continued Healthcare Learning (ACHL) and the Simon Foundation for Continence, in their joint, interactive program, to educate people about how to speak with their healthcare providers and their loved ones to get the care they need. The program also discusses treatment options, how to manage social and lifestyle considerations, and incorporating shared-decision making into visits with health care providers. The program is freely available to all participants. “ACHL & Pro-ficiency previously collaborated on a highly successful OAB educational activity, however, given the depth and breadth of OAB, it was clear that continued education was needed. ACHL is proud to continue the education movement with this most recent program,” adds Amanda Kaczerski, with ACHL. Read more.
Source: Newswire, November 5, 2018
Last week, The Journal of Urology published the feasibility data of Valencia Technologies’ (“Valencia“) eCoin™ device indicated for treatment of overactive bladder. The manuscript, “Feasibility of a fully-implanted, nickel-sized and shaped tibial nerve stimulator for the treatment of overactive bladder syndrome with urgency urinary incontinence,” details the design of Valencia’s 46 patient study and the study’s excellent clinical results. The manuscript has an embargo date of February 15, 2019. Implanted in a 20-minute office procedure across seven clinical centers in the United States and New Zealand, the coin-sized and shaped tibial nerve stimulator is distinctly simple to implant in stark contrast to a highly invasive and operator dependent therapy called sacral nerve stimulation. An author of the eCoin™ publication, Dr. Vincent Lucente, concludes, “I believe tibial nerve stimulation with eCoin™ will become the therapy of choice for patients after medications are tried. These early results clearly show a better therapy is on the horizon for patients with urinary incontinence.” Read more.
Source: PRNewswire, November 1, 2018