Below you will find news and press releases from industry, government, and academia regarding product developments and medical/scientific research news.
You may not think that the topic of fecal incontinence (FI) and management sounds very lucrative or interesting, and within demanding and stressful healthcare environments it is usually last to receive attention. Even if healthcare workers do think about these issues, they often do not have as much time as they would like to invest in fecal management, and they have had few options to choose from until now. Consure Medical has developed Qora, a novel stool management kit, that not only improves management, patient care, and provides ease of use with no compromise of patient safety, but it also greatly reduces overall hospital stay and associated costs. Qora can greatly reduce the incidence, occurrence, and the costs associated with hospital acquired conditions (HACs), including nosocomial infections such as C. diff, Catheter-Associated Urinary Tract Infections (CAUTI), Central Line-Associated Bloodstream Infection (CLABSI), and hospital-acquired pressure injury (HAPI), in comparison to the traditional practices of FI management. Read more.
Source: medGadget, September 15, 2017
RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the Department of Defense office of the Congressionally Directed Medical Research Programs (CDMRP) has funded the Spinal Cord Injury Research Program (SCIRP) Translational Research Award – Clinical Trial application. The grant of $1.28M will enable initial U.S. clinical development of RDD-0315 for fecal incontinence in spinal cord injury patients including preparations for and conducting of a Phase 1 study in healthy volunteers to assess acute tolerance and PK. “We are pleased the CDMRP recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients,” stated Jason Laufer, Chief Executive Officer, RDD Pharma. “We can now move forward more aggressively in the U.S. to develop RDD-0315 which has the potential to positively impact the health, well-being and quality of life in this patient population.” Read more.
Source: PRNewswire, September 14, 2017
Cogentix Medical, Inc. (NASDAQ: CGNT), a global medical device company focused on providing the Urology, Uro/Gyn and Gynecology markets with innovative and proprietary products, today announced that Cahaba Government Benefit Administrators, LLC has modified their policy for Percutaneous Tibial Nerve Stimulation (PTNS) delivered via Cogentix Medical’s Urgent® PC Neuromodulation System to allow for ongoing maintenance treatments for an indefinite period of time. “This policy update further reinforces the medical necessity of Urgent PC as a long-term solution for patients suffering with overactive bladder symptoms,” said Darin Hammers, President and CEO. “Additionally, the policy change to indefinite coverage allows the patient and physician to decide whether to continue ongoing treatment with Urgent PC to sustain their symptomatic improvements.” Read more.
Source: PRNewswire, September 13, 2017
GTx, Inc. (Nasdaq: GTXI) today announced top-line clinical trial results demonstrating that a daily dose of enobosarm 3 mg (GTx-024) substantially improved stress urinary incontinence (SUI) in women, as well as related quality of life measurements. In this open-label clinical trial, all 17 patients completing 12 weeks of treatment saw a clinically significant reduction (50 percent or greater) in stress leaks per day, compared to baseline. Mean stress leaks decreased by 83 percent from baseline over 12 weeks, and the reductions in daily stress leaks following completion of treatment have been sustained as patients are being followed for up to 7 months post-treatment to assess the durability of treatment effect. No patient has relapsed to her baseline levels. These results were presented at the International Continence Society (ICS) Annual Meeting currently being held in Florence, Italy from September 12-15, 2017. Read more.
Source: Business Wire, September 13, 2017
Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, today announced the presentation of positive results from its prospective, multicenter clinical study at the 2017 International Continence Society (ICS) Congress in Florence, Italy. The presentation, entitled “A prospective multicenter clinical study evaluating a miniaturized rechargeable sacral neuromodulation system for the safe and effective treatment of overactive bladder (RELAX-OAB study),” was delivered by Bertil F.M. Blok, M.D., PhD, Dept. of Urology, Erasmus University Medical Centre, Rotterdam, Netherlands. Read more.
Source: Business Wire, September 13, 2017
Astellas Pharma Inc. announced today that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that seeks approval for the use of mirabegron in combination with solifenacin succinate 5 mg for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The anticipated Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 28, 2018. In the United States, mirabegron and solifenacin succinate are marketed as Myrbetriq® and VESIcare®, respectively. Each is approved by the FDA as a monotherapy for the treatment of OAB with symptoms of urge urinary continence, urgency and urinary frequency. Read more.
Source: Gurufocus.com, September 12, 2017
A Connecticut venture fund is backing a Monroe startup that is seeking Food and Drug Administration approval of a device to help alleviate a urological disorder affecting millions of women. In April, Newtown residents Gloria and Eric Kolb won U.S. patent protection on Monroe-based Elidah’s Elitone device to help women with stress urinary incontinence, with the Elitone device emitting mild electric impulses to stimulate and strengthen pelvic muscles. Women diagnosed with the condition can suffer urinary leakage during physical exertion or while coughing or sneezing. To date, physicians have recommended solutions ranging from exercises to surgical implants called pelvic meshes, with thousands of lawsuits having been filed against three manufacturers of the devices the past few years after women suffered adverse reactions. Read more.
Source: ctpost, August 17, 2017