clinical medical

Axonics® Reports 2-Year Clinical Results from ARTISAN-SNM Pivotal Study

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, has reported full 2-year clinical results from its ARTISAN-SNM pivotal study.  Read more.

Source: Business Wire, September 10, 2020

product approval introduction

InterStim Micro Neurostimulator and SureScan MRI Leads Cleared in Europe for Incontinence Control

Medtronic won EU regulatory clearance to introduce its InterStim Micro neurostimulator and InterStim SureScan MRI leads. The devices are used to deliver sacral neuromodulation therapy to treat overactive bladder (OAB), fecal incontinence, and non-obstructive urinary retention.  The InterStim Micro is a much tinier version of Medtronic’s InterStim II neuromodulator, as it is 80% smaller, but it is a rechargeable device with an expected longevity of about 15 years. This is made possible partially thanks to so-called Overdrive technology that lets the battery maintain almost its full capacity to recharge throughout its working life. Read more.

Source: Medgadget, January 13, 2020

product approval introduction

Bioness StimRouter Cleared in Europe to Treat Fecal Incontinence

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

business buildings

Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing a novel implantable rechargeable sacral neuromodulation (“SNM”) device for the treatment of urinary and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”). The Axonics System is the first rechargeable SNM system approved for sale in the United States, Europe, Canada and Australia.  The FDA approval grants Axonics the right to market its product in the United States for the clinical indication of fecal incontinence. The approval includes the claim of a 15-year functional life and the ability of patients to undergo full-body MRI scans without the necessity of having the device explanted.  Axonics has an additional pre-market approval (“PMA”) filing currently under review with the FDA for the clinical indications of overactive bladder (urinary urgency incontinence and urinary urgency frequency) as well as urinary retention for which the Company anticipates a determination in the near term. Read more.

Source: Business Wire, September 9, 2019

product approval introduction

InControl Medical Wins FDA Clearance for Attain: The First Over-the-Counter, At-Home Device for the Treatment of Urinary and/or Fecal Incontinence in Women

InControl Medical wins FDA clearance for new Attain, the first over-the-counter (OTC) non-implantable muscle stimulator designed for at-home use to help treat the approximately 60 million women in the U.S. suffering with stress, urge, mixed urinary incontinence and/or bowel incontinence.  This is good news for all those affected by urinary and/or involuntary bowel leakage that can increase with age: 20% -30% of young women, 30%-40% of middle-aged women, and up to 50% of older women suffer from incontinence.  It’s time to talk about this taboo topic before diapers become the newest accessory in the Nike store. So, strengthen your calves and abs, but don’t forget to strengthen your pelvic floor muscles too, says Lauren Streicher, M.D., Medical Director of the Northwestern Medicine Center for Sexual Health and Menopause and Clinical Professor of Obstetrics and Gynecology at Northwestern University. All kidding aside, many of my patients who suffer with urinary incontinence, can also have leaky bowel, and truly suffer in silence and embarrassment. Post-partum, anal or rectal cancer, and the natural aging process can cause incontinence. Thankfully, many patients respond well to pelvic-floor electrical stimulation and biofeedback as a first-line treatment, before considering surgery or medication. Attain is a small, painless, easy to use medical device for women to self-treat in the privacy of their own home, reducing or eliminating the need for pads or diapers. Read more.

Source: Global Banking & Finance Review, March 26, 2019

doctor and patient

Axonics® Submits Pivotal Clinical Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System

Axonics Modulation Technologies, Inc. (NASDAQ: AXNX) a medical technology company focused on the development and commercialization of novel implantable Sacral Neuromodulation (“SNM”) devices for the treatment of urinary and bowel dysfunction, today announced the submission of pivotal clinical data from the ARTISAN-SNM pivotal clinical study designed to gain marketing approval from the U.S. Food & Drug Administration (“FDA”) for the Axonics r-SNM® System1.  The ARTISAN-SNM study is a 129-patient single-arm, prospective, multi-center, unblinded pivotal clinical study approved under an FDA Investigational Device Exemption (“IDE”) to evaluate the safety and efficacy of the Axonics r-SNM System for urinary dysfunction.  Read more.

Source: Business Wire, February 26, 2019

business buildings

Topical Gel Gets Fast-Tracked for Fecal Incontinence in Spinal Cord Injury Patients

The Food and Drug Administration (FDA) has granted Fast Track designation to RDD-0315, a novel topical gel for the treatment of fecal incontinence in spinal cord injury patients.  RDD-0315 contains the alpha-agonist oxymetazoline in a topical gel formulation; it works by contracting the internal anal sphincter muscle. In a randomized, controlled crossover study involving 19 patients with spinal cord injury, the investigational gel was found to be beneficial, due to the local effect of oxymetazoline; a statistically significant reduction in the number of fecal incontinence episodes was observed 8 hours and 12 hours post-administration. Read more.

Source: MPR, February 15, 2019

clostridium difficile C. diff

Microrobots Take Minutes to Detect C. diff in Stool Samples

Detecting bacterial infestations within the GI system, particularly using low cost methods, takes so much time that treatment is often administered too late. Clostridium difficile (C. diff) is a particular nasty nuisance that kills many frail patients, and even with a hospital lab it can take up to two days to get the results.  Researchers at Chinese University of Hong Kong (CUHK) have developed fluorescent microrobots that can spot C. diff in a stool sample within a matter of minutes without relying on expensive laboratory equipment. Read more.

Source: Medgadget, February 15, 2019

imaging brain head

Certain Sites of Brain Lesions in MS Tied to Bowel Incontinence

Specific locations of cerebral multiple sclerosis lesions appear to be associated with bowel incontinence, according to a study published online Dec. 11 in the Journal of Neuroimaging.  Kilian Frohlich, M.D., from the University Hospital Erlangen in Germany, and colleagues used a voxel-wise lesion symptom mapping analysis to assess associations between bowel incontinence and cerebral multiple sclerosis lesions identified on magnetic resonance imaging of 51 patients. The researchers found associations between fecal incontinence in a total of 93 lesioned voxels, with 63 voxels located in the gray matter and 30 voxels in the white matter.  Read more.

Source: Practice Update, December 17, 2018

business buildings

Astellas Makes Another Gene Therapy Play with Juventas Deal

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