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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

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

product approval introduction

Axonics Sacral Neuromodulation for Urinary and Fecal Dysfunctions Cleared for MRI in Europe

Axonics, based in Irvine, California, won European regulatory approval for MRI conditional labeling for its sacral neuromodulation (SNM) system for treatment of overactive bladder, urinary retention, and fecal incontinence. The Axonics SNM system is now compatible, given certain precautions, with 1.5 Tesla and 3 Tesla MRI scanners. It is the only SNM system cleared in Europe with such labeling. The implant is rechargeable, and so can be used for much longer periods than similar devices that have to be replaced with fresh batteries. The company promises a lifetime of up to 15 years, Axionics claims is three times longer than Medtronic’s InterStim. Additionally, it’s 60% smaller. Read more.

Source: Medgadget, February 26, 2019

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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

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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

fiber rich diet for bowel retraining

FODMAP Diet Helps Fecal Incontinence

Two-thirds of patients with fecal incontinence associated with loose stool experienced an improvement in symptoms when following a low FODMAP diet, a researcher reported here. “Fecal incontinence is an underappreciated complaint, and patients often suffer in silence,” said Stacy Menees, MD, of the University of Michigan in Ann Arbor, in a presidential plenary session at the annual meeting of the American College of Gastroenterology (ACG).  In an earlier, large population-based study of more than 71,000 people, one in seven reported having had fecal incontinence at some point in their lives. Of these, one-third reported fecal incontinence in the last 7 days, which is often associated with diarrhea and loose stool. People with diarrhea have a 5.6-fold higher risk of fecal incontinence, and people with urgency have a more than 8-fold risk of diarrhea. “So if we are going to help people with fecal incontinence, the key is to concentrate on their stool consistency,” Menees said. Read more.

Source: MedPage Today, October 8, 2018

Derick Fage

Breakfast Television Montreal Host Has Unique Take on Potty Humour

Breakfast Television Montreal co-host Derick Fage has joked that doctors made him an asshole. Thing is, though, they did. He was born without one — the condition is known as a high imperforate anus — and, despite surgery to create an anal opening, he has contended all his life with fecal incontinence. That means, among other things, that if he goes to a restaurant, he makes sure to know where the washroom is — because if he needs it, he needs it right away. If he is, say, hosting a charity event, he’ll pop a couple of Imodium pills beforehand. Accidents at work are rare, but they happen. “Just a few weeks ago, I had a major accident live on the air.” He handed over to his co-host and left the set to clean up and change into the spare set of clothes he keeps at work. Today Fage, 48, speaks publicly about his condition in a bid to help others living with its challenges. In April at the Global Forum on Incontinence in Rome, he gave an eloquent and emotional address, last year in Laval he gave a TEDx talk, and he is an ambassador and champion for the Canadian Continence Foundation. Read more.

Source: Montreal Gazette, July 19, 2018

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Restech acquires Mederi Medical

Medtech developer Respiratory Technology Corp said today it acquired Mederi Therapeutics, and its Stretta catheter and Secca system, for an undisclosed amount.  Houston-based Restech said that the addition of the Stretta catheter, designed to treat gastroesophageal reflux disease, and the Secca system, designed to treat bowel incontinence, are complimentary to its existing diagnostic devices.  Mederi’s Stretta catheter system is designed to apply low-power radio frequency energy to remodel the lower esophageal sphincter to restore natural barrier function and reduce spontaneous regurgitation caused by transient relaxations of the sphincter.  The Secca device uses a low-power radiofrequency generator to remodel the muscle of the internal anal sphincter to treat bowel incontinence, the company said.  Read more.

Source: Mass Device, April 26, 2018

abdominal pain

Nurses Welcome NICE Support for Irrigation Device for Constipation and Faecal Incontinence

A medical device for treating constipation and faecal incontinence has been recommended for health service use by the National Institute for Health and Care Excellence.  Specialist stoma care nurses working with both children and adults affected by faecal continence problems welcomed the decision by NICE to back the use of the Peristeen transanal irrigation system.In new medical technology guidance published today, NICE said the “case for adopting” the Peristeen for managing bowel dysfunction was “supported by the evidence”.  According to NICE, the system can “reduce the severity of constipation and incontinence, improve quality of life and promote dignity and independence”.  Read more.

Source: Nursing Times, February 23, 2018