Axonics Provides Full One-year Results From ARTISAN-SNM Pivotal Study

Axonics announced the presentation of detailed one-year results from its ARTISAN rechargeable sacral neuromodulation (r-SMN) pivotal study at a plenary session at the joint scientific meeting of the American Urogynecologic Society (AUGS) and the International Urogynecological Association (IUGA). The presentation of positive data, as well as numerous launch activities, highlighted Axonics’ first scientific meeting following the US Food and Drug Administration (FDA) clearance of the Axonics r-SNM System1 in September 2019. During the meeting, more than 350 physicians of the approximate 2,000 at the conference, attended a one-hour symposium at which experienced physician implanters from the ARTISAN-SNM pivotal study discussed their first-hand impressions of the Axonics r-SNM System and post-implant patient feedback. Read more.

Source: Neuro News, October 7, 2019

Axonics® Announces Publication of ARTISAN Clinical Study Results in the Journal of Urology

Axonics Modulation Technologies, Inc. (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 results from its ARTISAN-SNM study were published online in the peer-reviewed Journal of Urology (https://doi.org/10.1097/JU.0000000000000458). This is the first journal publication to detail outcomes for patients in the United States treated with a rechargeable sacral neuromodulation system. The study, conducted under a U.S. Food & Drug Administration (FDA) Investigational Device Exemption (“IDE”), found that 90% of all implanted patients with the Axonics r-SNM® System had successful therapy outcomes. Read more.

Source: Business Wire, July 29, 2019

TARIS Announces Presentation of Clinical Data for TAR-302 for Overactive Bladder

TARIS Bio™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today that results of the company’s Phase 1b study of TAR-302 for the treatment of overactive bladder (OAB) will be presented in a podium session on Wednesday, September 4^th at the Annual Meeting of the International Continence Society (ICS) in Gothenburg, Sweden. The presentation will detail the safety, tolerability, pharmacokinetics and preliminary efficacy data including a durable benefit of TAR-302, which was administered to 11 OAB patients for six weeks. The abstract is available on the ICS website. Read more.

Source: PRNewswire, July 25, 2019

TARIS Bio Initiates New Clinical Study of TAR-302 in Overactive Bladder

TARIS Bio^™, a biopharmaceutical company developing transformational therapies to treat people with debilitating urological disorders, announced today the initiation of a new clinical investigation of TAR-302 for the treatment of overactive bladder (OAB). As a new follow-on arm of the company’s previously concluded Phase 1b trial, the study is designed to investigate the safety, tolerability, and preliminary efficacy of a single 12-week dose of the system, doubling the previous treatment experience and representing a duration that better meets the real-world needs of patients with this serious and chronic disease. Read more.

Source: Yahoo! Finance, May 1, 2019

Tepha Initiates Clinical Evaluation of P4HB Regenerative Scaffold for Stress Urinary Incontinence

Tepha has announced the initiation of a pilot clinical evaluation of the Company’s P4HB regenerative polymer scaffold for the surgical treatment of stress urinary incontinence (SUI). The study was initiated in Cape Town, South Africa in partnership with the Pelvic Floor Foundation of South Africa(“PFFSA”) and the University of Cape Town. The first procedures were performed by co-principal investigators, Dr. Stephen Jeffery of the University of Cape Town and Professor Jan-Paul Roovers of the Academic Medical Center, Amsterdam, The Netherlands. The Cape Town SUI study represents the first clinical application of Tepha’s P4HB polymer technology in the field of urogynecology. Based in Lexington, MA, Tepha is the pioneer developer and exclusive supplier of the P4HB polymer for medical applications that include hernia repair, plastic surgery, tendon & ligament repair, and wound closure. Read more.

Source: Compelo, February 28, 2019

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

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

The Journal of Urology Publishes Valencia’s Excellent Feasibility Data on eCoin™ for Overactive Bladder

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

Stress Incontinence – A Hidden Disease Finds Some Light

While many of us have seen the ads for Attends, the problem being treated, urinary stress incontinence in women, is rarely mentioned [1]; and that is odd for a problem that by some reports effects 25% of women over age 25. (The incidence of breast cancer is about 12%). A recent article in the American Journal of Obstetrics and Gynecology sheds light on this somewhat unmentioned disease. Urinary incontinence is the involuntary passing of urine, frequently associated with coughing, laughing or any activity that causes a person to bear down. It is a result of the loss of support for the bladder, rectum, and vagina – all the structures of the pelvis and is most often seen in women after childbirth. For all the beauty and miracles of birth, passing an eight-pound object through the vagina causes some wear and tear. But physicians know little about the natural history and progression of this loss of pelvic support (clinically termed prolapse). The study provides a better understanding of the course of the disease and some possible milestones. Read more.

Source: American Council on Science and Health, April 3, 2018

Axonics® Receives IDE Clearance from US FDA to Conduct Pivotal Study

Axonics Modulation Technologies, Inc., developer of the first rechargeable sacral neuromodulation (r-SNM™) system for the treatment of overactive bladder (OAB) and bowel dysfunction, today announced the U.S. Food & Drug Administration (FDA) has granted an Investigational Device Exemption (IDE) in accordance with 21 CFR 812 regulations allowing Axonics to conduct a pivotal study designed to gain FDA approval in the United States. “During 2017, as part of the IDE process, the FDA conducted a significant review of our product. A major focus of the technical review was the long-term safety of our implant. The fact that we were able to support our anticipated 15-year full system life-in-the-body claim based on our robust design and development processes, risk analysis and extensive validation testing is testament to the high-quality work of our team,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “Given the demand in the U.S. market for SNM therapy, gaining FDA approval is our main focus. To that end, we fully intend to execute this well-designed pivotal study with velocity and in the best interests of patients.” Read more.

Source: Pharmaweb, November 7, 2017