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Axonics Modulation Technologies Inc.

    First Commercial U.S. Patient Implanted with Axonics® Sacral Neuromodulation System

    Following the completion of customary post-approval regulatory activities, the first implant outside of a clinical study setting was conducted in California on October 29.

    1-year Follow-Ups and Top-Line Clinical Results from ARTISAN-SNM Pivotal Clinical Study

    The study results at 1-year demonstrate that patients implanted with the Axonics r-SNM System continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life.

    Axonics® Granted Expanded CE Mark Label; First and Only Sacral Neuromodulation System Approved for Use with Full-Body MRI Scans

    2/22/19: The company reports the Axonics r-SNM System is the only implantable SNM system that has received full-body MRI conditional labeling for sale in Europe.

    ARTISAN-SNM Pivotal Study Shows Positive Top-Line Clinical Data

    2/19/19: The clinical study demonstrated that patients implanted with the Axonics r-SNM System received clinically meaningful and statistically significant improvements in Urinary Urgency Incontinence (“UUI”) symptoms and quality of life. Additionally, the study met all secondary endpoints. No serious device-related adverse events have been reported.

    Axonics® Submits Full Body MRI Data to U.S. Food & Drug Administration for its Sacral Neuromodulation System

    2/12/19: Raymond W. Cohen, CEO of Axonics, commented, “Without this Full Body labeling, any patient requiring an MRI scan on any body part below the head must have their neurostimulator and lead surgically explanted prior to the MRI scan, resulting in loss of an effective treatment, another surgery for the patient and additional cost to the patient and healthcare system. Our robust testing and analyses conclude that Full Body MRI scans can be safely performed on patients with an implanted Axonics r-SNM system.”

    Axonics® Files for Premarket Approval with U.S. Food & Drug Administration for its Sacral Neuromodulation System

    12/5/18: This PMA filing submitted by Axonics is referred to as a “literature-based PMA”. While most PMAs are supported by original clinical investigations, in rare cases, literature-based evidence may be accepted as the sole basis for approval of a PMA to establish reasonable assurance of safety and effectiveness when the literature is sufficient, detailed, objective, and directly applicable to the subject device. In this PMA filing, Axonics has submitted existing literature reporting on InterStim II®, manufactured by Medtronic plc, the only currently approved SNM device.

    Axonics® Receives CE Mark for its Sacral Neuromodulation External Trial System

    7/8/18: “To date, over 225 patients have been implanted with an Axonics r-SNM System in Europe and North America, the vast majority of which without undergoing an external trial period before permanent implant. We demonstrated that with quality lead placement and confirmation of intraoperative responses, outstanding clinical results can be achieved without an external trial,” said Raymond W. Cohen, Chief Executive Officer of Axonics. “However, from a commercial standpoint, having an External Trial System is necessary given that payors prefer to reimburse permanent implants after confirming that the patient is a trial responder. We are confident that Axonics is now well positioned to capture significant worldwide share and, due to the benefits of our product offering, accelerate growth in the large $700 million Sacral Neuromodulation market.”

    Axonics® Completes Enrollment of U.S. FDA Pivotal Study for its Sacral Neuromodulation System

    Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) System for the treatment of urinary and bowel dysfunction, announced today that...

    Axonics Announces $20.5 Million Second Closing of its Series C Financing

    Axonics Modulation Technologies, Inc., developer of the first rechargeable Sacral Neuromodulation (r-SNM™) system for the treatment of urinary and bowel dysfunction, announced today that...

    Axonics® Announces $14.5 Million First Close of Series C Financing

    “These world-class investors have provided Axonics with phenomenal support throughout the development phase of our project, including attainment of key milestones such as European...

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