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Axonics Modulation Technologies Inc.

www.axonicsmodulation.com

Latest From Axonics Modulation Technologies Inc.

Global Approvals Snapshot: November 2019

November’s approvals include the US FDA approval of Medtronic’s In.Pact AV paclitaxel-coated balloon, for the treatment of arteriovenous access in patients with end-stage renal disease, and a CE mark that expands the indication for Edwards’ Sapien 3 TAVR device to include patients at low-risk during surgery.

Approvals Clinical Trials

FDA Expands Indication For Axonics’ Incontinence System; Medtronic Claims Patent Infringement

The US FDA approved Axonics’ r-SNM sacral neuromodulation system for treating overactive bladder and urinary retention on 14 November. The agency approved the same device for treating chronic fecal incontinence on 9 September. Axonics expects r-SNM to rival Medtronic's InterStim II non-rechargeable sacral neuromodulation system, but Medtronic claims the r-SNM technology infringes on Medtronic’s intellectual property.

Approvals Legal Issues

Global Approvals Snapshot September 2019

September’s approvals include the US FDA’s approval of Axonics sacral neuromodulator for fecal incontinence and AMO’s Star S4 IR excimer laser for photorefractive keratectomy.

FDA Approves Axonics’ Neuromodulation Device For Incontinence

The US FDA has approved r-SNM sacral neuromodulation system for treating chronic fecal incontinence and Axonics expects the agency to approve it for overactive bladder and urinary retention in the next few weeks. The company expects r-SNM to compete with Medtronic's Interstim non-rechargeable sacral neuromodulation system.

Approvals Clinical Trials
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Company Information

  • Industry
  • Medical Devices
    • Implantable Devices
    • Surgical Equipment & Devices
      • Minimally or Less Invasive
  • Therapeutic Areas
  • Gynecological, Urological
  • Neurology, Nervous System
  • Alias(es)
  • American Restorative Medicine Inc.
  • Ownership
  • Public
  • Headquarters
  • Worldwide
    • North America
      • USA
  • Parent & Subsidiaries
  • Axonics Modulation Technologies Inc.
  • Senior Management
  • Raymond W Cohen, CEO
    Dan L Dearen, Pres. & CFO
    Jiang Guangqiang, PhD, CTO
    Rinda Sama, COO
    John Woock, PhD, Chief Mktg. Officer
    Karen L Noblett, MD, CMO
  • Contact Info
  • Axonics Modulation Technologies Inc.
    Phone: (949) 396-6322
    26 Technology Dr.
    Irvine, CA 92618
    USA
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