Image Credit: Axonix
Medtronic and Boston Scientific have reached a confidential settlement over the IP dispute between Medtronic and Axonics (now part of Boston Scientific). The settlement, which includes a payment from Boston Scientific to Medtronic resolves all outstanding litigation between Medtronic and Axonics.
Image Credit: Axonix
Axonix announced that a jury in the U.S. District Court for the Central District of California returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic against Axonics in Axonix favor.
The jury ruled unanimously for Axonics, on claims related to three separate patents. One relates to transcutaneous recharging, and the other two two to the implantation of electrodes for stimulating the sacral nerve to help support urinary and bowel control.
The case has been one of several intellectual property disputes between Medtronic and Axonics, which is expected to become a Boston Scientific subsidiary in a $3.7 billion deal.
First-generation RF-powered BION (RFB1) microstimulator. Image Credit: Alfred Mann Institute for Biomedical Engineering
In 1991, Dr. Gerald Loeb, at the time a Professor of Physiology and Biomedical Engineering at Queen’s University (Kingston, Canada), first proposed a miniature, injectable, RF-powered device for the stimulation of tissue or motor neurons. The BION® device was developed based on this concept as a joint project between Queens University (Kingston, ON, Canada), IIT (Chicago, IL), and the Alfred E. Mann Foundation (Valencia, CA) with funding from the NIH Neural Prosthesis Program. The RF BION 1 (RFB1) was then manufactured by the Alfred Mann Institute for Biomedical Engineering at USC.
Image Credit: Axonix
In January of this year Boston Scientific announced it had entered into a definitive agreement to acquire Axonics a publicly-traded developer of devices to treat urinary and bowel dysfunction. The purchase price was set at $3.7B. However, the proposed deal is facing scrutiny by the FTC, most probably because the companies are dominant providers of some treatments for incontinence.
The Axonics product portfolio includes the Axonics R20 and the Axonics F15 Systems used to deliver sacral neuromodulation (SNM) therapy. In clinical studies, Axonics Therapy has demonstrated meaningful improvement in patients’ quality of life in follow-up out to two years, with no serious device-related adverse events reported.
Image Credit: Victor Pikov, Ph.D., Medipace Inc.
Victor Pikov, Medipace’s founder and CEO, presented the OpenNerve Project at the First Workshop on Active Implantable Medical Devices last week. As part of his excellent presentation, he discussed the current commercial landscape of bioelectronic medicine therapies. A picture (in this case, the graph above) is worth a thousand words.
Image Credit: Axonix
Boston Scientific Corporation announced it has entered into a definitive agreement to acquire Axonics, a company that develops implantable sacral neuromodulation devices to treat urinary and bowel dysfunction. According to the announcement, the purchase price is $71 in cash per share, reflecting an equity value of approximately $3.7 billion.
Image Credit: Axonix
On March 7, 2022 Axonix announced that it had received FDA Approval for its 10cc F15 Recharge-Free Sacral Neuromodulation System for the treatment of bladder and bowel dysfunction. The device features 15+ years of functional life at typical stimulation parameters and 20+ years at lower energy settings.
Image Credit: Axonics
Axonics Modulation Technologies is an Irvine, CA company founded in 2013 that developed a novel implantable sacral nerve stimulator to treat patients with urinary and bowel dysfunction disorders.
The Axonics r-SNM system is a miniaturized rechargeable implantable stimulator with a longevity of at least 15 years. The system also features a charging system designed for quick charge times and a user-friendly remote control and programming interface.
The r-SNM device won CE Mark approval in June 2016. Axonics announced today that it had received FDA approval 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.
Image Credit: Axonics
Axonics Modulation Technologies is an Irvine, CA company founded in 2013 that developed a novel implantable sacral nerve stimulator to treat patients with urinary and bowel dysfunction disorders.
The Axonics r-SNM system is a miniaturized rechargeable implantable stimulator with a longevity of at least 15 years. The system also features a charging system designed for quick charge times and a user-friendly remote control and programming interface.
The r-SNM device won CE Mark approval in June 2016, and is currently pursuing FDA approval using its “literature-based PMA submission”. This type of submission relies on supporting literature that is “sufficient, detailed, objective, and directly applicable to the subject device.” Axonics is quoting the Medtronic InterStim II device, which is the only U.S.-approved sacral neurostimulator. Axonics also provided to FDA one-year post-market data from its 51-patient European Relax-OAB study.
In February 2019 Axonics announced that its IDE pivotal clinical study demonstrated that patients implanted with the r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of life, met all secondary endpoints, and no serious device-related adverse events were reported.
Axonics had an Initial Public Offering in November 2018 which yielded $138M.
Axonics website: http://www.axonicsmodulation.com/
Image Credit: Axonics