Axonics Archives - Medical Design Sourcing

PTAB upholds two Medtronic patents in spat with Axonics, could go to jury trial

Medtronic (NYSE: MDT) + announced today that the U.S. Patent and Trademark Office upheld claims around two of its patents in its battle with Axonics (Nasdaq:AXNX).

The office’s Patent Trial and Appeal Board (PTAB) affirmed the validity of claims in two of Medtronic’s patents in the latest development in a long-running spat between the two companies. It means the PTAB has now upheld the validity of five of the company’s patents at issue in its lawsuit against Axonics.

Medtronic in November 2019 filed a lawsuit against Axonics alleging patent infringements over sacral neuromodulation (SNM) technologies. Since then, the battle has gone back and forth, with the medtech giant most recently asking the U.S. International Trade Commission (ITC) to block the sales of certain Axonics devices.

Medtronic now wants to ask the federal court in the Central District of California to lift its stay on the lawsui…

Axonics wins CE mark for 4th-gen rechargeable sacral neuromod system

The next-gen R20 rechargeable sacral neuromodulation system [Image courtesy of Axonics]Axonics (Nasdaq:AXNX) announced today that it received CE mark approval for its R20 rechargeable sacral neuromodulation (SNM) system.

The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. Axonics won FDA approval for this generation of the R20 in January 2023. The R20 neurostimulator uses the same small 5cc form factor as the previous-generation R15. It pairs with the same tined lead and intuitive patient remote control. It also features enhanced programming capabilities with expanded MRI labeling.

R20 has a functional life in the body of at least 20 years and reduces charging frequency to every 6-10 months for just one hour.

Axonics expects to begin selling R20 to European customers in mid-April.

“Delivering a superior patient experience has been at the forefront of our SNM development efforts,” said CEO Raym…

FTC reportedly may scrutinize Boston Scientific’s Axonics deal

Bloomberg reports that the U.S. Federal Trade Commission (FTC) may look into the $3.7 billion acquisition of Axonics (Nasdaq:AXNX) by Boston Scientific (NYSE: BSX) + .

In January, Boston Scientific announced its plans to buy Axonics and its neuromodulation and hydrogel technologies. The companies said at the time that they expected the deal to close in the first half of this year.

Irvine, California-based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. The technology delivers mild electrical pulses to the sacral nerve, restoring communication between the brain and the bladder. The company also offers the Bulkamid urethral bulking agent for stress urinary incontinence symptoms.

According to the report, the scrutiny may arrive due to the companies’ shares of the urinary incontinence market. Bloomberg Intelligence Analyst Jennifer Rie claimed in the report that Boston Scien…

Medtronic asks ITC to stop Axonics’ sales of neuromod devices

Medtronic (NYSE: MDT) + today announced that it filed a complaint to the U.S. International Trade Commission (ITC) to block the sales of certain Axonics (Nasdaq:AXNX) devices.

The complaint to the ITC runs parallel to action in the U.S. District Court for the District of Delaware. Medtronic wants to block Axonics from “improperly importing and selling products that infringe two of its patents related to the MRI compatibility of implantable medical devices.”

Medtronic wants the ITC to investigate and exclude the importation of Axonics products believed by the company to infringe its patents. The company has a separate infringement suit pending in the U.S. District Court for the Central District of California as well. That suit asserts that Axonics infringed additional technologies developed by and belonging to Medtronic.

“Medtronic is continuing our efforts to stop Axonics from profiting off of …

Boston Scientific to acquire Axonics for $3.7B

Boston Scientific (NYSE: BSX) + announced today that it agreed to acquire Axonics (Nasdaq:AXNX) in a deal worth approximately $3.7 billion.

Shares of AXNX skyrocketed before the market opened today, rising 21.1% to $69.72 apiece. Shares of BSX stayed even.

Marlborough, Massachusetts-based Boston Scientific priced the acquisition at $71 in cash per share. It amounts to an equity value of about $3.7 billion and an enterprise value of approximately $3.4 billion.

Irvine, California-based Axonics develops neuromodulation systems for treating urinary and bowel dysfunction. Its fourth-generation R20 rechargeable sacral neuromodulation (SNM) system received FDA approval around a year ago. Axonics also launched the recharge-free F15 SNM system in mid-2022.

Axonics’ technology delivers mild electrical pulses to the sacral nerve, restoring communication between the brain and the bladder. The company also offer…

Artificial heart maker BiVacor names Axonics CEO as chair of its board

New BiVacor Chair Raymond W. Cohen. [Image from Axonics]BiVacor announced today that it appointed Axonics CEO Raymond W. Cohen as the new chair of its board of directors.

Cohen serves as CEO and as a member of the board at Axonics, which develops sacral neuromodulation technologies. He originally founded Axonics in 2013 and took the Irvine, California-based company public in October 2018. The long-time executive has more than 40 years of experience in the life sciences industry.

In addition to his roles at Axonics, Cohen serves as an independent director of SoniVie. The clinical-stage, venture-backed company develops denervation technology for uncontrolled hypertension.

Cohen now heads up the board at BiVacor, a company making a total artificial heart (BTAH). BiVacor received FDA investigational device exemption (IDE) for the artificial heart last month. It’s now set to conduct a first-in-human clinical feasibility study evaluating the use of the syst…

Medtech Big 100: These companies just missed the list

Each year, it takes more and more revenue to make our Medtech Big 100 ranking of the world’s largest medical device companies.

This year’s No. 100 — Artivion (formerly CryoLife) — secured the final spot in our ranking with revenue of $313.8 million.

Last year, $236.2 million was enough to get Cardiovascular Systems (now part of Abbott) onto the Medtech Big 100 company ranking at No. 100.

Companies on the bubble in recent years have made their way onto the Medtech Big 100. For example, Inspire Medical Systems missed the list by a single spot last year, but made No. 94 in our new ranking.

With that in mind, here are the companies that would have ranked Nos. 101 to 105 on this year’s list. Watch out for them in future versions of the Medtech Big 100.

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Axonics CFO to retire, successor promoted from within

Dan Dearen. [Image from Axonics]Axonics (Nasdaq:AXNX) announced today that Dan Dearan, president and CFO, is retiring from his position at the neuromodulation company.

Irvine, California-based Axonics tabbed Kari Keese, VP of finance and accounting, to succeed Dearen. Her appointment goes into effect on Oct. 2.

“On behalf of the Axonics team and the board of directors, I want to thank Dan, my co-founder and longtime colleague, for his many contributions to the company over the last 10 years,” said CEO Raymond W. Cohen.

Cohen added that Dearen “played an instrumental role” in the company’s success and the value created for its shareholders.

“It has been a privilege working alongside the talented, mission-driven team at Axonics,” Dearen added. “I am incredibly proud of the impact the company’s therapies have had on improving the quality of life for tens of thousands of incontinence patients. I will follow Axonics with prid…

New medtech to watch for in 2023: boosting health outcomes

[Image from Pixabay]As earnings season is upon us, we’re receiving a clearer view of what new medtech could be launching this year in the medical device space.

Companies still feel hamstrung by macroeconomic pressures, supply chain issues and more. However, many pointed out that 2023 has plenty to look forward to. Several quarterly reports and earnings calls included positive outlooks for the year ahead, with plenty of companies banking on significant revenue growth and other successes.

For many, that comes down to some new medtech product launches. Here are a few picked out from earnings calls and other announcements that you might want to look out for:

Abbott

On Abbott’s earnings call last month, CEO Robert Ford pointed to product launches as a major part of its outlook for 2023.

Abbott said it expects to log adjusted EPS of between $4.30 and $4.50. Excluding COVID-19-related sales, the company expects high-single-digit revenue growth.<…

FDA approves fourth-gen rechargeable sacral neuromod tech from Axonics

The next-gen R20 rechargeable sacral neuromodulation system [Image courtesy of Axonics]Axonics (Nasdaq:AXNX) announced today that the FDA approved its fourth-generation R20 rechargeable sacral neuromodulation system.

The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence.

The approval indicates the Axonics R20 for a functional life in the body of at least 20 years. It also reduces the frequency with which a patient must recharge their implanted device, cutting it to once every 6-10 months. Charging takes only one hour.

According to a news release, this improves upon the third generation’s recharge interval of once a month for one hour.

The Axonics R20 neurostimulator uses the same small 5cc form factor as the previous-generation R15. It pairs with the same tined lead and intuitive patient remote control.

Axonics said it expects to commercially launch the R20 neurostimulation in the U.…

FDA approves fourth-gen rechargeable sacral neuromod tech from Axonics

The next-gen R20 rechargeable sacral neuromodulation system [Image courtesy of Axonics]Axonics (Nasdaq:AXNX) announced today that the FDA approved its fourth-generation R20 rechargeable sacral neuromodulation system.

The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence.

The approval indicates the Axonics R20 for a functional life in the body of at least 20 years. It also reduces the frequency with which a patient must recharge their implanted device, cutting it to once every 6-10 months. Charging takes only one hour.

According to a news release, this improves upon the third generation’s recharge interval of once a month for one hour.

The Axonics R20 neurostimulator uses the same small 5cc form factor as the previous-generation R15. It pairs with the same tined lead and intuitive patient remote control.

Axonics said it expects to commercially launch the R20 neurostimulation in the U.…

Axonics receives Health Canada approval for rechargeable sacral neuromod

Axonics (Nasdaq:AXNX) announced today that Health Canada approved its fourth-generation rechargeable sacral neuromodulation (SNM) system.

Irvine, California-based Axonics’ R20 neurostimulator received labeling for a functional life in the body of at least 20 years. It reduces how frequently a patient must recharge their implanted device to once every six to 10 months. The devices charge for only one hour.

The previous generation of the device had a recharging interval of once a month for one hour. R20 utilizes the same small 5cc form factor as that device and pairs to the same tined lead and patient remote control.

“Since Axonics’ founding, delivering superior patient experiences has been at the forefront of our development efforts,” said Raymond W. Cohen, CEO of Axonics. “Patients with overactive bladder want efficacy and a long-lived solution to address their chronic condition. The Axonics R20 represents a significant breakthrough for rechargeabl…