Axonics Modulation Technologies Archives

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…

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…

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…

Axonics stock dips after hours despite Street-beating Q3, raised guidance

Axonics (Nasdaq:AXNX) shares took a hit after hours despite third-quarter results that bettered the consensus forecast.

Shares of AXNX dipped 7% to $68 apiece after the market closed. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the day up 0.2%.

The Irvine, California-based sacral neuromodulation (SNM) technology developer posted losses of $16.3 million. It reported sales of $70.4 million for the three months ended Sept. 30, 2022.

Axonics produced a slight bottom-line gain despite remaining in the red on sales growth of 50%. Its losses per share of 34¢ beat Wall Street expectations by 14¢. Meanwhile, sales topped the analysts’ expectations of $63 million.

The company reported sales of $56.9 million from its sacral neuromodulation business. The remaining $13.5 million came from sales of Bulkamid, a urethral bulking hydrogel.

“This quarter’s record revenue …

10 big earnings stories from the last quarter: How are medtech stocks doing now?

(From Ishant Mishra on Unsplash)

Economic uncertainty appears to have produced a wide variety of medtech earnings stories during the most recent round of quarterly results.

Some medical device companies received massive boosts from their quarterly performance, while others saw their stocks sink amid missed projections and other various issues. The phrase “macroeconomic headwinds” was a common phrase. Medtech faces a strong U.S. dollar (a hurdle for American companies selling overseas), supply chain disruption and inflation.

For all of MassDevice’s medtech earnings stories, click HERE

MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — has mostly been on the rise over this period, getting as high as $90.10 per share (a 6.5% increase from the price of $84.60 at the start of the period). It is now at $85.27 for the last month, representing a 0.7% r…

Axonics expands IP portfolio with new patents

Axonics (Nasdaq:AXNX) announced today that it has been granted eight patents and allowed a further four applications in the past 12 months.

Irvine, California-based Axonics eight granted patents and four applications to the U.S. Patent and Trademark Office relate to its portfolio of sacral neuromodulation (SNM) technology.

According to a news release, the patents represent technology internally developed by the company, including the Axonics external trial system, tined lead, implantable neurostimulator, clinician programmer, wireless charging system and patient remote control.

“Axonics is committed to developing best-in-class technology to serve the unmet needs of the millions of adults suffering from incontinence. The volume, subject matter diversity, and breadth of these patents demonstrate the investment in innovation that Axonics continues to make in sacral neuromodulation technology,” said Axoncis CEO Raymond W. Cohen.

The granted U.S. paten…