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.…

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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.…

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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…

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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 …

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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…

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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…

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Axonics stock ticks up on Street-beating Q2, increased guidance

Axonics (Nasdaq:AXNX) shares are on the rise today on second-quarter results that came in ahead of the consensus forecast.

The Irvine, California-based sacral neuromodulation technology developer posted losses of $34.1 million, or 47¢ per share, on sales of $69 million for the three months ended June 30, 2022, for a nearly $10 million bottom-line slide further into the red on sales growth of 50.4%.

Axonics’ losses per share of 47¢ came in 7¢ ahead of expectations on Wall Street, where analysts were looking for sales of $60.1 million.

In a news release, CEO Raymond W. Cohen said the quarterly results — which include a record revenue total — reflect the growing demand for the company’s incontinence solutions, with sacral neuromodulation sales growing 39% year-over-year thanks in large part to the April launch of the F15 recharge-free sacral neuromodulation system. Additionally, the Bulkamid system for stress urinary incontinence symptoms produc…

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Axonics files FDA PMA supplement for 4th-gen rechargeable neurostimulator

Axonics (Nasdaq:AXNX) announced that it filed a premarket approval (PMA) supplement with the FDA for its next-generation neurostimulator.

Irvine, California-based Axonics designed its fourth-generation rechargeable sacral neuromodulation implantable neurostimulator (INS) to reduce the frequency with which a patient needs to recharge their implanted device to just once every six months for one hour.

The current recharging interval comes once per month for one hour with Axonics’ third-generation rechargeable INS, according to a news release.

Axonics’ latest INS utilizes the same small 5cc form factor as its R15 system and pairs with the same tined lead and intuitive, easy-to-use patient remote control. The company expects the INS to receive FDA labeling for 20 years of useful life in the body, with projections for FDA approval set for the fourth quarter of 2022, followed by shipment of the new device to customers in the first quarter of 2023. Read more

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Axonics raises 2022 sales guidance on Street-beating Q1

Axonics Modulation Technologies (Nasdaq:AXNX) reported first-quarter financial results that topped analysts’ consensus forecast.

The Irvine, California-based sacral neuromodulation technology developer posted losses of $22.7 million, or 50¢ per share, on sales of $48.4 million for the three months ended March 31, 2022, for a slight bottom-line loss of just over $150,000 year-over-year on sales growth of 40.9%.

Axonics’ losses per share of 50¢ came in 13¢ ahead of projections on Wall Street, where analysts were looking for sales of $45.4 million.

“We are pleased with this quarter’s revenue result considering the significant impact the Omicron surge had on elective procedures in January and February,” Axonics CEO Raymond W. Cohen said in a news release. “Sacral neuromodulation procedure volumes recovered nicely in March and continued to trend favorably in April. Bulkamid generated yet another quarter of record revenue and we are delighted to re…

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Axonics launches F15 recharge-free sacral neuromodulation system

Axonics (Nasdaq:AXNX) announced today that it launched its F15 recharge-free sacral neuromodulation (SNM) system in the U.S.

Irvine, California-based Axonics received FDA approval for the F15 SNM system in March.

The company designed the newly developed F15 recharge-free SNM system to feature a functional life span of over 15 years at typical stimulation parameters, with the capacity to last more than 2 decades at lower-energy settings.

Axonics said in a news release that the 10 cubic centimeter size of the F15 system makes it 20% smaller than the market’s other non-rechargeable SNM device, while it has compatibility for full-body MRI with 1.5T and 3.0T whole-body scanners.

The F15 system’s proprietary algorithm recommends optimal stimulation parameters based on intraoperative responses, while its constant current automatically adjusts stimulation output. The platform features an intuitive, recharge-free key fob control with SmartMRI t…

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FDA clears Axonics’ recharge-free sacral neuromodulation system

Axonics Modulation Technologies (Nasdaq:AXNX) announced today that it received FDA approval for its new implantable neurostimulator.

Irvine, California-based Axonics designed the Axonics F15 recharge-free sacral-neuromodulation (SNM) system with a functional life span of over 15 years at typical stimulation parameters and over 20 years at lower-energy settings.

The system’s size totals 10 cubic centimeters, making it 20% smaller than the market’s other non-rechargeable SNM device, Axonics said in a news release. Its constant current automatically adjusts stimulation output, while it also offers intuitive, recharge-free key fob control featuring SmartMRI technology.

Axonics’ recharge-free SNM system has MRI compatibility for full-body MRI with 1.5T and 3.0T whole-body scanners, as well as a proprietary algorithm that recommends optimal stimulation parameters based on intraoperative responses.

Axonics CEO Raymond W. Cohen said last…

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Axonics ticks up on Street-beating Q4, expects recharge-free SNM launch in Q2 of 2022

Axonics Modulation Technologies (NSDQ:AXNX) shares rose today on fourth-quarter results that beat the consensus forecast on Wall Street.

The Irvine, California-based sacral neuromodulation (SNM) technology developer posted losses of $15.2 million, or 34¢ per share, on sales of $53.1 million for the three months ended Dec. 31, 2021, for a bottom-line of nearly $4 million despite sales growth of 52.8%.

Axonics’ losses per share of 34¢ came in 2¢ ahead of projections on Wall Street, where analysts were looking for sales of $50.5 million.

“We are proud of our fourth-quarter and fiscal year 2021 results considering the disruption Covid-19 has had on elective procedures in the U.S. and around the world,” Axonics CEO Raymond W. Cohen said in a news release. “In 2021, in addition to strong commercial execution, Axonics made important progress on several strategic initiatives, including the successful acquisition and launch of Bulkamid in the U.S., growth o…

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