Axonics Modulation Technologies Archives - Page 2 of 3

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…

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

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…

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…

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…

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…

Medtronic’s IP dispute against Axonics could resume in court after PTAB decisions

Medtronic (NYSE:MDT) and Axonics (NSDQ:AXNX) could see their patent dispute over neurostimulation technology resume in court.

Yesterday, the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office affirmed an additional three patents in a long-term dispute between the companies over intellectual property for Medtronic’s Interstim sacral neuromodulation (SNM) system, completing the review process initiated by Axonics to challenge the validity of the seven total patents in the case brought by Medtronic, according to a news release.

“Medtronic appreciates the Patent Trial and Appeal Board’s efforts in this matter,” Medtronic EVP & president of the neuroscience portfolio Brett Wall said in the release. “We are pleased with the outcome of the review process and look forward to our day in court to protect the proprietary technology that brings SNM therapy to patients around the world.”

Following the …

Axonics loses IP challenge to Medtronic patents

Medtronic (NYSE:MDT) announced that it picked up three victories in an intellectual property (IP) dispute against Axonics (NSDQ:AXNX) over sacral neuromodulation devices.

According to a news release, the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) rejected Axonics’ attempt to invalidate three Medtronic patents in its IP infringement lawsuit related to Medtronic’s InterStim neuromodulation device family. Nearly one year ago, the PTAB handed down a decision to reject one of Axonics’ claims to invalidate a Medtronic patent and has now added three more.

Axonics develops the r-SNM sacral neuromodulation system, which it touts as the first of its kind approved for sale in the U.S., Europe, Canada and Australia and the only SNM device approved for full-body MRI scans without needing the device explanted.

The company, a direct competitor of Medtronic in the space, has rivaled the medtech giant with multiple regulator…

Axonics files FDA PMA supplement for its non-rechargeable SNM system

Axonics (NSDQ:AXNX) announced that it filed a premarket approval supplement with the FDA for its sacral neuromodulation (SNM) system.

Irvine, Calif.-based Axonics filed the PMA supplement for its newly developed, long-lived, non-rechargeable SNM implantable neurostimulator (INS), according to a news release.

The company designed its new non-rechargeable SNM system to replicate the key features of its currently marketed and FDA-approved rechargeable SNM system. The new version includes a primary cell battery with an expected life of at least 10 years with standard constant-current stimulation parameters for longevity.

Axonics’ INS is 11 cubic centimeters and has compatibility with full-body MRIs with 1.5T and 3.0T scanners, while patients can remotely control it with an intuitive, recharge-free key fob featuring SmartMRI technology.

The company expects to begin shipping the new system to customers upon FDA approval, which is anticipated to co…

Axonics wins CE mark approval for sacral neurostim implant

Axonics Modulation Technologies (NSDQ:AXNX) today said it received CE mark approval for its second-generation r-SNM implantable neurostimulator and wireless patient remote control.

The r-SNM system is an implantable sacral neuromodulation device designed to treat urinary and bowel dysfunction. Irvine, Calif.-based Axonics previously won FDA approval for the device in April last year.

Axonics’s r-SNM reduces how frequently a patient needs to recharge the sacral neuromodulation device to once a month with an hour of charging time. The wireless remote control with SmartMRI technology simplifies the process of receiving full-body MRIs to avoid the need for patients to visit implanting physicians.

“There has been a significant backlog of pending regulatory submissions in Europe due to COVID-19 and the transition to the new European Union Medical Device Regulation, which will become fully applicable later this month,” chief operating officer Rinda Sama s…

Axonics closes $201.3M offering

Axonics (NSDQ:AXNX) announced today that it closed a public offering of common stock worth proceeds of more than $200 million.

Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, offered more than 4 million shares of its common stock at $50 per share, according to a news release.

With underwriters exercising in full the option to purchase 525,000 additional shares at the public offering price, the proceeds before deducting discounts, commissions and other expenses totaled approximately $201.3 million.

In announcing the commencement of the offering earlier this week, Axonics said it plans to use the net proceeds collected from the offering to repay all or a portion of its outstanding indebtedness of $75 million.

Additionally, funds raised in the offering may be used to support the commercialization of its products in the U.S. and internationally. Further intended use…

Axonics announces $150M offering

Axonics (NSDQ:AXNX) announced today that it commenced a proposed public offering of common stock worth $150 million.

Irvine, Calif.-based Axonics, which develops the Axonics r-SNM (sacral neuromodulation) system to treat bladder and bowel dysfunction, also expects to grant underwriters a 30-day option to purchase up to $22.5 million in additional shares of its common stock, according to a news release.

The company plans to use the net proceeds collected from the offering to repay all or a portion of its outstanding indebtedness of $75 million, it said.

Additionally, funds raised in the offering may be used to support the commercialization of its products in the U.S. and internationally. Further intended uses of the funds include R&D and the technological enhancement of its products, along with working capital and general corporate purposes.

BofA Securities, Piper Sandler and SVB Leerink are acting as the joint book-running managers for the pro…