Axonics Modulation Technologies Archives - Page 3 of 3

Axonics rises on mixed-bag Q1 results

Axonics (NSDQ:AXNX) posted first-quarter results yesterday that beat the revenue consensus on Wall Street but missed on earnings projections.

The Irvine, Calif.-based company reported losses of -$22.5 million, or -57¢ per share, on sales of $34.4 million for the three months ended March 31, for a sales growth of 30.72% compared with Q1 2020.

Earnings per share were -57¢, 16¢ behind The Street, where analysts were looking for sales of $27.88 million.

“This quarter’s revenue result reflects the growing demand for our long-lived r-SNM system and Bulkamid despite the resurgence of COVID cases in the U.S. in early 2021 and ongoing lockdowns in Europe,” CEO Raymond Cohen said in a news release. “Physician and patient satisfaction remain high and Axonics is poised to take full advantage of the strong growth outlook for sacral neuromodulation as the vaccine rollout continues and we return to a more normalized elective procedure environment.”

“Response to …

Axonics, Micro Systems Technologies partners to make rechargeable SNM device

Axonics (NSDQ:AXNX) announced today that it entered into a strategic alliance with Micro Systems Technologies.

Micro Systems Technologies (MST) manufactures printed circuit board assemblies for the Axonics r-SNM (sacral neuromodulation) system in Lake Oswego, Oregon, according to a news release.

The newly minted strategic alliance expands the relationship between the two as the companies collaborate on the non-rechargeable SNM device that Axonics has developed and plans to bring to market after receiving FDA approval.

“We have been working with MST for over half a decade and we have developed a strong relationship,” Axonics CEO Raymond W. Cohen said in the release. “As Axonics develops new SNM embodiments for the benefit of patients suffering from bladder and bowel dysfunction, working with an experienced, best-in-class contract manufacturer with proven implantable device experience and the ability to rapidly scale is critical to support our …

Axonics acquires Contura and its Bulkamid bulking agent for $235M

Axonics (NSDQ: AXNX) announced today that it acquired Contura and its flagship Bulkamid product for up to $235 million.

London-based Contura’s Bulkamid is a urethral bulking agent for women with stress urinary incontinence (SUI). It is a next-generation hydrogel injected into the urethral wall in a minimally invasive office or outpatient facility procedure to restore the natural closing pressure of the urethra.

It has been clinically proven to retain its bulking characteristics and maintain efficacy over many years, according to a news release. Bulkamid has held CE Mark approval since 2003 and garnered FDA premarket approval in February 2020 before a limited U.S. rollout in mid-2020.

The acquisition includes a total consideration of $200 million in cash and stock, plus a potential future milestone of $35 million. The upfront consideration is comprised of $141.25 million in cash, plus nearly 1.1 million shares of Axonics stock. The cash is funded wi…

Axonics implantable neurostimulator wins FDA PMA supplemental approval

Axonics (NSDQ: AXNX) today said it received FDA PMA supplemental approval for its third-generation implantable neurostimulator.

The new iteration go the device upgrades the embedded software in the implantable neurostimulator (INS), as well as the functionality of the patient remote control. The modifications give patients the ability to make broader stimulation parameter adjustments from home. It also provides an appropriate level of flexibility to maximize symptom relief as patients settle into their everyday lives.

“This is another significant upgrade we have made to the Axonics System, underscoring our commitment to continuous innovation that enhances the patient experience. While our long-lived INS device is as close to a ‘set it and forget it’ therapy, the new features will benefit physician practices in which patients have to travel long distances should they require therapy adjustments,” CEO Raymond Cohen said in a news release. “…

UK recommends Axonics SNM for overactive bladder

Axonics Modulation Technologies (NSDQ:AXNX) announced today that NICE suggested using its r-SNM system in the UK.

The National Institute for Health and Care Excellence (NICE) offers evidence-based guidance to the UK and, in guidance published last week, it recommended Axonics’ sacral neuromodulation (SNM) system for treating refractory overactive bladder for the country’s National Health Service (NHS).

NICE’s guidance claimed that, based on clinical evidence, the r-SNM system improves symptoms and quality of life while providing longer battery life than the non-rechargeable system currently used by the NHS. Additionally, NICE’s cost modeling estimates that the r-SNM system would save more than $7,850 (£6,025) per person, beginning about six years after implant.

The evaluation also determined that Axonics’ battery life of 15 years or more will likely reduce the number of avoidable replacement procedures a patient may need to …

Axonics beats on Q2 earnings despite losses

Axonics Modulation Technologies (NSDQ:AXNX) shares dipped slightly today on second-quarter results that beat the consensus earnings forecast.

The Irvine, Calif.-based sacral neuromodulation (SNM) device maker posted losses of -$19.8 million, or -54¢ per share, on sales of $15.1 million for the three months ended June 30, 2020, for a -3.8% bottom-line slide on massive sales growth from just $1.5 million in revenues in the second quarter of 2019.

Axonics Modulation Technologies’ losses per share of -54¢ came in 11¢ ahead of the projections from analysts on Wall Street.

The company reported that new order flow was de minimis in April because of COVID-19-related deferrals of elected procedures, but Axonics saw a gradual recovery in early May and continued improvement in June.

Weekly new order flow came in at approximately 70% of the weekly average from the first quarter of the year, prior to the pandemic.

“Axonics was exceptionally produc…

Axonics’ SNM system wins FDA nod for 3T-MRI scans

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it has won FDA approval for full-body 3 Tesla (T) MRI scanning for patients implanted with its r-SNM sacral neuromodulation system.

The premarket approval supplement represents an upgrade from a previous PMA conditional labeling for r-SNM, which allowed for for full-body scans using 1.5T MRI scanners. With this incremental approval for 3T scans, the Axonics device continues to be the only SNM system available in the U.S. that is MRI-compatible for both 1.5T and 3T full-body scans, according to the company.

Axonics’ r-SNM system won FDA pre-market approval in November for the treatment of overactive bladder and urinary retention, which followed the FDA approval that r-SNM won in September for fecal incontinence.

The implantable, rechargeable sacral neuromodulation device is touted as the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM de…

FDA approves remote to check out Axonics neuromod device before MRI

Axonics Modulation Technologies (NSDQ:AXNX) announced today that it received FDA pre-market approval for its SmartMRI wireless patient remote control.

Irvine, Calif.-based Axonics’ wireless control for SmartMRI is used with its implantable r-SNM (sacral neuromodulation) systems that treat urinary and bowel dysfunction.

The new control allows for a simplified full-body MRI process by offering a technician a way to perform a simple check with the patient’s remote control immediately before the MRI takes place, eliminating the need for an in-person visit with a physician or Axonics personnel.

Axonics said in a news release that it will include the new remote control with SmartMRI technology in all new orders of its r-SNM system in the U.S., beginning this month.

Currently, the system is approved for 1.5T full-body MRI scans in the U.S. and both 1.5T and 3T full-body MRI scans in Canada and Europe. In April, the company submitted a PMA sup…