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 […]
Axonics Modulation Technologies
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 […]
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 […]
Axonics prices $130m public offering
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it priced a public offering of its common stock with gross proceeds expected to be $130 million. The Irvine, Calif.-based sacral neuromodulation (SNM) device maker is offering 4 million shares of common stock at $32.50 per share, before underwriting discounts and commissions. Underwriters have an additional 30-day option to […]
Axonics Modulation Technologies up on Street-beating Q1 results
Axonics Modulation Technologies (NSDQ:AXNX) posted first-quarter results that beat the consensus forecast on Wall Street. The Irvine, Calif.-based company reported losses of -$14.6 million, or -43¢ per share, on sales of $26.3 million for the three months ended March 31, for a sales growth of 2,341.6% compared with Q1 2019. Earnings per share were -43¢ per […]
Axonics wins FDA approval for next-gen neurostimulator
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it received FDA approval for its next-generation rechargeable neurostimulator for its r-SNM system. The Irvine, Calif.-based company’s r-SNM system is an implantable sacral neuromodulation (SNM) device for treating urinary and bowel dysfunction. Its most recent regulatory win came in January when the FDA approved a second-generation programmer for the […]
U.K.’s NICE recommends Axonics’ device for overactive bladder treatment
The U.K.’s National Institute for Health and Care Excellence (NICE) recommended the sacral neuromodulation (SNM) system developed by Axonics Modulation Technologies (NSDQ:AXNX) for treating overactive bladder in its latest draft guidance. Axonics’ system is the only SNM device approved for full-body MRI scans without needing the device explanted, according to the company. The device itself is […]
Axonics wins FDA approval for enhanced neurostimulator programmer
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA approval for a second-generation programmer for its r-SNM sacral neuromodulation system. The Irvine, Calif.–based company’s new programmer is designed to program the Axonics external trial neurostimulator and the implantable neurostimulator in the procedure and post-operative environments, according to a news release. The device is a touchscreen […]
Axonics granted nine new patents
Sacral neuromodulation device-maker Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won nine utility patents from the U.S. Patent & Trademark Office in 2019. Axonics’ patents cover the company’s lead design, patient remote control, external trial system, wireless charging, current control stimulation, electromyography and internal system electronics. The patent numbers are: 10,478,619; 10,406,369; 10,384,067; 10,376,704; 10,447,083; 10,449,277 […]
Axonics raises additional $17m in public offering
Sacral neuromodulation device-maker Axonics Modulation Technologies (NSDQ:AXNX) announced that the underwriters of its follow-on public offering exercised in full their option to buy an additional 750,000 shares of common stock. The additional shares are set to be purchased from Axonics at the offering price of $22 per share, less underwriting discounts and commissions, according to a news […]
Axonics inks deal to supply SNM system to University of Tennessee Medical Center
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it entered into an agreement to supply its r-SNM (sacral neuromodulation) system to the University of Tennessee Medical Center (UTMC) in Knoxville, Tenn. UTMC has been implanting SNM devices for more than a decade and is one of the first hospitals in the U.S. to use the Axonix r-SNM […]