Sacral neuromodulation device-maker Axonics Modulation Technologies (NSDQ:AXNX) has commenced a proposed public offering worth more than $100 million in shares of its common stock. The offering is placed at $110 million, with Irvine, Calif.-based Axonics expecting to offer $100 million in shares to go along with $10 million in shares offered by selling stockholders. Axonics plans […]
Axonics Modulation Technologies
Axonics slides on earnings, misses on revenue in Q3 results
Axonics Modulation Technologies (NSDQ:AXNX) posted third-quarter results today that missed the consensus forecast on Wall Street. The Irvine, Calif.-based company posted losses of $25 million, or -89¢ per share, on sales of $1.3 million for the three months ended Sept. 30, 2019, for a bottom-line loss of 228.9% sales growth of 546.8% compared with Q3 2018. […]
Axonics wins FDA approval for sacral neuromodulation device
Axonics Modulation Technologies (NSDQ:AXNX) announced today that it won FDA premarket approval for its r-SNM sacral neuromodulation system for the treatment of overactive bladder and urinary retention. The implantable, rechargeable sacral neuromodulation device is the first of its kind approved for sale in the U.S., Europe, Canada and Australia. It is also the only SNM device […]
Medtronic bids for FDA approval of OAB/FI neuromodulation device
Medtronic (NYSE:MDT) said today that it filed a pre-market approval supplement with the FDA for its InterStim Micro neurostimulator and its InterStim SureScan MRI leads. The InterStim Micro is a rechargeable, implantable sacral neuromodulation device designed to send electrical impulses to sacral nerves and normalize connections between the brain, bladder and bowel for treating patients with […]
Axonics touts one-year data for r-SNM device, inks supply deal with Nebraska urology group
Axonics Modulation Technologies (NSDQ:AXNX) said today that results from its Artisan-SNM pivotal study highlighted durable outcomes and significant improvements in patients implanted with the Axonics r-SNM system for patients with urinary and bowel dysfunction. The announcement came one day after the company said it entered into an exclusive agreement to supply the Axonics r-SNM System to […]
FDA approves Axonics sacral neuromod for FI
Axonics Modulation Technologies (NSDQ:AXNX) today said it received FDA approval for its rechargeable sacral neuromodulation device. The rechargeable SNM device is designed to treat urinary and bowel dysfunction in adults and features a neurostimulator about the size of a USB drive that lasts 15 years in the body. Irvine, Calif.-based Axonics also has a pre-market approval […]
Axonics wins FDA nod for MR-safe neurostim device in trial
Axonics Modulation Technologies (NSDQ:AXNX) said today that the FDA approved the use of full-body MRI for clinical trial participants implanted with the company’s sacral neuromodulation device. The Irvine, Calif.-based company submitted a supplement to the FDA regarding the use of full-body MRIs in its Artisan-SNM 129-patient pivotal trial. The FDA, which is evaluating Axonics’ device via […]
Axonics touts results from pivotal FDA IDE r-SNM urinary dysfunction trial
Axonics Modulation Technologies (NSDQ:AXNX) today released the results from the FDA investigational device exemption pivotal study of its r-SNM Sacral Neuromodulation system exploring its use in treating urinary dysfunction. The Irvine, Calif.-based company said it presented results from the study, dubbed the ARTISAN-SNM study, at the 2019 American Urological Association’s Annual Meeting in Chicago this week. Axonics […]
Axonics Modulation Technologies slides on misses Q4, 2018 earnings
Axonics Modulation Technologies (NSDQ:AXNX) took a hit after it posted fourth-quarter and 2018 losses that exceeded the consensus forecast on Wall Street. The company is developing a sacral nerve stimulation device to treat incontinence. Irvine, Calif.-based Axonics said yesterday that its losses grew 95.6% to -$9.6 million, or -50¢ per share, on sales of $494,000 […]
Axonics wins expanded MRI-safe CE Mark approval for r-SNM system
Axonics Modulation Technologies (NSDQ:AXNX) said today that it won expanded CE Mark approval clearing its r-SNM Sacral Neuromodulation system for use with 1.5T and 3T full body magnetic resonance imaging. The Irvine, Calif.-based company touted the r-SNM as the only implantable SNM system to have received full-body labeling in the EU. “Without this labeling, any patient […]
Axonics Modulation touts results of sacral neuromodulation study
Axonics Modulation Technologies (NSDQ:AXNX) announced positive top-line results from a pivotal study of its novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction. The clinical study demonstrated that patients implanted with the Axonics r-SNM system experienced clinically meaningful and statistically significant improvements in urinary urgency incontinence (UUI) symptoms and quality of […]