Axonics, a medical technology firm, has submitted a premarket approval (PMA) supplement to the FDA for its innovative non-rechargeable sacral neuromodulation (SNM) implantable neurostimulator (INS). This device, expected to have a lifespan of at least 10 years, features full-body MRI compatibility and an intuitive remote control. Axonics anticipates FDA approval and plans to start shipments in the first half of 2022. The company aims to solidify its market leadership with this groundbreaking product, which promises significant clinical benefits and high patient satisfaction.
Axonics, Inc. (Nasdaq: AXNX) has received FDA approval for the use of detachable extremity coils, enhancing its MRI safety profile for patients with its r-SNM system. The new labeling covers both 1.5T and 3.0T MRI scans, and this expansion allows better image quality and increased flexibility for extremity scans, accounting for approximately 24% of all MRI procedures. This approval positions Axonics as a leader in MRI safety for sacral neuromodulation and underscores its commitment to innovative patient care.
Axonics, Inc. (Nasdaq: AXNX) has received European CE Mark approval for its second-generation Axonics r-SNM® implantable neurostimulator (INS) and wireless patient remote control equipped with SmartMRI™ technology. This advanced device allows patients to recharge the neuromodulation system monthly, significantly improving usability. The new remote control facilitates full-body MRIs without prior visits to the physician. Despite delays caused by regulatory transitions and COVID-19, Axonics remains dedicated to enhancing therapy experiences for bladder and bowel dysfunction treatment.
Axonics, Inc. (Nasdaq: AXNX) has successfully closed its public offering of 4,025,000 shares of common stock at $50.00 per share, raising approximately $201.3 million in gross proceeds. This includes 525,000 shares purchased through underwriters' options. The offering was managed by BofA Securities, Piper Sandler, and SVB Leerink, with several firms acting as co-managers. The shares were offered under an automatic shelf registration statement filed with the SEC.
Axonics, Inc. announced the pricing of its public offering of 3,500,000 shares of common stock at $50.00 each, aiming for gross proceeds of $175 million. The underwriters have an option to buy an additional 525,000 shares. Proceeds will be used to pay down $75 million in debt, support product commercialization, and fund R&D activities. The offering is set to close on May 14, 2021, pending customary conditions. Joint book-running managers include BofA Securities, Piper Sandler, and SVB Leerink.
Axonics, Inc. (Nasdaq: AXNX) has initiated a public offering of $150 million in common stock, with a potential additional option of $22.5 million for underwriters. The proceeds will primarily be utilized to repay $75 million of existing debt, enhance product commercialization, fund R&D, and for general corporate purposes. BofA Securities, Piper Sandler, and SVB Leerink are leading the offering, which is dependent on market conditions. The offering is conducted under an existing SEC registration statement.
Axonics, a medical technology company, reported Q1 2021 financial results with net revenue of $34.4 million, a 31% increase from $26.3 million in Q1 2020. Sacral neuromodulation generated $32.9 million. However, the company experienced a net loss of $22.5 million, worsening from $14.6 million in the prior year. Operating expenses rose to $42 million compared to $31.1 million a year earlier. Axonics anticipates fiscal year 2021 net revenue between $176 million to $180 million, representing 58% to 61% growth over 2020.
Axonics, a medical technology firm, will present at the BofA Securities 2021 Virtual Healthcare Conference on May 13, 2021, at 12:30 p.m. ET. The live webcast and replay will be available on their investor relations website. Axonics specializes in innovative therapies for bladder and bowel dysfunction, including a rechargeable sacral neuromodulation system and a urethral bulking agent, Bulkamid®. These products offer significant symptom relief to millions affected by overactive bladder, fecal incontinence, and stress urinary incontinence across the U.S. and Europe.
Axonics, Inc. (Nasdaq: AXNX) will release its first quarter 2021 financial results on May 6, 2021, after market closure. A conference call is scheduled for 4:30 p.m. ET, accessible via phone or webcast. Axonics specializes in medical technologies for bladder and bowel dysfunction, offering products like a rechargeable sacral neuromodulation system and Bulkamid® for stress urinary incontinence. With millions affected by these conditions, Axonics’ products provide clinically proven therapies and are reimbursed in the U.S. and most of Europe.
Axonics Modulation Technologies, Inc. (Nasdaq: AXNX) will participate in the virtual Barclays Global Healthcare Conference on March 10, 2021, presenting at 10:55 a.m. Eastern Time. The event will be accessible through the Axonics investor relations website.
Axonics focuses on innovative treatments for bladder and bowel dysfunction, impacting millions. They offer implantable sacral neuromodulation devices and Bulkamid® for stress urinary incontinence.