Welcome to our dedicated page for Axonics news (Ticker: AXNX), a resource for investors and traders seeking the latest updates and insights on Axonics stock.
Axonics, Inc. (NASDAQ: AXNX) is a pioneering medical technology company headquartered in the United States. The company specializes in the development and commercialization of innovative products designed to enhance the lives of adults experiencing bladder and bowel dysfunction. Axonics' primary offering includes the Sacral Neuromodulation (SNM) system, a fully implantable device aimed at treating conditions such as urinary urge incontinence, urinary urgency frequency (UUF), overactive bladder, fecal incontinence, and urinary retention.
Another key product is Bulkamid, a urethral bulking agent used to treat female stress urinary incontinence. These products are based on advanced neuromodulation technology licensed from the Alfred Mann Foundation, featuring a miniaturized, rechargeable, and fully-implantable IPG (implantable pulse generator).
Axonics' innovative SNM system has been specifically designed to improve the clinical experience for both healthcare providers and their patients. The company's technology facilitates better management of urinary and fecal dysfunction, providing significant relief and improved quality of life for patients.
Financially, Axonics generates the majority of its revenue from the United States, with additional income coming from various international markets. The company's recent achievements include significant advancements in their neuromodulation platform and ongoing projects aimed at enhancing their product offerings.
Overall, Axonics, Inc. has established itself as a significant player in the medical technology field, offering cutting-edge solutions to address prevalent and often debilitating conditions affecting millions globally.
Axonics, Inc. (NASDAQ: AXNX) has announced critical updates from the U.S. Patent Trial and Appeal Board (PTAB) regarding its contestation of three Medtronic patents. The PTAB's final decisions are an important step following Axonics' petitions filed in March 2020, which challenged the validity of the patents claimed to be infringed. Axonics views the decisions as favorable, particularly the invalidation of claims in Medtronic's '112 patent, which strengthens Axonics' non-infringement arguments. Axonics remains committed to its innovative solutions for bladder and bowel dysfunction.
Axonics (NASDAQ: AXNX) announced that the U.S. Patent Trial and Appeal Board (PTAB) issued final decisions on three of six patents from Medtronic that Axonics contests. The PTAB invalidated four claims of the '069 Patent while upholding claims of the '314 and '756 Patents, which will expire in 2022. Axonics plans to appeal the upheld claims but emphasizes that the decisions do not imply patent infringement. This outcome is viewed as a significant victory for Axonics, reflecting the strength of their arguments against Medtronic's claims.
Axonics, a medical technology company based in Irvine, California, announced its participation in three upcoming virtual investor conferences. The conferences include the Wells Fargo Healthcare Conference on September 9, 2021; the Morgan Stanley Healthcare Conference on September 13, 2021; and the Baird Healthcare Conference on September 15, 2021. The company specializes in developing products for bladder and bowel dysfunction, including a rechargeable sacral neuromodulation system and a urethral bulking agent. A webcast of the presentations will be available on their investor relations website.
Axonics, Inc. (NASDAQ: AXNX) reported a record revenue of $45.9 million for Q2 2021, up 202% from $15.2 million a year ago. Sacral neuromodulation revenue reached $40.2 million, with a gross margin of 62.6%. The company raised its 2021 revenue guidance to $186-$188 million, reflecting a 67%-69% increase over 2020. Despite a net loss of $25.1 million, cash reserves stood at $231.1 million after terminating a $75 million loan. Recent milestones include FDA approval for a non-rechargeable implant and significant training initiatives for its Bulkamid product.
Axonics, Inc. (Nasdaq: AXNX) has appointed Esteban López, M.D., MBA, to its board of directors. Dr. López brings significant healthcare experience, currently serving as the Americas healthcare and life sciences Market Lead at Google Cloud and previously as chief medical officer at Health Care Service Corporation. With a strong background in innovation and strategy, he is expected to play a crucial advisory role as Axonics pursues its growth objectives in treating bladder and bowel dysfunction. His clinical expertise enhances the board's capabilities in addressing patient needs.
BioLife Solutions (Nasdaq: BLFS) has announced changes to its board of directors, effective July 12, 2021. Raymond W. Cohen resigned from the board after serving since 2006 and as chairman since 2013. Mike Rice, the current CEO, has been appointed as the new chairman. Cohen expressed gratitude for his time at BioLife, highlighting the company's growth in bioproduction tools for cell and gene therapies. The leadership transition aims to ensure continued strategic direction and growth.
Axonics, Inc. (Nasdaq: AXNX) is set to release its second quarter 2021 financial results on August 5, 2021, after market close. The company will host a conference call at 4:30 p.m. Eastern Time, accessible via phone or a live webcast on its investor relations website. Axonics specializes in medical technology for bladder and bowel dysfunction, offering innovative products like its rechargeable sacral neuromodulation system and Bulkamid®, a urethral bulking agent. These products address overactive bladder, fecal incontinence, and stress urinary incontinence, with established reimbursement coverage in the U.S. and Europe.
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.
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