Axonics® Announces U.S. Food & Drug Administration Approval for its Sacral Neuromodulation System for Urinary Clinical Indications
Axonics, Inc. (AXNX)
Last axonics, inc. earnings: 3/4 04:01 pm
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Source: Business Wire
IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable rechargeable sacral neuromodulation (“SNM”) devices for the treatment of bladder and bowel dysfunction, today announced the approval of the Axonics r-SNM® System by the United States Food & Drug Administration (“FDA”) for the clinical indications of overactive bladder (“OAB”) and urinary retention.The FDA premarket approval (“PMA”) grants Axonics the right to market its product in the United States for the clinical indications of OAB (urinary urge incontinence and urinary urge frequency) as well as urinary retention, representing the largest segment of the market for SNM devices. The FDA approval follows the Company’s September approval for the clinical indication of fecal incontinence, which, according to published clinical studies, is a co-morbidity reported by as many as a third of patients presenting wit
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AXNX
News
- Axonics, Inc. (NASDAQ: AXNX) had its "hold" rating re-affirmed by analysts at Needham & Company LLC.MarketBeat
- Axonics Reports Third Quarter 2024 Financial ResultsBusiness Wire
- Axonics Shares Fall Despite Australia's Approval for R20 SNM Device [Yahoo! Finance]Yahoo! Finance
- Axonics' sacral neuromodulation device cleared in Australia [Yahoo! Finance]Yahoo! Finance
- Axonics Receives Regulatory Approval for Fourth-Generation Rechargeable SNM System in AustraliaBusiness Wire
AXNX
Earnings
- 11/7/24 - Miss
AXNX
Sec Filings
- 11/12/24 - Form 4
- 11/7/24 - Form 10-Q
- 11/7/24 - Form 8-K
- AXNX's page on the SEC website