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Tuesday, Nov 29, 2022
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Axonics Modulation Device Gets FDA Approval

Irvine-based Axonics Modulation Technologies Inc. (Nasdaq: AXNX) has been granted Food and Drug Administration approval for its device for overactive bladders.

The rechargeable implantable neurostimulator, or INS, decreases the frequency of battery charges from once every two weeks for one hour to once a month for one hour. The company said this INS will experience “virtually no battery degradation” over a 15-year life of the device. Shipping should begin in the third quarter.

“This FDA approval is another example of our commitment to innovation and to creating awareness, particularly among middle-aged women, that sacral neuromodulation is a safe and efficacious treatment for bladder and bowel dysfunction,” Chief Executive Raymond Cohen said in a statement.

The company has been involved with a patent infringement lawsuit with medtech giant Medtronic PLC, which has alleged that Axonics’ charging mechanism infringed on its design.

Axonics’ shares have doubled since March 16 to about $34 and a $1.2 billion market cap. The company is scheduled to report first quarter results May 5.

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