Axonics bags $14M+ for neuromodulation device with eyes on FDA nod

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Axonics is gearing up for a pivotal trial of its rechargeable neuromodulation device for overactive bladder and hopes to take on Medtronic in the sacral neuromodulation market.

Axonics Modulation Technologies raised $14.5 million in the first close of its Series C round, which will bankroll a pivotal study of its neuromodulation implant in patients with overactive bladder.

The company plans to raise a total of $30 million in its Series C and expects its U.S. pivotal study to kick off in the second half of the year, according to a statement. It will take place in medical centers in the U.S. and Europe.

The company previously picked up $38.5 million in a Series B last year, and six months later, notched a CE mark for its Sacral Neuromodulation System (SNM).

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Designed to treat overactive bladder and fecal dysfunction, the SNM system comprises a four-electrode-tined lead, remote control, wireless charging system and a touchscreen tablet for lead placement and programming.

It is the first rechargeable implant for this indication and, with a lifespan of 15 years, it is said to last three times longer than Medtronic’s FDA-approved InterStim SNM implant. It is also 60% smaller than Medtronic’s device. Its long life and rechargeable nature means that patients will require fewer device replacement surgeries and could reduce costs for the U.S. healthcare system.

All of Axonics’ existing shareholders participated in the financing, including Edmond de Rothschild Investment Partners, Advent Life Sciences and Cormorant Asset Management.

“These world-class investors have provided Axonics with phenomenal support throughout the development phase of our project, including attainment of key milestones such as European and Canadian regulatory approval and completion of our 50-patient European clinical study,” said Axonics CEO Raymond Cohen. “Revenue from the sale of SNM devices is estimated at nearly $700 million in 2016 and is projected to grow to over $1 billion by 2021. With only one player in the SNM market today, our miniaturized rechargeable system represents a very attractive opportunity in the medtech space.”