Axonics Modulation Technologies (NSDQ:AXNX) said today that it submitted interim clinical data from the pivotal study of its implantable sacral neuromodulation system to the FDA. The company is evaluating its r-SNM system as a therapy for people with urinary dysfunction. Axonics’ interim analysis was submitted as a supplement to the company’s “literature-based” premarket approval application. The […]
Axonics Modulation Technologies
What should the Mann Foundation do next?
Dr. Robert Greenberg, the Mann Foundation’s new executive chairman, has ideas about where to take one of medtech’s top research and development outfits. He explained more at DeviceTalks West in December. The new executive chairman of the Alfred E. Mann Foundation for Scientific Research sees the foundation continuing its mission of developing devices for unmet medical needs. The foundation […]
Axonics bids for FDA approval of sacral neuromod device
Fresh from a $138 million initial public offering, Axonics Modulation Technologies (NSDQ:AXNX) said today that it re-filed yesterday for pre-market approval from the FDA for its r-SNM sacral neuromodulation treatment for urinary and bowel dysfunction. The Irvine, Calif.-based company said it last month withdrew the PMA application it filed in January 2018 after an FDA […]
Axonics adds $18m to $120m IPO
Axonics Modulation Technologies (NSDQ:AXNX) said today that the underwriters behinds its $120 million initial public offering exercised their over-allotment option, adding another $18 million to its coffers. Irvine, Calif.-based Axonics, which makes the r-SNM device sacral neuromodulation system for treating overactive bladder, fecal incontinence and urinary retention, said the underwriters picked up 1.2 million shares at $15 each, taking […]
Axonics closes $120m IPO
Axonics Modulation Technologies (NSDQ:AXNX) today closed its $120 million initial public offering, saying it could reap still more from the flotation if an underwriters option is exercised. Irvine, Calif.-based Axonics, which makes the r-SNM device sacral neuromodulation system for treating overactive bladder, fecal incontinence and urinary retention, had set the range for the flotation at $93.3 million to $106.7 million, but […]
Axonics prices upsized $120m offering
Axonics Modulation Technologies yesterday priced an upsized initial public offering that could fetch a maximum of $138 million. Irvine, Calif.-based Axonics, which makes the r-SNM device sacral neuromodulation system for treating overactive bladder, fecal incontinence and urinary retention, last week set the range for the flotation at $93.3 million to $106.7 million, saying it would issue nearly 6.7 million shares […]
Axonics sets range for $100m IPO
Axonics Modulation Technologies yesterday set the range on an initial public offering that would fetch $100 million at the midpoint. The Irvine, Calif.-based company makes the r-SNM device sacral neuromodulation system for treating overactive bladder, fecal incontinence and urinary retention. Axonics touts it as the first such rechargeable device; it’s designed to deliver mild electrical stimulation using a four-electrode […]
Axonics Modulation files for $86m IPO
Axonics Modulation Technologies last week registered for an initial public offering worth more than $86 million for its neuromodulation system for treating urinary and bowel conditions. The Irvine, Calif.-based company touts its r-SNM device as the first rechargeable sacral neuromodulation system for treating overactive bladder, fecal incontinence and urinary retention. It’s designed to deliver mild electrical stimulation using […]
Medtech companies raised more than $738 million in Q2
Venture capital firms invested more than $738 million during the second quarter of 2018, $1 million less than the first quarter of this year, according to the MoneyTree Report from PricewaterhouseCoopers (PwC) and CB Insights. There was a total of 61 deals during Q2, an increase from the 48 that the industry saw during Q1. […]
Axonics wins CE Mark for sacral neuromod trial device
Axonics Modulation Technologies said today that it won CE Mark clearance in the E.U. for its sacral neuromodulation external trial device. The Irvine, Calif.-based company developed the first rechargeable sacral neuromodulation system for the treatment of urinary and bowel dysfunction, which won CE Mark approval in June 2016. Axonics’ external trial system is an additional […]
20 medical device startups you need to know
There’s a lot of excitement these days around digital health. But there are actually many medical device startups out there in other spaces that continue to push the overall boundaries of medtech. From neuromodulation to drug delivery, surgical robotics and more, here’s a roundup of 20 medical device startups catching the eye of Medical Design […]