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 review prompted the agency to request additional information. The re-filing includes all of the prior bid plus responses to the federal safety watchdog’s queries, Axonics said.
The approval bid is a “literature-based PMA” that doesn’t require a dedicated clinical trial, so long as the supporting literature is “sufficient, detailed, objective, and directly applicable to the subject device,” the company said. Axonics is citing documentation about the InterStim II device made by Medtronic (NYSE:MDT), the only U.S.-approved sacral neurostim device. The filing includes a year’s worth of post-market data from the 51-patient Relax-OAB study in Europe, Axonics said. Accounting for the 180-day review period and 90-day response evaluation, the earliest possible approval date is June 2019, the company said.
Another study, a pivotal trial of 129 patients with urinary dysfunction, is running under an investigational device exemption. “Substantially all” patients in the Artisan-SNM study are slated to reach the six-month endpoint on Jan. 4 next year, Axonics said.
“This PMA filing gets Axonics on the review clock with the FDA. We believe the filing is robust and provides substantive responses to requests for additional information made by the FDA in May of this year. This filing also includes one-year clinical follow up data from our European Relax-OAB study,” CEO Raymond Cohen said in prepared remarks. Given the FDA authorized an interim analysis of a partial cohort of 6-month post-implant safety and effectiveness data from our ongoing Artisan-SNM pivotal study for the same device, we have the option to submit this data to the FDA as part of this PMA. Moreover, we also retain the option to submit a traditional PMA in Q1 2019 once our full ARTISAN-SNM cohort reaches the 6-month primary endpoint. This strategy of filing both a literature-based PMA and conducting a pivotal clinical study in parallel provides Axonics with several pathways to ultimately obtain PMA approval of our r-SNM System.”
Earlier this month the underwriters behinds Axonics’ $120 million initial public offering exercised their over-allotment option, adding another $18 million to its coffers.
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