Irvine, Calif.-based Axonics Modulation Technologies Inc., which is marketing implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, reported the submission of a premarket approval (PMA) supplement. Specifically, it is looking to gain full-body magnetic resonance imaging-conditional labeling for 3.0 Tesla (T) MRI scans.

According to the company, overactive bladder affects roughly 87 million adults in the U.S. and Europe, while about 40 million adults suffer from fecal incontinence/accidental bowel leakage. The company faces competition from Dublin-based Medtronic plc, which has dominated the SNM space with its Interstim device.

For its part, Medtronic said in January that it had gained the CE mark for its Interstim Micro neurostimulator and Interstim Surescan MRI leads. The Interstim Micro is a rechargeable device that delivers sacral neuromodulation therapy to treat overactive bladder, fecal incontinence and non-obstructive urinary retention. The Surescan leads are designed to allow for full-body 1.5T and 3T MRI-conditional scans.

FDA nod

Last September, the U.S. FDA approved the Axonics rechargeable SNM system with full-body conditional labeling for 1.5T MR scanners. Now, the company has reported that it performed the necessary tests to support a PMA supplement for full-body conditional labeling on 3.0T MR scanners for the implantable components of its r-SNM system.

"The Axonics r-SNM system is already approved for 1.5T and 3.0T full-body MRI scans in Europe,” explained CEO Ray Cohen. He added that roughly 15% of MRI scanners operating in the U.S. are 3.0T; however, he viewed the investment as worthwhile.

Cohen highlighted survey data from the IMV benchmark report 2018 to BioWorld that found the 1.5T magnets were most of the fixed MR systems, coming in at 69%. It also determined that bigger facilities were more likely to have the high-field strength magnets.

The situation is similar in Europe, he added, noting that he could not break out how many of the company’s patients had undergone 1.5T or 3.0 MR scans.

During its fourth-quarter earnings call March 4, Kristen Stewart with Barclays had asked where the company stood on the 3.0T front. Cohen acknowledged that fewer facilities had this capability, but he did not want to see those that do put at a disadvantage. "We've done the work. We're not afraid to invest the money to get this capability, and we will have it,” he continued.

Working during COVID-19

The company emphasized in its April 6 statement that the review timeline for a labeling expansion is 180 days.

“[W]e have been working closely with the FDA during the coronavirus time period and have had a number of PMA supplements approved,” Cohen told BioWorld when he asked if expected any delay as a result of the pandemic. He continued that the agency has worked diligently to stay in line with standard timelines.

“Therefore, we do not anticipate a longer review period for this filing – in particular because we already held a in person ‘pre-sub’ meeting at FDA where our test protocols and results were reviewed. Based on that review, the agency suggested we file for approval.”

Other wins

The company has seen several successes over the past few months, most recently in reporting its results for the fourth quarter.

CFO Dan Dearen reported that the company saw net revenue of $9.9 million for the quarter. That figure compares to $494,000 in the fourth quarter of 2018. “Net revenue for the fourth quarter of 2019 was derived primarily from the sale of our r-SNM systems to customers in the U.S., England, the Netherlands, Germany, Switzerland and Canada,” he explained.

In addition, it reported Feb. 4 that the German Institute for the Hospital Remuneration System had granted status 1 reimbursement approval to the Axonics rSNM system under a New Examination and Treatment Method. That program allows hospitals to apply to the German government for additional funding for innovative medical devices when existing reimbursement is limited.

The previous month, the company said the U.S. FDA had approved an enhanced, second-generation Programmer for its r-SNM system under a PMA application supplement. It is used to program the Axonics external trial neurostimulator as well as the implantable neurostimulator in both the procedure and postoperative environments

Meanwhile, in December, Axonics revealed that Health Canada had approved the use of full-body MRI using 1.5 and 3.0 Tesla scanners for patients implanted with the Axonics rSNM system.

Medtronic suit

The company also has faced a patent infringement suit from Medtronic since last year that was filed in the U.S. District Court for the Central District of California. The suit is seeking injunctive relief and damages for infringement. In a note dated March 20, Wells Fargo analyst Larry Biegelsen provided an update, revealing that Axonics had filed inter partes review (IPR) petitions against the seven patents that Medtronic asserted in the case. Citing his organization’s patent consultant, "the petitions are strong and very likely will (a) cause the patent case to be delayed by 2-3 years, as the court waits for results from the IPRs; and (b) cause many of the patents to be deemed invalid.”

The consultant labeled the patents as weak and thought they likely would be invalidated at trial, which is slated for March 2021.