Axonics® Provides Update on Inter Partes Review Proceedings

IRVINE, Calif.--(BUSINESS WIRE)--Axonics Modulation Technologies, Inc. (NASDAQ: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today announced that the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office has made the decision to institute a review regarding the validity of six Medtronic patents that Axonics is contesting.

On March 16, Axonics filed seven inter partes review (IPR) petitions contesting the validity of certain Medtronic patents. The PTAB has instituted the IPR petitions on U.S. Patent Nos. 7,774,069; 8,036,756; 8,457,758; 8,626,314; 8,738,148; and 9,821,112. The IPR petition for U.S. Patent No. 9,463,324 was not instituted.

Raymond W. Cohen, Axonics CEO, said, “We are pleased that the PTAB has instituted IPR petitions on these patents, which means that Axonics has demonstrated that there is a ‘reasonable likelihood’ that at least some, if not all, of the claims in each of these Medtronic patents are invalid.”

Cohen continued, “Since its founding, Axonics has focused on innovation and developing best-in-class SNM solutions for patients. We have made significant investments in R&D and created a strong portfolio of intellectual property. Support from our physician customers has been exceptional, with their patients delighted by the enhancements Axonics has brought to SNM, including longevity in the body and extending the recharge interval to once per month for one hour. We remain focused on increasing the awareness and expanding the adoption of SNM, which has the potential to significantly improve quality of life for millions of patients suffering from bladder and bowel dysfunction.”

About Axonics Modulation Technologies, Inc.

Axonics, based in Irvine, Calif., has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction. These conditions are caused by a miscommunication between the bladder and the brain and significantly impacts quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe. Another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. Axonics SNM therapy, which has been clinically proven to reduce symptoms and restore pelvic floor function, is now being offered at hundreds of medical centers across the U.S. and in dozens of select hospitals in Western Europe. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. The Axonics System is the first long-lived rechargeable SNM system approved for sale in the world, and the first to gain full-body MRI conditional labeling. For more information, visit www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.