Mainstay Medical Announces New ICD-10 Diagnosis Code for Multifidus Dysfunction

Mainstay Medical today announced that the United States Centers for Disease Control and Prevention (CDC) has designated an International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) diagnosis code specifically for multifidus dysfunction in the low back. The new diagnosis code – M62.85: dysfunction of the multifidus muscles, lumbar region – went into effect on October 1, 2024.

In response to an acute injury in the low back, the brain typically reduces the neural drive that activates the multifidus muscle, resulting in reduced multifidus activity. Because the multifidus muscle is a primary stabilizer of the lumbar spine, this inhibition can lead to joint instability and overload, exacerbating the problem and contributing to chronic low back pain (CLBP). The ReActiv8® Restorative Neurostimulation™ system is designed to provide electrical stimulation to the nerves activating the multifidus muscle, aid in restoring its function and facilitate recovery from CLBP. ReActiv8 is the only FDA-approved treatment for the management of intractable CLBP associated with multifidus muscle dysfunction.

“The CDC has recognized multifidus muscle dysfunction as a prominent cause of CLBP and is now providing clinicians a clearer pathway to specifically diagnose this condition. Multifidus dysfunction is a highly specific disease state that does not respond to palliative forms of stimulation, and we are excited that this new code provides for clear reflection of the underlying disease state,” stated Jason Hannon, Chief Executive Officer of Mainstay Medical.

About ReActiv8®

ReActiv8 is an implantable medical device designed to treat adults with intractable chronic low back pain (CLBP) associated with multifidus muscle dysfunction. Multifidus muscle dysfunction may be evidenced by imaging or physiological testing in adults who have failed therapy including pain medications and physical therapy, and who are not candidates for spine surgery. ReActiv8 has received regulatory approval in several geographic areas, and is commercially available in the European Economic Area, Australia, the UK, and the US.

About Mainstay Medical

Mainstay Medical is a medical device company focused on commercializing its innovative implantable Restorative Neurostimulation system, ReActiv8, for people with disabling mechanical CLBP. Mainstay Medical is headquartered in Dublin, Ireland and has subsidiaries operating in Ireland, the United States, Australia, Germany, and the Netherlands.

Further information can be found at www.mainstaymedical.com.

Mainstay Forward-Looking Statements

All statements in this announcement other than statements of historical fact are, or may be deemed to be, forward-looking statements. These forward-looking statements may include, without limitation, statements regarding the company’s intentions, beliefs or current expectations concerning, among other things, the company’s use of the new ICD-10 code and the company’s commercial efforts and performance, results, financial position, financing strategies, product design and development, intellectual property portfolio and its scope, regulatory applications and approvals, and reimbursement arrangements.

Forward-looking statements involve risk and uncertainty and are not guarantees of future performance. Actual results may differ materially from those described in, or suggested by, the forward-looking statements. A number of factors could cause results and developments to differ materially from those expressed or implied by the forward-looking statements herein, including, without limitation, the risks and uncertainties included in the company’s Annual Report for the year ended 31 December 2022, which should be read in conjunction with the company’s public disclosures (available on the company’s website (www.mainstaymedical.com)). The forward-looking statements herein speak only as of the date of this announcement.

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