Newton, Mass.—March 4, 2024—Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, welcomes the Centers for Medicare & Medicaid Services’ (CMS) new Healthcare Common Procedure Coding System (HCPCS) Level II code for the Leva^® Pelvic Health System. The Leva System’s patented, motion-based technology allows women to treat urinary incontinence (UI) and fecal incontinence (FI) through pelvic floor muscle training, also known as Kegels, correctly and in the privacy of their home. Effective on April 1, 2024, the new code makes it easier for clinicians, distributors, payers and, most importantly patients, to access Leva System’s clinically validated, non-invasive treatment.

 Pelvic floor muscle training (PFMT) is globally recommended as a first-line treatment for urinary and fecal incontinence. A study published earlier this year showed the Leva System yielded superior UI symptom improvement vs. doing typical unsupervised, home PFMT and that just eight weeks of treatment resulted in two years of symptom improvement. The Leva System’s unique accelerometer-based technology allows real-time visualization and guidance during PFMT, helping women perform PFMT correctly. The Leva System’s new HCPCS Level II code simplifies access for patients, eliminating barriers that can delay coverage through their insurance plan.

 “The new HCPCS code is a significant milestone that accelerates our mission to make Leva more accessible for patients, prescribers and insurance plans,” said Eileen Maus, CEO of Axena Health. “Several years of data across numerous published studies affirm that Leva helps women access first-line, conservative treatment for incontinence and the results they achieve are long lasting. The new code removes barriers that have kept treatment out of reach by defining a clear path as a medical benefit through patients’ durable medical equipment coverage.  The Leva System’s HCPCS code along with its previously established pharmacy code, make either channel an option to increase access through insurance.  Every woman deserves safe and effective treatment for incontinence. We’re confident clinicians, insurers and medical distributors are now able to help women gain faster, easier access to Leva.”

 “UI is a progressive disease that, if left untreated, can severely impact women’s quality of life, imposing enormous physical, psychological, and economic burdens and placing her at risk for disability,” said Samantha Pulliam, M.D., Axena Health’s Chief Medical Officer. “PFMT, commonly practiced via Kegels, is a first-line treatment, but data show achieving effective, consistent practice is challenging. The Leva System makes PFMT accessible by guiding women through their treatment, effectively, enabling supervised PFMT.  And this new code is a huge step towards making the Leva System available to all women who need symptom relief.”

About the Leva^® Pelvic Health System  

The Leva Pelvic Health System, recently named a Medical Breakthrough in women’s health by AARP, is a prescription medical device that offers an effective, non-invasive, medication-free way for women to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared intra-vaginal probe embedded with multiple motion sensors and integrated software, the Leva System allows women to visualize pelvic floor muscle movement in real-time and guides them to complete their treatment correctly. Available by prescription only, the Leva System gives providers/clinicians the opportunity to treat UI and chronic FI on a broad scale and with continued involvement in patient success. The Leva System has multiple clinical trials with globally recognized medical centers supporting its efficacy in treating UI, including two studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG). The U.S. Food and Drug Administration (FDA) granted the Leva System Breakthrough Device Designation in 2021 as a treatment for chronic FI.

About Axena Health 

Axena Health, Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Axena Health’s flagship product, the Leva^® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), underreported conditions affecting over 78 million and 12 million women in the U.S. alone. Axena Health’s technology enables non-invasive, drug-free treatment which they can do at home, in just five minutes a day while also allowing clinicians to monitor usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com, follow Axena Health on LinkedIn and follow Leva Pelvic Health System on Instagram and TikTok. 

Important Indication and Other Information for the Leva® Pelvic Health System 

The Leva^® Pelvic Health System is intended for (1) strengthening of pelvic floor muscles, (2) rehabilitation and training of weak pelvic floor muscles for the treatment of stress, mixed, and mild to moderate urgency urinary incontinence (including overactive bladder) in women and (3) rehabilitation and training of weak pelvic floor muscles for the first-line treatment of chronic fecal incontinence (>3-month uncontrolled passage of feces) in women. Treatment with the Leva System is by prescription and is not for everyone. Please talk to your prescriber to see if Leva System is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use the Leva System while pregnant, or if you think you may be pregnant, unless authorized by your doctor. For a complete summary of the risks and instructions for the Leva System, see its Instructions for Use available at www.levatherapy.com.  

Media:

Shanti Skiffington

[email protected]

617-921-0808