Please replace the release issued April 11, 2024 with the following corrected version due to multiple revisions.
“Insurance coverage equals access for most women in the U.S.”
The updated release reads:
AXENA HEALTH RECEIVES TWO ADDITIONAL POSITIVE INSURANCE COVERAGE DECISIONS FOR LEVA
Axena Health, Inc. (Axena Health), a medical device company specializing in female pelvic health, announced today that two of the largest health plans in Pennsylvania and North Dakota have expanded coverage to include the Leva® Pelvic Health System for women seeking effective treatment for urinary incontinence. Both positive coverage decisions were implemented on April 1, 2024.
The Leva Pelvic Health System (HCPCS Level II code, S9002) consists of a small, flexible intra-vaginal probe embedded with multiple accelerometer motion sensors. It communicates with integrated software to guide pelvic floor muscle treatment. Urinary incontinence (UI), affecting 62% of adult women in the U.S., is a progressive disorder that typically worsens without treatment. Untreated UI can significantly impact a woman’s quality of life and lead to negative health outcomes. The Leva System is cleared by the U.S. Food and Drug Administration (FDA) for treating stress, mixed, and mild-to-moderate urgency UI, including overactive bladder, in women. It is also FDA-cleared as a first-line treatment for chronic fecal incontinence in women. The Leva System is available by prescription only, ensuring ongoing clinician involvement in patient care. It requires just five minutes of daily use over eight to twelve weeks, which women can perform at home according to their schedule.
“Pelvic floor disorders like stress urinary incontinence and pelvic organ prolapse can significantly impact quality of life and are increasingly prevalent,” noted Vincent Lucente, MD, MBA, FACOG, URPS and Physician Leader for Urogynecology at The Institute for Female Pelvic Medicine and Reconstructive Surgery, an Axia Women’s Health center. “Pelvic floor muscle strengthening is an effective initial treatment, but proper muscle recruitment and activation can be challenging. However, Leva enables me to confidently prescribe this proven intervention. Recent peer-reviewed studies demonstrate that women can successfully use Leva to manage incontinence. Importantly, they can do so privately and conveniently at home, while allowing me to remain engaged in their therapy. Insurance coverage is crucial for ensuring broader access to effective treatments, and I commend these health plans for prioritizing women’s pelvic floor health.”
“On behalf of the millions of women who now have improved access to UI treatment without medications or surgery, I’d like to thank these two health plans for recognizing the compelling studies supporting the Leva System’s effectiveness,” said Samantha J. Pulliam, M.D., Chief Medical Officer at Axena Health. “Axena Health is committed to delivering evidence-based solutions through rigorous clinical trials with leading academic institutions and publishing real-world evidence. Women deserve better treatment options, including those who lack access to specialized pelvic floor care locally. The Leva System facilitates improved treatment accessibility for women and their healthcare providers regardless of location.”
“Insurance coverage is synonymous with access for most U.S. women,” said Jim O’Connor, interim CEO of Axena Health. “Securing two additional positive coverage decisions for the Leva System expands access to effective, first-line UI treatment. Women living with urinary leaks should not feel limited to drugs, surgery, or lifelong use of incontinence pads. Our recent study shows that just eight weeks of at-home treatment with the Leva System results in two years of clinically significant symptom improvement. This makes the Leva System particularly valuable for women in rural areas with limited access to specialized care. These innovative health plans join Cigna in demonstrating a clear commitment to women’s health. I look forward to other payers following their lead.”
About the Leva® Pelvic Health System
The Leva® Pelvic Health System offers a non-invasive, medication-free method for women to strengthen their pelvic floor muscles and treat urinary incontinence (UI) and chronic fecal incontinence (FI). Using a small FDA-cleared vaginal motion sensor with integrated software, the Leva System provides real-time visualization of pelvic movements, tracks progress, and supports active physician involvement to enhance treatment outcomes. Recognizing that pelvic floor muscle training is most effective under the supervision of a healthcare provider, the Leva System is available only by prescription. This approach allows physicians to address UI and chronic FI comprehensively and maintain ongoing engagement in patient care. The Leva System has been validated through multiple clinical trials and published research from prominent medical centers demonstrating its efficacy in UI treatment, including studies in Obstetrics and Gynecology (The Green Journal), the official publication of the American College of Obstetricians and Gynecologists (ACOG).
About Axena Health
Axena Health, Inc. is dedicated to enhancing the lives of women affected by pelvic floor disorders. The company’s flagship product, the Leva® Pelvic Health System, offers an innovative, effective, first-line treatment for urinary incontinence (UI) and chronic fecal incontinence (FI), conditions that impact over 78 million and 12 million women in the U.S., respectively. Axena Health’s technology enables non-invasive, drug-free treatment through precise visualization of pelvic movement during pelvic floor muscle training, monitoring of progress, and encouraging ongoing physician involvement. For more information, please visit www.axenahealth.com or www.levatherapy.com, and follow Axena Health on LinkedIn.
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 the 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.
