NEWTON, Mass.--(BUSINESS WIRE)--Axena Health, Inc. (Axena Health), a medical device company focused on female pelvic health, is now offering the Leva® Pelvic Health System through www.levarx.com. In collaboration with UpScriptHealth, the new telehealth offering connects women with prescribing clinicians who can evaluate their incontinence symptoms and, if appropriate, prescribe the Leva System. With the U.S. experiencing a growing shortage of OB-GYNs, the new telehealth service will allow women to access effective first-line incontinence treatment quickly and easily, improving individual outcomes and decreasing overall costs for the healthcare system.
Urinary incontinence (UI) affects more than 60 percent of U.S. adult women: over 28 million U.S. women experience moderate to severe UI. Pelvic floor muscle training (PFMT) is a globally recommended first-line treatment for UI. However, PFMT can be difficult to perform correctly without guidance. The Leva System can help women access PFTM successfully, enabling them to treat UI without medications or surgery.
Women can take advantage of the telehealth offering by visiting www.levarx.com. After completing a brief questionnaire that captures medical history and symptom information, a woman will have a short, private online consultation with a healthcare provider from UpScriptHealth, who will explain the Leva System and, if appropriate, write a prescription. Next, the Leva Women’s Center will reach out to discuss insurance coverage and out of pocket costs. There’s no obligation to move forward with treatment.
Axena Health’s Interim CEO Jim O’Connor commented: “Nearly half of U.S. women skipped a preventive care service in 2022, with difficulty scheduling an appointment among the most common causes. Telehealth can be an important part of fixing this distressing gap in care. We remain steadfast in our commitment to breaking down barriers to first-line care for urinary incontinence, whether the normalization by adult diaper industry or the disparity in insurance coverage for women’s health conditions such as urinary incontinence. We believe this new offering in partnership with UpScriptHealth can help women who have had difficulty accessing first-line treatment.”
The Leva Pelvic Health System (HCPCS Level II code, S9002) is a small, flexible intra-vaginal probe embedded with multiple motion sensors, that helps women perform PFMT correctly to treat UI. A progressive disorder, UI typically worsens with age. Untreated, it can lead to significant negative comorbidities. The Leva System is U.S. Food and Drug Administration (FDA)-cleared to treat stress, mixed and mild-to-moderate urgency UI (including overactive bladder) as well as chronic fecal incontinence in women. It requires just five minutes of use per day, typically over eight to twelve weeks, which women can do at home, on their own schedule.
“We are incredibly grateful to Axena Health for launching this innovative telehealth platform,” said Sarah Jenkins, Executive Director at the National Association for Continence. “Access to care is a growing issue, particularly in women’s health and for those outside major cities. This initiative will significantly enhance access to treatment for urinary incontinence, empowering more women to manage their health with greater convenience and confidence.”
About the Leva® Pelvic Health System
The Leva® Pelvic Health System offers an innovative, non-invasive, medication-free way for women to train and strengthen their pelvic floor muscles—at home in just five minutes a day—to treat urinary incontinence (UI) and chronic fecal incontinence (FI). Combining a small FDA-cleared vaginal motion sensor with integrated software, the Leva System offers precise visualization of pelvic movement in real-time, enables progress tracking and allows active physician involvement, all of which support women’s success. Recognizing that level-one evidence shows pelvic floor muscle training is most effective when performed under the supervision of a skilled healthcare provider, the Leva System is available by prescription only, allowing physicians 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 and published data from 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).
About Axena Health
Axena Health, Inc. is 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 via precise visualization of movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information, please visit www.axenahealth.com or www.levatherapy.com and follow Axena Health on LinkedIn.
About UpScriptHealth
UpScriptHealth provides a fully compliant direct-to-consumer telemedicine platform for pharmaceutical companies and consumer products companies. This unique platform allows for convenient access to high quality health care including state of the art medicines. In 2002 UpScriptHealth was the first company in the US to be licensed to write prescriptions on the internet through an online physician consultation. Since then, we’ve treated more than a million patients in all fifty states. Learn more at www.UpScriptHealth.com.
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 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.
