Renovia advances access to first-line treatment for female urinary incontinence with 1,000 leva prescribers

Key milestone underscores unmet need for easy access to first-line treatment; recent randomized controlled study reinforces leva's superiority over Kegel exercises alone

BOSTON, May 17, 2022 /PRNewswire/ -- Renovia Inc. (Renovia), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that 1,000 healthcare providers have prescribed the leva^® Pelvic Health System, a convenient, easy-to-use, at-home pelvic health program that can help women decrease the symptoms of urinary incontinence (UI), including overactive bladder. The milestone follows an April 2022 randomized controlled superiority study in Obstetrics and Gynecology (The Green Journal), showing that leva was statistically and clinically superior to Kegel exercises alone for improving UI symptoms. leva's accelerated adoption among healthcare providers reflects their deep desire to improve access to conservative treatment for UI, a condition that affects 62% of adult women in the U.S. and tends to progress and worsen over time

Multiple studies show that Pelvic Floor Muscle Training (PFMT) offers effective, first-line treatment for UI. Often, however, patients must choose between attending a series of physical therapy visits or attempting to strengthen their pelvic floor through unsupervised Kegel exercises. However, Kegel exercises are difficult to perform correctly or consistently when performed alone, limiting the potential positive impact on UI symptoms. The leva Pelvic Health System is an FDA-cleared, prescription digital therapeutic (PDT) that helps women strengthen their pelvic floor by guiding them through PFMT. Combining unique motion sensor technology and a smartphone app, and supported through live personalized coaching if desired, leva requires just five minutes of practice a day, which women can do at home, on their own schedule. Significantly, clinicians can incorporate leva into their practices easily and remain connected with patients throughout treatment through monthly reports on patient adherence and symptom status.  

Renovia's Chief Medical Officer Samantha J. Pulliam, M.D. commented: "leva's rapid adoption speaks to the enormity of the unmet medical need associated with female UI. As a clinician, I can say with assurance that when a woman's well-being is central to your professional mission, it's incredibly frustrating to know that effective first-line treatment for UI exists but that the challenges associated with Kegels keep it out of reach for most. leva not only makes first-line treatment accessible, it's supported by data from rigorous, peer-reviewed clinical studies. Women and healthcare providers alike deserve a high-quality option that allows them to work together to address a condition that's highly treatable."

"We're heartened by the response we've received from healthcare providers nationally," said Eileen Maus, CEO of Renovia. "The Green Journal publication accelerated the momentum generated by our direct sales force. The introduction of our new brand campaign, Stronger Women, at ACOG earlier this month affirms our continued drive to make first-line treatment for UI widely accessible by delivering a pelvic health system that's backed by exceptional data from some of the best medical centers in the world. Women deserve this level of excellence in their care."

The Green Journal study, "Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial," posted online early on March 10, 2022 and appeared in the April 2022 print edition accessed here or by visiting Obstetrics & Gynecology online.

About the leva^® Pelvic Health System
The leva Pelvic Health System offers a novel, 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). Combining a small FDA-cleared vaginal motion sensor connected to a smartphone app, leva 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, leva is available by prescription only, allowing physicians the opportunity to treat UI on a broad scale and with deep involvement in patient success. leva is the first femtech product included in the Digital Therapeutics Alliance product library and has multiple clinical trials and published data from globally recognized medical centers supporting its efficacy in treating UI. leva received the 2021 Excellence Award for Research from Medical Device Network.

About Renovia
Boston-based Renovia Inc. is a women-led company dedicated to improving the lives of women with pelvic floor disorders. Renovia's flagship product, the leva^® Pelvic Health System, offers a novel, effective, first-line treatment for urinary incontinence (UI), an underreported condition affecting 78 million women in the U.S. alone. Renovia'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 about Renovia or leva please visit www.renoviainc.com and www.levatherapy.com and follow us on Twitter, Facebook, LinkedIn and Instagram.

Important Indication and Other Information for the leva Pelvic Health System
The leva Pelvic Health System is intended for strengthening of pelvic floor muscles, and 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. Treatment with the leva System is by prescription and is not for everyone. Please talk to your prescriber to see if leva is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use leva 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.renoviainc.com and www.levatherapy.com.

Renovia Inc. and leva^® are trademarks or registered trademarks of Renovia Inc. in the United States and other countries. All Rights Reserved.

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Shanti Skiffington
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SOURCE Renovia Inc.