Abstracts at AUGS/IUGA Scientific Meeting affirm leva's treatment value for female urinary incontinence

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Jun 17, 2022, 07:00 ET

8 weeks of treatment with leva delivers symptom improvement for one year: real-world data establishes efficacy outside of a research setting

AUSTIN, Texas, June 17, 2022 /PRNewswire/ -- AUGS/IUGA Scientific Meeting 2022- Renovia Inc. (Renovia), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that researchers presented new data supporting the value of the leva^® Pelvic Health System in treating female urinary incontinence (UI). Three accepted abstracts showed that leva delivers durable UI symptom improvement for 12 months following eight weeks of therapy, generates valuable real-world data that both supports leva's effectiveness and provides an opportunity to enhance future women's health research, and continues to improve access to first-line treatment for UI through scalable at-home pelvic floor muscle training (PFMT). Researchers presented their findings at the 2022 Scientific Meeting of the American Urogynecologic Society (AUGS) and International Urogynecological Association held in Austin, TX from June 14-18, 2022.

The study, "Digital Therapeutic Device for Urinary Incontinence: A 6- and 12-month Follow-up of a Randomized Controlled Trial," extends the findings of an April 2022 randomized controlled superiority trial (RCT) in Obstetrics and Gynecology (The Green Journal), showing that leva was statistically and clinically superior to Kegel exercises alone for improving UI symptoms. At the 2022 Annual Meeting, several researchers from the original RCT gave two oral presentations, showing that leva delivers durable and significantly more improvement in UI symptoms compared to home PFMT alone at 6 and 12 months from the start of treatment. Notably, this continued superior symptom improvement was seen regardless of whether the woman continued treatment beyond 8-weeks.

Significantly, the leva arm of the study also provides valuable detail about the potential for machine learning to process large quantities of clinical data including changes in physiologic parameters, validated survey results and adherence. These findings may be useful in the future as researchers understand and possibly even predict outcomes for women who engage in PFMT with leva to treat urinary incontinence. Dr. Milena M. Weinstein, MD of Massachusetts General Hospital/Harvard Medical School presented the data.

A second presentation, "A Digital Health Program for Treatment of Urinary Incontinence: Retrospective Review of Real-World User Data," analyzes real-world clinical data to show that leva is a safe and effective treatment for stress, mixed, and urgency urinary incontinence, including overactive bladder. The findings align with the results of the RCT published in the Green Journal, which demonstrated leva's superiority to standard care. Lead Investigator Laura E. Keyser, PT, DPT, MPH, Renovia's Snr. Manager, Medical Affairs, commented: "This paper is among the first in urogynecology to provide real-world evidence related to PFMT and its effectiveness in UI treatment. Our data not only demonstrate leva's value for UI treatment but also its ability to capture and evaluate real-world data from women to generate real-world evidence. This is especially important for behavioral interventions like PFMT, where adherence to treatment may be challenging."

"The alignment between the data from academic studies and real-world user data that researchers have observed underscores the strength of the data generated by leva and points to potential future use in both therapeutic and diagnostic applications," said Samantha J. Pulliam, M.D, Chief Medical Officer for Renovia. "The ability to capture real-world data is also rare in women's health. Combined, these achievements affirm leva as an effective and accessible treatment for UI backed by rigorous data."

The 2022 Scientific Meeting seeks to improve women's urogynecologic care. Multiple studies show that PFMT, commonly referred to as Kegel exercises, can offer effective, first-line treatment for UI. However, most women cannot strengthen and train their pelvic floor effectively performing Kegels on their own. leva is an FDA-cleared, prescription digital therapeutic (PDT) that combines a small vaginal motion sensor with a smartphone app that guides a woman through treatment, offering an easy, non-invasive, drug-free way for women to effectively strengthen their pelvic floor muscles to improve UI symptoms. leva requires just five minutes of therapy a day, which women can do at home, on their own schedule. Importantly, women's prescribing clinician remains involved in their UI treatment through monthly reporting on adherence and symptom status. This closed loop approach is meant to help ensure women and their clinicians remain supported and informed.

Published RCT available in the Green Journal:

"Digital Therapeutic Device for Urinary Incontinence: A Randomized Controlled Trial," Obstetrics & Gynecology, April 2022

At the Scientific Meeting:

Thursday, June 16, 2022; 2:00 PM - 3:00 PM
Digital Therapeutic Device for Urinary Incontinence: a 6- and 12-month Follow-up of a Randomized Controlled Trial as part of the abstract session, "Urinary Incontinence: Treatment"

Friday, June 17, 2022, 3:21 PM – 3:27 PM CDT
Pelvic Floor Excursion and Endurance in Response to Pelvic Floor Muscle Training Using a Digital Therapeutic Device. (#103) as part of the session, "Anatomy, Pelvic Pain and Functional Problem 2"

The unmoderated poster, "A Digital Health Program for Conservative Treatment of Urinary Incontinence: Retrospective Review of Commercial User Data," is #499.

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 continued 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.

Media inquiries:
Shanti Skiffington
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SOURCE Renovia Inc.