Global award for Research and Development recognizes Renovia’s commitment to generating the highest quality data supporting leva as effective treatment for urinary incontinence
BOSTON, Jan. 6, 2022 /PRNewswire/ — Renovia Inc. (“Renovia”), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that it has won Medical Device Network’s (MDN) Excellence Award for its randomized controlled trial (RCT) for the leva® Pelvic Health System, a Food and Drug Administration (FDA)-cleared prescription digital therapeutic that can help women train their pelvic floor muscles for the treatment of urinary incontinence (UI). Renovia received the Excellence Award in the Research and Development category, which recognizes companies committed to developing new concepts. Launched and completed during the Covid-19 pandemic, Renovia’s RCT was conducted virtually, without any need for subjects to visit a traditional healthcare facility. The virtual study enabled higher participation rates from diverse populations, better data quality and accelerated patient enrollment, which resulted in early study completion.
As many as 20 million women in the U.S. alone have bothersome UI, which can have a negative impact on a woman’s quality of life and can contribute to other significant and potentially severe medical conditions. Numerous clinical trials and systematic reviews indicate strengthening pelvic floor muscles can help reduce the symptoms of UI. The leva System is a prescription device that can help women strengthen their pelvic floor muscles effectively. Combining a small vaginal wand with a smartphone app, leva offers a non-invasive, drug-free way for women to improve their UI symptoms at home, in just five minutes a day. Multiple clinical trials and published data support leva’s efficacy.
Initiated in October 2020, Renovia’s virtual clinical trial evaluated leva’s efficacy in helping perform pelvic floor muscle exercises compared with women performing the exercises on their own. Requiring no in-person physician visits, the study enrolled over 300 women across diverse socioeconomic backgrounds, locations, ages and ethnicities. Renovia completed the study ahead of schedule during the Covid-19 pandemic when stay-at-home recommendations stalled or delayed thousands of clinical studies.
The Medical Device Network Excellence Awards celebrate the greatest achievements and innovations in the medical device industry. Described as “providing a platform to recognize the people and companies that are driving change,” the award reviewers examined 1,000 programs across a range of corporate activities, including corporate transactions, business projects and company initiatives. The Research and Development category recognizes the promise of new product concepts, specifically focusing on time and investment commitments.
“Our virtual study was a first for the many women who experience urinary incontinence,” said Eileen Maus, Renovia’s CEO. “Digital medicine is the future of healthcare because it offers a convenient, effective way for healthcare providers to deliver care equitably regardless of geography, socioeconomic status, age or ethnicity. With so many women living with UI in silence, we’re committed to generating additional data supporting leva and the value of digital health so that the broadest group of women possible can access easy, at-home, drug-free treatment for UI. MDN’s award for Research and Development recognizes this commitment and we’re deeply honored they selected Renovia to represent their Excellence Award.”
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 wand 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.
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 20 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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