Renovia Inc. ("Renovia"), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that Capital Women's Care is recommending the leva® Pelvic Health System to its patients who experience stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder). Capital Women's Care is the largest private OB/GYN practice in the mid-Atlantic with more than 200 providers across over 55 locations in Maryland, Virginia, and Washington DC.
The latest data show that 62% of adult women in the U.S. experience urinary incontinence, which can have a negative impact on quality of life and contribute to other significant and potentially severe medical conditions. Numerous studies show Pelvic Floor Muscle Training (PFMT), commonly known as "Kegels," can help reduce the symptoms of UI by strengthening a woman's pelvic floor muscles. However, as few as 25% of women who perform Kegels do so effectively, limiting the potential positive impact on UI symptoms. The leva Pelvic Health System is a Food and Drug Administration (FDA)-cleared device-app combination for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (including overactive bladder). It combines the leva sensor with a smartphone app, offering an easy, non-invasive, drug-free way for women to strengthen their pelvic floor muscles to improve UI symptoms. leva requires just five minutes of practice a day, which women can do at home, on their own schedule. Multiple clinical trials and published data support leva's efficacy. leva is available by prescription only.
"As one of the largest private OB/GYN practices in the mid-Atlantic region, we have a long history of clinical excellence," said Craig Dickman, M.D., FACOG, Vice Chairman of Capital Women's Care's Board of Directors. "Urinary incontinence in women is a vastly undertreated condition that impacts a woman's ability to participate in the activities they love such as travel, socializing with friends and exercise. We're pleased to offer easy, effective, at-home treatment for UI that's drug- and surgery-free. Importantly, leva allows our team of physicians to stay integrated in our patients' success, which aligns well with our mission to nurture the spirit of caring for every woman."
"Today, more than 78 million U.S. women experience a treatable condition that impacts their social lives, exercise preferences, relationships and travel plans—and that's wrong," said Eileen Maus, Renovia's CEO. "We commend Capital Women's Care for their commitment to providing women with the best possible care, which includes keeping their pelvic floor strong. Digital medicine is the future of healthcare because it offers a convenient, effective way for CWC clinicians to keep in touch with their patients along their healing journey. We're pleased to be working with a group of providers that share our deep commitment to ensuring that women can live leak free."
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 ongoing 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. Renovia's clinical study work with leva received the 2021 Medical Device Network Excellence Award for Research and Development.
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 experienced by over 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.
