Boston, Mass—October 29, 2021—Renovia Inc. (“Renovia”), a women-led company that develops digital therapeutics for female pelvic floor disorders, announced today that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for the leva® Digital Therapeutic System as a first-line treatment for chronic fecal incontinence (FI) in women. The leva Digital Therapeutic is currently FDA-cleared for the treatment of urinary incontinence (UI) and pelvic floor strengthening in women.
The FDA’s Breakthrough Devices Program is a voluntary program available to therapeutic devices that establish they have the potential to provide more effective treatment of life threatening or irreversibly debilitating diseases or conditions. Breakthrough designation confers several important benefits, including prioritized review of future regulatory submissions and greater opportunity to interact with FDA experts throughout the clearance review process.
“We’re very grateful for the opportunity to continue to work closely with the FDA to improve first-line care for chronic accidental bowel leaks for as many women as possible,” said Renovia’s CEO Eileen Maus. “While the leva Digital Therapeutic is not yet FDA cleared for the treatment of fecal incontinence, we are hopeful that Breakthrough Device Designation will help expedite patient access to the leva System as a first-line treatment for a profoundly debilitating condition.”
Fecal incontinence, commonly referred to as accidental bowel leakage, is a debilitating and progressive condition affecting 12 million U.S. women. The involuntary loss of stool is an “excruciatingly embarrassing” and, therefore, silencing condition that places women at increased risk for depression, shame, guilt, social isolation, and nursing home placement. First-line treatments for bowel leaks include antidiarrheal medications and rectal biofeedback devices. However, antidiarrheal medications and rectal biofeedback training can be challenging to maintain and there is little published evidence supporting the effectiveness of current biofeedback devices in treating FI.
Steven Gregg, Executive Director of the National Association for Continence (NAFC) offered, “Women with chronic fecal incontinence have few treatment options beyond drugs or surgery. For them, daily living can be stressful, lonely and logistically challenging as they accommodate burdensome hygiene demands and a dependence on diapers and pads. There is a tremendous unmet need for an easy, effective solution that could offer them freedom. One that women can self-direct in the privacy of their own home would be an A plus. We applaud the FDA and Renovia for offering hope for what is a desperate situation for many millions of women.”
The leva System is a small vaginal wand combined with a smartphone app that offers a non-invasive, surgery- and drug-free way for women to train and strengthen their pelvic floor muscles successfully, at home and in just five minutes a day. leva is currently FDA-cleared for the treatment of stress, mixed and mild to moderate urgency urinary incontinence (UI), a condition affecting 20 million women that is also caused by pelvic floor damage. Not surprisingly given the importance of pelvic floor muscles to maintaining continence, 20% of women with UI also experience bowel leakage.
“The consequences of untreated chronic FI are profoundly negative for women,” said Dr. Samantha Pulliam, Chief Medical Officer for Renovia Inc. “However, it remains vastly untreated: fewer than 30% of women seek care. Like UI, accidental bowel leaks often result from pelvic floor damage, so it makes sense that a treatment for UI focused on pelvic floor health promises to help women suffering from FI. As the prevalence of FI increases with our aging population, it’s imperative that these women have access to affordable first-line treatments. No women should have to endure the shame, emotional distress and health consequences associated with bowel leaks if an easy, at-home treatment can exist.”
About the leva® Digital Therapeutic
The leva Digital Therapeutic 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 a women’s success. leva is available by prescription, allowing physicians the opportunity to treat UI on a broad scale and with deep involvement in patient success. Published data from globally recognized medical centers support leva’s efficacy.
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® Digital Therapeutic, 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 pelvic movement in real time during pelvic floor muscle training, while monitoring usage and progress. For more information about Renovia or the leva please visit www.renoviainc.com.
Important Indication and Other Information for the leva Digital Therapeutic
The leva Digital Therapeutic 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.
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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