BOSTON, Sept. 17, 2021 /PRNewswire/ -- Renovia Inc. ("Renovia"), a women-led company that develops digital therapeutics for female pelvic floor disorders, today announced that the Digital Therapeutics Alliance (DTA) has added the leva® Pelvic Health System to its Product Library of innovative treatments that meet DTA's definition of an evidence-based digital therapeutic satisfying its ten rigorous Core Principles. Renovia is the first company focused solely on women's health to have a product included in the DTA Product Library.
DTA is a global, non-profit organization dedicated to advancing high-quality digital therapeutics in healthcare. Alliance members align with its mission to improve clinical and health economic outcomes using high quality, evidence-based digital therapeutics to prevent, manage, or treat a medical disorder or disease. The DTA's Product Library lists the digital therapeutics that have successfully complied with all ten of the organization's Core Principles, which include:
Publishing trial results inclusive of clinically-meaningful outcomes in peer-reviewed journals.
Having been reviewed and cleared or certified by regulatory bodies as required to support product claims of risk, efficacy, and intended use.
Making only claims appropriate to clinical evaluation and regulatory status; and
Collecting, analyzing, and applying real world evidence and/or product performance data.
"The pandemic exacerbated existing gaps in women's healthcare but also highlighted the importance of remotely accessible and innovative products like digital therapeutics to address them," said Andy Molnar, Chief Executive Officer, of the Digital Therapeutics Alliance. "Women's health is a critical segment of the overall digital therapeutics ecosystem, so we're thrilled to see leva added as the first 'femtech' offering in our Product Library. Our ten Core Principles are focused on what we consider to be central to world-class evidence-based, patient-centered therapeutic interventions and intentionally set a high bar."
Renovia's leva System is FDA-cleared and includes a small, flexible vaginal wand combined with a smartphone app that offers a non-invasive, surgery- and drug-free way for women to improve their urinary incontinence (UI), at home and in just five minutes a day. Published data from globally recognized medical centers supports leva's efficacy for UI (commonly referred to as bladder leaks) through leva's real-time visualization of movement when a woman correctly contracts her pelvic floor muscles. Inclusion in DTA's Product Library is further affirmation of Renovia's evidence-based approach to pelvic health that promises to extend the reach of clinical care and improve health equity.
UI is an underreported condition affecting over 20 million women in the U.S. alone, negatively impacts women's quality of life and can contribute to other potentially severe medical conditions. Despite its prevalence and adverse effects on women's health, UI is often underreported by women and thus not addressed by many clinicians. Fortunately, groups such as ACOG (American College of Obstetricians and Gynecologists) and WPSI (Women's Preventive Services Initiative) are increasingly recommending screening for pelvic floor disorders including UI. Early intervention has been shown to resolve or reduce symptoms, improve immediate and long-term condition-specific quality of life, and limit the need for more invasive and costly treatments.
"We're grateful to the DTA for their tireless efforts leading innovation, advocating for policy change and establishing rigorous standards for digital therapeutics," said Eileen Maus, CEO of Renovia. "We're proud leva appears alongside a world-class set of digital therapeutics improving standards of care. UI can be a humiliating, often debilitating, condition and too many women don't seek treatment – and settle for pads and adult diapers. Working with DTA offers yet another way to raise awareness of available first-line treatments and encourage women to speak with their healthcare provider about bladder leaks."
About DTA The Digital Therapeutics Alliance (DTA) is a global non-profit trade association of industry leaders and stakeholders with the mission of broadening the understanding and adoption of digital therapeutics into healthcare. DTA works to enable expanded access to high quality, evidence-based digital therapeutics for patients, clinicians, and payors in order to improve clinical and health economic outcomes. To learn more, please visit: www.dtxalliance.org.
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. 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 continued involvement in patient success. Published data from globally recognized medical centers support leva's efficacy.
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 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 Pelvic Health System please visit www.renoviainc.com.
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.
Renovia Inc. and leva® are trademarks or registered trademarks of Renovia Inc. in the United States and other countries. All Rights Reserved.
Media inquiries: Shanti Skiffington mobile: 617 921-0808