Renovia names new president and CEO;
completes enrollment for randomized controlled trial

Women-led team achieves key milestone ahead of schedule

Boston, Mass.—January 19, 2021—Renovia Inc. (“Renovia”), a women-led company that develops digital therapeutics for female pelvic floor disorders, today announced the appointment of Eileen Maus in Q4 2020 as the company’s president and CEO. Under her leadership, Renovia completed patient enrollment in its all-virtual randomized controlled trial (RCT) for the leva® Digital Therapeutic one month ahead of schedule.

Ms. Maus is an accomplished leader in women’s health and has directed the success of notable device and diagnostics companies for more than two decades. During a 12-year tenure at Cytyc Corporation (now part of Hologic, Inc.), her leadership in building and managing sales teams supported the creation of several new standards of care in women’s health and the company’s accelerated growth to $700 million in annual revenue. Her most recent position as chief commercial officer for Constitutional Medical Investors, a Warburg Pincus portfolio company, led to its successful acquisition by Roche Diagnostics.

Renovia’s virtual study is a first for the 20 million women who experience urinary incontinence (UI). Initiated in October 2020, the study is evaluating the efficacy of the leva® Digital Therapeutic for the treatment of UI, comparing the success of women using the leva device to help them perform pelvic floor muscle exercises, to women performing the exercises on their own. The virtual nature of the study, which requires no in-person physician visits, supported accelerated enrollment during the Covid-19 pandemic when stay-at-home recommendations stalled or delayed thousands of clinical studies. At this time, Renovia has enrolled all of the 350 total planned participants. Significantly, the study’s virtual format allowed women of diverse ethnicities, ages and locations to participate and connect with leading urogynecologists at the study sites.

“Kegel exercises can be effective in treating UI, but many women have a hard time knowing whether they are performing them correctly, as well as remembering to do them. This study has been designed to establish whether the leva Therapeutic can provide a better treatment option for some of these women,” said Holly E. Richter, one of the study’s principal investigators, Professor and The Endowed Chair Obstetrics and Gynecology at the University of Alabama at Birmingham. She is also the Director of Research for the Division of Urogynecology and Pelvic Reconstructive Surgery and Associate Director, Gynecologic Research in the Center for Women’s Reproductive Health. “The study’s outcomes are important, but I am also excited to be part of this novel all-virtual trial. Access to clinical studies is typically a challenge for many women and studies like this have the potential to lessen some of these barriers, which may help inform future study designs even when we are beyond the Covid-19 pandemic.”

“UI is an embarrassing and sometimes debilitating condition that can severely impact a woman’s quality of life,” said Milena M. Weinstein, MD, one of the study’s principal investigators and Female Pelvic Medicine and Reconstructive Surgery Fellowship program director and Co-Chair, Center for Pelvic Floor Disorders at Massachusetts General Hospital, and Assistant Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. “A non-surgical, non-drug first-line approach is always the goal. This study will provide us with critical data about how well the leva device can help women treat UI without surgery or systemic therapy. Its virtual platform means any women from any location or background can participate, ensuring that our data reflects the rich diversity of women who will use the device.”

Commenting on her role and the early completion of Renovia’s study, Ms. Maus shared: “Our team was not only able to meet this important milestone early, they are doing it during the most challenging global public health crisis of our time. Additionally, longstanding challenges to equitable participation in research are being addressed. Our ability to recruit patients quickly across diverse socioeconomic backgrounds, locations, ages and ethnicities can be attributed to the virtual nature of the study and the fact that there is a large population of women burdened by UI and seeking a solution. I’m honored to lead this remarkable team that not only achieved its goal early but also, and perhaps most importantly, is validating a new model for conducting studies equitably and cost effectively in both ordinary and extraordinary times.”

Addressing UI with the leva® Digital Therapeutic System
Urinary incontinence, or “UI,” affects 20 million women in the U.S. alone. Commonly referred to as bladder leakage, UI can have a negative impact on a woman’s quality of life and lead to potentially severe medical conditions. While data show that strengthening pelvic floor muscles can reduce involuntary bladder leaks, reluctance to discuss the condition and difficulty performing strengthening exercises correctly keep non-invasive, drug-free treatment out of reach for many millions of women who “just live with it.” The leva® Digital Therapeutic is an FDA-cleared device that can help women strengthen pelvic floor muscles effectively. The leva Therapeutic offers women a novel way to train and strengthen muscles through real-time visualization of movement when a woman contracts the appropriate muscles. The leva Therapeutic requires only 5 minutes of practice a day and has multiple clinical trials and published data supporting its 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® 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 Digital Therapeutic, 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 Therapeutic is by prescription and is not for everyone. Please talk to your prescriber to see if the leva Therapeutic is right for you. Your prescriber should discuss all potential benefits and risks with you. Do not use the leva Therapeutic 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 Therapeutic, 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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