Proof of Concept Results for OAB CeCe® and Welcoming Michael Seggev to Strategic Advisory Board

We are pleased to report that we recently completed our Proof of Concept Study for our first digital therapeutic, OAB CeCe®, designed to treat symptoms of Overactive Bladder (OAB) in people assigned female at birth. While specific results are confidential prior to publication we can share that we achieved strong, significant results for our primary and key secondary endpoints. Participant feedback was strong on both their experience with the app as well as feelings of agency over their OAB symptoms.

We will be meeting with the FDA on July 8th for our Pre-submission Meeting to discuss these results and the design of our randomized, double-blind controlled Pivotal Trial, anticipated to begin patient recruitment no later than January 2023. We anticipate recruiting approximately 200 persons assigned female at birth, administered remotely using Telehealth providers.

Additionally, we wanted to announce that Michael Seggev (https://www.linkedin.com/in/michael-seggev/) has recently joined our Strategic Advisory Board. Michael brings 25+ years in commercialisation, both in the pharmaceutical industry, and for the past 6 years, in digital health. He will help us to develop our paths to commercialisation for OAB CeCe® and future products. We are thrilled to have Michael and his expertise within the Renalis Team.

Thank you for your support and interest in Renalis and the work we are doing to change the way pelvic healthcare is delivered.

Yours in pelvic health,

Missy