Cornwall, ON, January 2025—Cntrl+, a ground-breaking solution for female stress urinary incontinence, has officially received clearance from the U.S. Food & Drug Administration (FDA). Developed by Cornwall-based Cntrl+ Inc., this reusable product is poised to revolutionize the incontinence market by offering women a simple, affordable way to prevent bladder leaks, especially during physical activity.
Founded in 2020 by Karen Brunet, who personally experienced the challenges of urinary incontinence while exercising, Cntrl+ Inc. was created to provide a better solution for the 1 in 3 women facing these issues. “My mission is to improve women’s lives with a solution that is not only effective but also user-friendly and accessible,” says Brunet. “Achieving FDA clearance is a crucial milestone for us, moving us closer to offering Cntrl+ directly to consumers.”
What sets Cntrl+ apart is its FDA-approved use of up to 12 hours a day for ten years or more, thanks to its rigorous long-term safety testing. In contrast, a newly launched bladder support pessary in the U.S. has only been cleared for 30 uses over a lifetime. With Cntrl+, women can enjoy lasting, reliable support every day.
Support for Innovation: A $500,000 Investment from LSIF
Cntrl+ recently closed a CAD 1 million pre-seed funding round, boosted by a pivotal $500,000 investment from Ontario’s Life Sciences Innovation Fund (LSIF), led by the Ontario Centre of Innovation (OCI). LSIF provides capital to help entrepreneurs and innovators bring their prototypes from the lab to the marketplace, supporting the commercialization of made-in-Ontario products both locally and globally.
With OCI’s investment, Cntrl+ is positioned to capture a significant share of the global incontinence market—estimated at USD 10 billion in 2024. “Given that women account for the majority of this market, we are confident that Cntrl+ will become the go-to solution for millions of women worldwide,” says Brunet.
Navigating Final Regulatory Approvals
In addition to its FDA clearance, Cntrl+ has engaged Avania, a leading medical technology contract research organization (CRO), to guide the company through the final stages of the regulatory process.
Global Launch in 2025
Cntrl+ expects to launch its direct-to-consumer (DTC) sales in the U.S. and Canada by the summer of 2025, followed by releases in the UK and EU later in the year. This global expansion will ensure that women around the world have access to a solution that combines effectiveness, affordability and environmental sustainability—revolutionizing how they manage bladder leaks. “Women globally are in desperate need of better, more comfortable options to manage urinary incontinence, and Cntrl+ represents a game-changing alternative,” says Brunet.
About Cntrl+
Cntrl+ is an innovative Canadian life science company focused on advancing women’s wellness around the world. This female-founded firm manufactures the most comfortable, effective and eco-friendly solution to address female stress urinary incontinence. Cntrl+ will soon export this over-the-counter product so women around the world can walk, run, jump, laugh, and live with comfort and confidence.
Cntrl+ has 10 international granted utility patents with 20 more to grant in Europe in the oncoming months.
For more information: cntrlplus.com
About OCI
The Ontario Centre of Innovation (OCI) brings industry, academic, and government partners together to invest in collaborative R&D, technology development, and commercialization opportunities that generate the highest return on innovation for Ontarians.
As an ecosystem connector, OCI initiates unparalleled partnership opportunities, develops and manages successful industry-academic collaborations, supports high-potential SMEs in commercializing ground-breaking research, and provides hands-on training and skills development opportunities for the next generation of highly-skilled talent.
OCI drives economic growth and job creation through investments in the development, commercialization, and adoption of advanced technologies.
For more information: oc-innovation.ca
For media inquiries, please contact:
Karen Brunet, Founder
Cntrl+ Inc.
[email protected]
Phone: +1 (613) 935-5073