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The Queen's Partnerships and Innovation (QPI) team supports the University’s strategic goal to build community partnerships and fully embed in the community. Led by QPI, the WE-CAN (Women Entrepreneurs Can) Project inspires and empowers existing and aspiring women-identifying entrepreneurs by providing them with tools, resources, expert mentors, networks and community building to expand existing businesses and to launch new ventures.

After an arduous journey, Cornwall-based officially received clearance from the U for its reusable female bladder support in December 2024. Founded by Cornwall-based entrepreneur Karen Brunet, Cntrl+ is a startup with a goal to help women regain their comfort and confidence by helping them to manage bladder leaks without surgery, pads, or traditional pessaries.

Brunet has an extensive career in marketing, sales, and management, including in the Prince Edward County winery industry. After a four year pause to raise her daughters, she founded a medical devices distribution start-up which included reusable devices for men addressing urinary incontinence. She credits navigating the regulations of the wine industry with having the confidence to build her own quality management system securing import licenses with , and further regulatory bodies around the world in order to export these medical devices.

“After the birth of my second daughter, I started to experience bladder leaks myself,” says Brunet, who still lives an active lifestyle. “I thought ‘Why am I marketing all these medical devices for men with incontinence? What is out there for women like me’?”

So, in 2019, Brunet began designs for a new flexible and more comfortable female bladder support to help prevent stress urinary incontinence. By trying the few existing devices from around the world and using knowledge from graphic design schooling, Karen drafted drawings and her first prototype was 3D printed in early 2020. Her own drawings led her to be able to begin the process to file an international patent application. She then set her sights on tackling US FDA clearance, knowing that it was one approval that is well-respected around the world.

Knowing she would need money to launch the product she had designed, Karen pitched to (then the Southeastern Ontario Angel Network) in February 2020, landed an Angel investment a few months later, and incorporated Cntrl+ Inc.

“There were 40 men and two women in the room when I pitched Cntrl+, which didn’t even have a name at the time. When I finished, you could hear a pin drop. It felt like the men were uncomfortable with the product and topic, and they didn’t really know how to react to it. But one of the women asked me some very direct questions – questions I couldn’t answer at the time,” says Brunet. Even though she didn’t know the answers, Brunet felt encouraged. “I love when I'm challenged - that's how you grow.”

That woman was , a serial entrepreneur who happened to be mentoring a group of technology-based women entrepreneurs through the WE-CAN Project’s Compass North Accelerator Program, for companies poised for growth. The program was the first from the WE-CAN Project, co-designed by �ϳܱ���’s Partnership and Innovation (QPI) and . Ms. Cau encouraged Brunet to apply to the program and ended up being her mentor throughout the eight-month program.

Brunet’s participation in the Compass North Accelerator Program put her on the radar of Angela Lyon, Patent Agent with QPI. “I first came across Cntrl+ at the Compass North graduation pitch,” says Angela. “I contacted her in October 2020, and we met up so I could see the product in person. I went to her home, and we met outside due to COVID restrictions.”

Although Karen already had a provisional patent application in place with the help of , based out of Ottawa, Angela was in time to provide advice prior to a formal patent application being filed. Angela worked with Karen and the formal international application for patent was filed in January 2021 by MBM. The QPI team has patent agents and other staff members who can provide advice on patentability, commercialization, and other intellectual property matters. Eligible WE-CAN Project clients can access these services from QPI.

“Angela has been absolutely amazing at guiding me through all the processes for international patent filings for the device and design,” says Brunet of her experience working with QPI’s patent team. “She has been instrumental at getting us where we are with granted patents in nine countries so far - she is a woman who understands this health space, and with her experience in sexual health education - she understands everything. I really consider her part of my team.”

Local innovation support

“I went in very naive with an ‘I can do this!’ attitude that deflated rather quickly. I didn't know how difficult and expensive it would be,” says Brunet. The FDA eventually accepted clinical data from a related product in 2023, which helped navigate some of the clearance process, but she knew she would need more help to keep going – especially financially.

Until May 2023, Karen was going through the US FDA process alone, and the testing requirements from the FDA had her feeling backed into a corner. She reached out to research organization (formerly Ironstone Product Development) and they were contracted to help. Avania has the domestic and international lab contacts and experience to address the testing that the FDA required. For a year and a half, they worked together with Karen to obtain the FDA clearance.

“I was so overwhelmed. It was tough… really, really, tough, because the FDA was not letting down. There was one test that we just couldn't pass, and it was a test that had nothing to do with the efficacy or safety of my product,” says Brunet. “I was running out of money and thankfully Cornwall’s stepped in with a significant loan. Unfortunately, we quickly burned through it with further testing costs.”

Having advisors and advocates in the southern Ontario innovation ecosystem has been key in helping Cntrl+ get over some major hurdles. In February 2024, Cntrl+ pitched to KNDL and closed a $500 thousand pre-seed funding round in less than six months. , Business Development and Commercialization Manager from was present during the KNDL pitch and encouraged Karen to apply to Ontario’s . 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. Karen’s LSIF application was successful, which boosted her pre-seed funding by another $500,000!

“There were times when I didn't think I could get through all of this, but I have cheerleaders like from who’s also my fractional CFO, plus Angela Lyon (QPI). My family and friends have been extremely supportive, and the encouragement from 100’s of women who’ve reached out waiting to purchase has been overwhelmingly positive,” says Brunet, those are the people who keep her going forward.

What comes next

Achieving FDA prescription clearance in December was a crucial milestone for Cntrl+ but to sell to sell directly to consumers as an over-the-counter product in the USA, the FDA needs a small study completed. Cntrl+ is working with the University of Ottawa to complete the study to demonstrate that the product can be easily fitted by a patient themselves without a doctor’s assistance.

Cntrl+ also has a Stage 2 ISO 13485 and MDSAP Quality System Audit in mid-April for Health Canada clearance and plans to launch the product in Canada in July 2025.

Cntrl+'s journey from concept to FDA clearance is a testament to the power of perseverance, innovation, and community support.

“My goal is to get my product directly into women's hands as fast as possible,” says Brunet. “I want people to know Cntrl+ is designed and developed by a woman for women; this product will change women’s lives”.

With the product poised to launch in Canada and the United States this year, plus expand into the UK and Europe next year, Karen Brunet's vision of empowering women by regaining their comfort and confidence is becoming a reality.