The Queen's Partnerships and Innovation (QPI) team supports the 카지노게임사이트카지노 게임 컬렉션s 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.

Karen Brunet sitting at a desk with the Cntrl+ product on front of her
Karen Brunet, founder of Cntrl+, with the product that she recently received US FDA clearance for. Photo credit: Karen Brunet.

카지노 게임 컬렉션After the birth of my second daughter, I started to experience bladder leaks myself,카지노 게임 컬렉션 says Brunet, who still lives an active lifestyle. 카지노 게임 컬렉션I thought 카지노 게임 컬렉션Why am I marketing all these medical devices for men with incontinence? What is out there for women like me카지노 게임 컬렉션?카지노 게임 컬렉션

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.

카지노 게임 컬렉션There were 40 men and two women in the room when I pitched Cntrl+, which didn카지노 게임 컬렉션t 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 didn카지노 게임 컬렉션t really know how to react to it. But one of the women asked me some very direct questions 카지노 게임 컬렉션 questions I couldn카지노 게임 컬렉션t answer at the time,카지노 게임 컬렉션 says Brunet. Even though she didn카지노 게임 컬렉션t know the answers, Brunet felt encouraged. 카지노 게임 컬렉션I love when I'm challenged - that's how you grow.카지노 게임 컬렉션

That woman was , a serial entrepreneur who happened to be mentoring a group of technology-based women entrepreneurs through the WE-CAN Project카지노 게임 컬렉션s Compass North Accelerator Program, for companies poised for growth. The program was the first from the WE-CAN Project, co-designed by Queen카지노 게임 컬렉션s 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.

Brunet카지노 게임 컬렉션s participation in the Compass North Accelerator Program put her on the radar of Angela Lyon, Patent Agent with QPI. 카지노 게임 컬렉션I first came across Cntrl+ at the Compass North graduation pitch,카지노 게임 컬렉션 says Angela. 카지노 게임 컬렉션I 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.카지노 게임 컬렉션

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.

카지노 게임 컬렉션Angela has been absolutely amazing at guiding me through all the processes for international patent filings for the device and design,카지노 게임 컬렉션 says Brunet of her experience working with QPI카지노 게임 컬렉션s patent team. 카지노 게임 컬렉션She 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.카지노 게임 컬렉션

Local innovation support

카지노 게임 컬렉션I went in very naive with an 카지노 게임 컬렉션I can do this!카지노 게임 컬렉션 attitude that deflated rather quickly. I didn't know how difficult and expensive it would be,카지노 게임 컬렉션 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 카지노 게임 컬렉션 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.

카지노 게임 컬렉션I was so overwhelmed. It was tough카지노 게임 컬렉션 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,카지노 게임 컬렉션 says Brunet. 카지노 게임 컬렉션I was running out of money and thankfully Cornwall카지노 게임 컬렉션s stepped in with a significant loan. Unfortunately, we quickly burned through it with further testing costs.카지노 게임 컬렉션

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 Ontario카지노 게임 컬렉션s . 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. Karen카지노 게임 컬렉션s LSIF application was successful, which boosted her pre-seed funding by another $500,000!

카지노 게임 컬렉션There were times when I didn't think I could get through all of this, but I have cheerleaders like from who카지노 게임 컬렉션s also my fractional CFO, plus Angela Lyon (QPI). My family and friends have been extremely supportive, and the encouragement from 100카지노 게임 컬렉션s of women who카지노 게임 컬렉션ve reached out waiting to purchase has been overwhelmingly positive,카지노 게임 컬렉션 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 카지노게임사이트 of Ottawa to complete the study to demonstrate that the product can be easily fitted by a patient themselves without a doctor카지노 게임 컬렉션s 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.

카지노 게임 컬렉션My goal is to get my product directly into women's hands as fast as possible,카지노 게임 컬렉션 says Brunet. 카지노 게임 컬렉션I want people to know Cntrl+ is designed and developed by a woman for women; this product will change women카지노 게임 컬렉션s lives카지노 게임 컬렉션.

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.