Perseverance is paying off for two Waterloo Engineering graduates who co-founded an ambitious medical hardware company.

Five years after launching Vena Medical to commercialize their fourth-year design project, Michael Phillips and Phil Cooper announced their first government approval this week for a device to remove blood clots from the brains of stroke patients.

 “We couldn’t be more excited that our first regulatory success is right here in Canada, and this means the first patients in the world to benefit from our technology are going to be Canadian,” Phillips, the chief executive officer, said in a media release.

Michael Phillips, left, and Phil Cooper of Vena Medical during their early days at Velocity.

Michael Phillips, left, and Phil Cooper of Vena Medical during their early days at Velocity.

Phillips and Cooper were classmates in the mechanical engineering program when they were inspired at an on-campus talk by celebrated alumnus and venture capitalist Chamath Palihapitiya to tackle the much harder of two ideas they had for their Capstone Design project.

Six months later, working out of the Velocity incubator at the University of Waterloo, they won $50,000 in backing from Palihapitiya and his former wife, Brigette Lau, also a Waterloo alumnus, to pursue commercialization after graduation in 2017.

“We have a long way to go, but we’re still excited about it,” Cooper said at the time.

They also won financial spport from Waterloo Engineering via the Engineer of the Future Fund, the Tanguay Prize, the Norman Esch Entrepreneurship Awards for Capstone Design and the Baylis Medical Capstone Design Award.

Now based out of the Medical Innovation Exchange in Kitchener, Vena celebrated a key milestone this week after earning Health Canada approval for a device that combines a balloon guide catheter and a distal access catheter used in thrombectomy to remove blood clots in the brain.

Going from start-up to scale-up

The inflatable balloon temporarily restricts blood flow while surgeons use tools to remove the clot, increasing the chances of success on the first attempt. Advantages over existing, separate devices include better patient outcomes and reduced costs.

“Obtaining important regulatory clearances like this one, coupled with the expansion of our team through key senior hires, is allowing us to transition from a start-up to a scale-up,” Cooper said.

Phillips and Cooper, president of the seven-person startup, expect to work towards U.S. Food and Drug Administration approval later this year. With its Canadian licence in hand, Vena is initially collaborating with hospitals in Ontario with a goal of starting a pilot project to use the device in operating rooms.

The Vena Balloon Distal Access Catheter, as it is called, developed out of the company’s flagship product, a tiny camera – billed as the world’s smallest – to allow doctors to see inside veins and arteries during stroke surgery.