Vena Medical, the medical device company providing physicians with the world’s smallest camera for a live, full-colour view from inside the vasculature, announced today it has received regulatory clearance from the U.S. Food and Drug Administration (FDA) for the use of its flagship technology, the Vena MicroAngioscope System,  in the peripheral vasculature.

This landmark regulatory achievement opens the door for international exporting, beginning with entry into the United States, the largest peripheral vascular market in the world with 2.5 million procedures annually. It marks Vena’s most significant commercial expansion to date and the opportunity to impact patient care at meaningful scale.

To support this rapid commercial expansion, Vena Medical simultaneously celebrated the grand opening of its new $4.5M Manufacturing Centre of Excellence in Kitchener, Ontario. The state-of-the-art facility, made possible through strategic funding from the Life Sciences Scale-Up Fund (LSSUF), was officially unveiled today with a ribbon-cutting ceremony led by the Honourable Vic Fedeli, Ontario’s Minister of Economic Development, Job Creation and Trade.

Empowering Physicians in the U.S. Market 

Traditionally, physicians navigating the peripheral vasculature have relied heavily on X-ray fluoroscopy, navigating complex anatomies using black and white images from outside the body. By providing an unprecedented, full-colour view directly from inside the peripheral blood vessels, Vena Medical is empowering doctors to make more informed treatment decisions in real-time.

The company has already facilitated the treatment of over 100 patients in Canada using this technology. With their first FDA clearance secured, Vena is poised to introduce this transformative, live-imaging capability to healthcare providers across the United States in their upcoming limited market release.

"This is a milestone moment for Vena Medical, unlocking the export market for the first time," said Michael Phillips, Co-founder & CEO of Vena Medical. "We built this technology to take physicians out of the dark. Having the device used in over 100 patients in Canada, we've seen firsthand how live, intravascular imaging changes patient care. With this FDA clearance, we are thrilled to bring that same transformative capability to the United States market."

"Designed in Canada, Built in Canada" 

The perfectly timed $4.5M investment brings the production of Vena’s micro-camera technology in-house. This project will create at least 13 new high-tech jobs in the Kitchener-Waterloo region, fulfilling the company’s commitment to keeping its manufacturing local.

“The extraordinary talent, ambition, and innovation demonstrated by Ontario’s life sciences sector is reinforcing our province’s position as a global innovation powerhouse,” said Vic Fedeli, Ontario’s Minister of Economic Development, Job Creation and Trade. “With support from the Life Sciences Scale-Up Fund, Vena Medical’s Manufacturing Centre of Excellence will play a key role in strengthening Ontario’s end-to-end medical technology ecosystem and ensure that more homegrown medical solutions are manufactured and delivered to markets around the world.”

"Our team has engineered a highly complex, microscopic medical device, and now we have the state-of-the-art cleanroom and manufacturing infrastructure to build it at scale," added Phillip Cooper, Co-founder & COO of Vena Medical. "With the backing of the LSSUF, we are scaling our manufacturing right here in Kitchener. We are ready to take this Kitchener/Waterloo-born innovation to the rest of the world.”