June 17, 2026
Procedures follow Health Canada Medical Device License for the Company’s advanced neurovascular portfolio
More than 100,000 patients suffer from strokes annually in Canada
WEST JORDAN, UTAH – (GLOBE NEWSWIRE) — Route 92 Medical, Inc., a privately held medical technology company dedicated to improving outcomes for patients undergoing neurovascular intervention, today announced the first commercial cases in Canada. The procedures follow receipt of a Health Canada Medical Device License for the Company’s portfolio of advanced neurovascular technologies.
Route 92 Medical’s HiPoint® 88 system featuring the unique Monopoint® approach was used in the first commercial Canadian procedures by Vitor Mendes Pereira, M.D., at St. Michael’s Hospital in Toronto, one of Canada’s leading neurovascular centers.
“In the cases we performed, Route 92 Medical’s platform enabled smooth, atraumatic navigation through complex neurovascular anatomy and successful delivery of implants to the target vessels,” said Vitor Mendes Pereira, M.D., Professor of Surgery and Medical Imaging at the University of Toronto and Director of Endovascular Research and Innovation at St. Michael’s Hospital. “The ability to advance the system without guidewires from a single point of control simplifies access and supports procedural efficiency. Moreover, the telescoping design coupled with the Tenzing delivery catheter allows for atraumatic navigation, particularly in challenging anatomy.”
More than 100,000 patients suffer from strokes annually in Canada, including acute ischemic strokes, many of whom could benefit from endovascular treatment. The country’s established neurovascular treatment infrastructure and reimbursement pathways provide a significant commercial opportunity for Route 92 Medical’s differentiated portfolio.
“Receiving Health Canada authorization marks an important milestone in Route 92 Medical’s international expansion and enables us to bring our differentiated neurovascular intervention platform to physicians and patients across Canada,” said Tony Chou, M.D., founder and Chief Executive Officer of Route 92 Medical. “We are particularly encouraged by the successful first clinical experience at St. Michael’s Hospital and look forward to supporting Canadian physicians treating patients with acute ischemic stroke and other neurovascular conditions.”
The Canadian regulatory authorization covers the company’s product portfolio, including:
• HiPoint 70/Tenzing® 7 Reperfusion System
• HiPoint 88/Tenzing 8 Reperfusion System
• FreeClimb® 54/ Tenzing 5 Reperfusion System
• FreeClimb 70/Tenzing 7 Reperfusion System
• Base Camp® Sheath System
For more information about Route 92 Medical, visit www.r92m.com.
Route 92 Medical is on a mission to improve outcomes for patients undergoing neurovascular intervention through cutting-edge engineering and innovative product design. Founded by physicians, the company collaborates with leading neurovascular clinicians to solve the biggest challenges in neurointervention and deliver meaningful, differentiated solutions that promote clinical success. For more information, visit www.r92m.com or follow the company on LinkedIn.
Contacts:
For Media
Gwen Gordon
858-245-5684
[email protected]