A medical device maker focused on developing treatments for stroke and other neurovascular conditions earned its first major regulatory approval earlier this month.
The FDA granted Irvine-based Toro Neurovascular’s Toro 88 Superbore Catheter 510(k) clearance earlier for the treatment of acute ischemic strokes, caused by impaired blood flow to the brain.
“The Toro 88 represents the beginning of a new generation of neurovascular devices grounded in purposeful engineering and physician partnerships, designed to set a new standard for high-performance catheters in this field,” Hyung Posalit, co-founder and chief executive of Toro Neurovascular, said in a statement.
Kaneka Medical America LLC, a subsidiary of Japanese chemical manufacturing company Kaneka Corp., will lead the U.S. launch of the Toro 88 catheter following the announcement of an exclusive distribution partnership between the two companies last October.
The companies are planning a phased rollout of the Toro 88 Catheter with additional product launches and portfolio expansion planned as part of their long-term strategy.
Toro appointed Marc Paris as chief commercial officer to strengthen its commercialization efforts, the company said. Paris is said to bring more than two decades of leadership in medical device commercialization and will oversee market launch strategy in collaboration with Kaneka.
Wide Inner Diameter Catheter
The Toro 88 Superbore Catheter has a wide internal diameter to ensure the complete removal of the blood clot.
Patients with large-bore catheters have significantly higher first-pass effect and shorter procedure times, according to the company’s website.
The catheter features MicroFlex technology, which uses reinforcement wires that bend freely and flex more than traditional catheters, to navigate complex neurovascular anatomy, according to Toro.
It was first used clinically in the U.S. by Dr. Satoshi Tateshima, professor of interventional neuroradiology at UCLA.
“Having been involved in its in-vitro testing and development, I was particularly impressed to see Toro 88 perform in patients exactly as intended,” Tateshima said in a statement.
The first in-man clinical trial for Toro 88 was conducted in 2024 at Shimizu Hospital in Japan.
Results from the 15-patient cohort were presented late 2025 with the catheter demonstrating 100% successful device delivery and no device-related serious adverse events reported.
Ischemic Stroke Focus
Toro Neurovascular was founded in 2021 to focus on treating ischemic strokes.
Stroke remains the second leading cause of death and third leading cause of death and disability combined, according to the National Health Institutes.
More than 795,000 people in the U.S. have a stroke every year with the majority being first or new strokes.
Posalit and Ryan Walker, who serves as chief operating officer, are listed as co-founders of Toro on the company’s website.
The two have overlap in their careers at NeuroVasc Technologies Inc., an Irvine-based medical device startup similarly developing a portfolio of neurovascular devices.
Posalit, an engineering graduate of UCI, has been a part of several R&D teams at multiple medical device startups prior to Toro including San Clemente-based Reflow Medical and Branchpoint Technologies.
