Route 92 Medical, the stealthy California developer of a catheter-based blood clot removal system for people suffering from stroke, has secured $111 million in funding to help complete its clinical testing and carry its device through the FDA.
The amount is split between a $56 million series E round—with equity financing co-led by InnovaHealth Partners and Norwest Venture Partners, plus backing from The Vertical Group and U.S. Venture Partners—and a loan worth up to $55 million from Runway Growth Capital.
Named after the state highway spanning San Francisco Bay via California’s longest bridge, the San Mateo-based Route 92 has been working on a specialized, tapered catheter designed to quickly snake its way through the especially twisty arteries of the brain and find the clots that block blood flow.
The company’s aspiration delivery system is also designed to handle catheters with a larger bore during the surgeon’s first attempt, at 0.070 inches and 0.088 inches wide, which can be more capable of retrieving sticky blood clots.
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In addition, while traditional approaches have involved pushing a thin guidewire through the clot itself to move an aspiration catheter or stent retriever into position, Route 92’s device is designed to reach its mark without disturbing the occlusion.
“We believe that our catheter technology featuring the Monopoint operating system will ultimately serve as a platform to revolutionize neurovascular aspiration thrombectomy for large vessel occlusions,” Route 92’s co-founder and CEO, Tony Chou, said in a statement. “This financing provides sufficient capital to carry out our U.S. pivotal trial and a limited commercial release of our products, the next critical steps in our company’s evolution.”
The funds will also help fuel the company’s development of new devices, and set up commercialization teams in multiple regions, the company said.
“We have seen remarkable physician response to the Route 92 Medical platform,” said InnovaHealth Managing Director Ariella Golomb, who joined the company’s board of directors. “The company’s Monopoint system featuring the Tenzing Delivery Catheter is well-positioned in the rapidly growing neurovascular market.”
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While the company has been largely quiet about its progress—despite attaining 510(k) clearances from the FDA in 2018 and 2020 (PDFs) for percutaneous catheter access devices—earlier this week, data from a first-in-human study was published in the BMJ’s Journal of NeuroInterventional Surgery.
The research paper tracked the use of Route 92’s aspiration system among 45 patients in New Zealand with acute ischemic stroke. After a first pass with the company’s device, blood flow was restored to more than half of the targeted tissue area in 62% of cases, with near-complete restorations of flow to the brain in 42% of cases.
A final reperfusion rate affecting at least the target area was achieved in 96% of patients, with about a third of those cases employing secondary devices and multiple passes. After 90 days, 48% of treated patients had shown enough cognitive improvements to be deemed functionally independent.