The stroke devicemaker Route 92 Medical has raised $50 million in funds, as it looks to expand the worldwide commercial reach of its clot-busting hardware.
Supplied by Novo Holdings, the financing comes as an extension to its series F round, which had previously announced a collection of more than $31 million in November 2023—including from U.S. Venture Partners, Norwest Venture Partners, InnovaHealth Partners and The Vertical Group.
Earlier this year, Route 92 received an FDA clearance for its FreeClimb 54 aspiration catheter and reperfusion system, for the removal of stroke-causing clots during thrombectomy procedures. Comparatively smaller, the 54 stands alongside the FreeClimb 70 and 88 models to help reach distal anatomy within the brain.
And regarding the large-bore FreeClimb 88, the California-based company announced in July that it had kicked off its U.S. commercial launch, after receiving access system green lights from the agency in 2020 and 2021.
Route 92 said the latest funds would help build out its global sales team, as well as pursue new international regulatory approvals for its devices. The company also reported this year that it has completed enrollment of a 250-patient clinical trial to test out its HiPoint 70 and 88 catheters through its Monopoint reperfusion system.
“Stroke is an acute event and the difference between life and death is often determined by ease of access and rapid removal of the entire clot. Route 92 Medical’s reperfusion systems provide practice-changing, much-needed innovation for clinicians and patients,” said Noel Jee, a partner in growth investments for the holding company of the drugmaker Novo Nordisk, who also joins Route 92’s board of directors.
This past year also saw Route 92 recall nearly 1,000 of its Tenzing 7 delivery systems, following reports of the catheter tip breaking off while inside the patient. At the time, the FDA said the devices were not made by Route 92 but by a contract manufacturer.