Route 92 Medical, a company specializing in neurovascular intervention products, has recently secured an additional $50 million investment. This latest funding boost is part of an extended November financing round that has brought the company’s total capital raised to $82 million. The funds are earmarked for the global commercialization of their products and to aid the company’s efforts in gaining regulatory approvals in new geographical markets.
The company’s portfolio includes devices that facilitate the insertion of microcatheters into neurovascular blood vessels and tools designed for the revascularization of patients suffering from acute ischemic stroke. Route 92 Medical has already achieved a series of 510(k) clearances from the U.S. Food and Drug Administration (FDA) for these devices, underscoring their compliance with clinical safety and effectiveness standards.
A particular focus of Route 92 Medical is the Tenzing delivery catheter system. This innovative suite of devices has been designed to address challenges that have emerged as physicians increasingly turn to larger catheters for first-line mechanical thrombectomy—a procedure to remove blood clots from the brain in stroke patients. As these catheters have grown in size, the ledge formed at the junction where the smaller microcatheter connects to the larger aspiration catheter has also expanded. This enlarged ledge can complicate the process of navigating through the intricate network of blood vessels.
The Tenzing system innovatively features a conical tapered tip. This design element significantly reduces the size of the ledge at the crucial connection point of the catheters, thereby facilitating easier and safer navigation through vessels. Clinical evaluations have noted that the Tenzing delivery catheters perform well, even within the highly tortuous extracranial vasculature. Notably, the company launched Tenzing 8 alongside its Freeclimb 88 catheter system in July, expanding its product offerings.
Apart from improving device design for better navigation and functionality, Route 92 Medical’s funding has also been fueled by interest from prominent investors. Notable among the investors in this recent funding round is Novo Holdings, the controlling shareholder of Novo Nordisk. They joined other returning investors such as U.S. Venture Partners, Norwest Venture Partners, InnovaHealth Partners, and The Vertical Group.
The funds will also support ongoing clinical trials. Route 92 Medical is currently evaluating the safety and effectiveness of its Hipoint 88 and Hipoint 70 reperfusion catheters, which are integral components of the Monopoint reperfusion system developed for the super-bore aspiration of common stroke targets. The trial related to these products completed its enrollment in February, signaling a forward movement in their clinical validation process.
With this blend of innovative product development, strategic investments, and expansive clinical trials, Route 92 Medical is positioned to significantly impact the field of neurovascular interventions, particularly in the treatment and management of acute ischemic strokes. The global commercialization efforts backed by the recent infusion of funds are set to broaden the availability of these critical medical devices, potentially improving outcomes for stroke patients worldwide.
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