Route 92 Medical has announced it has raised more than US$31 million in a Series F financing round to accelerate the commercial adoption of a neurovascular intervention portfolio focused on acute ischaemic stroke. The oversubscribed capital raise was led by existing venture capital investors US Venture Partners, Norwest Venture Partners, InnovaHealth Partners, and The Vertical Group, according to a company press release.
Route 92 claims to have “reimagined” neurovascular intervention through the development of a suite of reperfusion systems leveraging unique designs, including the Tenzing delivery catheter. These products are designed to work harmoniously as a system to improve the efficiency of endovascular thrombectomy procedures, enabling clinicians to quickly restore blood flow to a patient’s brain following acute ischaemic stroke.
Proceeds from this financing will be used to accelerate the US commercialisation of the FreeClimb 70 reperfusion system featuring the FreeClimb 70 aspiration catheter and the Tenzing 7 delivery catheter. Funds will also be used to complete SUMMIT MAX—a US Food and Drug Administration (FDA) investigational device exemption (IDE)-approved pivotal trial evaluating the HiPoint 88 and HiPoint 70 catheter systems, both featuring the Tenzing delivery catheter.
“The launch of the first complete reperfusion system with the Tenzing delivery approach is a tremendous step forward for stroke care,” said Chris Hartman, chief commercial officer of Route 92. “We have already seen early clinical adoption as the Route 92 organisation continues to execute on many fronts: product development and regulatory milestones, scaling manufacturing capabilities, hiring world-class sales personnel, and growing commercial operations.”
The funds will also support the company’s operational growth, the release continues. Route 92 is completing the process validations of its first commercially available products from its new high-volume manufacturing plant near Salt Lake City, USA. The new 40,000-square-foot facility will provide over 12,000 square feet of production clean room, warehousing, and distribution functions, with enough standalone capacity to fulfil the growing demand for the company’s products “well into the future”, the release adds.
“We are continuing to build our industry-leading commercial and support teams to bring our Tenzing, FreeClimb, HiPoint and Monopoint products to the market, serving our interventionist customers and their patients,” said Tony Chou, chief executive officer and founder of Route 92. “This latest investment validates our clinical and commercial performance as we focus on improving outcomes for patients suffering from devastating strokes.”
