FlowPhysix (formerly Expanse ICE) has partnered with 3comma Medical for the international distribution of its aspiration catheter, the FlowRunner Aspiration System.
With 3comma as its international distribution partner, California-based FlowPhysix will focus on commercialising the device in the US.
FlowRunner is designed to address the challenge of blood clots in peripheral thrombectomies. It is an aspiration catheter that is passed through an aspiration sheath and out of a distal valve to directly apply full and undecayed aspiration force to blood clots (thrombus) before being retracted back into the sheath.
The process is repeated to fully aspirate clots. In each cycle, segments of thrombus are sheared and evacuated through the catheter via an integrated saline flush.
According to the company, FlowRunner’s patented Surge Aspiration technology overcomes the issue of vacuum decay, in which vacuum pressure for clot removal decreases over time, due to issues including catheter blockage or leakage, that limit conventional aspiration catheters.
FlowPhysix CEO Jeff Hopkins commented: “This partnership provides FlowPhysix expanded reach in delivering our unique solutions to patients worldwide. We strongly believe that 3comma's proven leadership and deep expertise will drive commercial success internationally and increase shareholder value for the company.”
Formerly known as the ICE Aspiration System, the FlowRunner Aspiration System received 510(k) clearance from the US Food and Drug Administration (FDA) in April 2024. Previously known as Expanse ICE, FlowPhysix spun out from Expanse Medical and rebranded in August 2024.
According to GlobalData, the global thrombectomy device market was valued at around $1.7bn in 2023. It is forecast to reach a valuation of around $2.53bn by 2033.
Elsewhere in thrombectomy, Ceretrieve recently announced positive study results demonstrating that its aspiration catheter demonstrated clot removal, achieving complete restoration of blood flow in a single pass.
