FlowPhysix FlowRunner Aspiration System to Be Distributed Internationally by 3comma

September 11, 2024—FlowPhysix Inc, formerly known as Expanse ICE, announced a strategic partnership with 3comma Medical/3comma Medical GmbH, which is an international commercialization agency with expertise in building and scaling global revenue streams for early-stage medical device companies.

According to the FlowPhysix press release, the partnership will serve as the international commercial partner for the FlowPhysix FlowRunner aspiration system. It will provide physicians outside the United States access to the FlowRunner thrombectomy technology. FlowPhysix will focus on commercialization in the United States.

The company stated that the FlowRunner system leverages the FlowPhysix technology to overcome problems of vacuum decay.

As the press release outlines, the aspiration catheter is advanced through an aspiration sheath and out of a distal valve to apply full and undecayed aspiration force to the thrombus directly. The catheter is then retracted back into the aspiration sheath. This process of extension and retraction of the aspiration catheter is then repeated to fully aspirate the clot. In each cycle, segments of the thrombus are sheared and efficiently evacuated through the catheter via an integrated saline flush. The device has been shown to successfully remove a broad range and large volumes of thrombi and effectively restore blood flow, stated FlowPhysix.

The launch of the Expanse ICE aspiration system, branded as the FlowRunner, was noted in a company press release on August 29 that also announced the appointment of Jeff Hopkins as Chief Executive Officer and member of the board of Director of FlowPhysix, which is a spinoff company of Expanse ICE. In April 2024, Expanse ICE announced that the device received FDA 510(k) clearance for the peripheral thrombectomy market.