Cardio Flow

About Cardio Flow

Cardio Flow, Inc. is a privately held, commercial-stage medical device company founded in 2014 by Gary M. Petrucci. Located in St. Paul, Minnesota, the firm focuses on developing and commercializing minimally invasive peripheral vascular products. Petrucci, who also serves as Chairman, has a background in investment management and experience founding life science companies, including the company that became Cardiovascular Systems, Inc. (CSI), now part of Abbott. He is joined by CEO Dr. Michael J. Kallok, who previously served as CEO of CSI, leading it from a startup to a significant market capitalization.

The company's core offering is the FreedomFlow® Orbital Atherectomy Peripheral Platform, a medical device designed to treat Peripheral Artery Disease (PAD) by clearing plaque blockages in the arteries of the legs. This B2B-focused company serves physicians in hospitals, ambulatory surgical centers, and office-based labs. A key milestone was achieved in September 2023 when Cardio Flow received FDA 510(k) clearance for the FreedomFlow platform, with the first commercial cases completed in October 2023. The company generates revenue through the sale of its medical devices.

The FreedomFlow device is a catheter-based system that utilizes a novel mechanism of action based on the physics of angular momentum. It features five diamond-coated spheres that form a spiral geometry, maintaining simultaneous contact with the vessel wall to sand away plaque as the device advances or retracts. A diamond-coated tip facilitates navigation through tight blockages. This design allows physicians to treat complex PAD across a wide range of vessel sizes, from 2mm to 8mm, with a single device, which can increase efficiency and reduce costs for healthcare systems. The platform is engineered for ease of use, requiring no capital equipment and featuring a quick setup, which minimizes the learning curve for medical professionals.