CorFlow receives the FDA Breakthrough Device Designation

Around 50% of all acute heart attack patients develop microvascular obstructions (MVO), which translates into around 200,000 patients annually. Addressing such a largely unmet need, CoFlow Therapeutics developed the Controlled Flow Infusion (CoFi) System, a diagnostic and therapeutic medical device that enables detection and treatment of MVO while the heart attack patients are still in the catheter laboratory (cathlab) immediately following reopening of the larger epicardial arteries with a stent. CorFlow’s CoFI System is the only technology on the market that offers combined diagnostic and therapeutic features.

In May this year, the company kicked-off the ongoing European clinical trials at the Inselspital with the CoFl System Assessment (MOCA) I study – a safety and feasibility trial in 40 acute heart attack patients.

CorFlow has now been granted the Breakthrough Device designation from the US Food and Drug Administration (FDA) with a broad indication for use statement. As elucidated by the FDA, the Breakthrough Devices Program is a voluntary program for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. With this approval, therefore, CorFlow becomes one of the very few Swiss medical device companies with FDA Breakthrough Device designation.

In light of the breakthrough designation, CorFlow will now expedite the US submissions for clinical trials with the aim of bringing the CoFI System to the US market.

The CorFlow CoFI System is included in the Breakthrough Designation Program with the following indication for use statement: "The CoFI System is indicated for diagnostic assessment of the coronary microcirculation immediately following PCI ("stenting"), and to be a platform for controlled infusion of therapeutic agents into the microcirculation with or without vessel occlusion."

Jon H. Hoem, CorFlow's CEO and co-Founder, commented: "The FDA Breakthrough Designation approval is an important validation of the vision the CorFlow Founders had when founding the company in June 2016: to develop a technology which fits the workflow for acute heart attack patients and which provides a diagnostic tool as well as a therapeutic platform for the coronary microcirculation. It also reflects the true spirit of the CorFlow team and how the team achieves demanding milestones which will bring the CorFlow technology to patients in need of improved coronary microcirculation."

(Press release)