CorFlow Therapeutics said yesterday that it won breakthrough device designation from the FDA for its Cofi device.
Baar, Switzerland-based Corflow’s controlled flow infusion system is is designed to both assess coronary microcirculation after percutaneous coronary intervention procedures, including stenting, and to control the delivery of drugs to the smaller blood vessels not address by the PCI procedure.
“FDA’s breakthrough designation is a dramatic validation of the vision the CorFlow founders had when starting the company in June 2016: to develop a technology that not only fits into the standard workflow for acute heart attack patients but also provides a diagnostic tool as well as a therapeutic platform for the coronary microcirculation,” CEO Jon Hoem said in prepared remarks. “It also reflects the true spirit of the CorFlow team and how the team achieves demanding milestones that will bring the CorFlow technology to patients in dire need of improved coronary microcirculation.”
In September 2018, CorFlow raised $9.7 million to kickstart a clinical trial in Europe. The company said the Moca I trial is currently enrolling and will expedite U.S. submissions for trials as a result of the breakthrough designation. CorFlow plans to test the safety and feasibility of the CoFI system in 40 acute heart attack patients during the trial.
