
The Chicago-based startup is developing the investigational HELYX-PE System, a next-gen catheter-directed thrombolysis platform for pulmonary embolism.
The device developer froze its design this year, expects to perform a first-in-human case “very soon” and is planning for an IDE submission in 2027, Flow Medical co-founder and CEO Jennifer Fried said in an interview.
The company will use the new funds for that first-in-human clinical evaluation of the system, continued product development and manufacturing, and to prepare for a U.S. pivotal study in support of an FDA 510(k) submission.
Read the full story on MassDevice.
