MedCity News: Clear Catheter Gets European OK
Clear Catheter Systems gets European market OK for PleuraFlow
6.23.10 || Cleveland, Ohio
Clear Catheter Systems has received regulatory clearance to sell its active catheter-clearance system PleuraFlow in Europe and has launched the product in markets there.
So far, the spin-off from the Cleveland Clinic has the CE marking from the European Union and market approval from Health Canada, but the company is still awaiting a nod from the Food and Drug Administration to sell its self-clearing catheter system in the United States, according to a release (pdf).
The PleuraFlow Active Tube-Clearance System uses magnets and a wire loop to keep catheters clear while draining blood and other fluids from the chest after heart or lung surgery. Passive tubes can clog, posing threats like infection and death.
Last month, a pre-clinical evaluation of PleuraFlow demonstrated the tube that clears itself works better to drain the chest after surgery than a passive tube of the same size.
“This is the first study to demonstrate that active chest tube clearance improved drainage compared to a standard chest tube of the same size,” Dr. Edward Boyle, chief executive and co-founder of Clear Catheter Systems, said at the time (pdf).
Clear Catheter Systems is based in Cleveland and Bend, Oregon — where its two founders are located.
Boyle, a cardiovascular and thoracic surgeon in Oregon, came up with the idea for a self-clearing catheter system while watching his patients endure the discomfort of having large tubes — the patients called them “garden hoses” — inserted in their chests to drain fluid and air after heart or lung surgery.
While researching patents on such devices, Boyle found a patent by the Cleveland Clinic’s Dr. Marc Gillinov, also a cardiovascular and thoracic surgeon. The two agreed to work together on PleuraFlow.
The Clinic spun off Clear Catheter Systems, then known as PleuraFlow LLC, in 2007. The company closed its initial round of seed investment from the Cleveland Clinic and Bend Venture Angel Investors in August of that year.
A year later, the company raised $600,000 from the Cleveland Clinic-led Global Cardiovascular Innovation Center; Xgen Ltd., a Cleveland investment partnership primarily owned by the family of radio and dot-com mogul Tom Embrescia; and angel investors in Oregon.
In July 2008, Boyle said his company would use the second investment to move from an early development stage through prototyping, testing and FDA approval of its leading device. Boyle also said his company “would require a lot more funding” to do a formal product launch of its active chest tube.
That’s still true. “The company is currently seeking funding for the clinical launch of this product,” he said through a spokeswoman. In a November regulatory filing, the company said it had raised $690,500 of a proposed $725,500 from the sale of equity and options.Read More...