Clear Catheter Systems (CCS; Bend, Oregon), formerly named PleuraFlow, an early stage device company developing a catheter clearance platform, reported the completion of a $600,000 financing round.

X Gen (Cleveland, Ohio), a family venture fund, led the financing. The funding also includes a grant from the Cleveland Clinic Global Cardiovascular Innovation Center (GCIC) initiative, which is backed by $60 million from the state of Ohio's Third Frontier Project, a program to promote technical innovation and commercialization. BVC.CC, an angel group, also participated in the funding.

The funding will support CCS's development of its lead tube clearance product, the PleuraFlow system. The system will be used as an improved method for preventing the obstruction of surgical drainage tubes inserted after heart, lung and trauma surgery.

Edward Boyle, MD, CEO of CCS, told Medical Device Daily that patients who require heart surgery or lung surgery all have to have a chest tube placed after surgery and these tubes which are the same type that hospitals have used for the last 40 to 50 years, he said tend to clot. Because surgeons are aware that the tubes clot, they tend to put in larger tubes to reduce the clotting risk, Boyle said.

"I'm a cardiothoracic surgeon myself, so I identified this problem and started working on some inventions to improve this and it turns out some cardiothoracic surgeons at the Cleveland Clinic were working on something similar, so I approached them and we agreed to form a company," Boyle said. "Our ultimate goal is to make heart surgery safer, less invasive and less painful, and we think we can do this by making these tubes that are less prone to clogging so they can be smaller."

Boyle said patients often describe the current plastic tubing as more like a garden hose, about 36 Fr (or 11 mm, the size of an index finger tip). The new tubing comes in three sizes, he said, 15 Fr, 20 Fr and 32 Fr.

Boyle said this round of financing would hopefully carry the company far enough to have a product that is FDA cleared and ready to be used in humans. Once the PleuraFlow system is FDA cleared and ready for human use, CCS will start gaining its initial clinical experience, Boyle said. "At that point I think we'll be poised to scale up for a much broader market launch," he said.

CCS plans to go out for a full venture capital round for $4 million to $5 million once the product is FDA cleared, Boyle said.

The company raised its first seed-round of financing in August 2007, Boyle said. He said the company's most likely exit strategy would be a merger and acquisition.

"I've had patients say to me that the most memorable and painful part of heart surgery was the day their drainage tubes were pulled out," said Marc Gillinov, MD, the Cleveland Clinic cardiothoracic surgeon who helped develop the PleuraFlow system. "We need to develop smaller tubes that drain the wound effectively, but don't hurt as much." Gillinov serves as chairman of CCS's scientific advisory board and as a consultant to the company.

The company also said it is in the process of opening a Cleveland office to better facilitate its collaboration with the clinic, and to access other resources available to companies in the Ohio medical device community.

"Clear Catheter Systems is doing exciting work, and we are pleased to be involved in the continued development of the PleuraFlow System," said Mark Low, GCIC managing director. "Cleveland Clinic and GCIC are committed to expanding Ohio's economy, and we welcome this growing company to Northeast Ohio."