ClearFlow Inc. is aiming to become the new standard of care for cardiac surgeries.
A chest tube is required to drain excess blood, fluid and air from the chest cavity following open-heart surgery to prevent blockages. The main issue, however, is that most of the chest tube lies underneath the skin where blockages are invisible and unreachable by manual methods.
The Irvine-based medical device maker has developed a chest tube, the PleuraFlow, in response that “addresses this hidden risk” by proactively removing clots, said ClearFlow Chief Executive Hannah Beathard.
“We want to replace conventional drainage tubes with PleuraFlow,” Beathard told the Business Journal.
ClearFlow received FDA approval for the device in 2010 and began commercial launch in 2014. It’s the only approved system to “proactively maintain chest tube patency,” according to Beathard.
The technology was recently validated by a study, conducted by cardiac surgeons at Franciscan Health Indianapolis, which found that PleuraFlow minimized chest tube clogging and reduced average lengths of hospital stays.
Saving Hospitals Money
ClearFlow was made to help prevent blood syndrome (RBS), which occurs when the drainage in the chest tube becomes blocked with blood and causes postoperative complications.
PleuraFlow uses magnetic technology to move back and forth a clearance wire and loop inside the chest tube that pulls clots and other debris toward the drainage canister.
The Franciscan Health study, published in May, found that PleuraFlow caused a 41% reduction in RBS across 684 patients.
It also showed a 30% reduction in median ICU hours during recovery, as well as a 64% decrease in ICU readmissions, which could create significant cost savings for hospitals.
The average cost of inpatient stays per day in the U.S. is $3,000, according to the North American Community Hub Statistics.
“If PleuraFlow saves a patient from being in the hospital by one day, hospitals can realize millions of dollars in annual savings,” Beathard said.
Founded by Cardiac Surgeon
The company was founded in 2007 by cardiothoracic surgeon Dr. Edward “Ed” Boyle, who made the connection between chest tube clogging and blood and fluids retention.
Boyle, who is chairman of ClearFlow, founded Elixis, a healthcare information technology company which was acquired by Data Critical Corp., now a division of General Electric. He also founded early-stage medical device companies VenX and Prana Thoracic Corp., which raised an additional $3 million last year for an oversubscribed $9 million Series A round.
Beathard has been CEO of ClearFlow since 2023 after joining in 2018 as the head of the finance department.
She has a background in finance, and prior to arriving at ClearFlow, worked at Big 4 accounting firm PricewaterhouseCoopers (PwC).
“I was very interested in early-stage medical device companies in Orange County, so that’s what really led me to ClearFlow,” Beathard said.
Since taking over, she has overseen growing adoptions of PleuraFlow every quarter, driven by the release of the third and latest generation of the device that has a more ergonomic and streamlined design.
“We had some early growing pain problems with the earlier generation devices, and this updated device has really improved the usability and satisfaction of our surgeons and ICU nurses,” Beathard said.
While PleuraFlow remains its main product, the company has another device called ClearFix that’s used to stabilize and fix sternal fractures following reconstructive surgical procedures to promote fusion.
