Alum’s medical device solves a major problem
Written by Becky Brown
A staple of modern medicine, the indwelling urinary catheter has a critical, sometimes fatal flaw. Its outer surface encourages bacterial adhesion and biofilm formation, leading to catheter associated urinary tract infections (CAUTIs). Health care professionals have struggled to find a solution to this pervasive, costly problem, but thanks to the work of a Purdue Nursing alumnus, a new option soon will make its way to the market.
BLUcath™, a device developed by Francisco Portela (NUR ’14), uses a novel transurethral flushing mechanism to wash away harmful bacteria from the urinary tract and cleanse and hydrate the urethral membrane without antibiotics or anti-infective agents. In testing, use of BLUcath™ — short for biofilm limiting urinary catheter — with a one-time saline flush expelled an average of 80% of bacteria from the urinary tract, according to published results from Portela Soni Medical, the company bringing the product to market.
“The main functionality is the same. It’s still a drainage tube that goes into the bladder to empty it,” says Portela, co-founder and CEO of Portela Soni Medical. “The difference is the flushing mechanism that bathes the urinary tract with saline or medications. I wish it were more complicated, but it’s actually a very simple solution that has eluded people for a long time.”
A common problem with deadly consequences
According to the Centers for Disease Control and Prevention, CAUTIs are the fourth most common health care-associated infection, affecting about 93,000 patients annually in U.S. hospitals. Approximately 12-16% of adults are catheterized during hospitalization, and for each day a catheter remains in place, a patient’s risk of acquiring a CAUTI increases by 3-7%.
Most patients with CAUTIs suffer from discomfort, along with the expense and inconvenience of an extended hospital stay. The infection also can lead to various complications — and even death, which occurs in an estimated 13,000 cases each year.
In addition, CAUTIs are a major cost driver for hospitals. Medicare doesn’t reimburse for preventable health care-associated infections, and research published by the American Journal of Infection Control in 2018 indicates that one CAUTI can cost as much as $10,197, for an estimated annual economic burden of $1.7 billion.
For Portela, these statistics took on human form when he was a Purdue student working as an oncology fellow at Massachusetts General Hospital.
“I was at one of the top hospitals in the world, taking care of some of the wealthiest people on earth, and yet they’re suffering from this simple problem,” he says. “I thought, ‘If this is happening here, it’s probably happening everywhere.’ And it was.”
Nursing experience meets entrepreneurial mindset
Portela's experience at Mass General inspired him to look deeper into existing catheter design and other attempts to solve the CAUTI problem, many of which involved coating the catheter with low-level antibiotics.
“To me, that was a fundamentally flawed premise,” he says. “The data shows that these types of antibiotics hurt more than they help. They only kill the bacteria that wasn’t going to hurt you and allow the bacteria that can kill you to grow.”
Back at Purdue, Portela formulated the idea for BLUcath™ — which expels bacteria from the urinary tract rather than arbitrarily killing it — with his roommate, Amit Soni (AAE ’16). Then he began presenting the design in campus competitions as part of the Purdue Certificate in Entrepreneurship and Innovation program.
“When I started winning, that solidified it was an idea worth pursuing,” Portela says. “After graduation, I was talking to an attorney whose father was having problems with his catheter in the hospital. He offered his financial help and his connections, and that was the ignition point.”
Jane Kirkpatrick, professor emerita of nursing who was head of the School of Nursing when Portela was a student, remembers his entrepreneurial spirit and isn’t surprised that he has begun turning an idea into a successful business venture.
“Purdue’s entrepreneurship certificate is something not a lot of universities offer, and one of the things that makes Purdue Nursing unique is how we enable our students to learn to think differently,” she says. “I’m delighted Francisco gained skills here that led to this opportunity to change outcomes for all kinds of people. Being on the front lines, nurses can often envision better than anyone what needs to happen to change how we deliver health care.”
More innovation lies ahead
Change, at least in the area of CAUTIs, likely is coming sooner rather than later. Portela Soni Medical received FDA clearance in early 2019 to manufacture and sell BLUcath™. Portela also sees the potential to deliver medications, cancer therapies and analgesics through the device.
“There’s data that proves being catheterized is the worst thing patients experience in the hospital — more than any surgery,” he says. “Our device allows nurses to flush pain medicine into the urinary tract for comfort.”
Portela expects that BLUcath™ will be purchased by a larger company. But that won’t mark his exit from the medical device world. He already has other innovations in the works.
“It’s a unique field with tons of opportunity,” Portela says. “It feels good to be involved in running a business and still be helping people.”