Breaking the Barriers of Bronchitis

Heather Nigro and her team at CSA Medical, Inc. are working to create a cure for chronic bronchitis that breathes life into COPD patients

Heather Nigro, CSA Medical Sue Bruce Photography LLC

Growing up, Heather Nigro was passionate about two things: nursing and boats. With a mother working as a critical care nurse, she aspired to follow in her footsteps, but unfortunately the abundance of nursing jobs she hoped for out of high school didn’t exist. Swiftly, she transitioned her aspirations toward her second passion for the sea and attended the Massachusetts Maritime Academy, where she majored in marine safety. After graduating from the Academy, Nigro pushed full steam ahead to start a career and family.

Luckily, Nigro was able to revisit her passion for nursing as she worked in various hospital environments, inspiring her to earn her master’s degree in health and safety and begin a twenty-year tenure working in the regulatory field. Throughout her career, Nigro has commended the Maritime Academy for equipping her with sharp problem-solving skills.

“There was a get-it-done attitude,” she explains. “There’s always a sense of urgency instilled in the cadets, and one learns to recognize the value of good problem solving, coupled with rapid action to move things forward.”

Nigro’s eager attitude drove her initiative to take her regulatory affairs certification exam in 2002 and spearhead strategic global regulatory efforts for Class II and III medical devices. She was later nominated to the Aspire program at Covidien—a highly competitive leadership training program that propelled her career to the next level.

At Covidien, Nigro earned the senior director title, overseeing regulatory affairs and strategy for minimally invasive therapies. She carried that position with her into the mega-merged Medtronic-Covidien for about two years, after which she was offered her first vice president of regulatory affairs job. At the time, the hiring manager for that VP role was Todd Snell, NxStage Medical’s senior vice president of quality, regulatory, and clinical affairs. Snell recalls that Nigro was selected over other strong candidates, not only because of her technical regulatory prowess and management skills, but for her “can-do attitude,” which he knew would influence the business in positive ways.

“The little things you do make the biggest difference in people’s lives.”

When Nigro arrived at CSA Medical, Inc. three years later as their senior vice president of regulatory, quality, and clinical affairs, she channeled her passion for progress toward a pulmonary therapy technology so cutting-edge that it received a breakthrough device designation by the US Food and Drug Administration.

“Our company is addressing a huge unmet clinical need,” Nigro says. “From a regulatory strategy perspective, there are many benefits to obtaining the breakthrough device designation; and, therefore, my first task at CSA Medical was to create a strong rationale for why this rejuvenating product that we’re clinically investigating supports this unmet need and qualifies for this designation.”

Currently, chronic bronchitis treatments are limited to pharmaceuticals which address the symptoms of the disease rather than offering an actual cure. She is hopeful that CSA’s product will change that. For a healthy person, goblet cells in the airways produce normal levels of mucus, which is then moved to the top of the airway by cilia and coughed out. In chronic bronchitis patients, however, these goblet cells overproduce mucus, which drowns the cilia and prevents them from working.

“It’s a vicious cycle,” Nigro explains. “Many medications treat the symptoms of chronic productive cough, but with our new device, we are able to go in and spray liquid nitrogen into the airways at a temperature of negative 196 degrees Celsius, which basically kills all of the damaged cells on the top layer but leaves the extracellular structure in place. So, you’re essentially repaving the airway, allowing the goblet cells and cilia to regenerate and return to normal working levels.”

Early data is showing that within fourteen days, patients suffering with long-term COPD with chronic bronchitis can “reset” their airways and breathe new life into their lungs. As Nigro’s team works to get their product on the market as quickly as possible, Nigro is excited for the opportunity to change the way the medical space thinks about treating chronic bronchitis.

Cryotherapy can also be used to combat other complex diseases. Nigro says their truFreeze System is available commercially for the gastroenterology space for patients with Barrett’s esophagus and esophageal cancer and has witnessed its success in keeping the patient cancer-free years after treatment.

Nigro says her professional, short-term goal is to continue running this chronic bronchitis study (SPRAY-CB study) until the therapy is completely integrated into western medicine. Long-term, however, she sees herself continuing to serve as an advocate and mentor for other women in the medical device industry. In previous positions, Nigro was a member of various women’s leadership teams, which inspires her to continue these efforts of empowering women in the workplace. “The proverbial ‘glass ceiling’ was broken a long time ago,” says Nigro. “If you have a particular career goal, go after it and don’t let anyone stop you.”

Devoting her life to the medical device space has allowed Nigro to feed into her passion of working with and for people. Though she is behind the scenes, she believes that witnessing the impact of the work she does is the most rewarding aspect of her career.

“The little things you do make the biggest difference in people’s lives,” Nigro says. “In my role, the patients will likely never know of me. But personally, I will know that I’ve worked hard to develop the most expeditious regulatory and clinical pathway to provide access to this therapy for patients with chronic bronchitis. It is this mission that inspires me.”

John Compton of Agile Search Inc. contributed to this feature.