Respiratory treatment from Pitt spin-off gets FDA OK
The Hemolung gained FDA clearance earlier this year. It was developed by ALung, a Pitt spin-off that’s been acquired by LivaNova.
In 1997, when few people were worried about a pandemic, ALung spun out of the University of Pittsburgh. The startup’s cofounders—William Federspiel, the John A. Swanson Professor in Bioengineering, and the late Brack Hattler, surgery professor—had set their sights on developing artificial lung technology.
A quarter century later, COVID-19 has accentuated the need for treating patients with acute respiratory failure. And, in those 25 years, ALung Technologies has created a platform designed for such cases with its Hemolung Respiratory Assist System.
The ALung device Federspiel, a PhD, and Hattler, an MD, initially developed was designed to be implanted into the body. Alternatively, the Hemolung uses a small catheter to circulate blood outside the patient and efficiently remove carbon dioxide before the blood returns to the patient. It allows the lungs to rest and heal.
The system can keep patients off mechanical ventilation or wean them off through its low-flow extracorporeal (outside the body)carbon dioxide removal (ECCO2R) technologies. Last fall, the Hemolung System became the first and only ECCO2R device cleared by the FDA.
“Patients with COPD [chronic obstructive pulmonary disease], emphysema—these patients oftentimes will experience acute acerbation and will need to be on nasal oxygen,” says Federspiel.
“A lung infection can put them over the edge to the point at which they can’t breathe effectively. The carbon dioxide builds up in the lungs, and the Hemolung brings their CO2 levels back down to a manageable level.”
When the pandemic hit, the ALung team recognized that its technology could offer benefits to patients with acute respiratory failure caused by COVID-19; they thought its use might preempt the need for a mechanical ventilator, which often causes added lung damage. The company quickly received FDA emergency approval to treat COVID patients.
(ALung received its first FDA emergency use approval for the Hemolung in 2014 to treat a patient with cystic fibrosis who was waiting for a lung transplant at UPMC Presbyterian.)
The device’s success treating COVID-19 patients helped build a convincing case for its use. The company submitted data to the FDA from more than 1,000 Hemolung patient treatments on clinical safety and more than 230 patient treatments on clinical performance outcomes, which convinced the agency to give its approval.
“The Hemolung will be an important new treatment modality for acute respiratory failure to avoid or mitigate the harms from invasive mechanical ventilation,” says Steven Conrad, medical director at ALung and professor of medicine at Louisiana State University Health Sciences Center.
“FDA clearance of the Hemolung is a game-changer for the treatment of these critically ill patients and will usher in a new era of extracorporeal lung support.”
The London-based medical technology company LivaNova evidently agrees, because it recently acquired the company for $10 million, according to LivaNova’s 2022 first-quarter earnings report.
Paul Buckman, president of LivaNova’s Advanced Circulatory Support Division reports that ALung will become part of the ACS division that also includes Pittsburgh-based TandemLife, a 1996 cardiopulmonary startup spun out of Pitt and acquired by LivaNova in 2018. ALung’s 26 employees, like those of TandemLife, will remain in Pittsburgh.
The FDA clearance is even broader than what the company had been seeking through its COPD trial. The device can now be marketed for use in severe asthma, cystic fibrosis, as a bridge to transplant and for any condition requiring CO2 removal directly from the blood.
Buckman says plans for ALung now include scaling up manufacturing and commercial field capacity.