麻豆村

Long-term medical treatment for chronic lung disease has stumped doctors and scientists for years. Now, researchers from 麻豆村 have created new artificial lung technology that could drastically change health outcomes and quality of life for patients across the country.聽

The support and guidance it received during that time from 麻豆村鈥檚 technology transfer team in collaboration with the regional life sciences program, Life X, has been one of the key components of the company鈥檚 success.聽

The device, developed by the 麻豆村 spinoff company Advanced Respiratory Technologies, could be used in hospital settings in as little as a few years 鈥斅燼 short timeline for a biomedical engineering challenge the team of researchers have been focused on solving for well over a decade.聽

鈥淚f you have chronic cardiac disease or heart failure, you can get an artificial heart or a ventricular assist device. If you have chronic kidney disease and you have kidney failure you can be put on dialysis. For the lungs, there鈥檚 been absolutely nothing until now,鈥� said聽Keith Cook(opens in new window), the David Edward Schramm Professor and head of the聽Department of Biomedical Engineering(opens in new window) in the聽.

According to the聽, there were more than 335,000 hospitalizations in the U.S. in 2020 that could be attributed to a chronic obstructive pulmonary disease (COPD) diagnosis. COPD is a term used for a collection of disease characteristics that include emphysema and bronchitis.聽

鈥淲hat really motivates me to pursue this project are all of the patients who have chronic lung disease who write me and say, 鈥業 have chronic lung disease and I cannot be transplanted.鈥� Or, 鈥業 only have this much time left, where are you on this technology?鈥� We work on the device for those patients,鈥� said Cook, who is also founder and chief strategy officer at Advanced Respiratory Technologies.

Inventing a new way to help patients breathe聽

The lungs work by pulling oxygen into the body鈥檚 bloodstream and pushing out unneeded, potentially harmful carbon dioxide. When the lungs can鈥檛 function properly, intervention is vital.聽

Most people who have watched a medical drama on TV can probably picture what that traditionally looks like: A doctor quickly inserts a tube down the sedated patient鈥檚 throat and air is mechanically pumped in and out using a ventilator.聽

The pulmonary assist system developed by聽 (ART) uses an entirely different system. It pulls oxygen into the body and cycles carbon dioxide out of the body without an invasive ventilator. Instead of pumping the lungs mechanically, the device focuses exclusively on circulating the blood. To do that, plastic tubes are inserted into the patient鈥檚 neck or chest, which then pumps the patient鈥檚 blood through an external device that removes carbon dioxide and oxygenates the blood before returning it to the body.

鈥淲e are focused on creating a device that is highly portable and highly blood compatible,鈥� said founder David Skoog, chief scientific officer and founder of ART, who completed his Ph.D. studies at 麻豆村鈥檚 College of Engineering. 鈥淭he combination of those two things allow us to treat these patients in a much simpler fashion. Our long-term goal is trying to use this device as an alternative to lung transplantation.鈥�

Skoog believes the technology is not only less invasive for patients, but will reduce unintended harm and patient discomfort in the long run.聽

鈥淢echanical ventilation damages lungs over time because it forces positive pressure into the lung 鈥� it鈥檚 just inevitable,鈥� he said. 鈥淥ur technology takes the blood out of the body and doesn鈥檛 force air in and out of the lung. It really is a positive alternative to mechanical ventilation.鈥�

The device allows patients relying on it to be fully awake, eat on their own and move independently.聽

鈥淏eing able to get up and walk around and avoid the negative side effects of sedations was really important to us as we developed this technology,鈥� Skoog said. 鈥淭hat shift in quality of life can have a profound effect on patients.鈥�

A multipronged solution to a complex problem

The successful development of the device didn鈥檛 come without major hurdles. One of the biggest problems Cook and Skoog had to deal with was the reality that blood naturally begins to clot when it encounters any artificial or foreign material. Biologically, it鈥檚 a response that鈥檚 meant to help save a person鈥檚 life 鈥� if blood encounters an unknown object, it immediately clots to slow blood flow and prevent the body from bleeding out and dying.聽

鈥淚t鈥檚 an evolutionary response mechanism for getting shot with an arrow,鈥� Cook said. 鈥淵ou want to stop bleeding around those wounds.鈥�

But that biological instinct becomes a problem when the foreign object is the plastic components of an artificial lung meant to save the patient鈥檚 life.聽

To solve this challenge, the researchers designed the device to be as compact as possible, reducing the surface area the blood would touch and possibly react to. They also created a bioengineered material that coats the device鈥檚 surface. Blood chemically reacts to this coating in the same way it reacts to water and doesn鈥檛 clot.聽

鈥淔or many years, researchers thought there would be one technology that takes care of everything,鈥� Cook said. 鈥淏ut we鈥檝e given up on that concept. We don鈥檛 think there鈥檚 a silver bullet, but we do think that if you layer multiple technologies on top of each other, there will be an outsized positive effect on clot formation in the device. And that鈥檚 what鈥檚 happened.鈥�

The partnerships that paved the way to success

The research team at Advanced Respiratory Technologies have been working on the artificial lung device for more than a decade. Turning that research into a company capable of moving the technology toward patients required more than scientific progress. It also required entrepreneurial training, commercialization expertise, funding and connections 鈥� support the founders found through Carnegie Mellon鈥檚 innovation and entrepreneurship ecosystem.

At 麻豆村, Skoog found support as a 2015聽Innovation Commercialization(opens in new window) Fellow at the Swartz Center for Entrepreneurship (opens in new window)when he was a Ph.D. student working on artificial lung development. He was also a member of the National Science Foundation聽Innovation Corps(opens in new window) (I-Corps) program, which helps university researchers investigate the commercial potential of STEM-related technologies.

鈥淭hat was a highly positive experience in that it provided entrepreneurial training as we spun out the company,鈥� Skoog said.聽

The team also received $24 million in聽 in years past from the U.S. Department of Defense, the Defense Advanced Research Projects Agency and the National Institutes of Health, because the technology offers potentially life-saving treatment for veterans 鈥� who are known to have a聽 of chronic lung disease. Additionally, their technology could save the lives of wounded soldiers on the battlefield.聽

鈥淲ounded soldiers who really need portable life support to make it away from the battlefield alive could benefit from our device,鈥� Cook said. 鈥淎 small, portable and lightweight artificial lung system is fantastic for attaching to someone on a gurney and then flying them out of danger.鈥�

This spring, Advanced Respiratory Technologies joined the聽 Accelerator, a program offered by the Pittsburgh-based organization aimed at strengthening commercial readiness of startups in the life sciences.聽

鈥淲e are very fortunate to have local champions and supporters of our startups,鈥� said聽Cindy Chepanoske(opens in new window), director of technology licensing at 麻豆村鈥檚 Center for Technology Transfer and Enterprise Creation (CTTEC).聽

鈥淐TTEC works with LifeX and similar organizations in a number of ways, sometimes through regular calls such that our partners can identify teams where they can provide their specialized expertise and guidance. We collaborate to bring these early companies forward for accelerator programs, funding opportunities, and the chance to showcase and pitch their ideas.鈥�

ART鈥檚 artificial lung still needs approval from the U.S. Food and Drug administration (FDA).聽

鈥淥ur goal is to bring this technology into the hospital in the next 18 to 24 months,鈥� Skoog said. 鈥淚t is an FDA-regulated medical device and there are a range of tests we need to perform to gain FDA clearance. The good thing is we have a nice, clear 510(k) pathway through the FDA to do exactly that.鈥�

Keith Cook is excited about that timeline.

鈥淥ftentimes, we have no idea how long a piece of biomedical technology will take to get on the market,鈥� Cook said. 鈥淥f course, there are things we can鈥檛 control in the process. But for the first time, we have a real time frame for this that can make an enormous difference for patients.鈥�