Fraunhofer-GesellschaftBreathe Easy
Dr. Felix Wiegandt aims to improve premature infants’ chances of survival with an innovative inhalation therapy.
Lena is tiny. Each of her hands is about the size of an adult’s thumbnail, her bald head is barely bigger than an orange, and her tiny arms hang slack by her sides. She is wrapped in a diaper, a pacifier in her mouth, not making a sound. Dr. Felix Wiegandt, a biomedical engineer, often tucks her into his pocket to bring her along to trade shows, presentations, and investor meetings. Why? Because the incredibly lifelike plastic doll is such an excellent illustration of how fragile premature babies really are. Lena is also the perfect way for Wiegandt to demonstrate his innovation.
Wiegandt developed a technology intended to help preemies get off to a better start in life when he was working on his doctorate. “Almost 15 million babies are born prematurely each year around the world, about 60,000 of them in Germany,” he says. Globally, 43 percent of infants born before the 23rd week of gestation do not survive. One of the main reasons is that their respiratory system is not yet mature. “In many newborns, gas does not exchange properly in the lungs. Their alveoli – the tiny sacs inside the lungs – downright collapse when they exhale,” Wiegandt explains. This leads to shortness of breath, inflammation and scarring in the tissue that can cause issues up to adulthood. “Place a hand firmly over your mouth and nose and inhale through the resistance,” Wiegandt says. “That’s what breathing feels like for many preemies.”
The medical term for this phenomenon is bronchopulmonary dysplasia (BPD), and depending on how severe it is and the child’s age, it can be acutely life-threatening or have lifelong repercussions. Intravenous cortisone helps, but it can also cause internal bleeding, high blood pressure or growth problems in the babies’ tiny bodies. “The potential side effects are so extreme that this kind of systemic cortisone therapy is not used as a preventive measure,” Wiegandt explains. “But we’ve developed a method of administering cortisone on a much narrower basis, with fewer and less severe side effects.”
More medication for delicate infant lungs
The intravenous route isn’t the only way to administer cortisone. It can also be inhaled directly into the lungs. In this case, the side effects are much less pronounced because the cortisone is only administered locally. In the current standard of care, premature babies are given a breathing gas with slight positive pressure to help them breathe. Six liters of it cycle through the newborn circulatory system. Simply adding cortisone severely dilutes the medication, however. “Up to 96 percent of it is lost, so far too little reaches the lungs.”
The now patented Inhale+ technology works differently: “We divert a small portion of the breathing gas out of the cycle, add the medication to that, and then feed it through directly to the baby’s nose,” he explains. And that brings a whopping 320 percent more of the active ingredient into the lungs. This could be a breakthrough in neonatal care. “Our technology enables very early preventive treatment for respiratory illness with a low side effect profile, so it can help to prevent lung damage and long-term harm and reduce the mortality rate in premature infants.” Wiegandt and his three-person team are currently working to further improve their method, for example by synchronizing the release of the medication with the baby’s breathing. They are also hoping to make all of the parts smaller and more compact. In addition, the researchers plan to make the technology as easy as possible to use so it can succeed in real-world practice.
Their long-term strategy also calls for developing this method for adults as well, such as patients with chronic obstructive pulmonary disease (COPD) or asthma. Wiegandt had originally planned to become a patent attorney, but his doctoral studies at the Fraunhofer Institute for Toxicology and Experimental Medicine ITEM and the development of the Inhale+ technology ultimately set him on a different path. Plans call for a new company called Inhale+ GmbH to be spun off in 2025, followed by a proof of concept study and then, starting in 2026, the clinical trials that are required before any new medical technology is formally approved. The market launch is scheduled for 2029. “This whole start-up life feels pretty wild right now,” Wiegandt says. But he feels well prepared, due in part to the Fraunhofer AHEAD program. How do you draw up a business case? What makes for a good market analysis? How much funding is needed before the market launch? “All that was totally new to me,” Wiegandt says. “But now, I can’t imagine doing anything else. I have the chance to make the world a little bit better. And I’m determined to take it.”