Pediatric Device Innovators Forum (PDIF) is a recurring collaborative educational experience designed to connect and foster synergy among innovators across the technology development ecosystem who are interested in pediatric medical device development.
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced that the Food and Drug Administration (FDA) has granted the company De Novo clearance for the Hemolung Respiratory Assist System. This system was developed at the McGowan Institute for Regenerative Medicine by a team of researchers led by faculty member William Federspiel, PhD, the company’s cofounder and professor of bioengineering, chemical engineering, critical care medicine, and the Clinical Translation Institute at the University of Pittsburgh. Dr. Federspiel is also the director of the Medical Devices Laboratory at the McGowan Institute.
Soft tissue injuries — like rotator cuff tears or hip impingement — are fairly common, particularly among athletes and older populations. These injuries frequently require surgery where multiple suture anchors are inserted into the bone, providing a strong base through which a suture can be threaded to reattach tendons and ligaments.
Among critically ill patients with acute kidney injury and treated with dialysis in the intensive care unit, if one could accurately predict early which patients will develop low blood pressure then effective treatments could be given. In a recently funded study, co-principal investigators McGowan Institute for Regenerative Medicine affiliated faculty member Gilles Clermont, MD, Professor of Critical Care Medicine at the University of Pittsburgh, and Raghavan Murugan, MD, Professor of Critical Care Medicine at Pitt, and their team propose to develop and validate an artificial intelligence system that will predict low blood pressure even before it occurs and recommend correct treatment to clinicians. McGowan Institute affiliated faculty member Robert Parker, PhD, Professor in the Department of Chemical and Petroleum Engineering at Pitt, is a member of this team that will receive funding for an NIH grant proposal entitled “AI driven acute renal replacement therapy (AID-ART).” The award is for $2.9M and is for 4 years from the National Institute of Diabetes and Digestive and Kidney Diseases.
A person suffering from amyotrophic lateral sclerosis (ALS) endures the progressive loss of muscle function throughout their body. Eventually, they lose the ability to control their limbs, to swallow, and even to speak. Their inability to communicate becomes a particularly devastating symptom of the illness. Other diseases can cause similar, debilitating impairment.
In a proof-of-concept study, researchers led by McGowan Institute for Regenerative Medicine affiliated faculty member Riccardo Gottardi, PhD, Assistant Professor of Pediatrics and head of the Bioengineering and Biomaterials Laboratory at the Children’s Hospital of Philadelphia (CHOP), have created a coating that can be applied to endotracheal tubes and release antimicrobial peptides that target infectious bacteria with specificity. The innovation could reduce upper-airway bacterial inflammation during intubation, a situation that can lead to chronic inflammation and a condition called subglottic stenosis, the narrowing of the airway by an accumulation of scar tissue. The findings were published in the journal The Laryngoscope.
A sign of the strength of University of Pittsburgh’s innovation and entrepreneurship ecosystem is the reauthorization earlier in 2021 of the Chancellor’s Gap Fund, which provides grants of $25,000 to $75,000 for innovators with promising discoveries to explore the commercial potential of their ideas.
A relevant cardiac health trend is the United States’ growing maternal mortality rate — the worst among industrialized countries. The majority of maternal deaths occur postpartum and result from hypertensive disorders like preeclampsia and gestational hypertension.
This year, 20 projects were selected for 2021 Seed Grant Program, and a project of McGowan Institute for Regenerative Medicine affiliated faculty member Rory Cooper, PhD, FISA and Paralyzed Veterans of America Professor and Distinguished Professor of the Department of Rehabilitation Science & Technology and Founding Director and VA Senior Research Career Scientist of the Human Engineering Research Laboratories, was one of the projects funded.
Elite freedivers who dive unaided in open sea, have brain oxygen levels even lower than seals during their deepest dives, new research at the University of St. Andrews has found.
Most able-bodied people take their ability to perform simple daily tasks for granted—when they reach for a warm mug of coffee, they can feel its weight and temperature and adjust their grip accordingly so that no liquid is spilled. People with full sensory and motor control of their arms and hands can feel that they’ve made contact with an object the instant they touch or grasp it, allowing them to start moving or lifting it with confidence.
As much as 10% of the population develops some type of hernia during life.1 More than 1 million abdominal hernia repairs are performed each year, with inguinal hernia repairs constituting nearly 800,000 of these cases.2 According to a February 2012 Wall Street Journal article, more than 30% of patients may, unfortunately, suffer from long-term chronic pain and restricted movement after surgery to fix a hernia.3
An estimated two million people will need a coronary artery stent every year. A small mesh tube inserted into a narrow or blocked coronary artery, a stent can help ensure blood can continue to flow through the artery unimpeded. Today, many also contain a coating that releases a steady dose of medication to improve healing and keep the blockage from coming back.
An earthquake in a major city, a bomb in a subway, a bus crash in rural town, COVID-19 pandemic hot zones — any event that overwhelms the capacity of available health care facilities is considered a mass casualty event. Lung damage and other internal injuries are particularly challenging to diagnose in multiple casualties during these events.
The Defense Advanced Research Projects Agency (DARPA) has funded a cooperative agreement with multiple organizations worth up to $33 million over four-and-a-half years to develop a wireless, fully implantable device that will control the body’s circadian clock, halving the time it takes to recover from disrupted sleep/wake cycles. The project will be led by a Northwestern University team of researchers and includes McGowan Institute for Regenerative Medicine affiliated faculty members Douglas Weber, PhD, Professor of Mechanical Engineering and Neuroscience at Carnegie Mellon University (CMU), and Tzahi Cohen-Karni, PhD, Assistant Professor in the Department of Biomedical Engineering at CMU.
DiFusion Technologies, Inc. recently announced landmark data for the company’s ZFUZE Surgical Polymer and how it compares to traditional biomaterials like Titanium and Poly-Ether-Ether-Ketone (PEEK). The data and the importance of the immune system response in new technologies such as ZFUZE were debated by Stephen Badylak, DVM, MD, PhD, Deputy Director of the McGowan Institute for Regenerative Medicine, Professor in the Department of Surgery at the University of Pittsburgh, and Director of the Center for Pre-Clinical Tissue Engineering within the Institute, at the International Society for Advancement of Spine Surgery (ISASS) in late May 2021 in Miami. Dr. Badylak is a member of the Scientific Advisory Board of DiFusion Technologies, Inc.
In recent decades, computer mice have become just as ubiquitous as computers. Now, thanks to Human Engineering Research Laboratories (HERL) and VA researchers, there’s even a prosthetic hook mouse for people with upper-limb amputations.
Michael Behrens, a student in the lab of McGowan Institute for Regenerative Medicine affiliated faculty member Warren Ruder, PhD, associate professor and William Kepler Whiteford Faculty Fellow of Bioengineering at Pitt, created a side project to optimize his lab work. This side project piqued the interest of the global scientific community, putting it in the top 10 chemistry papers published in Scientific Reports in 2020.
ALung Technologies, Inc., the leading provider of low-flow extracorporeal carbon dioxide removal (ECCO2R) technologies for treating patients with acute respiratory failure, announced the recent achievement of a significant milestone – enrollment of 100 patients in its U.S. based VENT-AVOID pivotal trial.
Carmat, a developer of an artificial heart which offers a bridge to transplant in patients with end-stage biventricular heart failure, recently reported its total artificial heart (TAH) received the European CE mark. The artificial heart provides an alternative for individuals for whom maximal medical therapy and left ventricular assist device are insufficient or contraindicated. It is designed for patients expected to receive a heart transplant within 180 days.
Pediatric laryngotracheal stenosis (LTS), a narrowing of the airway in children, is a complex medical condition. While it can be something a child is born with or caused by injury, the condition can result in a life-threatening emergency if untreated. Treatment, however, is challenging. Depending on the severity, doctors will use a combination of endoscopic techniques, surgical repair, tracheostomy, or deployment of stents to hold the airway open and enable breathing.
McGowan Institute for Regenerative Medicine affiliated faculty member Youngjae Chun, PhD, associate professor of industrial engineering and bioengineering at the University of Pittsburgh Swanson School of Engineering, will receive second-year research funding as part of more than $735,000 from The Children’s Heart Foundation, the nation’s leading organization dedicated to funding congenital heart defect (CHD) research.
Researchers at the University of Pittsburgh School of Medicine have combined synthetic biology with a machine-learning algorithm to create human liver organoids with blood- and bile-handling systems. When implanted into mice with failing livers, the lab-grown replacement livers extended life.
At the University of Pittsburgh, the Center for Military Medicine Research (CMMR) recognizes the urgency for innovating to meet the demands of an increasingly complex security environment. Researchers have focused current and future efforts in the areas of trauma, emergency, and critical care. In doing so, the multi-disciplinary and multi-organizational-led team aims to significantly enhance the trauma care of the warfighter with direct relevance to civilian trauma care while also spurring the economic growth in the Pittsburgh region.
The FlowTriever percutaneous mechanical thrombectomy system (Inari Medical) is safe and provides immediate benefits to patients with acute pulmonary embolism (PE), interim results of the real-world FLASH registry suggest. McGowan Institute for Regenerative Medicine affiliated faculty member Catalin Toma, MD, Director of Interventional Cardiology for the Heart and Vascular Institute, Director of the Interventional Fellowship at UPMC, and an Assistant Professor of Medicine at the University of Pittsburgh School of Medicine, presented study results during TCT Connect 2020.
A neural interface — or brain-computer interface — is a device that uses electrical stimulation to induce changes in brain activity. Among other applications, its positive effects are being leveraged to rehabilitate neurological conditions, such as Parkinson’s disease.
Coronary artery disease – a leading cause of death in the US – narrows or blocks arteries that carry a vital supply of blood, oxygen, and nutrients to the heart. A stent can be inserted to widen the artery, but these devices must be closely monitored to ensure that they do not re-narrow, a common complication called restenosis.
Diabetic patients monitor their blood glucose throughout the day, watching for peaks and valleys. Just taking a sample once during a visit to the doctor’s office would not give a clear picture of whether the patient’s diabetes is under control. The same is true of glaucoma patients, whose intraocular pressure (IOP), or pressure within the eye, is too high.
University of Pittsburgh’s Human Engineering Research Laboratories (HERL) recently announced its latest patent to help improve mobility for people who use prosthetics.
Polymer particles of any architecture, e.g. combs, stars, rings, have been produced for years thanks to the groundbreaking ATRP method discovered by Krzysztof Matyjaszewski, PhD, the J.C. Warner Professor of Natural Sciences at Carnegie Mellon University and affiliated faculty member of the McGowan Institute for Regenerative Medicine. Now scientists show how to carry out such reactions even more easily – in the presence of oxygen, in homelike conditions.
After a baby is born, doctors sometimes examine the placenta—the organ that links the mother to the baby—for features that indicate health risks in any future pregnancies. Unfortunately, this is a time-consuming process that must be performed by a specialist, so most placentas go unexamined after the birth. A team of researchers from Carnegie Mellon University (CMU) and the University of Pittsburgh Medical Center (UPMC)—including McGowan Institute for Regenerative Medicine affiliated faculty member Philip Leduc, PhD, William J. Brown Professor of Mechanical Engineering with appointments in Biological Sciences, Computational Biology, and Biomedical Engineering at CMU—report the development of a machine learning approach to examine placenta slides in The American Journal of Pathology, published by Elsevier, so more women can be informed of their health risks.
Patients who suffer from thrombosis, pulmonary embolism or stroke are usually put on drugs that help their blood flow more smoothly through their body. Occupying a large section of the drug market, anticoagulants, or “blood thinners” as they are popularly known, can keep blood clots from forming or getting bigger, and can therefore help with recovery from heart defects or prevent further complications.
McGowan Institute for Regenerative Medicine affiliated faculty member John Pacella, MD, Associate Professor in the School of Medicine at the University of Pittsburgh and an Interventional Cardiologist within the UPMC Heart and Vascular Institute, is partnering with Microvascular Therapeutics (MVT), a biotechnology company based in Tucson, Arizona, and a leader in microbubble technology. MVT recently was awarded a Phase I Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI), a part of the National Institutes of Health.
The U.S. Department of Transportation recently announced $4.925 million in grants to fund four new Tier 1 University Transportation Centers (UTCs) to advance research and education programs that address critical transportation challenges facing our nation. The University of Pittsburgh was named one of the recipients of $1 million for its project entitled “Implications of Accessible Automated Vehicles and Mobility Services for People with Disabilities.”
The path to impact for basic life science research can be long and filled with big gaps: in time and in resources.
McGowan Institute for Regenerative Medicine Yu-li Wang, PhD, and his team are researching cell migration while using the technologies developed for potential applications in artificial organs and other devices. The team has been awarded a five-year research grant from the National Institute of General Medical Sciences (NIGMS), one of the National Institutes of Health, to support this work.
The team led by researchers at Carnegie Mellon University (CMU) has created a new technology that enhances scientists’ ability to communicate with neural cells using light. McGowan Institute for Regenerative Medicine affiliated faculty member Tzahi Cohen-Karni, PhD, CMU’s associate professor of biomedical engineering and materials science and engineering, led a team that synthesized three-dimensional fuzzy graphene on a nanowire template to create a superior material for photothermally stimulating cells. NW-templated three-dimensional (3D) fuzzy graphene (NT-3DFG) enables remote optical stimulation without the need for genetic modification and uses orders of magnitude less energy than available materials, preventing cellular stress. This work was presented in the Proceedings of the National Academy of the Sciences.
The Center for Disease Control estimates that roughly 40,000 infants are born with congenital heart defects (CHDs) each year. Among that population, 25 percent are critical cases that require cardiac surgery. The waitlist for a heart transplant continues to grow; yet, the only FDA-approved life-saving device for CHD has shortcomings and is based on technology from the 1970s.
Acute kidney injury is common in hospitalized patients, particularly those in intensive care units and older adults, and refers to a sudden episode of kidney failure or damage that happens within a few hours or days. It causes a build-up of waste products in the blood that can affect other organs, including the brain, heart, and lungs.
A respiratory dialysis system that was developed at the McGowan Institute for Regenerative Medicine Medical Devices Lab has been used to treat 16 COVID-19 patients, in conjunction with non-invasive or mechanical ventilation. The core technology developed at the Medical Devices Lab, was licensed to the spinout ALung Technologies, and ALung has designed and produced a clinically viable device, which is called the Hemolung® Respiratory Assist System (RAS).
