About us
Collaborations
CEO Hanna Sjöström and Dr. Janene H. Fuerch at the Stanford Impact1 CEO Summit 2023, first summit of the Stanford Impact1 program
Stanford University in the U.S.
Selected as a Stanford Impact1 company
Stanford University is one of the world’s leading universities in research on preterm born babies and connected to the hospital that is ranked number one in neonatal care in the U.S. In 2023, Stanford launched the Impact1 program with the vision of improving the health, safety and quality of life of pediatric and maternal patients globally. The name Impact1 comes from the purpose to promote innovations that provide precisely ”impact from day 1”.
In this mission, leading experts in neonatology at Stanford University recognised Neola® as a promising innovation with the potential to upgrade neonatal intensive care from the first day in the clinic. As a result, Neola Medical is one of the few companies that have been selected as a Stanford Impact1 company to receive support from the Stanford Impact1 program.
“I truly appreciate this as a neonatologist, as I frequently encounter cases of pneumothorax where a lung can collapse, and we do not detect it until vital signs begin to change. X-rays are not always particularly helpful. Gaining a real understanding of oxygenation and how well the lungs are expanded could therefore be extremely valuable for our patients.”
– Dr. Janene H. Fuerch, MD, Co-Director of Impact1, Clinical Associate Professor of Pediatrics, Division of Neonatal and Developmental Medicine at Stanford University School of Medicine, Medical Director, Neonatal ECMO at Stanford Children’s Hospital, Palo Alto, USA
Stanford Impact1 program
In the program, Neola Medical gets access to company development from Stanford and Silicon Valley experts in development for medical technology products, regulatory experts and close collaboration with leading doctors in neonatal intensive care as well as the FDA’s own pediatricians and regulatory experts.
The program is supported and partly financed by the US Food and Drug Administration (FDA), with the aim of supporting advanced technological innovation designed for children to reach the market and the vulnerable pediatric patient group as quickly as possible.
CEO Hanna Sjöström at exclusive Pediatric Medtech CEO Summit 2024 by Stanford Impact1
“Being part of this exclusive network of MedTech entrepreneurs, investors, and leading pediatric and neonatology specialists is invaluable. It is truly inspiring to see our vision for transforming neonatal intensive care resonate with such influential key opinion leaders, who recognises the critical role Neola® could play in improving outcomes for preterm born babies. The support by Stanford will be of great importance for our upcoming launch of Neola® in the U.S.”
– Hanna Sjöström, CEO Neola Medical
Watch the welcome speech to
Stanford Impact1
Chair of Executive Board and Founding Director, James Wall holds a welcome speech to all the selected Stanford Impact1 companies with promising innovations with the potential to upgrade neonatal intensive care from the first day in the clinic.
Cooper University Health Care is one of the leading academic medical centers in the U.S., renowned for its expertise in neonatal and pediatric care. It is affiliated with Cooper Medical School of Rowan University.
The Children’s Regional Hospital at Cooper in the U.S.
First clinical study site agreement signed with leading U.S. hospital
Neola Medical has signed an agreement with Children’s Regional Hospital at Cooper in Camden, New Jersey, to initiate a pivotal clinical study on preterm born babies with its non-invasive lung monitoring device, Neola®. This milestone follows Institutional Review Board (IRB) approval, confirming compliance with patient safety and clinical ethics.
Prominent key opinion leader
The agreement with Cooper’s Neonatal Intensive Care Unit (NICU), led by Professor Vineet Bhandari, represents a strategically important step in building the clinical evidence base for Neola®. The study is designed to support the company’s planned FDA application for market authorization in the U.S.
Children’s Regional Hospital at Cooper houses a Level III Neonatal Intensive Care Unit (NICU) with 35 beds, providing comprehensive care for full-term and premature infants with various medical and surgical conditions related to premature birth, respiratory, neurologic or immunologic disorders.
“I am looking forward to evaluating the innovative non-invasive Neola® lung monitoring device at Children’s Regional Hospital at Cooper NICU with the potential and hope of improving the care of the newborn”
– Vineet Bhandari, MD, DM, FAAP, Principal Investigator and Division Head of Neonatology, Cooper
“We are especially honored to work with Dr. Vineet Bhandari, one of the world’s most prominent key opinion leaders in neonatology.”
– Hanna Sjöström, CEO Neola Medical
CEO Hanna Sjöström and MD DM Professor Vineet Bhandari, Division Head of Neonatology at The Children’s Regional Hospital at Cooper, Camden, USA.
Keynote lecture on GASMAS technology
Neola Medical is proud to have had the opportunity to participate and showcase its GASMAS technology in the Xth RECENT ADVANCES IN NEONATAL MEDICINE Congress, held from October 12-14, 2024, in Würzburg, Germany. This prestigious event brought together over 500 of the world’s leading neonatal care experts, providing an invaluable platform for knowledge exchange and progress in the MedTech field.
At the Congress, Neola Medical was honored to sponsor a highly anticipated keynote lecture by esteemed U.S. Professor Vineet Bhandari, Division Head of Neonatology at The Children’s Regional Hospital at Cooper, Camden, USA. His presentation, titled “GASMAS Transit to the NICU – Are We There Yet?”, provided valuable insights into the potential of GASMAS technology to enhance clinical outcomes for preterm born babies.
University Collage Cork in ireland
Research at Tyndall National Institute
Since 2019, Neola Medical has been collaborating with a research group led by Professor Stefan Andersson Engels at the Tyndall National Institute, University College Cork, Ireland, to investigate the optimal placement of probes for “GASMAS” measurements.
In June 2021, Neola Medical also sold a research version of Neola® to University College Cork for use in a clinical study on full-term newborn babies at Cork University Maternity Hospital. The study was led by Professor Eugene Dempsey, Horgan Chair in Neonatology at the INFANT Centre, University College Cork (UCC).
The results were presented in 2023 at two international conferences and demonstrated that the GASMAS technology was able to measure oxygen in all 100 full-term newborn babies who participated in the study.
Lund university and Skåne University Hospital in Sweden
Exploring the potential use of GASMAS technology
Since 2015, Neola Medical has been involved in research conducted at Lund University in collaboration with neonatologists at Skåne University Hospital in Lund. In 2023, a new collaborative project was initiated between Neola Medical, Lund University, and Region Skåne with the aim of exploring the potential use of GASMAS technology in older children and adults, where there is a significant clinical need for continuous lung monitoring in intensive care.
Stay updated on our progress and milestones
Neola Medical is currently in clinical phase with Neola®, undergoing our first clinical study on preterm born babies in Sweden. As the company approaches commercial launch, the focus is on securing market authorization in the U.S., followed by Europe.
Invest in Neola Medical
At Neola Medical, our mission is to provide preterm born babies with a stronger and safer start in life. Through our innovative medical device, Neola®, we aim to advance neonatal intensive care by offering non-invasive, continuous, real-time lung monitoring, with the potential to support proactive care, reduce morbidity and improve quality of life for these vulnerable patients.
"We aim to detect lung complications immediately, giving healthcare professionals the tools they need to make life-saving decisions."
– Hanna Sjöström, CEO Neola Medical