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Amniotics AB announces positive pre-clinical proof-of-concept results for PulmoStem™ in end-stage lung disease

Non-Regulatory

April 28, 2022

Amniotics AB (publ) (Nasdaq Stockholm: AMNI) today announced that PulmoStem™ significantly reduces the incidence of Primary Graft Dysfunction (PGD) in a pre-clinical study of lung transplantation, which is the definitive treatment of patients with end-stage lung disease. The positive effects of the treatment with PulmoStem™ were presented at the International Society for Heart and Lung Transplantation (ISHLT) 42nd Annual Meeting & Scientific Sessions, which is being held on the 27-30th of April in Boston, US.

Dr. A. Niroomand, from the Lindstedt group at Lund University and Skåne University Hospital in Sweden presented results from the lung transplantation study using Acute Lung Injury (ALI)-damaged donor lungs. The data showed that following the administration of the company’s biological therapy PulmoStem™, the injured lungs were recovered to be suitable for transplantation. This is important as the donor utilization rate is cited to be as low as 20 to 50% and PulmoStem™ has the potential to increase the pool of donor lungs. In addition, the incidence of PGD, a severe complication, after the transplantation, was significantly reduced, whereas the non-treated lungs all had significant lung injury.
 
The oral presentation at ISHLT2022 of the new PulmoStem™ data, was part of a session presenting novel translational insights in lung transplant complications and care.
 
Lung transplantation is an area of high unmet need. We need both to make more donor lungs suitable for transplantation and to improve the outcome of transplantations. PulmoStem™ addresses both these important needs and my research group, and I, are very encouraged about these data,” says Professor Sandra Lindstedt at Skåne University Hospital.
 
"These very promising data supports PulmoStem™’s ability to regenerate lung tissue and this is important for the PulmoStem™ development program. Lung transplantation has become an increasingly common procedure, but it is lagging behind other transplantations in terms of survival outcomes. Amniotics is committed to helping patients suffering from lung disease, and we are thankful for our collaboration with Sandra and her team,” says CEO Kåre Engkilde.
 
About Lung Transplantation
Lung transplantation is currently the only treatment for patients with end stage lung disease. However, most potential donor lungs are considered unsuitable for transplantation. Once a suitable donor lung is found, a transplantation can be made. Thereafter, the patient undergoes a surgical procedure with the risk of developing PGD, which is a severe lung injury that occurs within the first 72 hours of lung transplantation and is the most common cause of early mortality and co-morbidity. There is currently no treatment to prevent PGD in connection with lung transplantation. 
 

About PulmoStem™
PulmoStem™ is a lung-specific stem cell product, derived from full-term amniotic fluid and intended for treatment of lung diseases with inflammatory components like ARDS due to COVID-19 and other causes. PulmoStem™ is also being investigated for treatment of the chronic lung-disease Idiopathic Pulmonary Fibrosis (IPF) and in lung transplantation.

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