This is a translation of the Swedish press release published 2023-11-09, 07:55 CET
New successful results from the completed independent clinical trial in Ireland show that Neola® measures oxygen in the lungs of 100% of the participating 100 newborn babies. Furthermore, it is confirmed that the technology is safe to use for lung monitoring in premature babies. The company is designated as a Stanford Impact1 company and thus receives market launch support and access to broad expertise from the FDA’s own pediatricians and regulatory experts as well as Silicon Valley experts in development for medical devices, commercialization and doctors in neonatal intensive care.
Summary of the period July-September 2023
Operating income: 0 tkr (0)
Operating result: -2 540 tkr (-2 148)
The period’s cash flow: -3 565 tkr (-4 730)
Result per share: -0,05 kr (-0,10)
Summary of the period January-September 2023
Operating income: 0 tkr (0)
Operating result: -7 482 tkr (-7 276)
The period’s cash flow: -13 476 tkr (-14 679)
Result per share: -0,13 kr (-0,34)
CEO comments
During the third quarter, the doors open for us in the U.S. when Stanford selects Neola® as a promising innovation with the potential to improve neonatal intensive care. Particularly significant is that we, as the only European company, have been selected by Stanford as an Impact1 company and thus receive market launch support from Stanford’s specialists. It is gratifying that our work to build up our American network of key people in both academia and healthcare is bearing fruit. In practice, this means that we now have the opportunity to work closely with Stanford’s team in an exclusive collaborative program, partially funded by the American pharmaceutical agency FDA.
The Stanford Impact1 program gives us access to a broad expertise of Silicon Valley experts in development for medical devices as well as forums with FDA pediatricians and regulatory experts for informal discussion about the companies’ regulatory strategy and study plan. During the quarter, we had meetings with the FDA and created a good picture of what is required to get Neola® approved for sale in the USA.
Strong new clinical results from the independent Irish clinical trial at University College Cork were presented at this year’s jENS conference in Rome in September. The study has been completed and the results show that Neola® measures oxygen in the lungs of 100% of the participating 100 newborn babies and that the company’s GASMAS technology is a safe, stable, and well-tolerated technology for lung monitoring of preterm born babies. The results also show that for each child there are many different possible positions of the placement of the probes on the children’s chest that provide good measurement signals. This gives Neola® the advantages of being easily integrated into an existing workflow in the time-critical neonatal intensive care.
In summary, during the first three quarters of 2023, we have focused on the market preparation work before the launch of Neola®, intensive work with technical verification studies and preparations for upcoming clinical, preclinical and user studies. We feel wind in our sails with strong clinical results from the Irish research study behind us and look forward to a continued intense autumn.
Hanna Sjöström, CEO
Neola Medical AB (publ) today publishes the Q3 report of 2023 (in Swedish). The report is available at the company’s website and is attached to the press release.
Read the entire press release (in Swedish) here: Neola Medical Q3 rapport 2023
The report presentation will be available at Neola Medical’s website:
https://www.neolamedical.com/investors/rapporter-och-finansiell-kalender/
For further information, contact:
Hanna Sjöström, CEO Neola Medical, phone: +46 (0)760-10 71 16, e-mail: hanna.sjostrom@neolamedical.com
Christian Gyllenberg, CFO Neola Medical, phone: +46 (0)727-44 50 10, e-mail: christian.gyllenberg@neolamedical.com
This information is information that Neola Medical AB (publ) is obliged to make public according to the EU’s market abuse regulation. The information was submitted, through the care of the above contact person, for publication on November 9, 2023, 07:55 CET.
Neola Medical AB (publ) develops medical technology device for continuous monitoring of preterm born infants’ lungs. Immediate detection of complications provides the possibility of early treatment and improved health care. The patented technology is based on a spectroscopic method developed at Lund University in Sweden. The company was founded in 2016 and is listed on NASDAQ First North Growth Market (ticker: NEOLA). Read more at www.neolamedical.com. The company’s Certified Adviser is FNCA Sweden AB.