Press communication
Lund, Sweden, May 22, 2024
This is a translation of the Swedish press release published 2024-05-22
The first quarter of 2024 commenced with a strengthened cash position following a strong finish to last year, which included a directed share issue at a premium to the share price, several achieved milestones, and successful results from an independent clinical study of Neola® in Ireland. Market establishment efforts in the USA have intensified, and the Company has been recognized by Stanford’s international industry experts as one of the world’s leading medical technology innovation companies with the potential to improve pediatric care. Preparations for clinical validation are proceeding as planned, culminating this quarter with successful results from the completed usability study of Neola® in Boston, USA. The results clearly demonstrate a user-friendly and safe design, confirming Neola®’s safety for its intended use by healthcare professionals in neonatal intensive care units.
Summary of the Period January–March 2024
Net operating revenue: SEK 0k (0)
Operating result: SEK -2,568k (-2,356)
Cash flow for the period: SEK 13,568k (-5,403)
Earnings per share: SEK -0.04 (-0.04)
CEO Comments
In the first quarter of 2024, we achieved another significant milestone in line with the company’s strategy. The well-executed Human Factors Validation Study of Neola® in Boston, USA, concluded with successful results that confirm Neola® is safe for its intended use by healthcare professionals in neonatal intensive care units. Beyond the positive formal outcomes, we also received valuable feedback from our future users, the neonatal nurses. They found Neola® easy to use and immediately understood its clinical benefits, indicating strong potential for Neola® to integrate well into American neonatal intensive care. The results, clearly demonstrating a user-friendly and safe design, will be part of the final report included in our upcoming FDA application for market approval of Neola® in the USA. With the wind at our back, we continue the clinical validation phase of product development with intensified planning for the clinical study on preterm born infants.
Our market preparation efforts for the launch of Neola® in the USA are intensifying with increased presence in the American market. Significantly, we have been recognized by Stanford’s international industry experts as one of the world’s top medical technology innovation companies capable of improving pediatric care. Neola Medical won a silver medal and 25,000 USD in the prestigious Stanford PDC Accelerator Pitch Competition 2024, partially funded by the FDA to promote innovation in pediatric medical technology.
We are also strengthening our clinical networks by visiting the top-ranked neonatal intensive care unit at Lucille Packard Children’s Hospital Stanford in Palo Alto, USA. Its strong connection to Stanford University benefits the hospital with world-leading research, expertise, and interest in the latest medical technology products in neonatal care. Additionally, we had several successful meetings at the largest international investor event in the life science industry, the J.P. Morgan Healthcare Conference 2024 in San Francisco. The conference is a significant opportunity for us to generate interest among neonatologists, physicians, investors, and industry partners for Neola®.
In summary, we have maintained a high pace in the first quarter of 2024, making significant strides in market preparation for the launch. We are proud to conclude the quarter with a major milestone achieved and secured cash flow into 2025. We continue to look forward to reaching the clinic and improving the care of preterm born infants, so that more children can be saved and live without severe disabilities.
Hanna Sjöström, CEO
The full report is attached to this press release and available on Neola Medical’s website, www.neolamedical.se.
Lund, May 22, 2024
The Board
Read the press release in Swedish here: Neola Medical Q1 Rapport 2024 – Framgångsrik studie i USA inför regulatoriskt godkännande av Neola®
For further information, contact:
Hanna Sjöström, CEO Neola Medical, phone: +46 (0)760-10 71 16, e-mail: hanna.sjostrom@neolamedical.com
This information is such that Neola Medical is obliged to make public in accordance with the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, on 2024-05-22 at 06:58 CEST.
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.