Neola Medical

17/06/2025

💡Help Us Improve – Take the Neola Medical Communication Survey 2025 💬

Neola Medical invites you to take a brief, approximately 5-minute survey to share your thoughts on how we communicate. Your input will help us improve our updates, website, and investor letters so they better reflect your interests and needs.

The survey is completely anonymous, open for two weeks, and all data is handled in accordance with GDPR.

👉 Take the survey here: https://www.survio.com/survey/d/NeolaMedicalCommunicationSurvey2025

Thank you for helping us grow and improve! ✨

16/06/2025

📣 Today we released the summer edition of Neola Medical’s Investor Letter 2025

“The first real-world use of Neola® to monitor the lungs of a baby, in our ongoing clinical pilot study in Sweden, marks a historic milestone for the company. At the same time, we are making important progress in preparing our pivotal clinical study in the U.S., which will support the foundation of our planned FDA application for market authorization,” says CEO Hanna Sjöström.

💡 Read the entire press release and the investor letter here: https://www.neolamedical.com/mfn_news/neola-medicals-ceo-shares-clinical-progress-and-recent-milestones-in-summer-2025-investor-letter/

10/06/2025

📣Neola Medical Signs Agreement with Leading U.S. Hospital for Pivotal Clinical Study on Preterm Born Babies Following IRB Approval 👶🇺🇸

“The IRB approval at Children’s Regional Hospital at Cooper University Health Care and the signed agreement to initiate the pivotal clinical study, mark an important milestone in advancing the clinical validation of our medical device, Neola®, in the U.S. We are especially honored to work with Dr. Vineet Bhandari, one of the world’s most prominent key opinion leaders in neonatology. His clinical leadership at Cooper’s NICU adds significant weight to this strategically important study site, which will play a central role in building the clinical evidence base for our planned FDA application and long-term market expansion,” says Hanna Sjöström, CEO at Neola Medical

💡Read more in the press release here: https://www.neolamedical.com/mfn_news/neola-medical-signs-agreement-with-leading-u-s-hospital-for-pivotal-clinical-study-on-preterm-born-babies-following-irb-approval/

04/06/2025

🌟 From Innovation to Impact - Highlights from SwedenBIO’s U.S. Market Seminar 🇺🇸

On Monday June 2, CEO Hanna Sjöström joined SwedenBIO’s Business Strategy working group to share Neola Medical’s experience of expanding into the U.S. medtech market. At a well-attended seminar, CEO Hanna Sjöström underscored the importance of establishing a local presence to unlock networks, navigate the regulatory landscape, and access strategic opportunities.

“Having a local presence in the U.S. has been essential for building networks and accessing clinical study opportunities through the right connections,” says CEO Hanna Sjöström

The seminar gathered Swedish life science CEOs to share key lessons from entering the U.S. – a large, complex, and high-cost market where strategy and presence matter.

🎥 Watch the seminar here: https://www.youtube.com/watch?v=72lyGW95W48

💡 Read more about the seminar and SwedenBIO here: https://swedenbio.se/swedish-ceos-share-what-it-takes-to-succeed-in-the-us-market/

03/06/2025

🌟 Interview Series: Voices from Neonatal Care 👶

In the first part of our interview series, we meet Linda Nilsson, an intensive care nurse at Skåne University Hospital in Lund. She emphasizes the critical importance of early detection and continuous monitoring in the acute phase of neonatal care, where even small changes in a newborn’s condition can signal serious complications.

We also hear from Veronica Hermansson, a specialist physiotherapist at the Pediatric Clinic at Södra Älvsborgs Hospital in Borås, who highlights the long-term challenges faced by preterm born babies. Their immature brains make them especially vulnerable to neurodevelopmental issues, requiring careful support beyond the neonatal period.

Together, their perspectives illustrate the complexity of neonatal care, from intensive care in the first hours of life to long-term developmental support, and the need for a comprehensive, lifelong approach for this vulnerable patient group.

💡 You can read the interview with Linda Nilsson here:https://storage.mfn.se/fde6b363-1656-442c-83d7-abedf2048a35/interview-with-linda-nilsson-voices-from-neonatal-care.pdf

26/05/2025

🚀 From Innovation to Impact: Neola Medical’s Journey to the U.S. 🇺🇸

CEO Hanna Sjöström, is invited to speak at SwedenBIO’s Business Strategy working group seminar on strategic expansion to the U.S. market. With the U.S. as our focus for clinical and commercial growth, CEO Hanna Sjöström will share insights from Neola Medical’s journey: from navigating FDA processes to building investor dialogue and preparing for clinical validation.

The session highlights key strategic decisions facing life science companies today: how to evaluate opportunities, build a presence, and reach the right stakeholders in the world’s most competitive health tech market.

📅 Read more and register: https://strategic-business-expansion2025.confetti.events

23/05/2025

🚀 Life Science Sweden highlights Neola Medical’s latest clinical milestone – the inclusion of the first baby in the ongoing clinical pilot study on preterm born babies in Sweden 🇸🇪🫁👶

💡 Read the full article in Swedish here:

Det Lundbaserade bolaget har inkluderat den första för tidigt födda bebisen i sin svenska pilotstudie. Det är första gången lungövervakningssystemet Neola testas på den tänkta patientgruppen inom neonatal intensivvård.

22/05/2025

📌 Neola Medical mentioned in Placera’s most-read Telegram

Neola Medical is highlighted in a recent article by Placera, listing healthcare stocks attracting fund interest.

💡 Read the full article in Swedish here: https://www.placera.se/nyheter/lakemedelsaktierna-som-fonderna-kastar-sig-over-2025-05-20

Please note that Neola Medical has not been involved in the production of this article and has no influence over its content.

Stockholmsbörsens bioteknik- och läkemedelsbolag kämpar ofta i motlut. Kliniska bakslag, regulatoriska förseningar och torktider på kapitalmarknaden är vanliga motgångar.

22/05/2025

🚀 CEO Hanna Sjöström on Clinical and Strategic Milestones – Redeye Interview Q1 2025

Following a strengthened shareholder base and the first baby enrolled in Neola Medical’s Swedish clinical pilot study, CEO Hanna Sjöström joins Redeye AB to discuss recent milestones and what lies ahead.

She shares insights into the company’s clinical progress, recent international patent grants, and the path toward U.S. market readiness, including upcoming plans for the pivotal clinical study and key strategic considerations around manufacturing.

🎥 Watch the full interview here: https://redeye-3.wistia.com/medias/g0v2rcc2kd

💡 Access the interview and additional insights from Redeye here: https://www.redeye.se/company/neola-medical

21/05/2025

📣 Neola Medical issued a press release following the Annual General Meeting 2025

💡 Read the press release in Swedish here: www.neolamedical.com/mfn_news/kommunike-fran-arsstamma-i-neola-medical-ab-den-21-maj-2025/

21/05/2025

📣 Neola Medical today released the Q1 report of 2025! 📘👶🏻

Neola Medical Q1 Report 2025 – Strengthened shareholder base with institutional investors ahead of clinical study start

“Strengthened by institutional investor confidence and with the first baby successfully included in our clinical study, we move forward with continued strength into the next phase of our clinical development,” says CEO Hanna Sjöström

💡 Read the entire press release and the report at our website: https://www.neolamedical.com/mfn_news/neola-medical-q1-report-2025-strengthened-shareholder-base-with-institutional-investors-ahead-of-clinical-study-start/

21/05/2025

📣 First Patient Enrolled in Clinical Pilot Study with Neola® on Preterm Born Babies 👶🫁

“This marks a truly meaningful milestone for Neola Medical. For the first time, our medical device, Neola® is being used for monitoring the lungs on its target patient group, preterm born babies, in neonatal intensive care,” says CEO Hanna Sjöström

💡Read more in the press release here: https://www.neolamedical.com/mfn_news/first-patient-enrolled-in-clinical-pilot-study-with-neola-on-preterm-born-babies/