Neola Medical AB (publ) (NEOLA.ST) develops and commercializes Neola®, a patented medical device for non-invasive continuous lung monitoring of preterm infants using laser spectroscopy to measure lung volume changes and oxygen gas concentration in real time. The device provides instant alerts for life-threatening pulmonary complications, enabling faster detection, reduced invasive procedures such as blood gas sampling and chest X-rays, shorter neonatal intensive care unit stays, and decreased nursing time for manual observation; it targets neonatal intensive care units globally with primary focus on the US market. Founded in 2016 as a spin-off from Gasporox AB and formerly known as GPX Medical AB until its name change in June 2022, the company maintains headquarters at Ideon Gateway, Scheelevägen 27, Lund, Sweden, alongside a US office in Palo Alto, California.
Neola Medical operates in the health care equipment and supplies industry, serving preterm infant care providers through its core offering of Neola®, which holds an international IP portfolio strengthened by new patents granted in China and Europe during 2025 alongside prior US protections. The company, listed on Nasdaq First North Growth Market since October 2020, employs approximately eight staff and pursues regulatory approvals including FDA clearance in the US and CE marking in Europe, supported by ISO 13485 certification for its quality management system and IECEE CB certification for safety and electromagnetic compatibility standards. Subsidiaries include Neola Medical, Inc., facilitating US operations.
Recent developments encompass clinical advancements with ongoing pilot studies in Sweden, a signed agreement in Q2 2025 with Children's Regional Hospital at Cooper in the US for its first pivotal clinical trial as a foundational step toward FDA submission, and a silver medal award plus $25,000 federal grant from the Stanford Pediatric Device Consortium in 2024 enhancing US neonatology partnerships. Financing activities feature a direct issue of approximately SEK 20 million in early 2025, onboarding initial institutional investors Adrigo and Cicero Funds while strengthening the shareholder base; major shareholders including LMK Venture acquired Cardeon's full stake in 2025, elevating LMK's ownership above 10%. Leadership changes include the appointment of David Folkesson as CFO in August 2025 and technical team expansion plans; the 2024 annual report was published in April 2025.