GPX Medical is building on a historic Swedish legacy of medical technology innovation and the company’s mission is to revolutionize the care of infants born preterm.

GPX Medical was founded in Lund, Sweden, in 2016 and is developing NEOLA, a lung analyzer for continuous monitoring of the lungs of preterm-born infants using a technology that measures lung volume and oxygen concentration. NEOLA will be sold to the neonatal intensive care units of hospitals as a standalone device, placed next to the ventilator, or as a module incorporated into the overall surveillance system in neonatal intensive care units.

GPX Medical was listed on Nasdaq First North Growth Market on October 2nd 2020, and its CEO, Hanna Sjöström, rang the bell; a historic first-time-ever bell ring in Lund. Nordic Life Science asked Hanna about the prospects of the company and her strategy moving forward.

Congratulations on the listing! Describe your business strategy and your future plans for the company?

“Thank you! It feels terrific to take this important step forward in our journey to revolutionize the care of preterm-born infants. Product development is in progress and consists of technical design and verification, clinical validation, CE-approval and establishment of a quality control system, among others. NEOLA has gained interest at the distributor level, and in parallel to our preparations for sale to hospitals via distributors, we have also begun work on plans for licensing our technology to global medtech actors. There is also potential for multiple medical applications of our technology, in addition to monitoring the lungs of preterm-born infants, such as diagnosis of sinusitis, a common and painful disease usually caused by viral infections that also contributes to a high rate of over-prescription of antibiotics, and lung monitoring for older children, and in the future perhaps also adults.”

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Describe the clinical need for your system?

“Every day, one in ten infants are born preterm and many depend on neonatal intensive care for their survival. Preterm birth is also the most common cause of death for infants under the age of five. Many of these infants are born with underdeveloped lungs that can advance to life-threatening conditions during their stay in the hospital and risk disabilities later in life. Health care professionals also need the support of modern technology to make life-changing decisions that can improve the health of these fragile patients. Today’s monitoring methods present only snapshots of what is going on and increase the infant’s risk of developing illness later in life. Neonatal intensive care needs new, safe and risk-free methods that can constantly monitor infants born preterm in a way that doesn’t harm them. All in all, our innovation NEOLA can upgrade today’s neonatal intensive care to include continuous lung monitoring and real-time alerts of life-threatening complications.”

“Our most important market is the United States. Neonatal care is associated with widespread healthcare costs and we estimate that nearly 80 percent of NEOLA’s sales will be in the US.”

What opportunities do you have on the market for neonatal intensive care?

“The market potential for NEOLA is 586 million EUR per year. We have already identified over 4,000 neonatal clinics, primarily in Europe and the United States, that are advanced enough to be interested in NEOLA. This focus market consists of approximately 60,000 beds in total. Our most important market is the United States. Neonatal care is associated with widespread healthcare costs and we estimate that nearly 80 percent of NEOLA’s sales will be in the US. Other important markets are European countries such as Germany, France and the United Kingdom.”

“Several factors suggest that GPX Medical with NEOLA has the potential to be a game-changer in the pediatrics landscape: preterm births are becoming more common because mothers are older when they first have children, have health issues such as diabetes and high blood pressure, or undergo fertility treatments that result in twins and triplets. C-sections are also becoming more common. We have also seen a positive investment climate within the medical technology sector.”

“Another benefit of being located near Medicon Village is being part of a community of inspiring female CEOs of medtech and life science companies as a member of SmiLe Incubator.”

You have your headquarters in Lund, Sweden. What are the benefits of being located in Medicon Village?

“Medicon Village is an inspiring community that is driven by a mission to bring science to life and help society at the same time. Our headquarters in Lund not only pay tribute to the University’s Division of Atom Physics, where our lung monitoring method GASMAS was originally developed, but also the region’s significant role in the history of neonatal care. Following in the footsteps of diagnostic ultrasound, which was developed in Lund in the 1950s, our Lund based medical technology innovation once again has the potential to revolutionize health care the world over.”

“Another benefit of being located near Medicon Village is being part of a community of inspiring female CEOs of medtech and life science companies as a member of SmiLe Incubator. SmiLe is a frontrunner when it comes to female leadership: almost 70 percent of its companies are headed by a female CEO. Of all the IPOs that have taken place so far this year, only 3 of 25 companies have a female CEO. In addition to myself as CEO, GPX Medical’s Chair of the Board and one of the innovators behind our technology, as well as the CTO, are all women.”

“In 2021 we also aim to develop NEOLA’s final product functions, conduct a user study with neonatologists and nurses, and recruit a Director of Clinical Affairs.”

Where do you see GPX Medical in 5-10 years?

“In 5-10 years we hope to have entered the US market and the major markets in Europe and have strong collaboration and partnerships with hospitals and within the medtech industry. We would also have expanded our platform technology beyond the neonatal application. In the short term our goals are to conduct a preclinical study, initiate a clinical pilot study on newborns, and determine a clinical study plan together with our key opinion leaders. In 2021 we also aim to develop NEOLA’s final product functions, conduct a user study with neonatologists and nurses, and recruit a Director of Clinical Affairs.”

How have you handled the changes from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR); has it affected your company and if so, how?

“I have a strong and experienced team that knows the drill, having previously worked with developing and commercializing medical technology innovations in Europe. They are closely monitoring the transition from MDD to MDR to ensure that NEOLA’s product development process is executed in accordance with the new guidelines. I have full confidence that with their expertise we will navigate this transition successfully and receive EU regulatory approval in line with our business goals.”

Photo: Roger Nellsjö