About Calmark

Background and Mission

Calmark was founded by Mathias Karlsson and Sofia Hiort af Ornäs in 2007 and has focused on newborn care ever since. The company's existing solution is based on ten years of research and experience in the industry. It began with clinical research and Mathias Karlsson's PhD thesis on oxygen deficiency in newborns and LDH biomarkers, which then developed into a company geared towards point-of-care diagnostics. The company has since adapted various measuring instruments and its goal is to start production of products for measuring LDH, glucose and bilirubin in Q4 2019. Calmark's activities are focused on improving the entire chain of care, with the aim of reducing patients' suffering, saving on care costs and time and making a significant difference in parts of the world lacking hospital laboratories.

Mathias Karlsson, Founder

Calmark was founded on the basis of my experiences from my first job as a licensed physician at a children's clinic in Stockholm, Sweden. During my first night as the sole on-call physician for the entire clinic, there was an emergency call from the Labor and Delivery ward at about 4 a.m. As I ran into the delivery room, the staff were holding the doors open for me, so I knew it was urgent. Inside the delivery room, I was met by a large team of staff, a frightened and distressed new father and a little baby who was blue and unable to breathe independently.

It struck me then how few objective measurement methods and informed decision supports there are actually developed for newborn patients.

My research indicated that elevated levels of LDH (lactate dehydrogenase, an enzyme that is present in all cells) could indicate the presence of a critical illness. However, there was no product on the market that was capable of measuring this quickly and at the point of care. This marked the beginning of Calmark, which I founded together with civil engineer Sofia Hiort af Ornäs.

After a ten-year journey, there is now considerable knowledge established within the company concerning point-of-care diagnostics, product development and the market. Calmark would like to unite the qualitative requirements for point-of-care diagnostics here in Sweden with the criteria required for the point-of-care diagnostics to operate on a global scale. The company's focus is to start with infants' medical needs and accordingly create products that offer a holistic solution for an infant's first week of life.

Mathias Karlsson, MD, PhD
Chairman of the Board, Calmark Sweden AB

Challenge

For the majority of all babies born around the world, the journey from birth through the first week of life goes smoothly and without complications. However, for a small but not insignificant group of babies, this journey does not go as planned. These so-called "at-risk infants" may need monitoring and care in a neonatal ward, a ward for premature and sick newborns. Some of these at-risk infants are vulnerable to permanent harm or, in the worst cases, death. Oxygen deficiency during birth (perinatal asphyxia), prematurity (pre-term birth) and infection are some of the most common causes of illness or death in newborns. These babies are also less able to break down waste products such as bilirubin (which leads to jaundice) or regulate vital blood sugar (low glucose levels) — two conditions that, in themselves, can lead to severe brain damage.

In the western world, the infant mortality rate is low. In many parts of the world, there is no infrastructure at the foundation of labor and delivery care. Effective prenatal care is lacking which, in turn, means a lack of preparedness for the birth of at-risk infants. Many hospitals simply do not have laboratories and/or economic opportunities required to take blood samples, and beds for newborns can be insufficient in number or geographically far away. Although five-year survival rates have increased significantly in the last few decades, this explains why the infant mortality rate continues to remain high in the world. Every day, around 7000 newborn babies die worldwide.

Today, there are several options available to laboratories, known as point-of-care testing (POC). With the help of a method like this, a healthcare facility can get results faster with a small amount of blood on the premises where the patient is actually located. In the case of newborns, the problem is that currently there is no customized POCT solution for this patient group. The technology is not suited to infants' needs and healthcare does not have sufficient decision support to be able to decide how sick a newborn is.

Mission

Calmark's mission is to develop reliable and easily accessible tests intended specifically for newborns. The company has developed a POC instrument adapted for measuring biomarkers for disease conditions in newborns and generating results faster and more easily. Point-of-care diagnostics are measuring instruments that are developed to perform measurements at the patient's location and, therefore, produce quicker results. Currently, there are no POC products on the market that are primarily designed for the care of newborns.

Calmark exists to help the journey for those at-risk newborns. The company's products contribute to the right patient receiving the right care. The products also help to avoid unnecessary care for those who do not need it and ensure that the healthcare for those who do need it is not delayed or insufficient.
Depending on where in the world an infant is born, their journey and Calmark's solutions have varying effects. Nonetheless, the bottom line is that Calmark offers decision support for the doctors, midwives and nurses who will guide the infant through their first days of life. Sometimes, those providing healthcare during this journey need to perform some sort of blood test to better understand the infant's health status. The most common blood tests performed during the first week of life are for blood gases, bilirubin and glucose. LDH can be an important complement to these tests, as several new studies show that this test has relevance in indicating whether an infant has suffered oxygen deficiency during birth, which can cause brain damage.

In countries that have developed healthcare systems, Calmark's products will aid the patient's journey with care and contribute to saving time and getting care to the right patient at the proper level of care. The products are also expected to facilitate the work of healthcare professionals by providing a more streamlined path through the healthcare system for both patients and families. Research shows that the introduction of point-of-care diagnostics can lead to a reduction in overall healthcare costs by approximately 8–25%. In less developed countries, Calmark's products can offer an inexpensive, reliable point-of-care technology that makes it possible to save lives.




A Message from the CEO

For far too many newborn babies, their date of birth is also their date of death. Although infant mortality rates have decreased significantly in recent years, there are still too many babies who do not survive. Each year, there are almost one million neonatal deaths and close to two million infants die within the first week of life. Some of the most common causes are oxygen deficiency during or close to birth, infection and premature birth. Other risks early in life include high levels of bilirubin (jaundice) and low blood sugar levels. These conditions can also cause sustained neurological disability in newborns.

By providing a simple way to test at-risk infants, many babies can be saved. Today, there are large regions of the world without access to laboratories. It is in these places that Calmark's tests can make the biggest difference. In the western world, we will facilitate the chains of care, accelerate processes and act as a valuable decision support for doctors, nurses and midwives.

At Calmark, we have been conducting research for ten years on methods that can more quickly indicate a newborn's condition and thus the level of care that they require. In line with rapidly changing technological advancements, our solutions and methods have been transformed and adapted to market and healthcare needs. We are proud to be close to the launch of a patented POC instrument with a technical design that can produce results more quickly and easily. A colorimetric method is used for assessment, in which the filters are chemically-treated. If the substance we are looking for is in the blood, then a color change occurs when the blood touches the filters. The color change is converted into a numeric value with the aid of software. By altering the chemicals on the filters, various tests can be developed using the same platform. The tests are performed directly where the family is and the results are available within a few minutes, which facilitates the chain of care and decision-making process.

Our goal is to become a leading player in POC products for newborns and to develop our offer to supply all relevant tests for the newborn's first period of life.

We estimate that approximately 20% of all infants born would be helped by at least one of our first three biomarkers (LDH, bilirubin and glucose). Our vision for the future is to be able to offer all the relevant tests for the assessment of a newborn infant's medical condition. There are currently no POC instruments for measuring LDH and no companies as yet that specialize in the care of newborns. Our POC instrument has received several crucial patents in Sweden, China and the United States, while additional patents are pending.

At Calmark, we want to save more babies and make it easier for all who struggle on a daily basis in the healthcare sector by making it easier to identify infants who are at risk. I hope that you will want to join us on our journey where we can save more lives, provide time-saving measures in healthcare and reduce suffering of the smallest patients.

Anna Söderlund,
CEO, Calmark Sweden AB