SIME Diagnostics Redefines Respiratory Care in the NICU and ICU

Harnessing the power of artificial intelligence (AI), SIME Diagnostics has designed a platform to predict acute respiratory diseases within 15 minutes from routinely collected fluid samples – delivering lifesaving results when it matters most. The patented platform is now available for investigational use.  

“Beyond its predictive diagnostic capabilities, SIME’s Clinical AI Platform generates millions of unique data points.” said company CEO Povl Verder. “These unique data points, analysed by our proprietary AI algorithms, fuel rapid product development and yield novel disease insights.” This approach enables SIME to continuously innovate while providing healthcare professionals with cutting-edge solutions and enhancing our understanding of respiratory conditions

Why is respiratory disease in the ICU and NICU an urgent unmet need? 

Acute respiratory distress significantly impairs breathing, leading to severe oxygen deprivation and respiratory failure. Without rapid intervention, it can quickly progress to a life-threatening situation and result in life-long morbidities, especially in new-born babies. Patients who develop acute respiratory distress often require immediate respiratory support, including invasive mechanical ventilation. Given these factors, the urgent management of acute respiratory distress in intensive care units (ICUs) is vital to prevent further respiratory compromise, optimise oxygenation, and provide timely interventions to improve patient outcomes and survival. 

As the leading cause of morbidity and mortality in premature babies, neonatal respiratory distress syndrome (NRDS) poses a significant challenge in neonatal intensive care units (NICUs). UNICEF estimates that 15 million babies are born prematurely every year. According to the NHS, around half of all babies born between 28 and 32 weeks (around seven and a half months) of pregnancy develop NRDS. In addition, a 2019 study on NRDS published by Pharmacy and Therapeutics showed that over 50% of infants born at less than 28 weeks are at risk of NRDS. As stated by the 2023 European Consensus Guidelines on the Management of Respiratory Distress Syndrome, there are currently no predictive diagnostics available for this condition and a bedside test would address an urgent unmet need. 

Acute respiratory distress syndrome (ARDS) in adult ICUs is a severe and life-threatening form of respiratory failure that can occur in response to various underlying conditions, infections such as COVID-19 or injuries. A study on ARDS published by the Cleveland Clinic Journal of Medicine showed that the mortality rate in ARDS is around 40%. According to SIME, predicting acute respiratory distress in the ICU before the onset of symptoms will enable early intervention, enhanced monitoring, tailored treatment plans as well as increased success rates for extubation (the removal of an endotracheal tube).  

Predicting respiratory disease in minutes at the point-of-care  

SIME believe that monitoring respiratory health and screening for acute respiratory disease in the ICU and NICU could transform how we approach care, enabling targeted treatment and empowering clinicians to significantly improve outcomes and reduce time in hospital, thereby reducing cost of care in these very expensive patients.  

SIME estimates that the average cost of treating RDS in the US is $39,600 for newborns and $31,574 for adults. A report from the US Institute of Medicine shows that premature care costs in the US are estimated to total $26bn per year. A large portion of these costs are attributed to the need for mechanical ventilation. The Society of Critical Care Medicine reports that in the US, there are over five million annual admissions to the adult ICU each year. Global Industry Analysts estimate that the global market for the ICU was worth $7.4bn in 2022 and is projected to reach $21bn in 2030. 

SIME Diagnostics looks to pioneer point-of-care respiratory diagnostics in the ICU and NICU.

What does SIME Diagnostics do? 

The company have developed a CE-Marked intensive care AI solution designed to predict respiratory deterioration in the ICU and NICU. The patented platform features a reagent-free disposable and compact AI-diagnostic point-of-care device that analyses fluid samples in minutes.  

Clinically validated by its team of world-renowned neonatologists, SIME’s solution leverages proprietary AI and algorithms to generate rapid respiratory disease prediction and actionable results. According to SIME, these results are delivered to electronic health records (EHR) and a cloud database.  

Who is SIME helping? 

SIME’s technologies are dedicated to facilitating new-born screening for RDS in hospitals, promoting early treatment and intervention, thereby leading to improved outcomes and reduced time spent in the NICU. According to the company’s estimations, implementing this approach can potentially result in average savings of $43,000 for each prevented case of RDS. 

SIME’s product pipeline is designed to address critical unmet needs in both the ICU and NICU settings. In the NICU, the initial focus lies in developing a screening test for RDS immediately after birth. Additionally, the company’s NICU pipeline includes a predictive test for chronic lung disease (CLD). 

SIME is also committed to advancements in the ICU. The company is currently working on a solution that has the potential to enable personalised and targeted care for adult respiratory patients, particularly those who are at risk of ARDS. 

SIME gets excited because… 

SIME Diagnostics envisions a world where, rather than being a leading cause of mortality and morbidity in the ICU and NICU, respiratory disease is prevented before debilitating symptoms develop.  

To achieve this vision, the company has developed a first-of-its kind platform technology powered by SIME algorithms and engineering. The solution was developed by key opinion leaders in the field of neonatology, respiratory care, and data science. “Our technology has been validated in multiple peer-reviewed clinical studies, substantiating it as one of the most promising prognostic tools in acute respiratory care.” said company CEO Povl Verder. Clinical data is at the core of everything we do which is why we have collaborated with respiratory KOLs all around the world in developing this cutting-edge Clinical AI Platform.” 

SIME’s value may extend beyond point-of-care diagnostics. Every time a sample is analysed by the device, a unique biological dataset is generated and stored on the secure cloud platform. Analysis of these millions of datapoints will potentially enable the company to develop new types of digital biomarkers and new disease prediction algorithms. As of April 2023, SIME has developed three new products using this approach, and has registered six patent families. 

The next steps… 

SIME Diagnostics is preparing for commercialisation and launching its first product, a rapid screening test for NRDS for investigational use. Simultaneously, the CE-Marked Clinical AI Platform is being expanded to predict CLD shortly after birth. SIME Diagnostics is raising funds on Floww for its go-to-market strategy in 2023. With the goal of first sales in 2024, SIME are now focusing on manufacturing, further engaging with the FDA and deploying devices in pioneer centres in the US and Europe.  

In addition to its neonatal focus, SIME is also committed to developing solutions for adult ICU patients. Its tailored adult ICU care solution is currently in development and awaits further clinical validation. Notably, in May 2022 SIME published a study on ARDS in Nature and in February this year completed a clinical study in Denmark to assess the potential of rapid ARDS diagnosis in facilitating early interventions for critically ill patients. This study, which is pending publication, explores the benefits of timely diagnosis in enhancing patient outcomes in the ICU.

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