Revolutionizing ICU Care: Advancing Nutritional Technology Through Clinical Trials

Liron Elia
CEO
Art Medical

We sat down with Liron Elia, CEO of Art Medical, to discuss the company's innovative work in improving nutritional care in Intensive Care Units (ICU). Elia sheds light on the challenges in the field, the impact of Art Medical’s clinical trials, and the future trajectory of ICU nutritional care.

Moe Alsumidaie: Why are so few companies working on improving critical care technology, particularly in areas like enteral nutrition?

Liron Elia: Despite its importance in ICU patient care, enteral nutrition technology has not seen advancements in decades. This stagnation can be attributed to several factors.

First, there is a lack of awareness of nutrition's crucial role in intensive care therapy. This field is often considered niche and operates in silos, which means nutrition is treated as a separate domain rather than an integral part of the overall treatment. This lack of awareness limits the number of experts in the field, and consequently, the number of companies that are interested in exploring this space.

Additionally, the complexity of critical care can be a deterrent factor. It's a highly specialized area dealing with severely ill or injured patients requiring intense medical intervention. Healthcare providers face numerous challenges and responsibilities in treating ICU patients, which has historically limited the attention given to nutrition, leading to fewer clinical studies, and therefore, less innovation.

Lastly, inherent risk and uncertainty are involved in developing new technologies in critical care. Potential safety concerns and the need to prove clinical effectiveness can make companies hesitant to take on these challenges.

Alsumidaie: Could you share details about your clinical trials and your current status in terms of regulatory clearance?

Elia: In this study, we looked at extremely sick patients—those who spend more than the average amount of time in the ICU. We found by optimizing nutrition and its delivery, we were able to reduce patients’ length of stay in the ICU and their length of ventilation by more than three days. The length of ICU stay decreased from more than 13 days to less than 10 days, while the duration of ventilation decreased from more than 12 days to more than nine days. This outcome is truly remarkable. For the first time ever, our study establishes a direct correlation between the way people receive nutrition in the ICU and the length of time they spend there.

This study holds immense significance as it validates that our technology is transforming the standard of care. We've obtained regulatory approval in Europe and are in the process of seeking FDA clearance.

Alsumidaie: What challenges did you encounter during your first study with this device?

Elia: Changing the standard practice proved to be challenging. Caregivers have long been accustomed to manual routines or relying on predictive equations to assess nutritional requirements. These routines, while simple, often lead to inaccurate results. Implementing our platform, which fundamentallychanges these conventional approaches, required significant training and educational efforts.

Alsumidaie: How did you ensure the quality of data collection during your study?

Elia: Apart from the standard approach used in the industry, on things such as study design, protocol development, statistical design etc., most of our data collection was automatic and pre-validated. This not only reduced the likelihood of human error but also enhanced data accuracy and reliability. We were able to do so due to the fact that our technology is based on a holistic approach and the platform oversees the entire flow of clinical data.

Alsumidaie: How did you handle patient workflow during the study, especially considering the COVID-19 pandemic?

Elia: Safety was paramount during our study. To protect our team, we did not include COVID-19 patients. Of course, we followed ethical guidelines for including study patients. We received IRB approval, obtained consent from the next of kin, and approvals from the appropriate physicians.

Alsumidaie: What are your suggestions for how clinical trials in the ICU could be conducted more effectively?

Elia: To improve the effectiveness of ICU clinical trials, we need to establish more extensive patient databases and develop a more focused strategy. Additionally, we need to implement technology that provides real-time sensor data, integrates AI, and delivers seamless data flow could enhance the quality and effectiveness of these trials. New types of sensors could give us new types of data, such as reflux and gastrointestinal tolerance data. The goal is to create predictive models for personalized treatments, especially for critically ill patients.

Alsumidaie: How will the development of this technology improve critical care in the future?

Elia: Looking ahead, I see increased awareness regarding the importance of nutrition in critical care driven by the continuous work of critical care and clinical nutrition societies. I anticipate more research will be conducted, resulting in the discovery of new biomarkers, stronger evidence, and a deeper understanding of the role personalized nutrition plays in critical care.

Additionally, the concept of "food as medicine" is gaining traction. Especially in the ICU where malnutrition is linked to increased risk of mortality and morbidity, this concept emphasizes how nutrition is vital to critically ill patients’ recovery.

I also see technology playing a pivotal role in shaping the future of critical care and connected care. New sensors and data combined with AI can help us better predict outcomes and provide improved and personalized care in ICUs. We hope our platform serves as a steppingstone toward this future.

Alsumidaie: Is there anything else you'd like to add?

Elia: I'd like to emphasize the significance of our recent clinical data. Our study not only demonstrated that we can achieve close to 100% feeding efficiency but also highlighted a direct correlation between optimal nutrition and reduced ICU length of stay. To see an average ICU length of stay reduction of three days is unprecedented. This data sets a new benchmark in critical care nutrition and will guide our future research and commercialization efforts.