Hyla

The intensive care unit hasn't fundamentally changed in decades: patients lying immobile, often in medically induced comas, connected to intrusive mechanical ventilators while nurses try every few hours to draw blood samples from the patient in order to access and monitor their medical condition. But Inspira Technologies, an Israeli medical device innovator, envisions a different future. With its flagship INSPIRA ART system which is being developed to transform respiratory support by allowing patients to remain conscious during treatment, the company is now advancing the development of an AI-powered blood sensor that could eliminate the need for recurrent blood draws, providing real-time patient blood monitoring without the need to actually touch or take a physical blood sample.

As anticipation builds for clinical results from trials of this HYLA blood sensor, we spoke with Joe Hayon, President and co-founder of Inspira Technologies, about the science behind this potential breakthrough. "One of the challenges in critical care has always been the intermittent nature of blood monitoring," explains Hayon. "Every time we need to assess a patient's blood parameters, we require a physical blood draw. This means clinicians are making decisions often based on discrete and even just a handful of data points rather than on real-time data collected on a high scale, creating continuous trends to provide a wider and potentially a more reliable perspective on how the patient is responding to treatment. In critical care, where patient conditions can change rapidly and unnoticed, a gap in monitoring capabilities can be crucial and mean the difference between life and death."

The HYLA blood sensor approaches this challenge through a combination of optical sensing technology designed using artificial intelligence-based software. The device, which recently announced about the integration of a next-generation oxygenation indicator, uses sophisticated sensors to detect blood parameters non-invasively. "What makes our approach unique is how we develop the proprietary AI powered algorithms," Hayon notes. "The AI based software processes complex optical data in real-time and continuously, allowing us to monitor key blood parameters on a large scale in order to perform diagnostics, without many of the limitations associated with traditionally required blood draws."

Of particular interest is the device's design to provide data through real-time and continuous monitoring of oxygenation therapy, enabling the rapid detection of tissue hypoxia and the early warning of respiratory complications, a critical concern in intensive care settings. "When we talk about blood oxygenation, we're looking at one of the most fundamental aspects of patient care," says Hayon. "By integrating our new oxygenation indicator, we're targeting the early detection of hypoxia, which could provide crucial early warnings of deteriorating conditions that can often result in a patient ending up on a mechanical ventilator."

The technology could represent a significant advancement in the multi-billion point-of-care testing and arterial blood gas analyzer market. While traditional blood gas analysis requires frequent invasive procedures, HYLA's continuous monitoring approach could fundamentally change patient care. "We're not just creating an independent blood monitoring and diagnostics device," Hayon emphasizes. "We're developing an ecosystem with an affordable and easily scaled solution that could transform critical care, especially when integrated with our flagship INSPIRA ART system and other company products."

The HYLA is undergoing clinical evaluations in Sheba Hospital in patients undergoing open-heart procedures, in preparation of planned U.S. Food and Drug Administration (FDA) submission of the first configuration of the HYLA in 2025.
This advancement builds on Inspira's existing innovations in critical care. The company's FDA-cleared INSPIRA ART100 system has the potential to assist medical team procedures, and the addition of HYLA's monitoring capabilities could further enhance patient care.

"We're at a point where artificial intelligence isn't just an add-on feature," concludes Hayon. "It's becoming fundamental to how we think about medical tasks, patient monitoring and patient care. The integration of our blood sensor technology with our existing life-support and under-development respiratory support systems represents a comprehensive approach to critical care that was considered almost science-fiction."

In a recent press release, the company noted that it expects to share clinical results from the HYLA blood sensor evaluation study in the near future, with FDA submission planned for the second half of 2025. These results, if positive, could provide crucial validation for Inspira's innovative approach to critical care monitoring, which could signal the end to decades of reliance on invasive blood draws.