Noninvasix Receives FDA Breakthrough Device Designation for Non-Invasive Monitoring Technology for Sepsis

HUSTAN – (BUSINESS WIRE) – Noninvasix announced today its LIVOx The Central Venous Oxygen Monitoring has received from the U.S. Food and Drug Administration (FDA) a breakthrough device for noninvasive continuous or point-based monitoring of central venous oxygen saturation (ScvO2) in adults at risk for septic shock.

In the United States, 1.7 million adults suffer from sepsis each year, killing nearly 270,000 people.1 Global tissue hypoxia (abnormally low oxygen levels) is an important indicator of septic shock, and its rapid recognition allows for immediate therapeutic interventions and can reduce severe adverse outcomes such as polysystemic organ failure and death.

“The device’s breakthrough designation confirms the company’s focus on monitoring sepsis patients by non-invasively measuring central venous oxygenation, addressing a serious unmet health care need,” said David J. Jaraka, CEO of Noninvasix. “The non-invasive measurement of ScvO2 will open new avenues for more effective and earlier diagnosis of septic shock, which will provide better patient care and reduce healthcare costs. This milestone marks the beginning of future developments, improvements and evidence of the expanding use and clinical impact of our technology on other indications and conditions. We aim to make a difference in an important health issue. ”

Noninvasix will be the first company to conduct non-invasive sepsis monitoring, detecting a key indicator of septic shock as early as possible so that it can be treated to reduce complications and save lives. The LIVOx Central Venous Oxygen Monitor can provide a more effective diagnosis of this life-threatening condition.

“Sepsis remains a serious disease that affects millions of people around the world, and ranks third among the causes of death in the United States. We need new ways to prevent, detect and treat it to save lives and reduce suffering, ”said Dr. Donald. Prue, Rebecca Terry White, is an Honored Professor and Chair of the Department of Anesthesia in the Medical Department of the University of Texas.

Currently, there are no non-invasive approaches that can quickly provide ScvO2 information. Available methods for diagnosing low ScvO2 and monitoring treatment are: 1) non-invasive but do not measure ScvO2 directly and have no sensitivity and / or specificity for diagnosing shock (e.g., blood pressure measurement, laboratory tests, and ultrasound, 2 but invasive, prone to possible complications and time consuming (placement of a central venous catheter directly into the patient’s bloodstream, either for periodic blood collection or continuous oximetry).

Noninvasix’s patented optoacoustic platform consists of a disposable patient interface, a reusable probe, a data display and equipment. The probe can be worn on the patient’s chest to continuously monitor venous oxygen saturation levels in real time. The monitor can be used to target specific blood vessels based on a desired metric.

An urgent unmet global need

“We are rapidly moving towards realizing the potential of Noninvasix to facilitate early diagnosis of sepsis that turns into septic shock,” said Tom Lubi, Ph.D., director of the Texas Medical Center’s Inventory Venture Fund. “The breakthrough designation of the device brings us closer to giving clinicians new technology that will allow them to quickly and accurately diagnose their critically ill patients and adapt treatments to improve outcomes and even save lives.”

It is estimated that sepsis affects about 50 million people globally, including adults and children, and leads to 11 million deaths.4 Hospital sepsis affects approximately 30% of intensive care patients worldwide,2 resulting in a longer stay in hospital and a mortality rate above 40%.3 When sepsis is accompanied by low blood pressure, it is called septic shock and carries the highest risk of death and complications.5 To learn more about sepsis, visit the Sepsis Alliance at https://www.sepsis.org.

Breakthrough Devices program

The FDA Breakthrough Devices Program is a voluntary program for certain medical devices and combination products that provides more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The goal of the program is to provide patients and healthcare professionals with timely access to these medical devices by accelerating their design, evaluation, and review, while maintaining legal standards for pre-sale approval, 510 (k) approval, and De Novo marketing authorization. protection and promotion of public health.

About Noninvasix

Noninvasix is ​​expected to be the first company to monitor non-invasive central venous oxygenation, a key indicator of sepsis transition to septic shock, allowing clinicians to diagnose and monitor response to tissue hypoxia treatment in real time. Its patented optoacoustic platform technology is the first solution for non-invasive and continuous measurement of central venous oxygen saturation. It is expected that the inclusion of Noninvasix in the ICU workflow will allow clinicians to more quickly and accurately diagnose their critically ill patients and tailor treatments to improve outcomes. Future developments, improvements and evidence extend the use and clinical impact of the technology to other indications and conditions.

Links:

  1. What is sepsis? Centers for Disease Control and Prevention, August 17, 2021 https://www.cdc.gov/sepsis/what-is-sepsis.html.

  2. Sakr Y, Jaschinski U, Wittebole X, Szakmany T, Lipman J, Namendys-Silva SA, Martin-Loeches I, Leone M, Lupu MN, Vincent JL (2018) Sepsis in Intensive Care Patients: Evidence from Intensive Care Worldwide over the audit of nations. Open a forum to infect Dis 5 (12): ofy313. https: // doi. org / 10.1093 / ofid / ofy313.

  3. Markwart R, et al, Epidemiology and severity of sepsis acquired in hospitals and intensive care units: a systematic review and meta-analysis of Intensive Care Med (2020) 46: 1536-1551.

  4. Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S et al (2020) Global, regional and national incidence and mortality from sepsis, 1990–2017: analysis to study the global severity of disease. Lancet 395 (10219): 200–211.

  5. Septic shock. Sepsis Alliance, February 7, 2022 https://www.sepsis.org/sepsisand/septic-shock.

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