SAN ANTONIO – February 28, 2022 – Frost & Sullivan recently analyzed the European artificial respiratory market and, based on its findings, recognizes Inspira Technologies (Nasdaq: IINN/IINNW) with the 2021 Europe Technology Innovation Leadership Award. The company provides innovative medical technologies in the respiratory care industry. Inspira’s ART system, a proprietary, early extracorporeal respiratory support system that elevates oxygen saturation levels, is designed to be a new standard of care as a second-line treatment to minimize the need for invasive mechanical ventilation (MV). The system leverages Inspira Technologies’ hemo-protective low-flow technology, which rebalances patients’ saturation levels while they are awake and spontaneously breathing.
“Inspira Technologies’ ART system differs significantly from extracorporeal membrane oxygenation (ECMO) in many areas, including its intent of use, patient population, system size, and potential risks for the patient,” noted Debarati Sengupta, Industrial Analyst at Frost & Sullivan. “Unlike standard ECMO treatment, the ART system allows for early intervention. Alternative treatments, such as invasive mechanical ventilation, can be applied alongside the ART system if a patient’s health continues to deteriorate. The ART system demonstrates the company’s excellence in innovation within the respiratory care industry.”
The company expects to reach major milestones over the next two years, including a submission of the Class II 510(k) for its’ Extracorporeal Life Support system (ECLS) in H1-2023, followed by initial market penetration confirming the company as a meaningful player within the respiratory care industry. Furthermore, the company plans to file its novel treatment, the ART system, for de-novo or PMA to the US Food and Drug Administration (FDA) in H2-2023.
A variety of ART system features set it apart from ECMO. ECMO treatment requires two large cannulas (21-25 French) single lumen cannulas used to withdraw and return 5 to 7 liters of blood per minute. In comparison, the ART treatment is designed to use one dual-lumen cannula (16 to 21 French) for withdrawing and returning 1 to 1.5 liters of blood per minute. Moreover, ECMO is a high-flow device that cannot support low-flow treatment; the ART system optimizes the effectiveness profile of the low-flow extracorporeal treatment. The ART includes a proprietary disposable support cartridge with an oxygenator, tubes, and pump-head. The cartridge is a fully sterilized, closed system that incorporates an innovative auto-priming system that prevents air embolisms and minimizes the need for perfusionists who are necessary for ECMO operation. Patients are medically induced into a coma during ECMO treatment, whereas the ART system aims to treat patients while they are awake and spontaneously breathing.
The ART system has potential advantages in 3 prospective areas:
- The Patient: There is no need for induced medical comas, allowing patients to breathe spontaneously and communicate with their surroundings. Reduces the risks and complications associated with MV.
- The Clinician: An alternative to MV when Non-Invasive Ventilation solutions don’t work, with fewer human errors and no need for ICU-trained professionals.
- The Hospital: Reduced patient load and professional staff requirements within the ICU and costs associated with mechanical ventilation (MV) complications.
“Inspira will potentially overcome the complicated setup associated with ECMO and other systems, resulting in an efficient and effective procedure that safeguards a patient’s health,” Samantha Fisher, Best Practices Research Analyst for Frost & Sullivan, remarked. “The innovation of the ART system is that it overcomes the limitations of its predecessors to deliver a less-invasive respiratory support system.”
Each year, Frost & Sullivan presents this award to the company that develops a product with innovative features and functionality that is gaining rapid acceptance in the market. The award recognizes the quality of the solution and the customer value enhancements it enables.
Frost & Sullivan Best Practices Awards recognize companies in various regional and global markets for demonstrating outstanding achievement and superior performance in leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analyses, and extensive secondary research to identify best practices in the industry.
About Inspira Technologies
Inspira Technologies is an innovative medical device company in the respiratory care industry. Inspira is developing the ART system, a cost effective early extracorporeal respiratory support system with an intent to function as an “Artificial Lung” for deteriorating respiratory patients. The ART is designed to utilize a hemo-protective flow approach aimed at rebalancing oxygen saturation levels while patients are awake and breathing, potentially minimizing the patient’s need for mechanical ventilation. The Company’s product has not yet been tested or used in humans and has not been approved by the U.S. Food and Drug Administration (FDA) or the CE or other required regulatory agencies.
For more information, please visit our corporate website: https://inspira-technologies.com/
Miri Segal, Investors Relations
The CEO of MS-IR LLC