Inspira™ Announces 95% Accuracy Results for HYLA™ Blood Sensor, Planning FDA Submission for Clearance in 2024
- The development of the first HYLA™ variant marks a significant step towards submission under a 510(k) pathway with the U.S. FDA, expected in the second half of 2024.
- The sensor technology is designed to be integrated with the Company's INSPIRA ART100 and was submitted to the FDA in September 2023, with clearance anticipated in the first half of 2024.
- The HYLA™ Blood Sensor line is set to transform ICU operations, offering continuous, real-time blood data collection and analysis, enhancing patient care with critical insights and alerts, with the aim to improve medical procedures and device efficiency.
- None.
Insights
The recent development of Inspira Technologies' sensor technology, achieving a 95% accuracy rate relative to standard blood gas analyzers, represents a significant innovation in the field of medical device technology. The introduction of continuous, real-time blood monitoring capabilities is a notable advancement from the intermittent blood draws required by traditional systems. This technology could potentially revolutionize patient care in intensive care units by providing ongoing, accurate assessments of a patient's blood gas levels, which are critical for managing respiratory and metabolic conditions.
From a medical research perspective, the modular design and compatibility with various medical procedures, such as extracorporeal membrane oxygenation and dialysis, indicate a broad potential application. This versatility could lead to widespread adoption and integration into existing medical infrastructure. The move towards a 'razor blade business model' suggests a recurring revenue stream for Inspira, which could be financially significant given the large target market of annual open-heart surgery patients.
The announcement that Inspira Technologies is preparing to submit their HYLA™ Blood Sensor for FDA approval under the 510(k) pathway indicates a strategic move to enter the disposables market. The disposables market in healthcare is an area with high turnover and consistent demand, which could lead to a stable and growing revenue source for Inspira. The sensor's high accuracy and non-invasive nature align with current healthcare trends favoring minimally invasive procedures and patient safety.
Furthermore, the integration of this sensor with the Company's INSPIRA ART100 device, pending FDA clearance, could enhance the device's value proposition and marketability. If the technology proves to be reliable and effective in a clinical setting, it could disrupt the current standards of care in ICUs and operating rooms, potentially leading to market share gains and positive financial performance for Inspira.
The financial implications of Inspira Technologies' sensor technology innovation are multifaceted. The anticipated FDA submission and subsequent clearance could be a catalyst for the company's stock performance. Investors will likely monitor the progress of regulatory approvals closely, as these milestones are critical for the product's market entry and revenue generation. The potential entry into the disposables market could diversify Inspira's revenue streams and enhance its long-term financial stability.
It is important to note that the success of this technology will depend on several factors, including market acceptance, competitive responses and the ability of the company to scale production and distribution effectively. Investors should consider these variables when evaluating the potential impact of this development on the company's financial health and stock performance.
RA'ANANA,
The development of the first HYLA™ variant, key to this advancement, marks a significant step towards its submission under a 510(k) pathway with the
The HYLA™ Blood Sensor line (the "Blood Sensor") is set to transform intensive care unit (ICU) operations, offering continuous, real-time blood data collection and analysis. This enhances patient care with critical insights and alerts, with the aim to improve medical procedures and device efficiency.
Key features of the Blood Sensor include:
- High Accuracy: Achieves
95% accuracy relative to standard blood gas analyzers; - Non-invasive: Eliminates the need for blood draws;
- Durability: Built to handle ICU and operating room environments;
- Versatility: Compatible with various medical procedures, including: the cardio pulmonary bypass, extracorporeal membrane oxygenation, continuous renal replacement therapy, and dialysis; and
- Modular Design: Engineered to complement existing medical devices, targeting the two-million annual open-heart surgery patients globally.
In developing the HYLA™ Blood Sensor line, Inspira utilizes in-house lab testing as well as hospital collaborations for the purpose of clinical research and development. This approach has enabled to define the Blood Sensor's disposable materials and methods, with HYLA's planned razor blade business model. While primarily designed for INSPIRA ART devices, plans are underway also to offer a variant of the Blood Sensor as a standalone device.
Dagi Ben-Noon, CEO of Inspira Technologies, commented: "With our sensor technology, we are not only enriching our INSPIRA ART device line but also forging a path into the disposables market, setting the stage for groundbreaking developments in healthcare."
Inspira Technologies OXY BHN Ltd.
Inspira Technologies is leading the way in transforming life-support care. Its innovative solutions are paving the way for direct blood oxygenation, bypassing the lungs, and potentially reducing the need for traditional mechanical ventilation. Beyond this, the Company is committed to advancing blood circulation technology and incorporating AI-driven monitoring systems. These advancements are part of its strategy to offer more patient-focused, data-informed care. The integration of these technologies signifies the potential to enhance patient outcomes and streamline hospital operations, marking a new era in respiratory care.
For more information, please visit our corporate website:
https://inspira-technologies.com/
Forward-Looking Statement Disclaimer
This press release contains express or implied forward-looking statements under US Federal securities laws. These forward-looking statements and their implications are based only on the current expectations of the management of the Company. They are subject to several factors and uncertainties that could cause results to differ materially from those described in the forward-looking statements. For example, the Company uses forward-looking statements when it discusses the Company's vision to supersede traditional mechanical ventilators, the expected timeline for FDA submissions and potential FDA approvals of its devices, the expected benefits and accuracy of its devices and the belief that with this new sensor technology, it is not only enriching its ART device lineup but also forging a path into the disposables market, setting the stage for groundbreaking developments in healthcare. Except as otherwise required by law, the Company undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or the occurrence of unanticipated events. More detailed information about the risks and uncertainties affecting the Company is contained under the heading "Risk Factors" in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2022, filed with the SEC, which is available on the SEC's website, www.sec.gov.
For more details:
Public Relations Manager
Adi Shmueli
Inspira Technologies
info@inspirao2.com
+972-9-9664485
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