RA'ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) (NASDAQ:IINNW), a company focused on respiratory and life-support technology, announced its intention to publish clinical results for its HYLA™ blood sensor in the fourth quarter of 2024. The sensor, which is designed for real-time, continuous blood monitoring, could potentially eliminate the need for intermittent blood samples in critical care settings.
The HYLA™ blood sensor, which clips onto patients, is intended for use during open-heart surgery and other high-risk medical procedures. It is part of the company's INSPIRA™ ART100 systems, which have received FDA 510(k) clearance for Cardiopulmonary Bypass procedures. The goal is to integrate the sensor into these existing systems and also to offer a standalone sensor variant.
Dagi Ben-Noon, CEO of Inspira Technologies, expressed confidence that the upcoming clinical results will align with the company's growth plans and attract significant interest from the medical community. He highlighted the importance of the HYLA™ blood monitoring technology and its potential market impact.
Inspira is currently expanding its blood testing facilities to expedite the development of the HYLA™ sensor. The company plans to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) in early 2025, following the expected clinical study results.
The company's product pipeline includes the INSPIRA™ ART (Gen 2) and the INSPIRA™ Cardi-ART, which are still in development and have not yet been tested on humans or approved by regulatory agencies. The INSPIRA™ ART500, featuring Adaptive Blood Oxygenation technology, is being developed to monitor blood parameters in real-time and deliver oxygen directly into the bloodstream.
Inspira's approach emphasizes collaboration with hospitals and partners to expand product offerings within the respiratory and life-support sectors. The company's efforts aim to address an estimated $59 billion annual market opportunity.
The information in this article is based on a press release statement from Inspira Technologies. The company's forward-looking statements are based on current management expectations and are subject to uncertainties that could cause actual results to differ materially. These statements have not been independently verified and should be considered in the context of the risks and uncertainties disclosed by the company.
In other recent news, Inspira Technologies has made considerable progress in the medical technology sector. The company's INSPIRA™ ART100, a Cardiopulmonary Bypass System, recently received 510(k) class II clearance from the U.S. Food and Drug Administration (FDA), marking a significant milestone. This development is part of Inspira's broader strategy to introduce the FDA-cleared INSPIRA™ ART100 system in leading hospitals in the U.S. and Israel.
Further, Inspira's new medical cart, the INSPIRA™ CART, designed for use with the INSPIRA™ ART100 system, has been listed by the FDA. The company has received an initial purchase order for five INSPIRA™ ART100 systems from Glo-Med Networks, Inc. Moreover, Inspira is also developing other products in its pipeline, such as the INSPIRA™ ART (Gen 2) and the HYLA™ blood sensor.
The company secured a direct share offering, resulting in expected proceeds of $1.65 million, which will be used for working capital and general corporate purposes. Inspira is also collaborating with Ennocure MedTech Ltd. on a new bio-electronic treatment aimed at preventing bloodstream infections. These recent developments highlight Inspira's commitment to advancing medical technology and enhancing patient care.
InvestingPro Insights
As Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN) gears up to release clinical results for its HYLA™ blood sensor, investors and industry observers are closely monitoring the company's financial health and stock performance. With a market capitalization of just over $20 million, Inspira Technologies is a small-cap company that's navigating through the competitive medical technology landscape.
One of the key InvestingPro Tips for Inspira Technologies is its ability to hold more cash than debt on its balance sheet, which can provide some financial flexibility in its operations and development efforts. However, it's also important to note that the company is quickly burning through cash, which could raise concerns about its long-term sustainability without additional funding or revenue streams.
The company's stock price has been quite volatile, reflecting a significant drop of 45% over the last three months. This could be indicative of the market's reaction to the company's financial performance or expectations surrounding its product pipeline. While Inspira Technologies does not pay dividends, which is common for growth-focused companies, investors may be looking for other signs of value, such as the potential market impact of the HYLA™ blood sensor.
From a financial perspective, Inspira Technologies is not profitable over the last twelve months, with an adjusted P/E ratio of -1.78, suggesting that the market expects future earnings to reverse the current loss-making trend. Additionally, the company's return on assets for the same period stands at -88.6%, indicating challenges in generating profits from its asset base.
For those interested in further analysis and tips on Inspira Technologies, there are additional InvestingPro Tips available, providing deeper insights into the company's financial health and stock performance. Discover more about Inspira Technologies by visiting InvestingPro.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.