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RA’ANANA, Israel - Inspira Technologies OXY B.H.N. Ltd. (NASDAQ:IINN), an innovator in respiratory support and blood-monitoring technology with a current market capitalization of $17 million, has provided an update on its strategic progress and upcoming milestones. According to InvestingPro data, the company’s stock is currently trading near its 52-week low of $0.65, reflecting recent market challenges. The company’s CEO, Dagi Ben Noon, outlined the advancements of its INSPIRA ART500 system, which is being developed to improve oxygenation for patients with Acute Respiratory Failure without the need for invasive mechanical ventilation.
The INSPIRA ART500 aims to replace a portion of the estimated 100,000 ventilators in the U.S., potentially treating dozens of patients annually with each device. The company’s strategy involves focusing financial resources on the development of the INSPIRA ART500, which they believe holds significant potential in the competitive landscape. InvestingPro analysis indicates the company is quickly burning through cash, with negative EBITDA of $11.1 million in the last twelve months.
Inspira’s technology suite includes the INSPIRA ART100, which received FDA clearance in 2024 for Cardiopulmonary Bypass procedures, and the HYLA Blood Sensor, targeted for FDA submission in the second half of 2025. The company also plans to submit a single-use patient kit for FDA approval in 2025/2026. These innovations are expected to undergo pivotal studies following the planned FDA submission of the INSPIRA ART500 within the next 18 months.
The global mechanical ventilation market is estimated at $19 billion annually. Inspira Technologies is positioning its INSPIRA ART500 as a disruptive solution in this space, with a less invasive and patient-friendly approach. The company anticipates a prepayment from its U.S. distributor for INSPIRA ART100 systems, indicating potential near-term revenue.
In the next 18 months, Inspira Technologies is aligning key milestones to support growth, including scaling U.S. deployment, forming strategic alliances, and exploring global distribution partnerships to capitalize on international demand for non-invasive respiratory solutions. With an overall Financial Health Score rated as WEAK by InvestingPro, investors seeking deeper insights into the company’s prospects can access additional ProTips and comprehensive financial metrics through an InvestingPro subscription.
The company’s vision for the future of critical care involves integrating the INSPIRA ART500 with the HYLA blood sensor and single-use patient kit, aiming to redefine patient care by allowing patients to remain awake and involved in their recovery process.
This update is based on a press release statement and contains forward-looking statements, which are subject to risks and uncertainties that could cause actual results to differ materially from those described.
In other recent news, Inspira Technologies OXY B.H.N. Ltd. has disclosed receiving a notice from Nasdaq regarding non-compliance with the minimum bid price rule. The company must maintain a closing bid price of $1.00 or more for at least 10 consecutive business days by September 8, 2025, to regain compliance. If Inspira fails to meet this requirement, it may be granted an additional 180-day period to comply, during which it could consider options like a reverse share split. Meanwhile, Inspira has announced promising initial results from a collaboration with Ennocure MedTech Ltd. Their novel bio-electronic patch demonstrated a 95% reduction in bacterial presence on porcine skin models within four hours. This technology, aimed at preventing bloodstream infections related to intravenous lines, still requires regulatory approval. Inspira continues to innovate with its respiratory support and diagnostic technologies, including the INSPIRA ART system and HYLA blood sensor technology.
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