Inspira™ Announces Breakthrough Update: Nears First FDA 510(k) Approval, 3 U.S. Patents Approved, $546 million in Summary Distribution Agreements

Rhea-AI Summary

Inspira Technologies progresses towards FDA 510(k) clearance for INSPIRA ART100 device, plans additional submissions for HYLA blood sensor and INSPIRA ART disposables. Company revolutionizing mechanical ventilator market with proprietary technologies. Signed $546 million in distribution agreements. President emphasizes the importance of HYLA blood sensor in delivering oxygen. Breakthrough patents approved by USPTO.

Positive

• Inspira Technologies is advancing towards FDA 510(k) clearance for its INSPIRA ART100 device in the first half of 2024.
• The Company plans to submit additional FDA 510(k) applications for the HYLA blood sensor in 2024 and for INSPIRA ART disposables in 2025.
• Inspira Technologies aims to revolutionize the $19 billion mechanical ventilator market with the INSPIRA ART device, equipped with innovative technologies.
• The Company has secured $546 million in pre-conditioned distribution agreements, subject to regulatory approvals.
• President Joe Hayon highlights the crucial role of the HYLA blood sensor in delivering oxygen and emphasizes the potential impact of the INSPIRA ART device in the medical field.
• Three breakthrough patents have been approved by the USPTO, with three additional patent applications pending for core technologies.

Negative

• None.

Insights

Medical Research Analyst

Progressing towards FDA 510(k) clearance is a crucial step for medical technology companies such as Inspira Technologies. The 510(k) process involves demonstrating that the medical device is as safe and effective as a legally marketed device that is not subject to premarket approval, thus allowing the company to market their device in the United States. The INSPIRA™ ART100, featuring adaptive blood oxygenation technology, could potentially disrupt the mechanical ventilator market by offering a less invasive alternative that may reduce the need for intubation.

The approval of three breakthrough patents by the USPTO not only strengthens the company’s intellectual property portfolio but also signals potential technological advancements that could be protected from direct competition. The pending patent applications, if approved, could further solidify the company's market position. The mention of $546 million in pre-conditioned summary distribution agreements indicates strong initial market interest, contingent on regulatory approval, which could translate into significant revenue streams upon successful commercialization.

Financial Analyst

The company's adoption of a 'razor-blade' business model, with plans for additional FDA submissions for the HYLA blood sensor in 2024 and INSPIRA ART disposables in 2025, suggests a strategy focused on recurring revenue through consumables. This model is often associated with high-margin sales and customer retention, as the initial device sale leads to ongoing purchases of necessary disposables. Investors should consider the potential for long-term revenue growth, especially in light of the company’s aim to revolutionize a $19 billion market.

However, it's important to note that the company's products have not yet been tested or used in humans and lack regulatory approval. This represents a significant risk, as clinical outcomes and regulatory decisions are yet to be determined. The company's valuation and stock performance could be highly volatile in response to news about regulatory progress or setbacks.

Healthcare Industry Analyst

The mechanical ventilator market is estimated at $19 billion, indicating a substantial opportunity for Inspira Technologies if their INSPIRA ART device gains market acceptance. The device's innovative features, such as real-time blood parameter scanning and direct oxygen delivery, could offer competitive advantages over traditional mechanical ventilators. These features could be particularly attractive in the current healthcare climate, which emphasizes patient comfort and reduction of invasive procedures.

However, widespread adoption hinges on clinical efficacy, ease of use and cost-effectiveness compared to existing solutions. The company's strategy to target this market will likely involve navigating complex healthcare procurement processes and demonstrating clear benefits to both patients and healthcare providers. The potential impact of these innovations on patient outcomes and healthcare costs will be a key factor in their market penetration.

RA'ANANA, Israel, Feb. 27, 2024 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (Nasdaq: IINN) (Nasdaq: IINNW) (the "Company" or "Inspira Technologies"), a breakthrough medical technology company, has announced that the Company is progressing towards 510(k) clearance from the U.S. Food & Drug Administration ("FDA") for its INSPIRA™ ART100 in the first half of 2024. The Company plans additional FDA 510(k) submissions for the HYLA blood sensor in 2024 and for INSPIRA ART disposables in 2025, as part of a scalable razor-blade business model. Three breakthrough patents have been approved by the United States Patent and Trademark Office ("USPTO") and an additional three patent applications are pending at the USPTO for certain core technologies. To date, the Company has signed $546 million in pre-conditioned summary distribution agreements, subject to regulatory approvals and authorizing authorities.

 

 

Inspira has set out in its investor presentation (link) its plans to revolutionize the $19 billion mechanical ventilator market with the next generation INSPIRA™ ART device, equipped with adaptive blood oxygenation technology. The INSPIRA ART device is the first INSPIRA device of its kind to be embedded with our proprietary HYLA blood sensor and VORTX™, an orbiting blood oxygenation delivery system. The INSPIRA ART device is designed to continuously scan blood parameters in real-time to deliver the needed oxygen volume straight into the blood, elevating patient oxygen levels within minutes.

Joe Hayon, President and Co-founder, stated: "The blood holds insights and valuable information needed when treating patients, so we believe that the HYLA blood sensor has a vital role to play while the INSPIRA ART delivers the needed oxygen straight into the blood. We vision the INSPIRA ART is expected to changing the medical landscape, with the VORTX orbiting blood oxygenation delivery system. This is the first patent of its kind, recently approved by the USPTO."

Inspira Technologies OXY B.H.N. Ltd.

Inspira™ Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough Augmented Respiration Technology (INSPIRA ART), designed to rebalance patient oxygen saturation levels. This technology potentially allows patients to remain awake during treatment while reducing the need for highly invasive, risky, and costly mechanical ventilation systems that require intubation and medically induced coma. The Company's products have not yet been tested or used in humans and has not been approved by any regulatory entity.

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 pursuant to U.S. Federal securities laws. These forward-looking statements and their implications are based on the current expectations of the management of the Company only and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. For example, the Company is using forward-looking statements when it discusses the expected timing of its 510(k) clearance from the FDA, that it intends to submit additional 510(k) submissions, the value and potential of its summary distribution agreements, each subject to regulatory approvals and authorizing authorities, the belief that the HYLA blood sensor has a vital role to play while the INSPIRA ART delivers the needed oxygen straight into the blood, the belief that the INSPIRA ART is expected to change the medical landscape, and the potential benefits of its products. These forward-looking statements and their implications are based solely on the current expectations of the Company's management and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. 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 to reflect 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 U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website, www.sec.gov.

MRK-ARS-088
Copyright © 2018-2024 Inspira Technologies OXY B.H.N. LTD. All rights reserved.

Logo: https://mma.prnewswire.com/media/1668495/Inspira_Technologies_Logo.jpg

For more details:
Adi Shmueli
Public Relations Manager
Inspira Technologies
info@inspirao2.com
+972-9-9664485 

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SOURCE Inspira Technologies

FAQ

When is Inspira Technologies expecting FDA 510(k) clearance for the INSPIRA ART100 device?

Inspira Technologies is progressing towards FDA 510(k) clearance for the INSPIRA ART100 device in the first half of 2024.

What additional FDA 510(k) submissions does Inspira Technologies plan to make in 2024 and 2025?

Inspira Technologies plans to submit additional FDA 510(k) applications for the HYLA blood sensor in 2024 and for INSPIRA ART disposables in 2025.

How does Inspira Technologies aim to revolutionize the medical ventilator market?

Inspira Technologies aims to revolutionize the $19 billion mechanical ventilator market with the next-generation INSPIRA ART device, equipped with innovative technologies.

What is the total value of distribution agreements signed by Inspira Technologies?

Inspira Technologies has signed $546 million in pre-conditioned distribution agreements, subject to regulatory approvals.

What role does the HYLA blood sensor play in delivering oxygen according to President Joe Hayon?

President Joe Hayon emphasizes the vital role of the HYLA blood sensor in delivering oxygen needed by patients.

How many patents have been approved by the USPTO for Inspira Technologies?

Three breakthrough patents have been approved by the USPTO for Inspira Technologies, with three additional patent applications pending.