Inspira Technologies Releases CEO Update: Major Milestones Signal Next-Level Respiratory Care

Rhea-AI Summary

Inspira Technologies (NASDAQ: IINN) CEO Dagi Ben Noon shared a comprehensive update on the company's progress in revolutionizing respiratory care. The company's flagship product, the INSPIRA ART500, aims to provide an alternative to mechanical ventilation for Acute Respiratory Failure patients.

Key developments include:

• The INSPIRA ART100 system received FDA clearance in 2024 for Cardiopulmonary Bypass blood circulation
• The HYLA Blood Sensor is targeting FDA submission in H2-2025
• A Single-Use Patient Kit is planned for 2025/2026 FDA submissions
• The INSPIRA ART500 FDA submission is projected within the next 18 months

The company is targeting the $19 billion global mechanical ventilation market and expects to receive a prepayment from its U.S. distributor for INSPIRA ART100 systems. The company is focusing its resources on accelerating the development of the INSPIRA ART500 system while exploring strategic distribution partnerships in Latam and Asia.

Positive

• FDA clearance already obtained for INSPIRA ART100 in 2024
• Multiple product submissions planned for FDA approval in next 18 months
• Targeting large $19B global mechanical ventilation market
• Imminent prepayment expected from U.S. distributor
• Strategic expansion planned in Latam and Asia markets

Negative

• No current revenue or sales figures disclosed
• Heavy focus on single product (ART500) could pose concentration risk
• Multiple pending FDA approvals create regulatory uncertainty
• Significant resources required for planned market expansion

Insights

Financial Analyst

Inspira Technologies' CEO letter reveals several key developments that signal momentum in its respiratory care product pipeline. The most concrete milestone is the FDA clearance of the INSPIRA ART100 platform in 2024, which has begun deployment in select U.S. centers for clinical evaluation. This establishes regulatory validation for the company's underlying technology platform.

Financially relevant is the disclosure that Inspira expects to receive a prepayment from its U.S. distributor for INSPIRA ART100 systems in the coming weeks. While no specific revenue figures are provided, this indicates the beginning of commercialization and potential near-term cash flow.

The company's ambitious target of the $19 billion global mechanical ventilation market shows substantial revenue potential if successful. Their strategy involves replacing a portion of the estimated 100,000 ventilators in the U.S. market with their less invasive alternative.

Most of Inspira's product pipeline remains in development with ambitious but uncertain timelines: their flagship INSPIRA ART500 system has a planned FDA submission within 18 months, their HYLA Blood Sensor is targeted for FDA submission in H2-2025, and their Single-Use Patient Kit is planned for 2025/2026 submissions.

The company is focusing its financial resources primarily on accelerating development of the INSPIRA ART500, which suggests careful cash management but also concentration risk on the success of this primary product.

Medical Technology Specialist

Inspira Technologies is developing a potentially disruptive platform in critical respiratory care, with the primary innovation being their non-invasive approach compared to traditional mechanical ventilation. The INSPIRA ART500 system aims to elevate oxygen levels in patients with Acute Respiratory Failure without invasive mechanical ventilation—a significant clinical advantage if proven effective.

What separates this technology from conventional approaches is the patient-centered design allowing patients to remain awake and engaged during treatment, potentially reducing complications associated with sedation and intubation. The integrated HYLA Blood Sensor would eliminate routine blood draws, providing continuous monitoring—a meaningful workflow improvement for clinical staff and comfort enhancement for patients.

From a technological standpoint, Inspira has built a foundation with the FDA-cleared ART100 system for cardiopulmonary bypass applications, validating core elements of their technology platform. This regulatory clearance represents a significant de-risking event for their broader technology ecosystem.

The system's modular approach with disposable Single-Use Patient Kits suggests a recurring revenue model typical of successful medical device companies. However, the timeline for ART500 FDA submission within 18 months and other components in 2025/2026 indicates that full commercial realization remains years away.

Clinical adoption will ultimately depend on published efficacy data and cost-effectiveness compared to existing ventilation methods—neither of which are addressed in detail in this update.

Letter from the CEO / March 14, 2025

RA'ANANA, Israel, March 14, 2025 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. ("Inspira," "Inspira Technologies" or the "Company") (Nasdaq: IINN), a pioneering force in the evolution of respiratory support and real-time blood-monitoring technologies, is pleased to share this update to shareholders from its Chief Executive Officer, Director, and Co-founder, Mr. Dagi Ben Noon.

Dear Valued Shareholders,

We founded Inspira Technologies with a bold vision: to radically transform life-support for the millions of patients who each year face the harsh realities of mechanical ventilation. Today, I believe that the INSPIRA ART500 system we are developing stands poised to become the breakthrough solution that could profoundly reshape respiratory care.

In this letter, I want to provide my perspective on some of our recent achievements, how they connect to our strategic direction and long term vision, and some details on our upcoming roadmap.

1. INSPIRA ART500: A Transformational Leap in Critical Care

At the heart of our mission lies the INSPIRA ART500, a next-generation device designed to elevate oxygen levels for patients suffering from Acute Respiratory Failure - without resorting to invasive mechanical ventilation. Our aspiration is straightforward yet revolutionary: replace a significant portion of the estimated 100,000 ventilators in the U.S. with a safer, more human-centered alternative. Each INSPIRA ART500 device is expected to treat dozens of patients annually.

Over the past year, we've observed how similarly disruptive med-tech companies have generated remarkable investor enthusiasm, often driven by a confluence of regulatory achievements, compelling market demand, and strategic milestones. We believe the INSPIRA ART500 embodies that same, if not greater, potential for success. With cost control in mind, we are focusing most of the Company's financial resources on the acceleration of the disruptive INSPIRA ART500, in light of the product's potential superiority in the competitive landscape and value creation for the Company and its shareholders.

2. Multi-Pronged Technological Momentum & Accelerated Path to Market

INSPIRA ART500 is being designed to integrate multiple cutting-edge core technologies in the Company pipeline - all converging to redefine what's possible in critical care.

• INSPIRA ART100 (FDA-Cleared in 2024)
  Our proprietary hardware and software platform, already cleared by the U.S. Food and Drug Administration ("FDA) for Cardiopulmonary Bypass blood circulation and oxygenation, has begun deployment in select U.S. centers for clinical use and evaluation by medical physicians. These initial sites will target capturing real-world performance data to fuel value creation towards further deployments and business development.
• HYLA Blood Sensor (Targeted FDA Submission H2-2025)
  A unique, continuous, real-time blood-monitoring solution with the power to replace routine blood draws. Early clinical studies show strong accuracy and reliability - two factors that we expect will resonate with hospital networks worldwide.
• Single-Use Patient Kit (Planned for 2025/2026 FDA Submissions)
  Incorporating advanced technologies for use with the INSPIRA ART500, the innovative kit includes components that are in direct contact with a patient's blood. These disposable elements are being designed to enhance patient safety and streamline workflow during procedures.

Taken together, these innovations are on track for pivotal studies shortly after the planned INSPIRA ART500 FDA submission - projected within the next 18 months. We believe the synergy among these technologies could ignite a wave of adoption in intensive care units across the globe.

3. Sizable Market Opportunity & Upcoming 18-Month Revenue Forecast

The global mechanical ventilation market is estimated at $19 billion annually. In the United States alone, tens of thousands of ventilators remain the backbone of critical care for severe respiratory conditions. INSPIRA ART500 aims to become the disruptive force that addresses this massive need with a safe, patient-friendly and less invasive approach.

In the coming weeks, the Company expects to receive a prepayment from its U.S. distributor for INSPIRA ART100 systems for planned deployment in select hospitals, a milestone that management believes underscores near-term revenue potential. 

4. Roadmap of Strategic Milestones

To build on this transformative momentum, we are aligning a series of key milestones to support sustained growth:

1. Core Technologies: Focus of Company resources on the acceleration of development, regulatory and clinical efforts pertaining to the INSPIRA ART 500 system.
2. Scaling U.S. Deployment: Collaborating with top-tier clinicians and institutions to expand post-market surveillance for the INSPIRA ART100 platform, reinforcing our clinical credibility.
3. Strategic Alliances: Maintaining a resilient financial framework remains a priority. We're in discussions with prominent and global healthcare enterprises to fully capitalize on the potential of our INSPIRA ART100 product. 
4. Global Distribution Agreements: Exploring strategic distribution partnerships in Latam and Asia, leveraging strong international demand for non-invasive respiratory solutions.

5. Envisioning the Future of Critical Care

Once fully integrated, our INSPIRA ART500 is intended to be equipped with the HYLA blood sensor. The single use patient kit aims to create a new and superior standard of patient-focused care. By allowing patients to stay awake and actively involved in their own recovery, we're not merely refining mechanical ventilation - we're redefining it.

6. A Personal Invitation to Our Investors

On behalf of the entire Inspira Technologies team, I want to thank you for your unwavering support and confidence in our vision. We're determined to lead a global shift in respiratory care - one that prioritizes patient dignity and significantly reduces the complications linked to conventional ventilation.

We invite you to stand with us as we reshape the landscape of acute respiratory care for millions of patients worldwide. Together, we have the opportunity to drive a wave of positive change in an industry that's ripe for disruption.

Warm Regards,

Dagi Ben Noon
CEO, Director, and Co-founder
Inspira Technologies

About Inspira Technologies

Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART500 system also known as the INSPIRA ART aims to revolutionize critical care by enabling patients to remain awake during treatment while stabilizing oxygen levels without mechanical ventilation. The FDA-cleared INSPIRA ART100 system has received regulatory approvals for Cardiopulmonary Bypass procedures in both the U.S. and for Cardiopulmonary Bypass procedures and Extra Corporeal Membrane Oxygenation in Israel. The Company's HYLA™ blood sensor technology is designed to provide continuous, real-time blood monitoring without the need for blood draws. The Company's pipeline products, including the INSPIRA ART500, INSPIRA Cardi-ART, and HYLA blood sensor, are currently in development and have not yet received regulatory approval.

For more information, visit: 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 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 potential benefits of the Company's products and impact on repository care and the market, that the INSPIRA ART500 device is expected to treat dozens of patients annually, its belief that the INSPIRA ART500 embodies the same or greater potential as other med-tech companies, the belief that the Company's innovations are on track for pivotal studies shortly after the planned INSPIRA ART FDA submission and that synergy among these technologies could ignite a wave of adoption in intensive care units worldwide, the expected timing of the FDA submission of the ART500, the HYLA blood sensor and single-use patient kit, the estimated size of the global mechanical ventilation market, the Company's aim to disrupt the existing approach with its technology, that the Company expects to receive  prepayment from its U.S. distributor for its devices for planned deployment in hospitals, the planned integration of the Company's devices, and the Company's belief that it has the opportunity to disrupt the mechanical ventilation market. 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, 2024, filed with the U.S. Securities and Exchange Commission (the "SEC"), which is available on the SEC's website at www.sec.gov.

Company Contact

Inspira Technologies – Media Relations
Email: info@inspirao2.com
Phone: +972-9-9664485

Capital Markets & Investor Contact

Arx | Capital Markets Advisors
North American Equities Desk
inspira@arxadvisory.com

 

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SOURCE Inspira Technologies

FAQ

When is Inspira Technologies (IINN) planning to submit the INSPIRA ART500 for FDA approval?

Inspira Technologies plans to submit the INSPIRA ART500 for FDA approval within the next 18 months from March 2025.

What is the market size that Inspira Technologies (IINN) is targeting with its respiratory care solutions?

Inspira Technologies is targeting the global mechanical ventilation market, estimated at $19 billion annually.

What FDA clearances has Inspira Technologies (IINN) already received for its products?

The INSPIRA ART100 received FDA clearance in 2024 for Cardiopulmonary Bypass blood circulation and oxygenation.

When is Inspira Technologies (IINN) planning to submit its HYLA Blood Sensor for FDA approval?

Inspira Technologies is targeting FDA submission for the HYLA Blood Sensor in the second half of 2025.

What immediate revenue potential does Inspira Technologies (IINN) expect?

The company expects to receive a prepayment from its U.S. distributor for INSPIRA ART100 systems for planned deployment in select hospitals.