Inspira Technologies Reports Full Year 2024 Financial Results and Provides Business Updates

Rhea-AI Summary

Inspira Technologies (NASDAQ: IINN) reported its full year 2024 financial results and business updates. The company achieved significant milestones, including FDA 510(k) clearance for its INSPIRA™ ART100 system and its deployment to Westchester Memorial Center, NY. The HYLA™ blood sensor showed promising clinical results with 96% accuracy compared to traditional analyzers.

Financial highlights for 2024 include:

• Total operating expenses decreased to $11.27M from $12.13M in 2023
• R&D expenses reduced to $6.32M from $7.32M
• G&A expenses increased to $4.19M from $4.06M
• Net loss was $11.05M compared to $11.29M in 2023
• Cash position stood at $5.78M as of December 31, 2024

Key developments include a manufacturing partnership with Zriha Medical, positive results from infection prevention technology showing 95% bacterial reduction, and new INSPIRA ART100 system enhancements for improved efficiency.

Positive

• FDA 510(k) clearance obtained for INSPIRA ART100 system
• HYLA blood sensor achieved 96% accuracy in clinical trials
• Successful deployment of ART100 system to major US hospitals
• New manufacturing partnership established with Zriha Medical
• Infection prevention technology showed 95% bacterial reduction
• Operating expenses decreased by $866,000 year-over-year

Negative

• Net loss of $11.05M in 2024
• Cash position declined from $7.36M to $5.78M
• G&A expenses increased year-over-year
• Financial liabilities at fair value increased to $1.58M from $1.47M

Insights

Financial Analyst

Inspira Technologies' 2024 financial results reveal a mixed picture with modest improvement in net loss position to $11.05 million from $11.29 million year-over-year. The company has successfully implemented cost control measures, reducing operating expenses by 7.1% to $11.27 million while maintaining focused R&D investments in core technologies.

The current cash position of $5.78 million represents a 21.5% decrease from December 2023, indicating a burn rate that could necessitate additional capital raising within 12-18 months at current spending levels. This timeline aligns with their product development roadmap, particularly the planned FDA submission for the HYLA blood sensor in H2 2025.

Most significantly, Inspira has transitioned from pure development to early commercialization with the FDA-cleared INSPIRA ART100 system now being deployed to hospitals. This represents a important inflection point typically associated with valuation reassessment in medical technology companies. The manufacturing partnership with Zriha Medical establishes a production infrastructure essential for scaling commercial operations.

While the company remains pre-revenue with continued losses, the combination of regulatory clearance, hospital deployments, and positive clinical data from the HYLA blood sensor (showing 96% accuracy) creates a favorable pathway to potential commercialization. However, execution risk remains high given the challenging market dynamics for novel medical technologies and the company's financial resources.

Medical Technology Expert

Inspira's technological developments represent meaningful advancements in critical care monitoring and support systems. The FDA 510(k) clearance for the INSPIRA ART100 system is particularly significant as it validates the technology's safety profile and opens the path to clinical adoption. The deployment to Westchester Memorial Center provides a important real-world testing environment that will generate valuable clinical feedback.

The HYLA blood sensor's clinical study results showing 96% accuracy compared to traditional blood analyzers is impressive for a non-invasive monitoring technology. The additional 92.3% accuracy for oxygen deficiency identification further strengthens its clinical utility. This dual-parameter capability positions the sensor favorably for critical care applications where continuous monitoring is essential but traditional blood draws are impractical or risky.

The modular configuration of the VORTX blood oxygenation technology represents an important advancement in extracorporeal support systems. By potentially reducing harmful effects on blood components, this technology addresses a significant clinical limitation of current oxygenation devices, which often cause hemolysis and inflammatory responses during prolonged use.

The infection prevention technology showing 95% bacterial reduction within 4 hours directly targets catheter-related bloodstream infections—a major complication in critical care with significant mortality implications. This diversification into infection control broadens Inspira's clinical applications beyond respiratory support into a high-need area with substantial market potential.

The integration of these technologies could create a comprehensive monitoring and support platform for critical care, positioning Inspira competitively in this specialized market segment.

Significant progress in HYLA blood sensor and INSPIRA ART core technologies

RA'ANANA, Israel, March 11, 2025 /PRNewswire/ -- Inspira™ Technologies OXY B.H.N. Ltd. (NASDAQ: IINN) ("Inspira" or the "Company"), a pioneer in innovative life-support and diagnostic technologies, today announced its financial results for the full year ended December 31, 2024, and provided a corporate update.

Dagi Ben-Noon, Chief Executive Officer of Inspira, commented: "2024 was a transformative year for Inspira, marked by significant technological advancements and a major regulatory milestone. We successfully obtained 510(k) clearance from the Food and Drug Administration ("FDA") for our INSPIRA™ ART100 system and began its preparation for deployment in leading hospitals in the United States. In 2025, our focus is on the rapid advancement of our flagship INSPIRA™ ART core technologies, with the HYLA™ blood monitoring sensor expected to lead the way towards our planned FDA submission for clearance in the second half of the year. We've already deployed the FDA-cleared INSPIRA ART100 system to Westchester Memorial Center, NY, for its evaluation by their team of medical experts using the device in clinical procedures pursuant to the collaboration with the hospital."

Recent Business and Operational Highlights

• FDA-Cleared System Deployment: In January 2025, Inspira delivered its FDA-cleared INSPIRA ART100 systems to Glo-Med Networks Inc. for distribution to hospitals across the east coast of the U.S., including, as reported, a cardiothoracic surgery division at a leading New York hospital ranked among the top 15 percent of cardiothoracic programs in the U.S. The deployment includes collaborative support from both parties to ensure seamless integration of this unique technology into clinical use.
• VORTX™ Technology Advancement: In January 2025, the Company unveiled a modular configuration for its VORTX blood oxygenation technology, representing a significant advancement in extracorporeal oxygenation with the potential to transform critical care practices by reducing harmful effects on blood components.
• HYLA™ Blood Sensor Clinical Results: In March 2025, Inspira announced positive results from the clinical study of its AI-powered HYLA™ blood sensor, which achieved 96% accuracy for a key parameter compared to traditional blood test analyzers. Additionally, a new indicator for identifying oxygen deficiencies demonstrated 92.3% accuracy. The clinical study, conducted at Sheba Medical Center, involved six patients undergoing open-heart surgery with the clip-on HYLA blood sensor monitoring blood parameters in real-time. The Company plans to advance with the ongoing clinical study and expects FDA submission for the first HYLA configuration in the second half of 2025.
• Manufacturing Partnership: In January 2025, the Company established a dedicated production line for a crucial flow mechanism component to be integrated into Inspira's products for use in the extracorporeal circulation of blood during the oxygenation process. The collaboration with Zriha Medical Ltd., a leading international manufacturer specializing in medical device production, enables to support scaling of production for its innovative respiratory support system and candidate technologies.
• INSPIRA ART100 System Enhancements: In January 2025, Inspira introduced new support features for the INSPIRA ART100 system designed to assist medical teams, reduce staff overhead, and improve efficiency through customizable protocols and advanced alarm troubleshooting capabilities.
• Infection Prevention Technology: In February 2025, Inspira reported positive initial results from its collaboration with Ennocure MedTech Ltd., with ex-vivo testing showing a 95% reduction in bacterial presence within 4 hours using a novel bio-electronic patch technology designed to prevent bloodstream infections.
• Leadership Strengthening: In January 2025, the Company appointed Mr. Tal Parnes as the new Chairman of the Board, bringing over three decades of experience in the medical technology and pharmaceutical sectors to enhance the Company's strategic vision and market positioning. In January 2025, the Company accepted Prof. Goldwasser's resignation from his position, which was due to personal reasons.
• Increasing Operational Efficiency: In 2024, Inspira implemented strategic cost management while maintaining focused research and development (R&D) investments and achieving significant technological advancements. The Company strategically managed R&D expenses by optimizing personnel resources, and securing government grants, all without compromising progress toward critical product milestones.

Full Year 2024 Financial Highlights

• Operating Expenses: Total operating expenses decreased to US$11,267,000 in the year ended December 31, 2024, from US$12,133,000 in the same period in 2023.
• R&D Investments: R&D expenses decreased to US$6,323,000 for the year ended December 31, 2024, from US$7,320,000 in the same period in 2023. The decrease was primarily attributable to the reflection of the exchange rate on salary and related expenses, changes in the Company's staffing and development project's needs, and an Israel Innovation Authority grant deducted from the R&D expenses.
• G&A Expenses: General and administrative (G&A) expenses increased to US$4,185,000 for the year ended December 31, 2024, from US$4,063,000 in the same period in 2023. The increase was primarily attributable to an increase in professional fees, salary and related expenses and share-based compensation.
• Sales and Marketing: Sales and marketing (S&M) expenses increased to US$754,000 for the year ended December 31, 2024, from US$746,000 in the same period in 2023. The increase is attributable to an increase in salary and related expenses and share-based compensation that is offset by decrease in professional fees paid for projects related to digital marketing and media materials.
• Net Loss: Net loss attributable to ordinary shareholders was US$11,053,000 in 2024, compared with US$11,286,000 in 2023.
• Cash Position: As of December 31, 2024, the Company had cash, cash equivalents and deposits of US$5,779,000 compared to US$7,361,000 as of December 31, 2023, providing financial stability to support ongoing product development and upcoming regulatory submissions.
• Financial Liabilities: As of December 31, 2024, financial liabilities at fair value totaled US$1,575,000 compared to US$1,470,000. The financial liabilities represent the fair value of the Company's equity liabilities.

About Inspira Technologies

Inspira Technologies is developing innovative respiratory support and diagnostics technologies. The Company's flagship INSPIRA ART system 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 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 ART (Gen 2), 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 its products, the expected timing of its FDA submissions, the expected results and impact of its clinical studies, the deployment of its product, and its belief that its reduced total expenses, its strategic investments in R&D and its cash position provide it with a solid foundation to support its ongoing product development initiatives and upcoming regulatory submissions in 2025. 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.

STATEMENTS OF BALANCE SHEETS
(US dollars in thousands)

	December 31,		December 31,
	2024		2023
ASSETS
Current Assets:
Cash and cash equivalents	5,111		5,041
Cash deposits	668		2,320
Other accounts receivable	587		432
Inventory	444		-
Total current assets	6,810		7,793
Non-Current Assets:
Right of use assets, net	761		1,011
Property, plant and equipment, net	499		506
Total non-current assets	1,260		1,517
Total Assets	8,070		9,310

	December 31,		December 31,
	2024		2023
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities:
Trade accounts payables	154		198
Other accounts payable	1,364		1,026
Lease liabilities	277		290
Financial Liabilities at Fair Value	1,575		1,470
Total current liabilities	3,370		2,984
Non-Current Liabilities:
Lease liabilities	378		588
Total non- current liabilities	378		588
Shareholders' Equity:
Share capital and additional paid in capital	70,896		61,259
Accumulated deficit	(66,574)		(55,521)
Total equity	4,322		5,738
Total Liabilities and Shareholders' Equity	8,070		9,310

 

STATEMENTS OF COMPREHENSIVE LOSS
(US dollars in thousands)

	Year ended December 31, 2024		Year ended December 31, 2023
Research and development expenses	6,323		7,320
General and administrative expenses	4,185		4,063
Sales and marketing expenses	754		746
Other expenses (income)	5		4
Operating loss	11,267		12,133
Interest Income from deposits	(172)		(318)
Finance expenses(income), net	(42)		(529)
Loss before tax	11,053		11,286
Taxes on income	-		-
Total comprehensive loss for the period	11,053		11,286

 

STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
(US dollars in thousands)

For the year Ended December 31, 2024:

		Number of shares				Share capital and additional paid in capital				Accumulated deficit					Total
Balance on January 01, 2024			15,652,176				61,259					(55,521)					5,738
Changes during the period:
Issuance of ordinary shares, private warrants and Pre-funded warrants, net			6,231,169				7,679					-					7,679
Exercise of options			19,048				2					-					2
Exercise of June 2024 Pre-funded warrants into ordinary shares			1,709,760				2					-					2
Restricted share unit ("RSU") vesting			594,943				-					-					-
Issuance of ordinary Shares- advisor fees			45,000				62					-					62
Share-based compensation			-				1,892					-					1,892
Comprehensive and net loss			-				-					(11,053)					(11,053)
Balance on December 31, 2024			24,252,096				70,896					(66,574)					4,322

For More Financial Information:

For a comprehensive understanding of the Company's financial reports and related management's discussion and analysis for applicable periods, please review the company's annual report on Form 20-F for the fiscal year ended December 31, 2024, available on the company's EDGAR profile at https://www.sec.gov/edgar 

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

What were the clinical results of IINN's HYLA blood sensor in 2024?

The HYLA blood sensor achieved 96% accuracy compared to traditional blood test analyzers and demonstrated 92.3% accuracy in identifying oxygen deficiencies during clinical trials at Sheba Medical Center.

How much did Inspira Technologies (IINN) reduce its operating expenses in 2024?

IINN's total operating expenses decreased from $12.13M in 2023 to $11.27M in 2024, representing a reduction of approximately $866,000.

When will IINN submit the HYLA blood sensor for FDA clearance?

Inspira Technologies plans to submit the first HYLA configuration for FDA clearance in the second half of 2025.

What was IINN's cash position at the end of 2024?

As of December 31, 2024, IINN had cash, cash equivalents and deposits of $5.78M, down from $7.36M at the end of 2023.

What results did IINN's infection prevention technology achieve in 2025?

In February 2025, ex-vivo testing of IINN's bio-electronic patch technology showed a 95% reduction in bacterial presence within 4 hours.