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Inspira Technologies Reports Full Year 2024 Financial Results and Provides Business Updates Significant progress in HYLA blood sensor and INSPIRA ART core technologies RA'ANANA, Israel

Key Takeaway: Inspira Technologies has reported its financial results for 2024, highlighting significant advancements in its core technologies, including the INSPIRA ART100 system, which has received FDA clearance. The company is preparing for deployment of this system in U.S. hospitals while also advancing its HYLA blood monitoring sensor for an anticipated FDA submission later in 2025. Despite progress, Inspira faced financial challenges, including an overall loss for the year and a growing accumulated deficit.

Market Sentiment Analysis

POSITIVE FACTORS

  • Achieved 510(k) clearance from the FDA for INSPIRA ART100 system.
  • Successful deployment of INSPIRA ART100 at Westchester Memorial Center.
  • Focus on rapid advancement of HYLA blood monitoring sensor expected for FDA submission.

CONCERNS & RISKS

  • The company reported a comprehensive loss of $11.05 million for the year.
  • Accumulated deficit increased from $55.52 million to $66.57 million.

Full Press Release Details

Inspira Technologies
Reports Full Year 2024 Financial Results and Provides Business Updates
progress in HYLA blood sensor and INSPIRA ART core technologies
RA'ANANA, Israel, March 11, 2025 -- 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
Year 2024 Financial Highlights
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
(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'
(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
Inspira Technologies - Media Relations
Phone: +972-9-9664485
Capital Markets & Investor Contact
Arx | Capital Markets Advisors
North American Equities Desk

Frequently Asked Questions

What are the key advancements made by Inspira in 2024?

Inspira achieved FDA 510(k) clearance for the INSPIRA ART100 system and advanced its HYLA blood sensor technology.

Where is the INSPIRA ART100 system being evaluated?

The INSPIRA ART100 system is being evaluated at Westchester Memorial Center, NY.

What is the goal of the HYLA blood monitoring sensor?

The HYLA blood sensor aims to enable continuous, real-time blood monitoring without blood draws.

When is the FDA submission for the HYLA sensor planned?

The FDA submission for the HYLA sensor is expected in the second half of 2025.

What was Inspira's total comprehensive loss for 2024?

Inspira reported a total comprehensive loss of $11,053,000 for the year 2024.

Last updated: Mar 11, 2025