Inspira Technologies Reports Full Year 2024 Financial Results and Provides Business Updates
PR Newswire
RA'ANANA, Israel, March 11, 2025
Significant progress in HYLA blood sensor and INSPIRA ART core technologies
RA'ANANA, Israel, March 11, 2025 /PRNewswire/ -- Inspira$(TM)$ Technologies OXY B.H.N. Ltd. $(IINN)$ ("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(TM) 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(TM) ART core technologies, with the HYLA(TM) 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(TM) 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(TM) Blood Sensor Clinical Results: In March 2025, Inspira announced
positive results from the clinical study of its AI-powered HYLA(TM) 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 Year ended
December 31, 2024 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:
Share
capital
and
additional
Number of paid in Accumulated
shares capital 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
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March 11, 2025 08:30 ET (12:30 GMT)