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)