Full Press Release Details
Technologies Reports Full Year 2023 Financial Results
Submission for approval of INSPIRA ART100
Accuracy Results for HYLA Blood Sensor Compared to Standard Blood Gas Analyzers
U.S. Patent for INSPIRA ART Medical Device
Israel, March 25, 2024 - Inspira Technologies OXY B.H.N. Ltd. (Nasdaq: IINN, IINNW) (the "Company" or "Inspira
Technologies"), a breakthrough medical technology company, today announced its financial results for the year ended December 31,
Ben-Noon, Chief Executive Officer of Inspira Technologies, commented, "In 2023, we achieved significant progress in diversifying
our business development to ensure continuous growth, reaching very important milestones that we believe will drive our next generation
innovations and market launch of our products in the near future. It's an exciting time with the U.S. Food and Drug Administration
(FDA) submission of our blood oxygenation device, the INSPIRA ART100, and with our plans to submit the HYLA blood sensor
for FDA clearance later this year. With our ground-breaking technologies and products, we are not just looking at the horizon but actively
shaping it, leveraging our proprietary technologies to make a meaningful impact."
advancing technology and development of the INSPIRA ART Gen 2 is progressing rapidly, and we eagerly anticipate the approval of
additional patents related to the device. Our orbiting blood oxygenation technology (VORTX ), currently under development, is delivering
unprecedented results, breaking through a significant technological barrier relating to eliminating pressure gradients, which plays a
dominant role in damaging red blood cells. The HYLA blood sensor is achieving even greater accuracy, and we plan to submit it
for FDA clearance later this year. The considerable interest in our systems and developments has led to the Company signing pre-conditional
summary distribution agreements totaling up to $546 million, subject to the completion of product development and regulatory approvals
and authorizing authorities, with expectations for more agreements to follow."
a business strategy perspective, we are currently focused on working with potential strategic partners, exploring avenues to harness
the strengths of large corporations alongside our Company's development and innovation capabilities."
Year 2023 Financial results
operating expenses decreased to US$12,133,000 in of the year ended December 31, 2023, from US$14,893,000 in the same period of 2022.
The decrease was mainly attributable to a decline in share-based compensation.
loss attributable to common stock shareholders was US$11,286,000 in 2023, compared with US$14,976,000 in 2022.
of December 31, 2023, the Company had cash and cash equivalents of US$7,361,000 compared to US$13,903,000 as of December 31, 2022.
of December 31, 2023, financial liabilities at fair value totaled US$1,470,000 compared to US$26,000. The financial liabilities represent
the fair value of the Company's equity liabilities.
Business Developments
December 26, 2023, the Company announced a significant advancement in its HYLA blood sensor technology by achieving 95% accuracy
compared to standard blood gas analyzers, bringing continuous and real-time blood monitoring capabilities compared to traditional blood
gas analyzer systems used in hospitals today.
November 6, 2023, the Company announced the approval of a grant from the Israeli Innovation Authority (IIA) for the groundbreaking VORTX
Disposable Blood Oxygenation Technology, being engineered to oxygenate blood and remove carbon dioxide, mitigating common fiber-membrane
complications, such as device failure, coagulation and hemolysis.
October 25, 2023, the Company announced the grant of an additional patent by the U.S. Patent and Trademark Office for its respiratory
medical device, the INSPIRA ART. The newly granted patent relates to a novel automated self-priming module designed for the INSPIRA
September 13, 2023, the Company announced it had submitted its INSPIRA ART 100, a cardio-pulmonary bypass device, to the U.S. Food and
Drug Administration (FDA) via the 510(k) pathway, with potential clearance expected during the first half of 2024 with an expected approval
timeline of approximately six months, which is expected in the first half of 2024.
August 29, 2023, the Company signed a strategic agreement with Innovimed SpA. z o.o for planned clinical trials (clinical pilot studies)
of the INSPIRA ART medical devices. As of today, the company has signed distribution agreements in Europe, North America, South
America, Israel, and the Gulf states, potentially generating over $546 million in revenues for the Company for a period of up to seven
years and subject to completion of product development and regulatory approval.
Technologies OXY B.H.N. Ltd.
Technologies is an innovative medical technology company in the respiratory treatment arena. The Company has developed a breakthrough
Augmented Respiration Technology (INSPIRA ART), designed to rebalance patient oxygen saturation levels. This technology potentially allows
patients to remain awake during treatment while reducing the need for highly invasive, risky, and costly mechanical ventilation systems
that require intubation and medically induced coma. The Company's products have not yet been tested or used in humans and has not
been approved by any regulatory entity.
more information, please visit our corporate website: https://inspira-technologies.com
Statement Disclaimer
dollars in thousands)
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| ASSETS | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | 5,041 | 6,783 | ||||||
| Cash deposits | 2,320 | 7,120 | ||||||
| Other accounts receivable | 432 | 589 | ||||||
| Total current assets | 7,793 | 14,492 | ||||||
| Non-Current Assets: | ||||||||
| Right of use assets, net | 1,011 | 1,263 | ||||||
| Property, plant and equipment, net | 506 | 411 | ||||||
| Total non-current assets | 1,517 | 1,674 | ||||||
| Total Assets | 9,310 | 16,166 |
| December 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| LIABILITIES AND SHAREHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Trade accounts payables | 198 | 152 | ||||||
| Other accounts payable | 1,026 | 1,216 | ||||||
| Lease liabilities | 290 | 268 | ||||||
| Financial Liabilities at Fair Value | 1,470 | 26 | ||||||
| Total current liabilities | 2,984 | 1,662 | ||||||
| Non-Current Liabilities: | ||||||||
| Lease liabilities | 588 | 873 | ||||||
| Total non- current liabilities | 588 | 873 | ||||||
| Shareholders' Equity: | ||||||||
| Share capital and additional paid in capital | 61,259 | 57,866 | ||||||
| Accumulated deficit | (55,521 | ) | (44,235 | ) | ||||
| Total equity | 5,738 | 13,631 | ||||||
| Total Liabilities and Shareholders' Equity | 9,310 | 16,166 |
OF COMPREHENSIVE LOSS
dollars in thousands)
| Year ended December 31, 2023 | Year ended December 31, 2022 | |||||||
| Research and development expenses | 7,320 | 8,183 | ||||||
| Sales and marketing expenses | 746 | 1,328 | ||||||
| General and administrative expenses | 4,063 | 5,375 | ||||||
| Other expenses (income) | 4 | 7 | ||||||
| Operating loss | 12,133 | 14,893 | ||||||
| Interest Income from deposits | (318 | ) | (192 | ) | ||||
| Finance expenses(income), net | (529 | ) | 275 | |||||
| Loss before tax | 11,286 | 14,976 | ||||||
| Taxes on income | - | - | ||||||
| Total comprehensive loss for the period | 11,286 | 14,976 |
OF CHANGES IN SHAREHOLDERS' EQUITY
dollars in thousands)
the year Ended December 31, 2023:
| Number of shares | Share capital and additional paid in capital | Accumulated deficit | Total | |||||||||||||
| Balance on January 01, 2023 | 11,338,940 | 57,866 | (44,235 | ) | 13,631 | |||||||||||
| Changes during the period: | ||||||||||||||||
| Issuance of shares and private warrants, net | 3,031,250 | 1,806 | - | 1,806 | ||||||||||||
| Issuance of Placement agent warrants | - | 131 | - | 131 | ||||||||||||
| Issuance of shares (pursuant to At-The-Market ("ATM") facility) | 17,566 | 26 | - | 26 | ||||||||||||
| Exercise of share-based payments | 37,972 | 3 | - | 3 | ||||||||||||
| Restricted share unit ("RSU") vesting | 1,226,448 | - | - | - | ||||||||||||
| Share-based compensation | - | 1,427 | - | 1,427 | ||||||||||||
| Comprehensive and net loss | - | - | (11,286 | ) | (11,286 | ) | ||||||||||
| Balance on December 31, 2023 | 15,652,176 | 61,259 | (55,521 | ) | 5,738 |