IR-Med Reports $253.7 Million Operating Loss in Q1 2025, Prepares for Product Launch

IR-Med, Inc. has reported its financial results for the first quarter of 2025, revealing a total operating loss of $253.7 million, compared to a loss of $228.3 million in the same period of 2024. The company did not generate any revenue during this quarter, maintaining its status as a pre-revenue entity. The net loss for the period was $773,657, slightly higher than the $657,000 loss reported in the first quarter of the previous year. The increase in net loss is attributed to higher non-cash expenses related to shares issued under an equity purchase agreement, despite reductions in payroll and contractor expenses.

In terms of operational metrics, IR-Med's total assets as of March 31, 2025, stood at $124.3 million, with current assets of $81.2 million, including cash and cash equivalents of $51.1 million. The company’s liabilities totaled $617,545, leading to a stockholders' deficit of $493,000, an increase from a deficit of $294,000 at the end of 2024. The company’s accumulated deficit has now reached $17.5 million, reflecting ongoing challenges in achieving profitability.

Strategically, IR-Med has made significant progress with its product development. The company received FDA listing certification for its first device, PressureSafe™, in April 2024, and is currently preparing for its commercial launch, expected in the second half of 2025. Additionally, the company is developing a second product, DiaSafe™, aimed at assessing diabetic foot ulcers. The Israeli Innovation Authority has approved funding for this project, which includes a grant of approximately $489,035 to support its development.

Operationally, IR-Med has implemented cost-cutting measures, including salary reductions for its executives, to manage its cash flow situation. The company has also entered into an Equity Purchase Agreement with Williamsburg Venture Holdings, allowing for up to $15 million in funding over the next two years. This agreement is expected to provide necessary capital as the company continues to develop its product lines and seek regulatory approvals. However, management has expressed concerns about the company's ability to continue as a going concern without additional financing, highlighting the need for ongoing capital to support its operations and development efforts.

Looking ahead, IR-Med anticipates that its existing cash resources will be sufficient to meet operational needs through the second quarter of 2025. However, the company acknowledges the necessity of raising additional capital to fund its ongoing research and development activities, as well as to establish marketing and distribution capabilities for its products. The management remains focused on executing its business plan while navigating the challenges posed by market conditions and the competitive landscape in the medical device industry.