By Thomas Kerr, CFA
IR-Med (OTC: IRME) released its annual 10-K filing on April 1, 2024 and the results were largely in line with expectations. The company recorded no revenues in 2023 and research and development expenses increased to $2.1 million from $1.9 million in 2022. Marketing expenses were $822,000 in 2023 compared to $759,000 in the prior year period. General and administrative expenses decreased slightly to $2.0 million compared to $2.1 billion in 2022. The net loss for the year was ($4.9) million compared to ($4.7) million in the prior year period.
The company raised $1.0 million in proceeds in 2023 from the sale of common stock and warrants. The company used ($3.3) million in cash during the full year. Cash balances as of December 31, 2023 were $767,000 and net working capital was $375,000.
The company announced that the Israeli innovation authority has recently approved a support plan in the amount of approximately $1.0 million to bring innovative products to market. 50% of this amount is in the form of a grant.
FDA Listing
On April 5, 2024, the company announced that its PressureSafe decision support device has received U.S. Food and Drug Administration (FDA) listing for the indication of pressure injuries. PressureSafe is classified as a Class I device and is exempt from 510(k) premarket submission.
Ronnie Klein, CTO and Interim CEO stated, "This regulatory milestone is a major step towards the commercial launch in the U.S. and signifies our commitment to advancing patient care and safety through cutting-edge medical devices. Following our successful usability studies for PressureSafe™ in Israel, we are expanding these studies into the U.S. and expect to commence with a major hospital network in 2024."
PressureSafe achieved 92% efficacy in the early, non-invasive detection of pressure injuries, regardless of skin color, in a study conducted in Israel with the world's second largest HMO, Clalit. Nearly 1,500 scans were performed on 154 body locations.
In the U.S. alone, 60,000 patients die every year as a direct result of pressure injuries. Patient care cost per pressure ...