IR-Med files Provisional Patent Application Covering Additional Features of its PressureSafe Device for Early Detection of Pressure Injuries

Rhea-AI Summary

IR-MED (OTCQB: IRME), a medical device innovator, has submitted a provisional patent application for its PressureSafe device, which aims to detect early-stage pressure injuries (PIs) using advanced infrared spectroscopy and AI. This development is crucial as PIs pose significant health risks, with around 60,000 related mortalities in the US annually and costs exceeding $26.8 billion. The PressureSafe device is set for usability studies in Israel, offering timely intervention data that could drastically improve patient outcomes and reduce hospital-related penalties for untreated PIs.

Positive

• Submission of a provisional patent application for PressureSafe, protecting valuable IP.
• PressureSafe device addresses a significant health issue, potentially reducing hospital costs and improving patient outcomes.
• Technology expected to provide accurate real-time information for early-stage pressure injury detection.

Negative

• Dependence on the success of usability studies and future FDA approvals for market entry.
• The company faces significant financial risks related to future funding and development efforts.

Rosh Pinna, Israel, Aug. 12, 2022 (GLOBE NEWSWIRE) -- (“IR-MED or the “Company”) (OTCQB:IRME), an innovative medical device company, developing non-invasive, real-time detection devices that utilize Infra-Red light spectroscopy (IR) and Artificial Intelligence (AR) for use by healthcare professionals, has announced that its wholly-owned subsidiary IR-Med Ltd. has submitted a new provisional patent application covering new methods relating to its non-invasive device, PressureSafe, for detecting and classifying early-stage pressure injuries (PI). The PressureSafe device is currently in the development stage and is intended to undergo a usability study in a few weeks in several locations in Israel.

The provisional patent application covers advanced methods that combine several technologies to obtain real time high accuracy data relating to suspected latent pressure injuries (PI) , measuring changes in biomarkers that are associated with Stage1 PI and deep-tissue pressure injuries (DTI). Changes in levels of biomarkers can support a healthcare professional’s decision to commence treatment for an Early-Stage PI.

PI are a major challenge for care providers throughout the world. Failure to identify and treat is potentially fatal, with an estimated 60,000 mortalities from PI in the US each year. A study published in 2019 measured the total cost of acute care attributable to Hospital Acquired Pressure Injury (HAPI) for the entire United States at over $26.8 billion (https://onlinelibrary.wiley.com/doi/pdf/10.1111/iwj.13071). PI remain a concern with regard to hospital quality in addition to being a major source of economic burden on the US health care system. It is expected that Hospitals would need to invest more in quality improvement of early detection and care for PI to avoid higher costs. In many countries, including the US, hospitals and nursing homes are penalized when failing to prevent PI while patients are in their care, including no reimbursement for the cost of treating PI.

Yoram Drucker, Vice President of Business Development and a Director, stated "The new provisional patent application was submitted to protect the Intellectual Property (IP) generated during the development of the PressureSafe device, combining several physiological parameters with non-invasive molecule measurement capabilities.”

The PressureSafe device has the potential to provide accurate and real time information regardless to the skin colors and may prevent development of Pressure Injuries where early detection and treatment by a health care professional are vital.”

About IR-MED

IR-MED, Inc., is developing a non-invasive spectrographic analysis technology platform, allowing healthcare professions to detect and measure, in real time, different molecules in the blood and in human tissue without any invasive procedures. The first product under development is a handheld optical monitoring device that is being developed to support early detection of pressure injuries (PI) to the skin and underlying tissue, regardless of skin tone and which calibrated personally to each patient’s body.

IR-MED technology is being developed to allow accurate readings of biomarkers in a non-invasive method, that may provide caregiver the optimal decision support-system in cases where uncertainties disturb physicians in their decision processes.

IR-MED holds patents protecting its innovation in the noninvasive tissue analysis, and in the modeling and analysis of subcutaneous tissue.

Safe Harbor Statement / Forward-Looking Statements

Statements included in this press release, which are not historical in nature, are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Statements relating to the future performance of IR-MED are subject to many factors including, but not limited to, the sufficiency or working capital and our ability to raise the capital needed to fund our development efforts, completion of the PressureSafe device, results of clinical/useability studies and trials, timing of product development, FDA approval/clearance of products in development, customer acceptance of our products in the market, the introduction of competitive products, the impact of any product liability or other adverse litigation, commercialization and technological difficulties, and the other risks identified in our most recent annual report on Form 10-K filed on March 31, 2022 with the Securities and Exchange Commission. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements. The forward-looking statements contained in this press release are made as of the date hereof, and we do not undertake any obligation to update any forward-looking statements, whether as a result of future events, new information, or otherwise.

Contacts
Moshe Gerber, Chief Executive Officer
Tel: +972 4 6555054

FAQ

What is the significance of IR-MED's provisional patent for the PressureSafe device?

The provisional patent protects the intellectual property of the PressureSafe technology, which aims to detect early-stage pressure injuries accurately.

How does PressureSafe impact hospital costs related to pressure injuries?

PressureSafe may help reduce costs associated with pressure injuries, which are estimated to exceed $26.8 billion annually in the US.

When will usability studies for the PressureSafe device take place?

Usability studies for the PressureSafe device are scheduled to occur in the upcoming weeks in several locations in Israel.

What health risks are associated with untreated pressure injuries?

Untreated pressure injuries can lead to severe health complications and are linked to approximately 60,000 fatalities annually in the US.

What technologies does the PressureSafe device utilize?

The PressureSafe device employs infrared light spectroscopy and artificial intelligence for real-time detection of pressure injuries.