ROSH PINNA, Israel, November 4th, 2026, FinanceWire

Peer-reviewed study published in the HCA Healthcare Journal of Medicine reports Phase 2 interim results of 90.0% sensitivity, 87.3% specificity and an AUC-ROC of 0.959 using a post hoc balanced classification threshold in assessing pressure injuries

Prospective pressure-injury study conducted at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak included 1,314 device scans across 219 anatomical sites, with approximately 54% of participants representing dark skin types

No device-related adverse events were identified during the pressure-injury study

Study demonstrated the investigational device’s usability and compatibility with routine pressure-injury assessment workflows in acute-care settings

IR-MED Ltd. (OTC: IRME) (the “Company” or “IR-MED”), a developer of infrared spectroscopy-based medical device technology, today announced the publication of peer-reviewed interim clinical results evaluating the Company’s Infra-Red Spectroscopy Scanner, or IRSS, the investigational device underlying its PressureSafe platform, for the assessment of pressure injuries in patients across a range of skin tones.

The original research article, titled “The Use of Infra-Red Spectroscopy to Assess Intact Skin of Various Skin Tones,” was published in the HCA Healthcare Journal of Medicine, Volume 7, Issue 5. The study evaluated the safety and performance of IR-MED’s non-invasive, machine-learning-enabled IRSS investigational device in distinguishing clinically healthy intact tissue from tissue classified by Certified Wound Ostomy Continence Nurses as a Stage 1 pressure injury or deep tissue injury.

PressureSafe is IR-MED’s proprietary platform based on the IRSS technology evaluated in the study.

• The interim Phase 2 analysis, which included nine participants and 65 anatomical sites, reported the following performance metrics using a post hoc balanced classification threshold:87.7% overall accuracy
• 90.0% sensitivity
• 87.3% specificity
• AUC-ROC of 0.959
• No device-related adverse events

The prospective, two-phase pilot device study was conducted at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak, two acute-care hospitals in San Antonio, Texas. Across both phases, 26 participants contributed 219 anatomical-site observations and 1,314 individual device scans. Approximately 54% of participants were classified as Fitzpatrick skin types IV–VI (dark skin tone). The interim Phase 2 analysis included nine participants, 65 anatomical sites and 390 individual device scans, including ten sites clinically classified as pressure injuries.

Addressing a Critical Clinical Challenge

Pressure injuries can begin beneath visually intact skin, making early tissue changes difficult to identify through conventional visual and tactile assessment alone. This challenge may be particularly significant in patients with darker skin tones, where melanin pigmentation can obscure visual indicators such as non-blanchable erythema and contribute to delayed or missed identification.

The investigational IRSS device underlying the PressureSafe platform uses diffuse-reflectance spectroscopy across visible and near-infrared wavelengths, together with a proprietary machine-learning classifier, to assess optical signals associated with tissue biomarkers and structural characteristics that may be associated with pressure injuries.

The handheld, battery-operated investigational device performs an individual scan in approximately 400 milliseconds and provides a real-time assessment intended to support clinical decision-making. The study also demonstrated the device’s usability and compatibility with routine clinical workflows in acute-care settings.

The technology underlying PressureSafe is designed to provide objective information that augments, rather than replaces, standard visual and tactile skin assessment by qualified healthcare professionals.

Study Design and Results

The study was conducted under protocol IRM-02-1123 and included two phases. Phase 1 supported IRSS device calibration and validation, clinical personnel training, safety evaluation and refinement of the machine-learning algorithm.

Phase 2, which remains ongoing, is evaluating the safety and diagnostic performance of the investigational device underlying PressureSafe against assessments performed by experienced Certified Wound Ostomy Continence Nurses.

During Phase 1, the IRSS demonstrated 81.2% accuracy, 90.5% sensitivity, 79.7% specificity and an AUC-ROC of 0.922.

Phase 1 data were subsequently used to refine the machine-learning model evaluated during Phase 2.

In the Phase 2 interim analysis, the balanced model demonstrated 87.7% accuracy, 90.0% sensitivity and 87.3% specificity. These results represented a 6.5 percentage-point improvement in accuracy and a 7.6 percentage-point improvement in specificity compared with Phase 1.

The AUC-ROC increased to 0.959, indicating strong discrimination between anatomical sites clinically classified as healthy tissue and those classified as pressure-injured tissue.

No device-related safety events were identified during either study phase, including participant discomfort, adverse tissue reactions, interference with patient-monitoring equipment or infection-transmission concerns.

“These peer-reviewed results represent an important clinical milestone for IR-MED and provide independent validation of the potential of the infrared spectroscopy and machine-learning technology underlying our PressureSafe platform,” said Dr. Yaniv Cohen, Co-Founder and Chief Scientific Officer of IR-MED.

“I would like to congratulate and thank Dr. Mary Lee Potter, the clinical research teams at Methodist Hospital Metropolitan and Methodist Hospital Stone Oak, our co-authors, and everyone who contributed to the successful completion and publication of this important research. Their dedication and clinical expertise were instrumental in advancing this study.”

“The improvement observed in Phase 2 highlights the potential of our technology to learn from high-quality clinical data and enhance its diagnostic performance. Most importantly, the study supports our mission to provide healthcare professionals with an objective, rapid and non-invasive tool that may strengthen pressure-injury assessment across diverse patient populations and help address a persistent healthcare equity challenge.”

Dr. Mary Lee Potter, PhD, MBA, RN, CWOCN, the study’s principal investigator and lead author, commented:

“Early-stage pressure injuries and deep tissue injuries can be difficult to identify, particularly when tissue damage develops beneath intact skin or when visual signs are less apparent. The interim findings demonstrate promising agreement between the investigational infrared spectroscopy scanner underlying PressureSafe and assessments performed by experienced wound-care clinicians.”

“The study also supports the feasibility of using the device across a range of skin phototypes and its compatibility with routine acute-care clinical workflows. Continued enrollment will allow us to further evaluate performance across skin-tone groups and anatomical locations.”

Next Steps

Phase 2 enrollment and data collection remain ongoing, with completion currently expected by March 2027. Continued enrollment is intended to expand the clinical dataset, improve the precision of performance estimates and further evaluate the performance of the IRSS technology underlying PressureSafe across different skin-tone groups and anatomical sites.

The published study concluded that the interim results demonstrated promising anatomical-site agreement between the IRSS and the clinical classification of healthy versus pressure-injured intact tissue, with no device-related adverse events identified.

Full Article

Potter MLA, Sosa S, Polm C, et al. The Use of Infra-Red Spectroscopy to Assess Intact Skin of Various Skin Tones. HCA Healthcare Journal of Medicine. 2026;7(5), Article 19. DOI: 10.36518/2689-0216.2573.

The full peer-reviewed article is available through the HCA Healthcare Journal of Medicine:

Read the full article

About IR-MED Ltd.

IR-MED Ltd. is developing a cutting-edge infrared spectroscopy and AI analysis platform technology as a basis for point-of-care decision-support devices. The infrared spectroscopy technology allows harmless and non-invasive gathering of bio-information from patient blood and tissue. That data is then processed by the Company’s AI-based system to provide healthcare professionals with decision support in the assessment of various medical conditions.

PressureSafe, the Company’s lead platform product, is based on the IRSS technology evaluated in the published study. It is a handheld device designed to support the assessment of pressure injuries affecting skin and underlying tissue, regardless of patient skin tone. IR-MED holds patents protecting its innovations in non-invasive tissue assessment.

For more information, visit: www.ir-medical.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws.

Statements that are not statements of historical fact, including statements regarding the clinical performance, safety, continued development, regulatory pathway, commercialization and potential clinical benefits of IR-MED’s IRSS technology and PressureSafe platform; the expected timing and completion of Phase 2 enrollment and data collection; the collection of additional clinical data; future performance across different skin-tone groups and anatomical sites; improvements in machine-learning performance; and the potential adoption or commercial acceptance of the Company’s technology; the potential clinical utility of the technology; the ability to replicate or improve upon the interim clinical results in larger patient populations; the ability to demonstrate consistent performance across different skin-tone groups and anatomical sites; and the Company’s ability to obtain any required regulatory authorizations; are forward-looking statements.

These statements are based on management’s current expectations and are subject to risks and uncertainties that could cause actual results to differ materially, including clinical trial outcomes, the ability to complete the study within the anticipated timeline, regulatory requirements and delays, the need for additional studies or data, product development and manufacturing risks, competition, market acceptance, availability of financing and general economic conditions.

IR-MED undertakes no obligation to publicly update or revise any forward-looking statements, except as required by applicable law.

Website: www.ir-medical.com

Contact

Investor & Media Contact
IR-MED Ltd.
contact@ir-medical.com

San Francisco, CA, November 3rd, 2026, ZEX PR WIRE, David Rhoads, a cybersecurity expert based in San Jose with 15 years of experience, is highlighting the importance of preparing businesses for cyber incidents. As companies become more dependent on digital systems, security breaches can interrupt essential operations. According to Rhoads, businesses need clear plans to manage these risks before an attack occurs.

A cyberattack can bring business operations to a standstill. Employees may lose access to essential files. Customers may be unable to use online services. Financial transactions may also be delayed.

According to Rhoads, businesses should begin by identifying the operations they cannot afford to lose. This includes determining which systems are essential and how long the company could function without them. Such an assessment helps businesses prioritize their security investments. It also allows managers to prepare for disruptions that could affect revenue, customer service, and daily operations.

Rhoads emphasizes that cybersecurity planning should involve business leaders as well as technical teams. Management needs to understand the potential consequences of an attack. It must also ensure that employees know how to respond when problems arise.

Many cyber incidents exploit weaknesses that businesses could have addressed earlier. Outdated software, weak passwords, and poorly managed access permissions can expose company systems to attack.

Rhoads points to regular security assessments as an important part of preparedness. These assessments help businesses identify vulnerabilities and decide which ones require immediate attention.

Companies should install security updates promptly. They should also restrict access to sensitive information. Employees should only have permission to access the systems and data required for their roles.

Artificial intelligence has added another challenge. Cybercriminals can use AI to create convincing phishing messages and automate parts of their attacks. These techniques can make fraudulent activity harder to recognize.

Rhoads stresses the need for businesses to review their security measures regularly. Organizations cannot assume that protections designed for yesterday’s threats will address tomorrow’s risks. Routine assessments can help identify gaps before attackers exploit them.

Employees play an important role in protecting business systems. A single careless action can expose sensitive information or provide attackers with unauthorized access. Rhoads believes employee awareness should form part of every organization’s cybersecurity strategy. Workers need to recognize suspicious messages and understand how to handle unexpected requests for confidential information.

Training should also explain how employees can report potential security problems. Clear reporting procedures allow technical teams to investigate concerns before they escalate.

Businesses can reinforce these lessons through practical exercises. Simulated phishing tests, for example, can help identify areas where additional training is needed.

According to Rhoads, security awareness should be an ongoing effort rather than a one-time exercise. Regular training helps employees remain alert as threats and attack methods change.

Even businesses with strong security measures can experience cyberattacks. Having a response plan can help limit the damage. Rhoads highlights the importance of assigning clear responsibilities before an incident occurs. Employees and technical teams should know who makes decisions, who investigates the problem, and who communicates with affected stakeholders.

An incident response plan should outline how to identify suspicious activity and isolate affected systems. It should also explain how to protect relevant evidence and restore normal operations.

Testing these procedures is equally important. Tabletop exercises allow teams to work through simulated cyber incidents. They can reveal communication gaps and unclear responsibilities before a real emergency occurs. Rhoads notes that confusion during an attack can waste valuable time. Businesses that establish procedures in advance are better prepared to make decisions under pressure.

Containing an attack is only part of the response. Businesses must also restore their systems and resume essential activities. Rhoads identifies secure data backups as one important element of recovery planning. Companies should protect backup copies from unauthorized access. They should also test their recovery procedures to ensure that information can be restored when needed.

Businesses should establish priorities for bringing systems back online. Critical services may need attention before less essential applications. This approach can help reduce unnecessary delays.

Alternative working arrangements may also prove useful. Some organizations may need manual procedures while their systems remain unavailable. Others may require backup communication channels to maintain contact with customers and employees.

According to Rhoads, recovery planning should reflect the specific needs of each business. A practical plan must account for the systems, information, and services that keep the organization running.

Cybersecurity preparedness requires regular attention. Businesses should review their security controls, update response plans, and address newly identified weaknesses. Rhoads encourages organizations to view preparedness as an ongoing responsibility. Cyber threats continue to evolve, and security measures must keep pace. Waiting until an attack occurs can leave businesses scrambling to make critical decisions.

By identifying vulnerabilities, training employees, and preparing recovery procedures, companies can improve their ability to withstand cyber incidents. These steps cannot eliminate every risk. However, they can help limit disruption and support a faster return to normal operations.

For Rhoads, the goal is to help businesses approach cybersecurity with greater foresight. Advance planning gives organizations a clearer path to follow when unexpected incidents threaten their operations.

San Francisco, CA, November 3rd, 2026, ZEX PR WIRE, Prosperity Partners LLC, a private stock trading consultancy focused on small-cap equities, is examining how premarket price activity can help traders assess potential opportunities before the regular trading session begins. The company emphasizes the importance of evaluating early price movements alongside trading volume, technical levels, and broader market conditions rather than treating premarket gains as a reliable indication of how a stock will perform after the opening bell.

Premarket trading can offer an early view of market interest in a stock. However, activity before the regular session often occurs under different conditions, including lower trading volume and wider bid-ask spreads. These factors can make price movements less reliable and complicate trade execution. For traders focused on small-cap stocks, understanding these limitations can be an important part of preparing for the trading day.

Small-cap stocks can experience substantial price changes before the regular market opens. Company announcements, earnings releases, regulatory developments, and shifts in investor sentiment can all contribute to increased activity. In some cases, a stock may rise sharply as traders respond to new information. In others, a price move may reflect limited trading activity rather than sustained demand.

Prosperity Partners emphasizes the importance of examining the circumstances behind these movements. A significant percentage gain may attract attention, but the size of the move alone does not establish whether a stock presents a viable trading opportunity. Traders also need to consider the volume supporting the move, the location of the current price relative to established technical levels, and whether the underlying catalyst offers a clear explanation for the activity.

This assessment can help traders distinguish between stocks showing signs of sustained interest and those experiencing temporary price fluctuations. It can also help them avoid making decisions based solely on rankings, headlines, or the fear of missing an early move.

Trading volume is one factor traders can examine when assessing premarket activity. A price increase accompanied by meaningful participation may warrant further investigation, while a sharp move on limited volume can be more difficult to interpret. Neither situation guarantees a particular outcome, but volume provides context that price alone cannot supply.

Technical levels offer another reference point. Previous highs, support and resistance areas, and anticipated breakout levels can help traders evaluate where a stock stands in relation to its recent price behavior. If a stock approaches a significant resistance level before the opening bell, traders may consider whether buying interest is strong enough to sustain a move beyond that level once regular trading begins.

The opening session can also produce conditions that differ considerably from those observed earlier. As more market participants enter, prices may continue moving in the same direction, reverse sharply, or fluctuate around important technical levels. A premarket breakout therefore does not necessarily confirm that a sustained trend has begun.

By evaluating price action in context, traders can develop clearer criteria for deciding whether to participate, wait for additional confirmation, or disregard a setup that does not meet their requirements.

Premarket activity presents challenges that are particularly relevant to small-cap equities. Lower liquidity can make it harder to execute orders at expected prices, while wider spreads can increase transaction costs. Prices may also change quickly when a small number of orders account for a substantial share of available trading activity.

These conditions can affect both entry and exit decisions. A trader who bases a position on a displayed premarket price may find that the available price changes before an order can be executed. Similarly, a stock that appears to offer a clear opportunity before the opening bell may experience a rapid reversal when regular-session volume increases.

Prosperity Partners’ focus on predefined entry and exit levels, technical analysis, and risk management provides a framework for evaluating these uncertainties. Rather than assuming that early price strength will continue, traders can establish the conditions under which a trade would become attractive and identify the circumstances that would invalidate the original setup.

Position sizing and potential downside also remain important considerations. A promising chart pattern does not eliminate the possibility of an adverse move, and traders must account for the possibility that an exit may not occur at the intended price.

Premarket analysis can be most useful when it informs preparation rather than dictates immediate action. Traders can use the early session to identify stocks attracting attention, review relevant company developments, mark important price levels, and develop scenarios for the regular session.

This process also creates an opportunity to define what would justify entering a trade and what evidence would suggest staying out. Such preparation can reduce the pressure to make rushed decisions when prices begin moving quickly after the opening bell.

For Prosperity Partners, the broader consideration is the relationship between market observation and disciplined execution. Early price activity can provide useful information, but its value depends on how that information is interpreted and incorporated into a wider decision-making process.

By approaching premarket movements with defined criteria and an awareness of their limitations, traders can make more deliberate assessments of small-cap opportunities. The objective is not to predict every opening move, but to evaluate available evidence, manage uncertainty, and participate selectively when market conditions align with an established trading plan. To learn more about Prosperity Partners, visit https://prosperitypartners.io/