IR MEDICAL

IR-MED Reports 92% Efficacy for PressureSafe™ in Early, Non-Invasive, Skin Color Agnostic Detection of Pressure Injuries

tamar IR — Tue, 20 Feb 2024 14:47:44 +0000

Incidence of pressure injuries reduced by 50% during the study period
As a decision support device, PressureSafe, can support early detection of pressure injuries, potentially setting a new standard of care to address a healthcare challenge that costs $26.8 billion annually in the U.S. alone
Data reported at NPIAP 2024 Annual Conference to key thought leaders and practitioners in the field of pressure injuries
Nearly 1,500 PressureSafe scans on 154 body locations conducted at hospitals owned by the world’s 2^nd largest HMO

Rosh Pina, Israel, Feb. 20, 2024 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive artificial intelligence (AI) driven spectrographic analysis technology platform to address significant healthcare needs, today reported highly favorable proof of efficacy data for PressureSafe, its decision support device which uses infra-red spectroscopy combined with an AI-based algorithm, for the early, non-invasive, and skin color agnostic detection of pressure injuries.

Data from the study conducted at two medical centers owned by Clalit, the world’s second largest health maintenance organization (HMO) and the largest in Israel, Beit Rivka Hospital and Rabin Medical Center, presented at the National Pressure Injury Advisory Panel (NPIAP) 2024 Annual Conference on February 16 and 17, 2024 in San Antonio, Texas. Dr. Gal Maydan of Beit Rivka Hospital Geriatric Rehabilitation Center, and Principal Investigator of the study, presented the data in a poster titled “Near Infra-Red Spectroscopy for early detection of stage 1 pressure injury and deep tissue injury – clinical study results”.

While the current standard of care for the detection of pressure injuries is visual and tactile clinical evaluation, physiological changes below the skin’s surface, including inflammation and interstitial fluids precede changes on the surface. The objective of the study was to evaluate the sensitivity, specificity, and usability of PressureSafe to detect early-stage pressure injuries Stage 1 / suspected deep tissue injuries (sDTI) before skin breakage, compared to standard of care. PressureSafe detected biomarkers and changes in tissue structures under the skin’s surface as they relate to pressure injuries.

The 14-day efficacy portion of the single arm, bi-center study evaluated 38 patients at high risk of pressure injury development. A total of 924 scans were conducted on 154 body locations. Nurses conducting the scans were blinded to PressureSafe’s results, which were encrypted. PressureSafe detected Stage 1 / sDTI pressure injuries with 92% sensitivity and 88% specificity. Additional portions of the study evaluated safety, as well as device calibration and validation. Total data from 66 patients was obtained for safety analysis and no safety signals were identified in 1,493 scans. Based on these data, the study concluded that PressureSafe is a safe, efficient, and valuable method for early detection of pressure injuries.

“These data demonstrate that PressureSafe, an IR-spectroscopy scanner combined with an AI- based algorithm, provides a very good option for detection of early stage pressure injuries – hence facilitating early treatment that is crucial for prevention of complications. This is especially important in diagnosis of people with darker skin colors, where visual and tactile inspection alone may miss early detection,” stated Dr. Maydan. “Our medical staff, including nurses, found the device very easy to use. During the study period the incidence of pressure injuries was reduced by approximately 50% compared to the same period before the study. It is time to integrate advanced technology to augment standard human visual and tactile perception in order to minimize the harmful consequences of pressure injuries. PressureSafe is a device that I can see being used for exactly this purpose.”

Tzur Di-Cori, IR-MED’s CEO, commented, “This robust and impressive data from our collaborative study with Clalit comes at an ideal time as we prepare to enter the U.S. market with PressureSafe. We believe the 92% efficacy findings in real-world data settings at two world-class hospitals will be a big factor in driving adoption in the U.S. We thank Dr. Maydan and his entire team at Clalit for leading this study.”

Yaniv Cohen, PHD, IR-MED’s CSO, added, “In addition to this study in Israel, we look forward to starting a usability study for PressureSafe in the U.S. in collaboration with Methodist Healthcare of San Antonio in the coming months. The Methodist study aims to enroll approximately 50% of patients with darker skin tones in order produce comparative data for PressureSafe’s accuracy as a decision support device in people with lighter and darker skin tones. This is a very important priority for IR-MED, as published studies show black patients in the U.S. suffer disproportionally from pressure injuries, which are harder to detect visually in darker skin tones.”

IR-MED’s clinical and execute team participated at NPIAP 2024 where they demonstrated PressureSafe at booth #102.

The poster outlined several advantages of the PressureSafe technology including:

Non-invasive, multi-biomarker analysis
Scans for changes at tissue structure under the skin’s surface
Effective for all skin tones
AI-based algorithm
Real-time analysis at the point-of-care
Personalized medical device
Cloud based
Harmless infra-red light

About PressureSafe

PressureSafe, an innovative non-invasive medical device that uses infrared optical spectroscopy and AI, is designed to effectively detect early-stage pressure injuries for all skin tones. Pressure injuries cost the U.S. healthcare system $26.8 billion and lead to 60,000 deaths annually. PressureSafe was found to be over 90% accurate in detecting pressure injuries based on interim results from a multicenter study. The skin-color agnostic device effectively addresses equity in healthcare by using infrared light to detect biomarker changes below the skin’s surface.

About IR-MED

IR-MED Inc. is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without invasive procedures. PressureSafe, 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 as it calibrates personally to each patient’s skin.

IR-MED’s 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 technology and innovations in the noninvasive tissue analysis, and in the modeling and analysis of subcutaneous tissue.

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use.

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. For example, IR-Med is using forward-looking statements when it discusses the parameters and timing of the study, the expected timing of FDA approval, the potential benefits from its PressureSafe product and the expected timing of the release of its useability study conducted in Israel. 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 development and design of 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 29, 2023 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.

Contact:
Sharon Levkoviz, Chief Financial Officer
Tel: +972 (0) 4 6555054

IR-Med, Inc.Non-Invasive, Skin Color Agnostic Detection of Pressure Injuries

The post IR-MED Reports 92% Efficacy for PressureSafe™ in Early, Non-Invasive, Skin Color Agnostic Detection of Pressure Injuries appeared first on IR MEDICAL.

IR-MED to Report New Clinical Efficacy Data for Detection of Pressure Injuries with its AI- Based PressureSafe™ Device at NPIAP 2024 Annual Conference on February 16

tamar IR — Tue, 13 Feb 2024 09:13:03 +0000

Final results to be reported from a study conducted at two medical centers owned by Clalit, the world’s second largest health maintenance organization (HMO) and the largest in Israel
PressureSafe, for the detection of pressure injuries, addresses a healthcare challenge that costs $26.8 billion and causes 60,000 deaths annually in the U.S. alone

Rosh Pina, Israel, Feb. 13, 2024 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive artificial intelligence (AI) driven spectrographic analysis technology platform to address significant healthcare needs, announced today that final data from a study conducted at two medical centers, Beit Rivka Hospital, and Rabin Medical Center, both in Petah Tikva and owned by Clalit, the world’s second largest health maintenance organization (HMO) and the largest in Israel, will be presented at the National Pressure Injury Advisory Panel (NPIAP) 2024 Annual Conference which will take place in San Antonio, Texas on February 16-17, 2024. The study’s Principal Investigator, Dr. Gal Maydan, of Beit Rivka Hospital Geriatric Rehabilitation Center, will present the data in a poster titled “Near Infra-Red Spectroscopy for early detection of stage 1 pressure injury and deep tissue injury – clinical study results”.

The single arm, bi-center, open label, safety and efficacy study evaluated PressureSafe , IR-MED’s decision support device, which uses infra-red spectroscopy combined with an AI-based algorithm to diagnose Stage 1 pressure injuries, compared to standard of care visual and tactile inspection.

IR-MED’s clinical and execute team will demonstrate PressureSafe at booth #102 at NPIAP 2024, which is attended by the world’s top thought leaders and practitioners in the prevention and treatment of pressure injuries.

“We are eager to share the results coming out of this collaborative study with Clalit, where real-world data was gathered at two hospitals, with hundreds of PressureSafe scans conducted on patients by hospital nurses and staff. We are grateful to the entire team at Clalit and to Dr. Gal Maydan for leading the study,” stated Tzur Di-Cori, IR-MED’s CEO. “PressureSafe’s non-invasive, skin color agnostic approach to detecting early-stage pressure injuries has the potential to significantly diminish the incidence pressure injuries and corresponding human suffering and medical costs.”

PressureSafe, an innovative non-invasive medical device that uses infrared optical spectroscopy and an AI-based algorithm, is designed to effectively detect early-stage pressure injuries for all skin tones. Pressure injuries cost the U.S. healthcare system $26.8 billion and lead to 60,000 deaths annually. PressureSafe was found to be over 90% accurate in detecting pressure injuries based on interim results from a multicenter study. Since Infra Read is agnostic to skin color the device shall effectively address equity in healthcare by using infrared light to detect biomarker changes below the skin’s surface.

About IR-MED

IR-MED Inc. is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professionals to detect, measure, and monitor, in real-time, different molecules in the blood, in human tissue, and in body fluids without invasive procedures. PressureSafe, 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 as it calibrates personally to each patient’s skin.

IR-MED’s 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 technology and innovations in the noninvasive tissue analysis, and in the modeling and analysis of subcutaneous tissue.

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use.

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. For example, IR-Med is using forward-looking statements when it discusses that final data from its study conducted at two medical centers, Beit Rivka Hospital and Rabin Medical Center, will be presented at the NPIAP 2024; that PressureSafe’s non-invasive, skin color agnostic approach to detecting early-stage pressure injuries has the potential to significantly diminish the incidence pressure injuries and corresponding human suffering and medical costs. 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 development and design of 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 29, 2023 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.

Contact:

Sharon Levkoviz, Chief Financial Officer
Tel: +972 (0) 4 6555054

The post IR-MED to Report New Clinical Efficacy Data for Detection of Pressure Injuries with its AI- Based PressureSafe™ Device at NPIAP 2024 Annual Conference on February 16 appeared first on IR MEDICAL.

AI-Driven Healthcare Revolution

tamar IR — Sun, 04 Feb 2024 17:22:49 +0000

Published at Journal Asian Hospital & Healthcare Management
issue 63 , February 2024

Transforming Pressure Injury Detection

Pressure injuries are a global healthcare concern leading to significant suffering and healthcare costs. Recent advancements in biotechnology and AI have emerged as promising tools in early pressure injury detection and prevention. AI, combined with non-invasive Infra Red subepidermal biomarker detection, can enhance healthcare practices for pressure injuries, leading to improved outcomes.

Pressure injuries are a persistent healthcare challenge worldwide, causing immense suffering to affected individuals and imposing substantial economic burdens on healthcare systems. These wounds result from prolonged pressure on the skin, frequently affecting immobile or bedridden patients. Most pressure injuries occur over bony prominences, such as heels and sacrum, where there is compressed or diminished tissue. Early detection and timely intervention are critical in mitigating the impact of pressure injuries.

Currently, visual inspection is used to detect and classify pressure injuries according to depth, width, degree of tissue loss and presence of granulated tissue. However, these traditional detection methods can suffer from subjectivity and error. In recent years, biotechnology and AI have emerged as potential game-changers in the realm of pressure injury management.

The transformative potential of AI, along with sub-epidermal biomarker detection, can improve healthcare practices for pressure injuries, with a focus on enhancing patient outcomes, improving equitable treatment, and reducing healthcare costs.

The Global Burden of Pressure Injuries

Pressure injuries are a global healthcare concern with a substantial incidence rate. According to a meta-analysis published in the International Journal of Nursing Studies, one in ten adults admitted to hospitals are affected. Another article published in BMJ Open Quality states hospital-acquired pressure injury incidence ranges from between 18.1% to 26%. In the U.S. alone, where 2.5 million people develop pressure injuries each year, 60,000 people die as a direct result of these injuries according to data from the National Pressure Injury Advisory Panel. Life threatening conditions resulting from pressure injuries include:

Infections: Pressure injuries can become infected, leading to complications such as cellulitis, an infection of the skin and connected soft tissues, and sepsis, a potentially life-threatening infection of the blood. Pressure sores can also burrow into joints and bones, causing bone and joint infections that impact the function of the joints.
Cancer: Long-term wounds that don’t heal can lead to squamous cell carcinoma.
Damage to Muscle, Bone, or Joints: The damage from pressure injuries can extend to the muscle, bone, or joints. This can lead to a serious infection of the bone, known as osteomyelitis.

Moreover, hospital acquired pressure injury rates are increasing while all other hospital acquired conditions are decreasing. In fact, pressure injuries occur across the healthcare spectrum in the U.S.: 10% of patients in acute care get pressure injuries; 25% of patients in long term acute care; 12% of patients in nursing homes; and 12% of patients in rehabilitation centers, according to the National Pressure Injury Advisory Panel. These injuries are not only physically painful but also carry a significant economic burden.

The Cost of Pressure Injuries

Pressure injuries exact a substantial financial toll on healthcare systems worldwide. The cost of treating pressure injuries includes hospital stays, wound care supplies, medications, and surgical interventions when wounds become severe. According to data from the National Pressure Injury Advisory Panel, the annual cost of pressure injuries in the United States alone was $26.8 billion in 2019. Patient care cost per pressure injury ranges from $20,900 up to $151,700 in the U.S. It is one of the five most common harms experienced by patients and the second most common claim for lawsuits after wrongful death.

Major Healthcare Inequity Issue

Due to the current standard of care method of visual inspection of the skin, pressure injuries can be harder to detect in people who have darker skin. While this is certainly a global challenge, the disparity is perhaps most evident in the U.S. which has one of the most diverse populations on the planet. According to a study published in Wounds, Research shows that people with dark skin tones in the U.S. suffer from pressure injury more than twice as much as those with lighter skin. They have higher pressure injury rates, higher risks of mortality from pressure injuries, and more severe pressure injuries. While white patients had the lowest incidence of pressure injuries, among all racial and ethnic groups in the U.S., black patients had the highest. Underscoring the need for improved skin assessment techniques for people with dark skin tones, a study in Advances in Skin & Wound Care states the diversity index in the U.S. has increased to 61.1% in 2020 and worldwide, people with dark skin tones comprise a majority of the population.

A skin-color agnostic technology that can detect pressure injuries beneath the skin’s surface, which is less influenced by the melanin content, could significantly address these challenges.

AI and Subepidermal Biomarker Detection & Analysis: A Promising Approach

AI is accelerating the pace of research, with its primary contribution being to serve as a decision support system for identification of specific disease states and their corresponding treatments. The enhanced capabilities in disease testing and the determination of their causes through biomarkers have opened up new avenues for more precise diagnoses. This includes the creation of noninvasive early-stage detection tools that can influence specialist decision-making, streamline medical treatments, and reduce healthcare costs.

Furthermore, AI-driven diagnostic tools delve deep into biomaterial analysis, reaching down to the cellular level. They not only examine individual cell components but also process entire cell samples to pinpoint deficiencies and identify the most suitable treatments. This personalized approach to treatment has become a reality thanks to AI, marking an exciting development in the field of medicine.

By providing objective and precise assessments of subepidermal biomarkers, AI can significantly reduce the risk of human error and improve the accuracy of early detection across numerous diseases and conditions. AI plays a central role in not only in sending but also in analyzing data from subepidermal biomarkers. The adaptability of AI to changing patient conditions enhances its predictive capabilities.

Figure 1 Infrared light harmlessly penetrates deep below the patient’s skin in less than a second. The pattern and intensity of light is captured by miniature sensors.

Figure 2 The light captured by the sensors capture bio info from targeted markers in blood and tissue.

Figure 3 Healthy and diseased tissue absorb and reflect light differently, allowing biomarker profiling.

Pressure injuries are a prime example of how AI can produce benefits in healthcare. Subepidermal biomarkers offer a promising avenue for early pressure injury detection. These biomarkers, located beneath the skin’s surface, can signal tissue damage before visible symptoms appear. Emerging research in this field demonstrates the feasibility of detecting subepidermal biomarkers, thereby enabling timely interventions to prevent bedsores.

One model for how this might work is the use of a handheld device that contains miniaturized electro-optics emitters and passive sensors that send and detect visible light and infrared light. The light can be used to acquire biological information by assessing light reflected from different layers under the skin’s surface down to the reticular dermis. Optical properties of biological tissue change the spectrum of reflected or absorbed light in accordance with the tissue’s structural and chemical composition including chromophore content such as water, collagen, oxyhemoglobin and melanin. Blood flow can be measured, as blood flow in pressure injuries is different from that in healthy tissues based on measures of blood cell perfusion in the microvasculature. Sensor results can then be classified and analyzed by an AI cloud-based system at the point of care into the predefined conditions.

Using this kind of model, AI algorithms can swiftly identify pressure injury risk factors, enabling healthcare providers to formulate personalized prevention plans tailored to individual patient needs. The algorithm itself can be driven by data from the three primary sources analyzed: 1) multiple
biomarkers related to pressure injury development in tissue; 2) structural changes in different skin layers; and 3) blood flow meter.

Transformative Implications for Healthcare

The integration of AI and subepidermal biomarker detection into pressure injury management holds immense transformative potential for healthcare including:

Enhanced Patient Outcomes: AI-driven early detection can significantly improve patient outcomes by enabling timely interventions. The reduction in the severity and incidence of pressure injuries can lead to better quality of life for affected individuals and even save lives.
Reduced Healthcare Costs: The adoption of AI in pressure injury prevention can lead to substantial cost savings for healthcare systems globally. By averting the need for costly treatments and interventions, healthcare expenditures can be minimized.
Objective Assessments: AI offers standardized and objective assessments, irrespective of geographical location. This ensures consistent quality of care and minimizes regional disparities in pressure injury management.

Challenges and Future Directions

While the potential of AI and subepidermal biomarker detection in pressure injury prevention is promising, challenges must be addressed for widespread implementation:

Integration into Electronic Medical Records and Data Standardization: Capturing and analyzing biomarker data using AI is a tremendous asset that needs to be integrated into patient and hospital electronic medical records. This calls for the need for data standardization and when needed, data sharing among various healthcare providers.
Education and Training: Ensuring that healthcare professionals worldwide receive training in AI utilization for pressure injury prevention is crucial for realizing the technology’s full potential.
Ethical and Health Equity Considerations: Ethical considerations surrounding AI in healthcare must be addressed universally to ensure responsible and compassionate use of these technologies. In the case of pressure injuries, AI can help improve ethics in healthcare through the combination of seeing beneath the skin’s surface and being a skin-color agnostic technology, thereby addressing inequities based on race and skin color. It is important that such a technology be universally adopted across various socio-economic groups and geographic regions.

Conclusion

Pressure injuries represent a significant healthcare challenge, causing suffering to patients and straining healthcare budgets globally. The integration of biotechnology and AI, along with subepidermal biomarker detection, holds immense promise in addressing these challenges and revolutionizing pressure injury prevention. As healthcare envisions a future empowered by AI, the focus on improving patient outcomes and reducing healthcare costs through AI-driven approaches is pivotal. The synergy of AI and subepidermal biomarker detection offers a beacon of hope for patients and healthcare systems worldwide, ultimately leading to enhanced patient well-being and more efficient healthcare practices.

Author Biography

Yaniv Cohen, PhD MSc, Co-Founder & Chief Science Officer of IR-MED is a skilled scientist and entrepreneur with years of experience leading R&D development for medical device companies. His fields of expertise include electro-optics, infrared spectroscopy, AI, and medical devices using infrared light. PressureSafe, co-invented by Dr. Cohen, is an early detection device for pressure injuries.

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IR-MED Awarded Most Innovative Non-Invasive Diagnostics Technology Developer 2023 by Corporate Vision Magazine

tamar IR — Thu, 21 Dec 2023 16:54:22 +0000

PressureSafe, for the early detection of pressure injuries, addresses a healthcare challenge that costs $26.8 billion and causes 60,000 deaths annually in the U.S. alone
Non-invasive device to augment visual inspection found to be more than 90% accurate in detecting pressure injuries

Rosh Pina, Israel, Dec. 21, 2023 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive artificial intelligence (AI) driven spectrographic analysis technology platform to address significant healthcare needs, announced today it has been awarded the “Most Innovative Non-Invasive Diagnostics Technology Developer 2023 – Israel” by UK-based Corporate Vision Magazine for the Company’s PressureSafe device and technology platform.

Corporate Vision’s Small Business Awards aim to be a beacon of light for businesses that make an incredible contribution to their clients and customers by shaping their industries and bringing something unique to the market.

Awards Coordinator Jessie Wilson commented on the success of IR-MED and others recognized in this year’s program, “Our Small Business Awards showcase sublime examples of businesses from those with a wide range of services to those serving singular niche markets, and I couldn’t be happier to have worked with such a fine selection of small businesses. Wishing you a fantastic end to 2023, and a monumental 2024 to come.”

“Our groundbreaking technology platform, and specifically our PressureSafe device, are increasingly being recognized by medical practitioners and technologists for its potential to make a significant contribution in healthcare by reducing the risk and severity of pressure injuries,” stated Tzur Di-Cori, IR-MED’s CEO. “We look forward to launching PressureSafe in the U.S. in 2024.”

PressureSafe, an innovative non-invasive medical device that uses infrared optical spectroscopy and AI, is designed to effectively detect early-stage pressure injuries for all skin tones. Pressure injuries cost the U.S. healthcare system $26.8 billion and lead to 60,000 deaths annually. PressureSafe was found to be 96% accurate in detecting pressure injuries based on interim results from a multicenter study. The skin-color agnostic device effectively addresses equity in healthcare by using infrared light to detect biomarker changes below the skin’s surface. PressureSafe is expected to launch in the U.S. in the first half of 2024, subject to regulatory approval.

About IR-MED

IR-MED Inc., is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without invasive procedures. PressureSafe, 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 as it calibrates personally to each patient’s skin.

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

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use.

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. For example, IR-Med is using forward looking statements when it states that its technology platform, and specifically the PressureSafe device, are increasingly being recognized by medical practitioners and technologists for its potential to make a significant contribution in healthcare by reducing the risk and severity of pressure injuries and that PressureSafe is expected to launch in the U.S. in the first quarter of 2024, subject to regulatory approval. 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 development and design of 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 29, 2023 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.

Contact:

Sharon Levkoviz, Chief Financial Officer

Tel: +972 (0) 4 6555054

The post IR-MED Awarded Most Innovative Non-Invasive Diagnostics Technology Developer 2023 by Corporate Vision Magazine appeared first on IR MEDICAL.

IR-MED Granted Patent in Israel for its AI-Driven Platform Technology: Non-Invasive Analysis of Subcutaneous Tissue

tamar IR — Wed, 13 Dec 2023 10:23:46 +0000

The Granted patent covers IR-MED’s PressureSafe decision support device for the early detection of pressure injuries addressing a healthcare burden that amounts to $26.8 billion in the U.S. annually with a non-invasive device that offers more than 90% accuracy

Rosh Pina, Israel, Dec. 07, 2023 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive AI-driven spectrographic analysis technology platform to address significant healthcare needs, announced today it has been granted a patent titled “System and method for noninvasive analysis of tissue” from the State of Israel Patent Office. This follows a similar patent granted in the U.S., and other patent applications pending in key markets including the European Union.

The patent addresses IR-MED’s platform technology, a method for noninvasive analysis of subcutaneous tissue. The method irradiates a surface of the tissue with infrared radiation (IR) in spectral bands that are strongly absorbed or scattered by tissue chromophores like water. The intensity of the radiation in each of the spectral bands emerging from the tissue is measured and then compared by an algorithm that produces data-driven support for the diagnostic assessment of subcutaneous tissue.

IR-MED’s first product, PressureSafe, slated for launch in the U.S. in the first half of 2024, is a handheld device that uses this patented technology to identify early-stage pressure injuries with more than 90% accuracy. PressureSafe provides a novel solution to the challenge of treating pressure injuries which costs $26.8 billion annually in the U.S. alone and disproportionately impacts people with darker skin tones.

(https://journals.lww.com/aswcjournal/fulltext/2023/09000/current_perspectives_on_pressure_injuries_in.5.aspx).

“We believe that growing our patent portfolio at this time adds significant value as we are nearing commercial launch of PressureSafe in the U.S., while this specific patent supports our potential future commercial activities in Israel,” stated IR-MED’s CEO Tzur Di-Cori. “By assisting healthcare providers to identify and treat pressure injuries earlier, patients can benefit from significantly improved health outcomes while payers and providers can substantially reduce expenses stemming from advanced-stage pressure injuries and related complications.”

About IR-MED

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

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use.

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. For example, we are using forward looking statements when we discuss that our PressureSafe is scheduled for launch in the U.S. in the first half of 2024; that PressureSafe can identify early-stage pressure injuries with more than 90% accuracy; and that PressureSafe will enable patients to benefit from significantly improved health outcomes while payers and providers can substantially reduce expenses stemming from advanced-stage pressure injuries and related complications. 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 development and design of 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 29, 2023 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.

Contact:

Sharon Levkoviz, Chief Financial Officer

Tel: +972 (0) 4 6555054

The post IR-MED Granted Patent in Israel for its AI-Driven Platform Technology: Non-Invasive Analysis of Subcutaneous Tissue appeared first on IR MEDICAL.

IR-Med to present at National Pressure Injury Advisory Panel 2023

irmed irmed — Wed, 20 Sep 2023 12:03:25 +0000

The company’s PressureSafe device is being designed to reduce healthcare disparity in pressure injury detection and treatment

Rosh Pina, Israel, March 14, 2023 (GLOBE NEWSWIRE) — “IR-MED” or the “Company”) (OTCQB:IRME), will be presenting its proprietary technology that is being designed to detect early-stage Pressure Injuries (PI) at the Annual Conference of the National Pressure Injury Advisory Panel – NPIAP 2023. The presentation is part of a special Pre-Conference Workshop titled “Detecting Early Skin Changes in Dark Skin Tones.” The conference will take place on March 17-18 in San Diego, California.

Nearly $26.8B1 is spent each year on prevention and treatment of PI. Early PI detection can often be challenging for minority populations. According to this study2, patients with dark skin tones suffered more than twice as much as those with lighter skin, which evidences a major health inequity in the United States.

To address this gap in healthcare, IR-Med’s PressureSafe device, which is in advanced development stage, uses highly penetrating infrared light to “look” beneath the skin’s surface to sense biomarkers and structural changes in tissue layers. This data is then processed using artificial intelligence software to provide clinical feedback as a decision support system (DSS). The device is automatically recalibrated per each patient’s skin and tissue to create a personalized medical experience for each patient.

IR-Med was invited to NPIAP 2023 as part of the conference’s focus on equity in the prevention and treatment of pressure injuries. The Company will present the benefits of its unique “sense the invisible” technology on Thursday, March 16th, and exhibit its product in Booth #108.

“We are honored to be recognized by NPIAP as a contributor to equity in healthcare,” said Moshe Gerber, CEO of IR-Med. “Our PressureSafe device is being designed to yield a robust and universally applicable solution that has the potential to serve a wide market and significantly reduce the burden and cost of PI-related treatment.”

About IR-MED
IR-MED Inc., is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without 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 as it calibrates personally to each patient’s skin.

1 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7948545/

2 https://www.hmpgloballearningnetwork.com/site/wounds/article/5-year-retrospective-study-descriptors-associated-identification-stage-i-and-suspected-deep

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

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use. Expected US launch: H2/2023, pending relevant regulatory approvals.

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 development and design of 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 (0) 4 6555054

The post IR-Med to present at National Pressure Injury Advisory Panel 2023 appeared first on IR MEDICAL.

IR-Med appoints Dr. Lynn Eschenbacher to its advisory board as Company advances towards its launch of PressureSafe wound care device

irmed irmed — Wed, 20 Sep 2023 12:00:00 +0000

– Innovative executive driving positive outcomes and profitability, Dr. Eschenbacher is focused on addressing healthcare access and equity

– Through early, non-invasive detection of pressure injuries, PressureSafe is poised to save billions in acute care costs and reduce patient deaths from pressure wounds

Rosh Pina, Israel, June 07, 2023 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive AI-driven spectrographic analysis technology platform to address significant healthcare needs, announced today the appointment of Lynn Eschenbacher PharmD, MBA, FASHP, CPEL to its Advisory Board.

Dr. Eschenbacher is an innovative business development executive with extensive experience in the healthcare industry. As CEO and Founder of Echelon Health Strategies, she develops and delivers innovative strategies, operational excellence, and relationship networking to drive growth resulting in positive business outcomes and profitability. Focused on addressing access, adherence, and affordability across the continuum of healthcare, Dr. Eschenbacher works to ensure equity . She addresses impactful issues by engaging with Boards of Pharmacy, professional organizations, and the U.S. Congress.

Dr. Eschenbacher serves as Venture Partner at SpringTide, a healthcare focused venture capital firm, Chief Customer Officer at RxLive, Strategic Advisory Board Member at Atlas Health, as well as several other key roles with innovative healthcare companies.

Among Dr. Eschenbacher’s many accomplishments, she held the position of the Chief Pharmacy Officer and Vice President Medication Management at Ascension Healthcare, the second largest non-profit health system in the United States with a vast network of healthcare facilities including 178 hospitals and senior living facilities, employing over 139,000 associates and reporting an operating revenue of $28 billion in fiscal 2022. Dr. Eschenbacher also held a number of positions including Medication Safety Officer at Duke University Health System. She earned her doctor of pharmacy from The University of Texas at Austin, an MBA from Duke University, and a BS in Biology from Indiana University.

As an Advisory Board member at IR-MED, Dr. Eschenbacher will advise on the development and strategic market launch of the Company’s lead product, PressureSafe, which uses penetrating infrared light to “look” beneath the skin’s surface, senses biomarkers and structural changes in tissue layers for the early detection of pressure injuries. The Company plans to file for regulatory approval of PressureSafe with the U.S. Food and Drug Administration in fourth quarter of 2023, with commercial launch soon to follow, pending approval.

Dr. Eschenbacher commented, “PressureSafe is an easy-to-use, cost-effective device that can have tremendous impact in reducing mortality and healthcare costs resulting from pressure wounds in settings across the board from hospitals to nursing homes, and home care. I believe PressureSafe is a device that will gain rapid traction in the market. Moreover, IR-MED’s platform technology has strong potential in numerous other applications. I’m pleased to be on board with the Company.”

IR-MED’s Chairman and Interim CEO Oded Bashan, added, “We are honored to have Dr. Eschenbacher join our Advisory Board and look forward to benefiting from her very hands-on approach to helping world-class innovators get products to market that have a transformational impact on healthcare. We estimate an addressable market of over 200 million tests for PressureSafe annually. This is an enormous market rollout and we are building out our Advisory Board with top-notch experts like Dr. Eschenbacher who are tactically skilled across the healthcare ecosystem.”

60,000 of the 2.5 million patients who develop pressure wounds die each year, and about $11 billion is spent annually to prevent and treat pressure injuries, according to the National Pressure Injury Advisory Council. Early detection of pressure injuries can be challenging for all patients, particularly for minority populations. Patients with dark skin tones suffered more than twice as much as those with lighter skin according to a study published in the peer-reviewed journal Wounds because visual cues commonly associated with the identification of Stage 1 pressure wounds may not be sufficient in persons with darkly pigmented skin. PressureSafe is skin-color agnostic because it detects biomarker changes below the skin’s surface.

About IR-MED

IR-MED Inc., is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without 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 as it calibrates personally to each patient’s skin.

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

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use. Expected US launch: Fourth Quarter/2023, subject to relevant regulatory approvals.

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 development and design of PressureSafe device, results of clinical/useability studies and trials, timing of product development, FDA approval/clearance of products in development, timing of market launch, 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 29, 2023 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.

Contact:
Sharon Levkoviz, Chief Financial Officer
Tel: +972 (0) 4 6555054

The post IR-Med appoints Dr. Lynn Eschenbacher to its advisory board as Company advances towards its launch of PressureSafe wound care device appeared first on IR MEDICAL.

IR-Med honors Juneteenth with commitment to healthcare equality: PressureSafe device sees beneath the skin to address inequality in pressure injury

irmed irmed — Wed, 20 Sep 2023 11:51:05 +0000

-Early detection of pressure injuries can be challenging for minority populations due to the current method of visual inspection

-Patients with dark skin tones suffered more than twice as much as those with lighter skin, evidencing a major health inequality in the U.S.

-Dr. Dalton, a visionary healthcare thought leader and hall of fame CEO, is supporting IR-Med in analyzing the benefits of the PressureSafe device for African American and Hispanic populations in the U.S.

Rosh Pina, Israel, June 12, 2023 (GLOBE NEWSWIRE) — IR-MED Inc., (“IR-MED” or the “Company”) (OTCQB:IRME), developer of a noninvasive AI-driven spectrographic analysis technology platform to address significant healthcare needs, today reiterated its commitment to healthcare equality globally and particularly in the U.S. Pressure injuries, ulcers that develop on the skin as a result of lying in bed or sitting in a wheelchair for long periods of time, are one of the most common harms experienced by patients, according to the National Pressure Injury Advisory Panel, with a prevalence of 25% in long term acute care centers and 12% in nursing homes. Approximately 2.5 million patients per year develop pressure injuries and 60,000 die every year as a direct result of pressure injuries. While $26.8 billion is spent each year on the prevention and treatment of pressure injuries, people with dark skin tones are more than twice as likely to suffer from pressure injuries than those with lighter skin according to 5-year study published in Wounds. A literature review study in the Journal of Clinical Nursing confirms that people with darker skin tones are more likely in comparison with people presenting as Caucasian to develop higher stage pressure injuries.

IR-MED’s breakthrough PressureSafe, an innovative non-invasive medical device that uses infrared optical spectroscopy and AI, is designed to effectively detect early-stage pressure injuries for all skin tones. PressureSafe is skin-color agnostic because it uses infrared light to detect biomarker changes below the skin’s surface. The decision support system device is expected to launch in the U.S. in the first quarter of 2024 with the of aim of improving patient care and healthcare equality.

Dr. David Dalton, a member of IR-MED’s Advisory Board, a hall of fame CEO, entrepreneur, pharmaceutical executive, and founder of The National Minority Health Association, he is currently Board Director and Executive Chairman of six companies and leads the chain drug industry as the first black pharmacist executive. His accolades include being an inductee into four halls of fame and a recipient of the Senatorial Medal of Freedom and veteran. Dr. Dalton was also selected by the International Forum on Advancement in Healthcare (IFAH) as one of the “Top 100 Healthcare Leaders” in 2019 and “Top 100 Healthcare Visionaries Award” in 2021.

Dr. Dalton commented, “While pressure injury is a major problem in all hospitalization situations, patients in the African American and Hispanic communities are statistically at a higher risk of developing pressure injuries since the early signs are not as visible on the patient’s skin. IR-MED’s device may offer a new decision support tool which could prevent pressure injuries and lead to better patient compliance and outcomes.”

About IR-MED

IR-MED Inc., is developing a noninvasive spectrographic analysis technology platform, allowing healthcare professions to detect, measure and monitor, in real time, different molecules in the blood, in human tissue, and in body fluids without 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 as it calibrates personally to each patient’s skin.

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

PressureSafe is currently undergoing usability studies at multiple medical centers. It is not yet available for commercial use. Expected US launch: First Quarter/2024, subject to relevant regulatory approvals.

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 development and design of 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 29, 2023 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.

Contact:
Sharon Levkoviz, Chief Financial Officer
Tel: +972 (0) 4 6555054

The post IR-Med honors Juneteenth with commitment to healthcare equality: PressureSafe device sees beneath the skin to address inequality in pressure injury appeared first on IR MEDICAL.

Yoram Drucker

irmedica_admin — Tue, 08 Aug 2023 08:15:30 +0000

Mr. Drucker is a successful Israeli serial entrepreneur and expert in the establishment of start-ups. He is a co-founder of Pluristem (NASDAQ:PSTI), Brainstorm (NASDAQ:BCLI) and InnoCan Pharma (CSE:INNO).

The post Yoram Drucker appeared first on IR MEDICAL.

Avi Vachnis

irmedica_admin — Tue, 08 Aug 2023 08:12:16 +0000

Mr. Vachnis is a seasoned and versatile R&D leader with over 17 years of experience in the design, development and delivery of software and hardware products. He has vast experience in early-stage start-ups, building full-stack SW, mobile, web, DevOps and cloud infrastructures. Mr. Vachnis excels at translating evolving design, prototypes and MVPs into full-fledged product launches. His expertise and passion are focused on cloud solutions, highly available distributed systems, big data, AI/ML and algorithms.

Before joining IR-Med, Mr. Vachnis served as VP R&D at OUTLOCKS where he led the company’s transition into a leading provider of access management solutions. Previously, Avi led the R&D at Lumos-Global,. Prior to Lumos-Global, Avi was a founder of CloudBand at Alcatel-Lucent.

Avi has a B.Sc. in Software Engineering from Ort Braude College of Engineering, Israel.

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