Methodist Healthcare Adopts IR-MED’s PressureSafe™ Device for Usability Study: Decision Support Device Aims to Reduce Substantial Healthcare Burden of Pressure Injuries
IR-MED Inc. (OTCQB:IRME) has announced the start of a usability study for its PressureSafe™ device at Methodist Healthcare in San Antonio, Texas. PressureSafe™ is a non-invasive AI-driven medical device designed to detect early-stage pressure injuries for all skin tones using infrared optical spectroscopy. The study, titled 'Safety and Efficacy of the PressureSafe Device for Early Detection of Pressure Injury in People with Various Skin Tones, Including Dark Skin Tones,' aims to improve early detection and prevention of pressure injuries, particularly addressing healthcare inequality for people with darker skin tones.
The study will enroll up to 104 participants, with approximately half having dark skin tones. In a previous study conducted at Israel's largest HMO, PressureSafe™ demonstrated 92% sensitivity in detection, and the incidence of pressure injuries was reduced by 50% during the study period. Pressure injuries result in 60,000 deaths annually in the U.S., with patient care costs ranging from $20,900 to $151,700 per injury.
IR-MED Inc. (OTCQB:IRME) ha annunciato l'inizio di uno studio di usabilità per il suo dispositivo PressureSafe™ presso il Methodist Healthcare di San Antonio, Texas. PressureSafe™ è un dispositivo medico non invasivo guidato dall'IA progettato per rilevare precocemente le lesioni da pressione su tutti i toni di pelle utilizzando la spettroscopia ottica a infrarossi. Lo studio, intitolato 'Sicurezza ed Efficacia del Dispositivo PressureSafe per il Rilevamento Precoce di Lesioni da Pressione nelle Persone con Vari Toni di Pelle, Inclusi i Toni di Pelle Scura', mira a migliorare la rilevazione precoce e la prevenzione delle lesioni da pressione, affrontando in particolare l'ineguaglianza sanitaria per le persone con toni di pelle più scuri.
Lo studio arruolerà fino a 104 partecipanti, circa la metà dei quali avrà toni di pelle scura. In uno studio precedente condotto presso il più grande HMO di Israele, PressureSafe™ ha dimostrato una sensibilità del 92% nel rilevamento, e l'incidenza di lesioni da pressione è stata ridotta del 50% durante il periodo dello studio. Le lesioni da pressione causano 60.000 decessi all'anno negli Stati Uniti, con costi per la cura del paziente che variano da $20,900 a $151,700 per lesione.
IR-MED Inc. (OTCQB:IRME) ha anunciado el inicio de un estudio de usabilidad para su dispositivo PressureSafe™ en el Methodist Healthcare de San Antonio, Texas. PressureSafe™ es un dispositivo médico no invasivo impulsado por IA diseñado para detectar lesiones por presión en etapas tempranas para todos los tonos de piel utilizando espectroscopía óptica infrarroja. El estudio, titulado 'Seguridad y Eficacia del Dispositivo PressureSafe para la Detección Temprana de Lesiones por Presión en Personas con Varios Tonos de Piel, Incluyendo Tonos de Piel Oscura', tiene como objetivo mejorar la detección y prevención temprana de lesiones por presión, abordando particularmente la desigualdad sanitaria para las personas con tonos de piel más oscuros.
El estudio inscribirá hasta 104 participantes, con aproximadamente la mitad teniendo tonos de piel oscura. En un estudio previo realizado en el HMO más grande de Israel, PressureSafe™ demostró una sensibilidad del 92% en la detección, y la incidencia de lesiones por presión se redujo en un 50% durante el período del estudio. Las lesiones por presión causan 60,000 muertes anualmente en EE. UU., con costos de atención al paciente que varían de $20,900 a $151,700 por lesión.
IR-MED Inc. (OTCQB:IRME)는 텍사스 샌안토니오의 메소드 헬스케어에서 PressureSafe™ 장치의 사용성 연구를 시작한다고 발표했습니다. PressureSafe™는 비침습적 AI 기반 의료기기로, 적외선 광학 분광법을 사용하여 모든 피부 톤에서 조기 단계의 압력 손상을 감지하도록 설계되었습니다. '다양한 피부 톤을 가진 사람들의 압력 손상 조기 감지에 대한 PressureSafe 장치의 안전성과 효능'이라는 제목의 이 연구는 조기 감지 및 압력 손상의 예방을 개선할 것을 목표로 하며, 특히 어두운 피부 톤을 가진 사람들을 위한 의료 불평등 문제를 해결하는 데 중점을 두고 있습니다.
이 연구는 최대 104명의 참가자를 등록할 예정이며, 이 중 약 절반은 어두운 피부 톤을 가진 참가자입니다. 이스라엘 최대 HMO에서 실시된 이전 연구에서 PressureSafe™는 92%의 감지 민감도를 나타냈고, 연구 기간 동안 압력 손상 발생률을 50% 감소시켰습니다. 압력 손상은 미국에서 매년 60,000명의 사망자를 초래하며, 환자 치료 비용은 부상당 20,900달러에서 151,700달러까지 다양합니다.
IR-MED Inc. (OTCQB:IRME) a annoncé le début d'une étude d'utilisabilité pour son dispositif PressureSafe™ au Methodist Healthcare de San Antonio, Texas. PressureSafe™ est un dispositif médical non invasif alimenté par l'IA conçu pour détecter les blessures de pression à un stade précoce pour tous les tons de peau en utilisant la spectroscopie optique infrarouge. L'étude, intitulée 'Sécurité et Efficacité du Dispositif PressureSafe pour la Détection Précoce des Blessures de Pression chez les Personnes avec Divers Tons de Peau, y compris les Tons de Peau Foncés', vise à améliorer la détection précoce et la prévention des blessures de pression, en s'attaquant notamment à l'inégalité en matière de santé pour les personnes avec des tons de peau plus foncés.
L'étude enrolera jusqu'à 104 participants, environ la moitié ayant des tons de peau foncés. Dans une étude précédente menée dans le plus grand HMO d'Israël, PressureSafe™ a montré une sensibilité de 92% dans la détection, et l'incidence des blessures de pression a été réduite de 50% pendant la période de l'étude. Les blessures de pression entraînent 60 000 décès annuels aux États-Unis, avec des coûts de soins aux patients variant de 20 900 à 151 700 dollars par blessure.
IR-MED Inc. (OTCQB:IRME) hat den Beginn einer Gebrauchsstudie für sein PressureSafe™-Gerät im Methodist Healthcare in San Antonio, Texas, bekannt gegeben. PressureSafe™ ist ein nicht-invasives, KI-gesteuertes Medizinprodukt, das entwickelt wurde, um frühe Druckschäden bei allen Hauttönen mithilfe von Infrarot-Optik-Spektroskopie zu erkennen. Die Studie mit dem Titel 'Sicherheit und Wirksamkeit des PressureSafe-Geräts zur frühzeitigen Erkennung von Druckschäden bei Menschen mit verschiedenen Hauttönen, einschließlich dunkler Hauttöne' zielt darauf ab, die frühzeitige Erkennung und Prävention von Druckschäden zu verbessern, insbesondere in Bezug auf gesundheitliche Ungleichheit bei Menschen mit dunklerer Haut.
Die Studie soll bis zu 104 Teilnehmer einschließen, von denen etwa die Hälfte dunkle Hauttöne hat. In einer früheren Studie, die in Israels größtem HMO durchgeführt wurde, zeigte PressureSafe™ eine Sensitivität von 92% bei der Erkennung, und die Inzidenz von Druckschäden wurde während des Studienzeitraums um 50% reduziert. Druckschäden führen jährlich zu 60.000 Todesfällen in den USA, wobei die Patientenkosten zwischen $20.900 und $151.700 pro Verletzung variieren.
- PressureSafe™ device is FDA listed
- Previous study showed 92% sensitivity in detection and 50% reduction in pressure injury incidence
- Addresses healthcare inequality in pressure injury detection for dark skin tones
- Potential to improve patient outcomes and reduce healthcare costs
- None.
- Patient enrollment and monitoring with PressureSafe™ has commenced
- In a similar study conducted at the world’s 2nd largest HMO, PressureSafe™ had efficacy of
92% in detection and the incidence of pressure injuries were reduced by50% during the study - A skin-color agnostic decision support device, PressureSafe™, uses an AI-based algorithm and infrared light to sense beneath the skin’s surface to detect biomarkers of pressure injuries
$26.8 billion is spent each year on the prevention and treatment of pressure injuries, and pressure injuries directly result in the death of 60,000 people annually in the U.S.
Rosh Pina, Israel, Sept. 10, 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 the start of a usability study for its lead product, PressureSafe™, at San Antonio, Texas based Methodist Healthcare. The study, titled “Safety and Efficacy of the PressureSafe Device for Early Detection of Pressure Injury in People with Various Skin Tones, Including Dark Skin Tones,” has received approval from Methodist Healthcare and has commenced patient enrollment and monitoring. Methodist Healthcare is widely regarded as one of the most respected healthcare providers in its region. With a growing network of care locations including hospitals, surgery centers, ERs, and family health clinics, each year Methodist Healthcare serves 608,000 patients, including 11,000 births, and 330,000 ER visits.
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. PressureSafe™ is skin-color agnostic because it uses infrared light to detect biomarker changes below the skin’s surface. The decision support device is FDA listed.
Principal Investigator of the study and Director of the Professional Nursing Practice at Methodist Healthcare, Mary Lee Potter, PhD, MBA, RN, CWOCN, commented, “This is a very important study for our nurses and entire medical team, as we are continuously seeking to improve outcomes for our patients. We look forward to utilizing PressureSafe™ at Methodist Hospital Metropolitan and are eager to evaluate its potential to increase the accuracy of early pressure injury detection and prevention. As the device evaluates the tissues beneath the skin and digitally assesses biomarkers, the technology can objectively augment human visual inspection, and this is very interesting for us.”
The study aims to improve the early detection and prevention of pressure injuries among all patients. Importantly, the study aims to address the substantial challenge of healthcare inequality in the detection of pressure injuries in people of dark skin tones who are more than twice as likely to suffer from pressure injuries than those with lighter skin tone, according to a 5-year study published in Wounds. The current standard of care relies on visual inspection of the skin, which can be less effective for early detection in individuals with darker skin tones.
Up to 104 people will be enrolled in the study, approximately half with dark skin tones. Registered nurses specialized in wound care (WOCN) will be trained in using PressureSafe™. Sensitivity and specificity will be assessed and compared to standard of care visual skin assessment done by the WOCN nurses.
“As our first major usability study in the United States, this marks a major milestone for IR-MED and PressureSafe™. We couldn’t be more pleased to partner with the Methodist Healthcare and Principal Investigator Dr. Potter,” stated Dr. Yaniv Cohen, IR-MED’s Co-Founder and Chief Science Officer. “At this highly prestigious institution, we hope to demonstrate that PressureSafe™ can provide support for nursing staff, significantly improve patient outcomes, and reduce healthcare costs.”
IR-MED’s prior usability study for PressureSafe™ was conducted at two hospitals in Israel owned by Clalit, Israel’s largest health maintenance organization (HMO) and the second largest in the world. PressureSafe™ detected pressure injuries with
According to the National Pressure Injury Advisory Panel, in the U.S. alone, 60,000 patients die every year as a direct result of pressure injuries. Patient care cost per pressure injury ranges from
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 planned to be launched, 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 caregivers 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.
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. 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
Attachment
FAQ
What is the purpose of IR-MED's PressureSafe™ usability study at Methodist Healthcare?
How does PressureSafe™ (IRME) detect pressure injuries?
What were the results of the previous PressureSafe™ (IRME) study in Israel?
How many participants will be enrolled in the PressureSafe™ (IRME) study at Methodist Healthcare?
