IR-MED CEO Issues Letter to Shareholders: Expanding Our Platform and Presenting New Clinical Data from Israel and the U.S.
IR-MED (OTCQB: IRME) has shared significant progress in its development of non-invasive AI-driven spectrographic analysis technology. The company's flagship device, PressureSafe™, targeting a $1.7B domestic and $2.9B global market opportunity, has shown promising results in clinical studies.
Key clinical findings include:
- Israeli study at Clalit Medical Centers: 89% sensitivity and 90% specificity across 924 scans, with no adverse events in 1,475 scans
- U.S. study at Methodist hospitals in Texas: 90% sensitivity rate across 294 scans, demonstrating effectiveness across diverse skin tones
The company is also developing DiaSafe™, a device for diabetic foot ulcer assessment. The first year of development was completed with a $1M budget (50% grant-funded by Israel Innovation Authority). IR-MED is pursuing a second IIA grant and planning first-in-human trials. The company is actively working toward uplisting to the Nasdaq Stock Exchange.
IR-MED (OTCQB: IRME) ha condiviso progressi significativi nello sviluppo della tecnologia di analisi spettrografica non invasiva guidata dall'IA. Il dispositivo di punta dell'azienda, PressureSafe™, che mira a un'opportunità di mercato domestico di 1,7 miliardi di dollari e globale di 2,9 miliardi di dollari, ha mostrato risultati promettenti negli studi clinici.
I principali risultati clinici includono:
- Studio israeliano presso i Centri Medici Clalit: 89% di sensibilità e 90% di specificità su 924 scansioni, senza eventi avversi in 1.475 scansioni
- Studio negli Stati Uniti presso gli ospedali Methodist in Texas: tasso di sensibilità del 90% su 294 scansioni, dimostrando efficacia su diversi toni della pelle
L'azienda sta anche sviluppando DiaSafe™, un dispositivo per la valutazione delle ulcere del piede diabetico. Il primo anno di sviluppo è stato completato con un budget di 1 milione di dollari (finanziato per il 50% dall'Autorità per l'Innovazione di Israele). IR-MED sta perseguendo un secondo grant IIA e pianificando prove cliniche su esseri umani. L'azienda sta lavorando attivamente per un'uscita alla Borsa Nasdaq.
IR-MED (OTCQB: IRME) ha compartido avances significativos en el desarrollo de tecnología de análisis espectrográfico no invasivo impulsada por IA. El dispositivo insignia de la empresa, PressureSafe™, que apunta a una oportunidad de mercado nacional de 1.7 mil millones de dólares y global de 2.9 mil millones de dólares, ha mostrado resultados prometedores en estudios clínicos.
Los hallazgos clínicos clave incluyen:
- Estudio israelí en los Centros Médicos Clalit: 89% de sensibilidad y 90% de especificidad en 924 escaneos, sin eventos adversos en 1,475 escaneos
- Estudio en EE. UU. en los hospitales Methodist en Texas: tasa de sensibilidad del 90% en 294 escaneos, demostrando efectividad en diversos tonos de piel
La empresa también está desarrollando DiaSafe™, un dispositivo para la evaluación de úlceras en pies diabéticos. El primer año de desarrollo se completó con un presupuesto de 1 millón de dólares (financiado en un 50% por la Autoridad de Innovación de Israel). IR-MED está buscando una segunda subvención IIA y planeando ensayos en humanos. La empresa está trabajando activamente para listar en la Bolsa de Valores Nasdaq.
IR-MED (OTCQB: IRME)는 비침습적 인공지능 기반 분광 분석 기술 개발에서 중요한 진전을 공유했습니다. 회사의 주력 장치인 PressureSafe™는 17억 달러의 국내 시장과 29억 달러의 글로벌 시장 기회를 목표로 하며, 임상 연구에서 유망한 결과를 보여주었습니다.
주요 임상 결과는 다음과 같습니다:
- 클라리트 의료 센터에서의 이스라엘 연구: 924개의 스캔에서 89%의 민감도와 90%의 특이성, 1,475개의 스캔에서 부작용 없음
- 텍사스 메소디스트 병원에서의 미국 연구: 294개의 스캔에서 90%의 민감도 비율, 다양한 피부 톤에서의 효과 입증
회사는 또한 당뇨병성 족부 궤양 평가를 위한 장치인 DiaSafe™를 개발하고 있습니다. 개발 첫 해는 100만 달러의 예산으로 완료되었으며(이스라엘 혁신청의 50% 보조금 지원). IR-MED는 두 번째 IIA 보조금을 추구하고 있으며, 인간 대상 시험을 계획하고 있습니다. 이 회사는 Nasdaq 증권 거래소에 상장하기 위해 적극적으로 노력하고 있습니다.
IR-MED (OTCQB: IRME) a partagé des progrès significatifs dans le développement de sa technologie d'analyse spectrographique non invasive pilotée par IA. Le dispositif phare de l'entreprise, PressureSafe™, visant une opportunité de marché nationale de 1,7 milliard de dollars et mondiale de 2,9 milliards de dollars, a montré des résultats prometteurs lors des études cliniques.
Les principales conclusions cliniques incluent:
- Étude israélienne aux Centres Médicaux Clalit : 89% de sensibilité et 90% de spécificité sur 924 scans, sans événements indésirables dans 1 475 scans
- Étude aux États-Unis dans les hôpitaux Methodist au Texas : taux de sensibilité de 90% sur 294 scans, démontrant l'efficacité sur divers tons de peau
L'entreprise développe également DiaSafe™, un dispositif pour l'évaluation des ulcères du pied diabétique. La première année de développement a été achevée avec un budget d'un million de dollars (financé à 50% par l'Autorité d'Innovation d'Israël). IR-MED cherche à obtenir une deuxième subvention IIA et prévoit des essais cliniques sur l'homme. L'entreprise travaille activement à son inscription à la Bourse Nasdaq.
IR-MED (OTCQB: IRME) hat bedeutende Fortschritte bei der Entwicklung nicht-invasiver, KI-gesteuerter spektrografischer Analysetechnologie gemacht. Das Flaggschiff-Gerät des Unternehmens, PressureSafe™, das auf eine Marktchance von 1,7 Milliarden Dollar im Inland und 2,9 Milliarden Dollar weltweit abzielt, hat vielversprechende Ergebnisse in klinischen Studien gezeigt.
Wichtige klinische Ergebnisse umfassen:
- Israelische Studie an Clalit Medizinischen Zentren: 89% Sensitivität und 90% Spezifität über 924 Scans, ohne unerwünschte Ereignisse bei 1.475 Scans
- US-Studie an Methodist-Krankenhäusern in Texas: 90% Sensitivitätsrate über 294 Scans, die Wirksamkeit über verschiedene Hauttöne hinweg demonstrierend
Das Unternehmen entwickelt auch DiaSafe™, ein Gerät zur Beurteilung von diabetischen Fußgeschwüren. Das erste Jahr der Entwicklung wurde mit einem Budget von 1 Million Dollar abgeschlossen (50% durch die Israelische Innovationsbehörde gefördert). IR-MED strebt eine zweite IIA-Förderung an und plant erste klinische Studien am Menschen. Das Unternehmen arbeitet aktiv daran, an die Nasdaq-Börse zu gehen.
- Strong clinical results: 89-90% sensitivity/specificity rates across studies
- No adverse events reported in 1,475 scans
- Successful completion of first-year DiaSafe development with $1M budget
- 50% grant funding secured from Israel Innovation Authority
- Progress toward Nasdaq uplisting
- Still in clinical/usability study phase, not yet commercialized
- Additional funding likely needed for continued development
- Currently trading on OTCQB, less liquid market
Rosh Pina, Israel, March 18, 2025 (GLOBE NEWSWIRE) -- IR-MED Inc. (“IR-MED” or the “Company”) (OTCQB: IRME), a developer of noninvasive, AI-driven spectrographic analysis technology addressing significant healthcare needs, is pleased to share the following shareholder update from its Chief Executive Officer, Mr. Ran Ziskind.
Dear Shareholders,
I am excited and honored to lead IR-MED as we continue to execute on value-driving milestones with our platform technology. We are actively expanding the usability studies of our first device, PressureSafe™, in the U.S., addressing a
Our commitment to a data-driven approach is evident in the usability studies we have already completed in Israel and are currently conducting in the U.S. Last month, our clinical and executive team had the privilege of demonstrating PressureSafe™ at the National Pressure Injury Advisory Panel (NPIAP) 2025 Conference, the leading U.S. conference for pressure injuries, held in the last week of February, 2025. During the conference our booth attracted significant interest from key opinion leaders, healthcare practitioners, scientists, and commercial partners, reinforcing the industry’s enthusiasm for our innovative technology.
Key Clinical Study Updates
Two principal investigators presented compelling results from key studies:
- Study Conducted at Clalit Medical Centers (Israel):
- Final results from Beit Rivka Hospital and Rabin Medical Center, both part of Clalit, the world’s second-largest Health Maintenance Organization (HMO).
- This study assessed PressureSafe™'s Infrared Spectroscopy Scanner (IRSS) for assessment of Stage 1 pressure injuries (PI) and suspected deep tissue injuries (sDTI).
- Findings from 924 scans showed a sensitivity of
89% and specificity of90% , with no device-related adverse events across 1,475 scans. - The device enhanced assessment of pressure injuries before skin breakage, reduced reliance on subjective visual assessment, and contributed to a measurable reduction in pressure injuries.
- Study Focused on Diverse Skin Tones (U.S.):
- Conducted at two Methodist hospitals in Texas to evaluate the effectiveness of Near-Infrared (NIR) Spectroscopy in overcoming pigmentation-related challenges.
- Ongoing Phase 1 data from 294 scans demonstrated a
90% sensitivity rate, proving PressureSafe™'s reliability across diverse populations. - The use of the IRSS to assess the underlying tissue with a multi biomarker approach, provides a reliable quantitative approach to assist with clinical assessment by health care professionals.
Attending NPIAP 2025 further reinforced our belief in IR-MED’s unique value proposition—we have both a groundbreaking technology and a receptive market ready for it. Moving forward, we are accelerating our usability studies in the U.S., paving the way for commercial milestones.
Expanding Our Product Pipeline: Introducing DiaSafe™
Beyond PressureSafe™, we are leveraging our platform technology to develop DiaSafe™—a decision-support device for diabetic foot ulcer (DFU) assessment. DFUs are a leading cause of amputations, resulting in severe patient suffering and placing a heavy financial burden on healthcare systems. 3 DiaSafe™ aims to provide real-time, non-invasive optical readings of biomarkers to assess DFUs, enabling earlier and more effective intervention.
Key updates on DiaSafe™’s development:
- We have successfully completed the first year of development, backed by the Israel Innovation Authority (IIA) with a
$1 million budget (50% grant-funded). - We have applied for a second IIA grant to support 2025 development.
- We are in advanced discussions with a healthcare provider to launch the first-in-human clinical trial.
Strategic Roadmap: Nasdaq Uplisting and Growth Plans
As part of our broader growth strategy, IR-MED is actively working toward uplisting to the Nasdaq Stock Exchange, a move that we believe will enhance shareholder value and expand our reach among institutional investors. We look forward to sharing additional updates on this initiative in the coming weeks and months.
We invite you to explore more about our technology, product pipeline, and clinical studies in our latest investor presentation and scientific posters HERE.
Thank you for your continued support as we advance our mission to transform non-invasive skin assessment and improve patient outcomes
Sincerely,
Ran Ziskind
CEO, IR-MED Inc.
1 Based on 2.4 million beds according to the American Hospital Association and the U.S. Centers for Disease Control. U.S. Centers for Disease Control; American Hospital Association;
2 Based on 8.3 million beds
3 Transparency Markets and Research https://www.transparencymarketresearch.com/diabetic-foot-ulcer-treatment-market.html
About IR-MED
IR-MED Inc. is developing a cutting-edge infrared spectroscopy and AI analysis technology platform 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. Bioinformation is then analyzed using the company’s AI based process to provide healthcare professionals with decision support in the assessment of various medical conditions.
PressureSafe, the company’s first product based on this platform, is a handheld device designed to revolutionize the assessment of pressure injuries (PI) affecting skin and underlying tissue. Pressure Injury in the US alone accounts for
IR-MED holds patents protecting its innovation in noninvasive tissue assessment
PressureSafe is currently undergoing usability studies at multiple medical centers and 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 future usability studies, addressable market opportunities both domestically and globally, PressureSafe™’s potential to significantly reduce the harm caused by pressure injuries and address healthcare challenges, future commercial milestones, the development of the DiaSafe™ and its potential future benefits, receiving a second IIA grant to support 2025 development, the launch of a first-in-human clinical trial, its potential Nasdaq uplisting and potential for the uplisting to enhance shareholder value and expand the Company’s reach among institutional investors. 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/A filed on April 8, 2024 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
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