IR-MED Investor Update Letter - Sept-2025
IR-MED (OTCQB: IRME) released an investor update highlighting significant progress in its AI-powered medical devices. The company's PressureSafe™ device received FDA listing and demonstrated 94% sensitivity in U.S. clinical trials, particularly effective for patients with darker skin tones. A usability study at Methodist San Antonio Texas included 786 scans across 163 anatomical sites, with 61% from patients with darker skin tones.
The company received a $500K grant from Israel Innovation Authority for DiaSafe™, its AI-powered diabetic foot ulcer diagnostic device. IR-MED plans pilot programs for first half of 2026 and aims to uplist to major exchanges after additional capital raising. However, the company needs to secure additional funding to continue operations, as current cash resources are limited.
IR-MED (OTCQB: IRME) ha pubblicato un aggiornamento agli investitori che evidenzia progressi significativi nei suoi dispositivi medici alimentati dall’IA. Il dispositivo PressureSafe™ ha ottenuto l’elenco FDA e ha mostrato una sensibilità del 94% negli studi clinici negli Stati Uniti, particolarmente efficace per i pazienti con tonalità di pelle più scure. Uno studio di usabilità presso Methodist San Antonio Texas ha incluso 786 esami su 163 siti anatomici, con il 61% dei pazienti provenienti da tonalità di pelle più scure. L’azienda ha ricevuto una $500K grant dall’Israel Innovation Authority per DiaSafe™, il suo dispositivo diagnostico IA per ulcere del piede diabetiche. IR-MED prevede programmi pilota per la prima metà del 2026 e punta a una uplist su mercati principali dopo ulteriori raccolti di capitale. Tuttavia, l’azienda deve assicurarsi ulteriori finanziamenti per continuare le operazioni, poiché le risorse liquide attuali sono limitate.
IR-MED (OTCQB: IRME) publicó una actualización para inversionistas que destaca avances significativos en sus dispositivos médicos impulsados por IA. El dispositivo PressureSafe™ recibió la listado de la FDA y demostró una sensibilidad del 94% en ensayos clínicos en Estados Unidos, especialmente eficaz para pacientes con tonos de piel más oscuros. Un estudio de usabilidad en Methodist San Antonio Texas incluyó 786 escaneos en 163 sitios anatómicos, con un 61% de pacientes con tonos de piel más oscuros. La empresa recibió una $500K grant de la Israel Innovation Authority para DiaSafe™, su dispositivo diagnóstico de úlceras del pie diabéticas impulsado por IA. IR-MED planea programas piloto para la primera mitad de 2026 y aspira a cotizar en bolsas principales tras una recaudación adicional de capital. Sin embargo, la empresa necesita asegurar fondos adicionales para continuar operando, ya que los recursos de efectivo actuales son limitados.
IR-MED (OTCQB: IRME)는 AI 기반 의료 기기에서 중요한 진전을 강조한 투자자 업데이트를 발표했습니다. PressureSafe™ 장치는 FDA 등재를 받았으며 미국 임상 시험에서 94% 민감도를 보였고 특히 피부 톤이 어두운 환자에게 효과적이었습니다. Methodist San Antonio Texas에서 실시된 사용성 연구에는 163 해부학적 부위에 대한 786건의 스캔이 포함되었고, 그중 61%가 피부 톤이 어두운 환자였습니다. 이 회사는 IA 기반 당뇨병성 족부궤양 진단 장치인 DiaSafe™를 위해 $500K grant를 Israel Innovation Authority로부터 받았습니다. IR-MED는 2026년 상반기에 파일럿 프로그램을 계획하고 추가 자본 조달 후 주요 거래소에 상장하려고 합니다. 그러나 현재 현금 자원이 한정되어 있어 운영을 지속하려면 추가 자금 확보가 필요합니다.
IR-MED (OTCQB : IRME) a publié une mise à jour destinée aux investisseurs qui met en évidence des progrès significatifs dans ses dispositifs médicaux alimentés par l’IA. Le dispositif PressureSafe™ a obtenu une inscription par la FDA et a démontré une sensibilité de 94% lors des essais cliniques américains, particulièrement efficace chez les patients à peau plus foncée. Une étude d’utilisabilité au Methodist San Antonio Texas a comptabilisé 786 scans sur 163 sites anatomiques, avec 61% des patients à peau plus foncée. L’entreprise a reçu une subvention de 500K$ de la Israel Innovation Authority pour DiaSafe™, son dispositif diagnostique de plaies du pied diabétique alimenté par l’IA. IR-MED prévoit des programmes pilotes pour la première moitié de 2026 et vise à être cotée sur des bourses majeures après une collecte de fonds supplémentaire. Cependant, l’entreprise doit obtenir des financements additionnels pour poursuivre ses activités, car les ressources de trésorerie actuelles sont limitées.
IR-MED (OTCQB: IRME) veröffentlichte ein Investorenupdate, das bedeutende Fortschritte bei den KI-gestützten medizinischen Geräten des Unternehmens hervorhebt. Das PressureSafe™-Gerät erhielt eine FDA-Auflistung und zeigte in US-klinischen Studien eine Sensitivität von 94%, besonders wirksam bei Patienten mit dunkler Hautfarbe. Eine Bedienbarkeitsstudie am Methodist San Antonio Texas umfasste 786 Scans auf 163 anatomische Stellen, davon 61% bei Patienten mit dunkler Hautfarbe. Das Unternehmen erhielt eine 500K USD Förderung von der Israel Innovation Authority für DiaSafe™, sein KI-gestütztes diagnostisches Gerät für diabetische Fußgeschwüre. IR-MED plant Pilotprogramme für die erste Hälfte von 2026 und strebt eine Listung an großen Börsen nach weiterer Kapitalbeschaffung an. Allerdings muss das Unternehmen zusätzliche Mittel sichern, um den Betrieb fortzusetzen, da die aktuellen liquiden Mittel begrenzt sind.
IR-MED (OTCQB: IRME) أصدر تحديثاً للمستثمرين يبرز التقدم الكبير في أجهزتها الطبية المعتمدة على الذكاء الاصطناعي. تلقى جهاز PressureSafe™ إدراجاً من إدارة الغذاء والدواء الأمريكية وأظهر حساسية 94% في التجارب الإكلينيكية الأمريكية، وهو فعال بشكل خاص للمرضى ذوي البشرة الداكنة. شملت دراسة قابلية الاستخدام في Methodist San Antonio Texas 786 فحصاً عبر 163 موضعاً تشريحياً، وواحد من كل 61% من المرضى ذوي البشرة الداكنة. كما تلقت الشركة منحة قدرها $500K من Israel Innovation Authority لديا-Safe DiaSafe™، جهازها التشخيصي المدعوم بالذكاء الاصطناعي لقرحات القدم السكرية. تخطط IR-MED لبرامج تجريبية في النصف الأول من 2026 وتطمح إلى الإدراج في البورصات الكبرى بعد جمع رأس مال إضافي. ومع ذلك، تحتاج الشركة إلى تأمين تمويل إضافي لاستمرار عملياتها، إذ أن الموارد النقدية الحالية محدودة.
IR-MED (OTCQB: IRME) 发布了投资者更新，强调其基于AI的医疗设备取得的显著进展。PressureSafe™ 设备已获得 FDA 上市许可，在美国临床试验中显示出 94% 的敏感性，特别适用于肤色较深的患者。Methodist San Antonio Texas 的 usability 研究涵盖 163 个解剖部位的 786 次扫描，其中 61% 来自肤色较深的患者。公司还从 Israel Innovation Authority 获得了 $500K 的资助，用于 DiaSafe™——其基于AI的糖尿病足溃疡诊断设备。IR-MED 计划在 2026 年上半年开展试点项目，并在进一步融资后计划在主要交易所上市。然而，由于当前现金资源有限，公司需要额外资金以维持运营。
- None.
- Current cash resources insufficient to support operations without additional funding
- Company admits current market valuation is significantly misaligned
- Uplisting plans delayed due to suboptimal operational and financial positioning
- No immediate revenue generation expected
Rosh Pina, Israel--(Newsfile Corp. - September 16, 2025) - IR-MED Inc. (OTCQB: IRME) ("IR-MED" or the "Company"), a developer of non-invasive artificial intelligence (AI)-powered spectrographic technology to address critical healthcare challenges, today published an investor update.
Dear Valued Investors,
As we enter September 2025, in addition to Q2 financial reports and to the 8K recently published, I find it appropriate to update you on the developments within our Company. As you will see from the information below, the Company has achieved meaningful milestones that could bring it closer to the start of commercial operations. In order to move from potential to realization, we need your continued support. Please note that based on the Company’s current expected level of operating expenditures, the Company’s cash resources as of June 30, 2025 , the Company’s ability to undertake the operational and strategic actions described in this update is contingent upon securing additional funding. The Company’s management is making active efforts through various financing avenues to obtain the required funding.
Product and Clinical Aspects
PressureSafe™
IR-MED's PressureSafe™ and its Disposable Tip are now FDA-listed, enabling commercial entry into the U.S.
PressureSafe™ has proven its effectiveness in multi clinical trials in diverse patient populations with different skin tones.
The Company's technology addresses longstanding disparities in skin assessment, particularly in patients with darker skin tones that suffer more than twice as much as those with lighter skin.
DiaSafe™
The Company received a
$500 K grant plan for DiaSafe™ that was awarded by the Israel Innovation Authority (the "IIA").The IIA grant funding will support clinical advancement of DiaSafe™, an AI-powered diagnostic device for diabetic foot ulcers. The first in human clinical study is planned to commence soon in a leading medical center in Northern Israel.
DiaSafe™ with its complementary AI-driven solutions positions IR-MED to address additional large wound care markets among high-risk diabetic patients.
Usability Study at Methodist San-Antonio Texas
Since the Company views the U.S. market as a key strategic priority, it is important for us to demonstrate clinical results within the U.S. and not rely solely on data from the clinical study conducted in Israel. U.S. healthcare providers place significant importance on this distinction. Our first active site in the U.S. is HCA Methodist Healthcare, the largest healthcare provider in South Texas, operating 10 hospitals and over 25 outpatient clinics in the San Antonio area.
The trial is a 2-stage trial, the first stage results achieved
94% sensitivity with no safety concerns.786 scans across 163 anatomical sites,
61% from patients with darker skin tones.
- Few weeks ago, we have initiated the second stage of the trial, we anticipate this stage will take up-to 6 months.
Principal Investigator Dr. Mary Lee Potter, PhD, MBA, RN, CWOCN, stated: "PressureSafe represents a promising advancement in pressure injury prevention, offering clinicians a rapid, objective tool to assess tissue risk, especially in patients with dark skin tones. These interim findings validate the device's clinical potential to improve equity and patient outcomes. To further highlight the impact of this research, Dr. Potter has been invited to provide a podium presentation at the 2025 ANCC Magnet/ANE Research Symposium, the largest annual gathering of nursing professionals in the U.S., to be held on October 7th, 2025, in Atlanta, GA, where she will showcase PressureSafe's role in addressing disparities in pressure injury assessment."
Additional Usability Trial at a Major East Coast Hospital
Following over 12 months of due diligence and preparation, we are now in the advanced stages of Institutional Review Board ("IRB") submission, as well as handling the associated legal and financial documentation.
These clinical milestones not only validate the strong performance of PressureSafe™ in real-world U.S. healthcare settings but also pave the way for broader adoption by frontline caregivers—positioning the device as a transformative tool in equitable and effective pressure injury prevention., we believe that gaining entry into two of the most prominent hospital networks in the U.S. is not only a significant honor, but also a major commercial opportunity that strengthens our foothold in the largest healthcare market in the world.
Pilot Studies and Transition to Initial Commercial Production
We are aiming to secure several pilot programs in the first half of 2026 in several health care settings across the U.S., which would serve as the cornerstone for our initial go-to-market strategy and will help shape our product's adoption path.
Fundraising
As we approach the final stage towards commercialization phase, we believe it is reasonable to expect that within the coming years, sales could become meaningful. In parallel, we are seeing growing interest from highly respected medical care networks and players in the industry. Collaborations with such entities—should they materialize—could further support our growth and contribute to our long-term value.
With regard to the company's strategic plan to uplist to a major stock exchange, such as NASDAQ or the New York Stock Exchange, NYSE American (NYSE), we wish to emphasize that this goal remains a top strategic priority. We are actively working toward achieving it, as we believe that uplisting will significantly enhance the company's valuation, improve share liquidity, and broaden our investor base.
However, we recognize that current conditions—both in terms of operational readiness and financial positioning—are not yet optimal for such a move. We therefore plan to pursue the uplisting after additional capital raise on the OTC market, as well as upon reaching key product development and clinical milestones anticipated in the coming months. These steps will better position the company for a successful uplisting.
As part of our preparations, we have engaged with a leading investment bank that will support and guide us through the near-term fundraising as well as the future uplisting process. We will continue to keep you informed as this effort progresses.
IR-MED's current market valuation is significantly misaligned with its actual stage and potential. While the reasons for this gap can be debated, the need to correct this misalignment is clear and urgent. We are committed to taking a more active and strategic approach to investor and public relations. As a publicly traded company, visibility, communication, and consistent market engagement are essential. We recognize the importance of investing in efforts that will raise awareness and better position the Company in the eyes of the market.
In Summary
We are navigating a demanding and pivotal period, both operationally and strategically. Despite the challenges, I remain confident and optimistic about our path forward. I sincerely hope that our existing investors, along with new collaborations, will share this optimism and continue to support us in driving the Company toward its goals.
Ran Ziskind,
Chief Executive Officer
About IR-MED
IR-MED Inc. 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 skin 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 platform product, 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 non-invasive 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 the Company's ability to initiate clinical trials in the first half of 2026 pending final approvals; the Company's ability to secure several pilot programs in the first half of 2026 in several health care settings across U.S.; that within the coming years, sales could become meaningful; that future collaborations could further support the Company's growth and contribute to its long-term value; future uplisting to a national exchange; future capital raises; reaching key product development and clinical milestones anticipated in the coming months. Statements relating to the future performance of IR-Med are subject to many factors including, but not limited to, the accuracy of the Company's estimates regarding expenses, future revenues, uses of cash, capital requirements and the need for additional financing; the initiation, cost, timing, progress and results of our development activities, usability studies, preclinical studies and any clinical trials that it may be required to undertake; the timing of and the Company's ability to obtain and maintain regulatory approval of our existing product candidates, any product candidates that it may develop, and any related restrictions and/or limitations; the company's plans to research, develop and commercialize its current and future product candidates; the Company's ability to attract collaborators with development, regulatory and commercialization expertise; the company's ability to obtain and maintain intellectual property protection for its product candidates; the Company's ability to successfully commercialize its product candidates; the size and growth of the markets for its product candidates and its ability to serve those markets; the rate and degree of market acceptance of any future products; the success of competing devices that are or may become available; regulatory developments in the United States and other countries; the performance of its third-party suppliers and manufacturers and its ability to obtain alternative sources of raw materials; the impact of global inflationary pressures; its ability to obtain additional financing; use of the proceeds from its securities offerings; any restrictions on its ability to use its net operating loss carry-forwards; the impact of Israel's multi-front war on its results, including potential economic restrictions imposed on and political and military instability in Israel; its ability to attract and retain key personnel, and the other risks identified in our most recent annual report on Form 10-K filed on April 4, 2025 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:
Hanover International, Inc.
Kathy Cusumano, President
Contact@ir-medical.com
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/266250
FAQ
What clinical trial results did IR-MED's PressureSafe device achieve in 2025?
How much funding did IR-MED receive from the Israel Innovation Authority in 2025?
When does IR-MED plan to begin commercial operations?
What are IR-MED's plans for uplisting from OTCQB?
What is the current financial status of IR-MED as of September 2025?
