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Revealia Breast(TM) Offers Glimpse Into the Future of Early Cancer Detection With a Simple Cheek Swab

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Ludwig Enterprises (OTC:LUDG) has announced the development of Revealia Breast™, a non-invasive breast cancer screening test expected to launch in Q3 2025. The test uses a simple cheek swab to detect cancer-related inflammation through mRNA biomarker analysis and AI technology, potentially identifying breast cancer before physical symptoms appear.

Recent data from the American Society of Breast Surgeons shows that early detection through multidisciplinary breast cancer clinics resulted in 39.7% of cases showing non-invasive disease, compared to 13.2% in traditional management. Revealia Breast™ aims to provide more affordable, accessible, and comfortable screening than mammograms, particularly beneficial for women with dense breast tissue where mammograms may miss early signs.

The test is part of Ludwig's broader pipeline targeting major cancers, with the global breast cancer screening market valued at over $4 billion. The company plans to submit additional clinical validation papers and announce new scientific advisory board members this quarter.

Ludwig Enterprises (OTC:LUDG) ha annunciato lo sviluppo di Revealia Breast™, un test di screening non invasivo per il cancro al seno previsto per il lancio nel terzo trimestre del 2025. Il test utilizza un semplice tampone sulla guancia per rilevare l'infiammazione correlata al cancro tramite analisi di biomarcatori mRNA e tecnologia AI, con la potenzialità di identificare il cancro al seno prima della comparsa dei sintomi fisici.

Dati recenti dell'American Society of Breast Surgeons mostrano che la diagnosi precoce attraverso cliniche multidisciplinari per il cancro al seno ha portato al 39,7% dei casi con malattia non invasiva, rispetto al 13,2% nella gestione tradizionale. Revealia Breast™ punta a offrire uno screening più economico, accessibile e confortevole rispetto alla mammografia, risultando particolarmente utile per le donne con tessuto mammario denso, dove la mammografia può non rilevare i primi segnali.

Il test fa parte del più ampio portafoglio di Ludwig che mira ai principali tipi di cancro, con un mercato globale dello screening del cancro al seno valutato oltre 4 miliardi di dollari. L'azienda prevede di presentare ulteriori studi di validazione clinica e annunciare nuovi membri del comitato scientifico consultivo nel corso di questo trimestre.

Ludwig Enterprises (OTC:LUDG) ha anunciado el desarrollo de Revealia Breast™, una prueba no invasiva para la detección del cáncer de mama que se espera lanzar en el tercer trimestre de 2025. La prueba utiliza un simple hisopo de mejilla para detectar inflamación relacionada con el cáncer mediante análisis de biomarcadores mRNA y tecnología de IA, con el potencial de identificar el cáncer de mama antes de que aparezcan síntomas físicos.

Datos recientes de la American Society of Breast Surgeons muestran que la detección temprana a través de clínicas multidisciplinarias de cáncer de mama resultó en un 39,7% de casos con enfermedad no invasiva, en comparación con un 13,2% en el manejo tradicional. Revealia Breast™ busca ofrecer un método de detección más asequible, accesible y cómodo que las mamografías, especialmente beneficioso para mujeres con tejido mamario denso, donde las mamografías pueden no detectar signos tempranos.

La prueba forma parte de la cartera más amplia de Ludwig enfocada en los principales tipos de cáncer, con un mercado global de detección de cáncer de mama valorado en más de 4 mil millones de dólares. La compañía planea presentar más estudios de validación clínica y anunciar nuevos miembros del consejo asesor científico durante este trimestre.

Ludwig Enterprises (OTC:LUDG)는 2025년 3분기 출시 예정인 비침습 유방암 검사 Revealia Breast™ 개발을 발표했습니다. 이 검사는 간단한 볼 면봉 채취를 통해 mRNA 바이오마커 분석과 AI 기술로 암 관련 염증을 감지하여 신체적 증상 발생 이전에 유방암을 식별할 수 있습니다.

미국 유방외과학회(American Society of Breast Surgeons)의 최신 데이터에 따르면 다학제 유방암 클리닉을 통한 조기 발견 시 비침습성 질환 비율이 39.7%에 달했으며, 전통적 관리에서는 13.2%에 불과했습니다. Revealia Breast™는 특히 유방 밀도가 높은 여성에게서 조기 징후를 놓칠 수 있는 유방촬영술보다 더 저렴하고 접근성 높으며 편안한 검진을 제공하는 것을 목표로 합니다.

이 검사는 주요 암을 겨냥한 Ludwig의 광범위한 파이프라인의 일부로, 전 세계 유방암 검사 시장은 40억 달러 이상으로 평가됩니다. 회사는 이번 분기에 추가 임상 검증 논문 제출과 새로운 과학 자문 위원회 멤버 발표를 계획하고 있습니다.

Ludwig Enterprises (OTC:LUDG) a annoncé le développement de Revealia Breast™, un test de dépistage non invasif du cancer du sein, dont le lancement est prévu au troisième trimestre 2025. Ce test utilise un simple prélèvement buccal pour détecter l'inflammation liée au cancer via l'analyse des biomarqueurs ARN messager et la technologie IA, permettant potentiellement d'identifier le cancer du sein avant l'apparition des symptômes physiques.

Des données récentes de l'American Society of Breast Surgeons montrent qu'une détection précoce via des cliniques multidisciplinaires du cancer du sein a conduit à 39,7 % des cas présentant une maladie non invasive, contre 13,2 % dans la prise en charge traditionnelle. Revealia Breast™ vise à offrir un dépistage plus abordable, accessible et confortable que la mammographie, particulièrement bénéfique pour les femmes ayant un tissu mammaire dense, où la mammographie peut manquer les premiers signes.

Ce test fait partie du portefeuille plus large de Ludwig ciblant les principaux cancers, le marché mondial du dépistage du cancer du sein étant estimé à plus de 4 milliards de dollars. La société prévoit de soumettre d'autres études de validation clinique et d'annoncer de nouveaux membres du comité consultatif scientifique ce trimestre.

Ludwig Enterprises (OTC:LUDG) hat die Entwicklung von Revealia Breast™ angekündigt, einem nicht-invasiven Brustkrebs-Screening-Test, der im dritten Quartal 2025 auf den Markt kommen soll. Der Test verwendet einen einfachen Wangenabstrich, um krebsbedingte Entzündungen mittels mRNA-Biomarker-Analyse und KI-Technologie zu erkennen und kann Brustkrebs möglicherweise vor dem Auftreten physischer Symptome identifizieren.

Aktuelle Daten der American Society of Breast Surgeons zeigen, dass durch multidisziplinäre Brustkrebs-Kliniken bei der Früherkennung 39,7 % der Fälle nicht-invasive Erkrankungen waren, verglichen mit 13,2 % bei herkömmlicher Behandlung. Revealia Breast™ zielt darauf ab, ein erschwinglicheres, zugänglicheres und komfortableres Screening als Mammographien anzubieten, was besonders für Frauen mit dichtem Brustgewebe von Vorteil ist, bei denen Mammographien frühe Anzeichen übersehen können.

Der Test ist Teil der umfassenderen Pipeline von Ludwig, die auf große Krebsarten abzielt, wobei der globale Markt für Brustkrebs-Screening auf über 4 Milliarden US-Dollar geschätzt wird. Das Unternehmen plant, in diesem Quartal weitere klinische Validierungsstudien einzureichen und neue Mitglieder des wissenschaftlichen Beirats bekannt zu geben.

Positive
  • Innovative non-invasive screening method using only a cheek swab
  • Addresses limitations of mammograms, especially for dense breast tissue
  • Targets $4+ billion global breast cancer screening market
  • Expected commercial launch in Q3 2025
  • First in pipeline of screening tests for major cancers
Negative
  • Product still in development phase, not yet commercially available
  • Clinical validation papers still pending submission
  • Launch timeline delayed from previous estimates

Ludwig Enterprises, Inc. (OTC:LUDG), previews its first in a pipeline of non-invasive cancer screening tests powered by mRNA biomarker analysis.

MIAMI, FL / ACCESS Newswire / May 7, 2025 / Ludwig Enterprises, Inc. (the "Company"), a biotech innovator in mRNA diagnostics and AI-driven health solutions, announced today the initial introduction of its lead product, Revealia Breast™, a non-invasive breast cancer screening test currently in advanced development. This innovative diagnostic tool uses a simple cheek swab to detect cancer-related inflammation early, aiming to identify breast cancer even before physical symptoms appear.

Revealia Breast™ is currently in advanced development, with an expected release in the third quarter of 2025.

Recent data presented at the American Society of Breast Surgeons (ASBS) underscores the urgent need for early detection: patients evaluated through multidisciplinary breast cancer clinics had significantly better outcomes, with 39.7% showing non-invasive disease compared to just 13.2% in traditionally managed groups (1). Revealia Breast™ is designed precisely to facilitate this kind of early diagnosis - and do so more affordably, accessibly, and comfortably than mammograms.

"This is more than just a test - it's a lifeline," said Marvin S. Hausman, MD, Chief Medical Officer at Ludwig Enterprises, Inc. "The earlier we find breast cancer, the better the chance for survival. By analyzing specific mRNA biomarkers from a simple cheek swab, Revealia Breast™ aims to provide that critical early insight, potentially leading to the kind of improved outcomes highlighted in recent clinical findings."

Revealia Breast™ is the first of many early cancer screening tests the Company plans to introduce, targeting most major cancers. Each test is based on the company's proprietary mRNA inflammatory biomarker panel and AI technology, with the mission of enabling earlier, more accurate detection and intervention.

Why This Matters to Patients - and Investors

  • Easy, Non-Invasive Testing
    Just a quick cheek swab. No needles, no radiation, no painful compression.

  • High-Tech Early Detection
    Uses proprietary mRNA biomarkers and artificial intelligence to evaluate a patient's cancer risk - even before symptoms appear.

  • Addressing Mammogram Gaps
    Mammograms can miss early signs, especially in women with dense breast tissue (2). Revealia Breast™ helps close that diagnostic gap.

  • Massive Market Potential
    The global breast cancer screening market is valued at over $4 billion, and Revealia Breast™ is poised to disrupt it.

  • Improved Patient Outcomes
    The ASBS study confirms what the science suggests: earlier detection often means less invasive disease and better treatment success. Revealia Breast™ aims to democratize that early access.

Commitment to Transparency and Education

While previous estimates targeted an earlier launch, the Company is now focused on a Q3 2025 rollout. The team is committed to transparency and will provide timely updates as key milestones are achieved.

Today's release is part of a larger public and investor education initiative. Upcoming videos, expert commentary, and insights into the Company's technology and team will be shared throughout the coming months.

The Company will also be announcing newly appointed members of its scientific advisory board and expects to submit additional clinical validation papers this quarter.

The Technology Behind Revealia Breast™

The Revealia Breast™ test analyzes a panel of inflammatory mRNA markers linked to cancer progression. Collected through a painless cheek swab, these biomarkers are interpreted using artificial intelligence to generate a personalized risk score.

Unlike traditional methods, Revealia Breast™ does not rely on imaging. Instead, it taps into the molecular biology of inflammation, which research shows is often a precursor to tumor development. This positions Revealia Breast™ as a first-of-its-kind frontline screening tool.

About Ludwig Enterprises, Inc.

Ludwig Enterprises, Inc. (which is in the process of changing its name to Revealia Diagnostics, Inc.), a biotech and healthcare holding company, is a global - innovator in mRNA genomics and machine learning AI technology. Our mission is to identify, monitor, and create solutions to - mitigate chronic inflammation, the causative agent of illnesses such as cancer and heart disease, which are responsible for more than 50% of deaths worldwide.

For more information, please visit: http://www.ludwigent.com.

About Revealia Breast™

Revealia Breast™ is a proprietary mRNA-based breast cancer screening test that establishes a personalized inflammatory index to assist individuals in understanding and managing their health. Artificial intelligence helps derive a unique risk score by comparing a person's biomarker profile to a growing clinical database.

For more information, please visit: www.revealia.com

SAFE HARBOR

Forward-looking statements in this release are made under the "safe harbor" provision of the Private Securities Litigation Reform Act of 1995. Ludwig Enterprises Inc.'s forward-looking statements do not guarantee future performance. This news release includes forward-looking statements concerning the future level of business for the parties. These statements are necessarily subject to risk and uncertainty. Actual results could differ materially from those projected in these forward-looking statements due to certain risk factors that could cause results to differ materially from estimated results. Management cautions that all statements as to future results of operations are necessarily subject to risks, uncertainties, and events that may be beyond the control of Ludwig Enterprises, Inc., and no assurance can be given that such results will be achieved. Potential risks and uncertainties include, but are not limited to, the ability to procure, appropriately price, retain, and complete projects and changes in products and competition.

FOR FURTHER INFORMATION:

CONTACT:

Ludwig Enterprises, Inc.
www.ludwigent.com
Twitter: @LUDG_inc

IR@revealia.com

References:

(1) Kobzeva-Herzog AJ, Palaniappan S, Jiangliu Y, et al. Evaluating the effect of a multidisciplinary breast cancer clinic on time to treatment at an urban safety net hospital. Presented at a press conference for the American Society of Breast Surgeons; April 24, 2025.
(2) Jiawei, L. et al. 2020. Non-Invasive Biomarkers for Early Detection of Breast Cancer. Cancers (Basel).12(10):2767. doi:10.3390/cancers12102767

SOURCE: Ludwig Enterprises, Inc.



View the original press release on ACCESS Newswire

FAQ

When will Ludwig Enterprises (LUDG) launch Revealia Breast cancer screening test?

Ludwig Enterprises plans to launch Revealia Breast™ in the third quarter of 2025.

How does LUDG's Revealia Breast cancer screening test work?

Revealia Breast™ uses a cheek swab to analyze mRNA inflammatory biomarkers using AI technology to generate a personalized cancer risk score, without requiring imaging or invasive procedures.

What is the market potential for LUDG's Revealia Breast cancer test?

The global breast cancer screening market is valued at over $4 billion, presenting significant market potential for Revealia Breast™.

What advantages does LUDG's Revealia Breast test have over mammograms?

Revealia Breast™ offers non-invasive testing without radiation or compression, can detect cancer before symptoms appear, and may be more effective for women with dense breast tissue where mammograms often miss early signs.

What are the next steps for Ludwig Enterprises' (LUDG) Revealia Breast test?

The company plans to submit additional clinical validation papers and announce new scientific advisory board members in the current quarter, leading up to the Q3 2025 launch.
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