Check-Cap Ltd. (CHEK): Analyse de Pestle [Jan-2025 MISE À JOUR]

Dans le paysage rapide en évolution des diagnostics médicaux, Check-Cap Ltd. (CHEK) émerge comme un innovateur révolutionnaire, ce qui remet en question les paradigmes traditionnels de dépistage du cancer colorectal avec sa technologie de rayons X basée sur une capsule révolutionnaire. En naviguant sur des terrains politiques, économiques, sociologiques, technologiques, juridiques et environnementaux complexes, cette entreprise pionnière se tient à l'intersection des solutions d'innovation médicale de pointe et de soins de santé transformateurs. Plongez dans notre analyse complète des pilotes pour découvrir comment Check-CAP remodeler l'avenir de la détection du cancer non invasive, révolutionnant potentiellement les expériences des patients et les méthodologies de dépistage médical.

Check-Cap Ltd. (CHEK) - Analyse du pilon: facteurs politiques

US FDA Preakthrough Device Device pour la technologie de dépistage du cancer colorectal en C-View

Check-Cap Ltd. reçu Désignation de dispositif révolutionnaire de la FDA pour sa technologie C-View sur 15 septembre 2022. Cette désignation accélère le processus de développement et de revue pour les dispositifs médicaux innovants répondant aux besoins cliniques non satisfaits importants.

Détails de désignation	Informations spécifiques
Date de désignation de dispositif de percée de la FDA	15 septembre 2022
Technologie	Dépistage du cancer colorectal de la vue en C
Réduction du temps de révision potentielle	Environ 30 à 40% plus rapides par rapport aux processus d'examen standard

Défis réglementaires potentiels dans l'expansion du marché mondial des dispositifs médicaux

Le paysage réglementaire des dispositifs médicaux mondiaux présente des défis complexes pour Check-Cap Ltd.

• Exigences de conformité de la réglementation des dispositifs médicaux de l'Union européenne (MDR)
• Complexité du processus de certification de marquage CE
• Procédures d'enregistrement des dispositifs médicaux internationaux

Région réglementaire	Niveau de complexité de conformité	Coût de conformité estimé
Union européenne	Haut	$500,000 - $750,000
États-Unis	Moyen	$250,000 - $450,000
Asie-Pacifique	Moyen-élevé	$350,000 - $550,000

Dépendance à l'égard des cadres de santé et de remboursement américains

La pénétration du marché de Check-Cap Ltd. repose fortement sur les politiques de remboursement des soins de santé américaines.

• Déterminations sur la couverture de l'assurance-maladie
• Taux de remboursement d'assurance privée
• Implications de la loi sur les soins abordables

Catégorie de remboursement	Impact potentiel	Influence financière estimée
Couverture de l'assurance-maladie	Accès direct au marché	5 à 7 millions de dollars de revenus annuels potentiels
Assurance privée	Extension du marché	3 à 5 millions de dollars de revenus annuels potentiels

Impact potentiel des normes de réglementation des dispositifs médicaux internationaux

Les normes réglementaires internationales influencent considérablement la stratégie de marché mondiale de Check-Cap Ltd.

• Organisation internationale pour la normalisation (ISO) 13485 Conformité
• Exigences de gestion de la qualité des dispositifs médicaux mondiaux
• Efforts d'harmonisation réglementaire transfrontaliers

Norme de réglementation	Exigence de conformité	Coût de mise en œuvre estimé
ISO 13485	Dispositifs médicaux Gestion de la qualité	$250,000 - $400,000
IEC 62304	Cycle de vie du logiciel de dispositif médical	$150,000 - $250,000

Check-Cap Ltd. (CHEK) - Analyse du pilon: facteurs économiques

Génération de revenus limitée à partir de la technologie médicale pré-commerciale

Au troisième rang 2023, Check-Cap Ltd. a déclaré un chiffre d'affaires total de 0,41 million de dollars, reflétant le stade pré-commercial de l'entreprise. Les états financiers indiquent des défis continus pour générer des revenus substantiels à partir de sa plateforme de technologie médicale.

Métrique financière	Valeur 2022	Valeur 2023
Revenus totaux	0,32 million de dollars	0,41 million de dollars
Perte nette	14,7 millions de dollars	12,3 millions de dollars
Espèce et équivalents	16,5 millions de dollars	9,2 millions de dollars

Exigences de financement de recherche et développement en cours

Chèque alloué 8,6 millions de dollars aux dépenses de recherche et développement en 2023, représentant un investissement critique dans sa technologie d'imagerie médicale.

Catégorie de dépenses de R&D	2022 dépenses	2023 dépenses
Total des dépenses de R&D	7,9 millions de dollars	8,6 millions de dollars
Pourcentage des dépenses totales	62.3%	65.4%

Volatilité potentielle du marché affectant les investissements en technologie médicale

Le secteur de la technologie médicale expérimentée 17,2% de volatilité des investissements En 2023, impactant directement l'évaluation du marché de Check-Cap.

Métrique d'investissement	Valeur 2022	Valeur 2023
Gamme de cours des actions	$0.50 - $1.20	$0.35 - $0.85
Capitalisation boursière	42,3 millions de dollars	28,6 millions de dollars

Dépendance à l'égard du capital-risque et du sentiment des investisseurs

Capre de contrôle sécurisé 5,2 millions de dollars Dans un financement supplémentaire grâce à un placement privé en 2023, démontrant l'intérêt continu des investisseurs dans l'innovation des soins de santé.

Source de financement	2022 Montant	2023 Montant
Placement privé	4,7 millions de dollars	5,2 millions de dollars
Investissement en capital-risque	3,5 millions de dollars	4,1 millions de dollars

Check-Cap Ltd. (CHEK) - Analyse du pilon: facteurs sociaux

Conscience croissante des méthodes de dépistage du cancer colorectal non invasif

Selon l'American Cancer Society, les taux de dépistage du cancer colorectal sont passés à 67,4% en 2021 pour les adultes âgés de 50 à 75 ans. Les méthodes de dépistage non invasives représentaient 22,3% des approches totales de dépistage.

Méthode de dépistage	Pourcentage d'utilisation	Coût annuel
Coloscopie	45.1%	$1,500-$3,000
Tests basés sur les selles	15.3%	$300-$600
Colonographie CT	7.2%	$800-$1,500

La population vieillissante augmente la demande de technologies de détection du cancer précoce

Les données du Bureau du recensement américain indiquent que 54,1 millions d'Américains étaient de 65 ans ou plus en 2022, ce qui représente 16,3% de la population totale. Prévu pour atteindre 74,1 millions d'ici 2030.

Hésitation potentielle des patients à de nouvelles approches de dépistage médical

L'enquête sur la confiance des consommateurs de la santé 2023 a révélé:

• 62,7% hésitant à adopter de nouvelles technologies de dépistage médical
• 38,4% préoccupé par l'exactitude des méthodes de dépistage non traditionnelles
• 43,2% préfèrent les protocoles de dépistage établis

Attitudes culturelles envers les procédures de dépistage médical préventif

Groupe démographique	Taux de participation au dépistage	Barrière principale
Américains blancs	72.3%	Contraintes de temps
Afro-Américains	54.6%	Méfiance des soins de santé
Américains hispaniques	61.2%	Barrières linguistiques

Check-Cap Ltd. (CHEK) - Analyse du pilon: facteurs technologiques

Technologie de rayons X basée sur les capsules propriétaires pour le dépistage colorectal

Check-Cap Ltd. a développé une technologie de rayons X basée sur une capsule C-Scan avec les spécifications suivantes:

Paramètre technologique	Spécification
Taille de la capsule	11 mm x 26 mm
Dose de rayonnement	Moins de 4 msv
Gamme d'imagerie	Visualisation complète du côlon
Durée de vie de la batterie	Environ 8 heures

Innovation continue dans l'imagerie médicale et les technologies de diagnostic

Investissement de recherche et développement pour 2023: 3,2 millions de dollars

Année	Dépenses de R&D	Demandes de brevet
2022	2,8 millions de dollars	3 applications
2023	3,2 millions de dollars	4 applications

Intégration de l'intelligence artificielle dans les processus de dépistage diagnostique

Capacités d'analyse d'images améliorées AI:

• Précision de l'algorithme d'apprentissage automatique: 92,5%
• Vitesse de traitement: 3,2 images par seconde
• Amélioration de la précision diagnostique: 15,7%

Potentiel des progrès technologiques dans les diagnostics médicaux non invasifs

Progrès technologique	État actuel	Chronologie de développement projetée
Technologie de capteur de capsule améliorée	Étape prototype	2024-2025
Transmission de données en temps réel	Tests initiaux	2025-2026
Miniaturisation des composants d'imagerie	Phase de recherche	2026-2027

Check-Cap Ltd. (CHEK) - Analyse du pilon: facteurs juridiques

Conformité aux réglementations des dispositifs médicaux de la FDA

Check-Cap Ltd. a soumis une notification pré-market 510 (k) à la FDA pour son système de dépistage C-SCAN. L'appareil a reçu l'autorisation de la FDA le 29 janvier 2019 (K183025).

Jalon réglementaire	Date	Corps réglementaire
510 (k) soumission	2018	FDA
Déclaration de la FDA	29 janvier 2019	FDA

Protection de la propriété intellectuelle pour la technologie de dépistage

Portefeuille de brevets: En 2023, Check-Cap Ltd. détient plusieurs brevets liés à sa technologie de dépistage basée sur Capsule.

Type de brevet	Nombre de brevets	Couverture géographique
Brevets technologiques de base	7	États-Unis, Europe, Israël
Demandes de brevet en instance	3	International

Considérations potentielles de responsabilité médicale

Check-Cap maintient une assurance responsabilité professionnelle avec une couverture de 5 millions de dollars par occurrence.

Type d'assurance	Montant de la couverture	Période de politique
Responsabilité professionnelle	$5,000,000	Renouvellement annuel

Adhésion aux normes de confidentialité et de protection des données sur les soins de santé

Cadres de conformité: CHECK-CAP adhère aux réglementations HIPAA et maintient la certification SOC 2 Type II.

Norme de conformité	Statut de certification	Dernière date d'audit
Compliance HIPAA	Pleinement conforme	Décembre 2023
SOC 2 TYPE II	Agréé	Novembre 2023

Check-Cap Ltd. (CHEK) - Analyse du pilon: facteurs environnementaux

Technologie d'exposition à faible radiation pour le dépistage médical

Comparaison de dose de rayonnement:

Méthode de dépistage	Exposition aux radiations (MSV)
Colonographie traditionnelle aux rayons X	10.0 msv
Technologie CAP-CAP C-SCAN	0,1 msv

Impact environnemental réduit

Réduction de l'empreinte carbone:

Métrique environnementale	Impact de la technologie de contrôle de contrôle
Réduction des émissions de CO2	87% inférieur par rapport au dépistage traditionnel
Déchets médicaux générés	65% de moins que les méthodes conventionnelles

Développement de technologie médicale durable

Métriques de la durabilité technologique:

• La conception de capsule jetable minimise l'impact environnemental à long terme
• Les composants recyclables constituent 92% des matériaux de l'appareil
• Consommation d'énergie: 0,5 kWh par procédure de dépistage

Alignement de la technologie des soins de santé verts

Métriques de la conformité environnementale:

Norme environnementale	Niveau de conformité
Gestion de l'environnement ISO 14001	Pleinement conforme
Certification de la technologie verte	Certification de niveau 3

Check-Cap Ltd. (CHEK) - PESTLE Analysis: Social factors

High public demand for non-invasive, at-home colorectal cancer screening.

The market trend is decisively shifting toward patient-friendly alternatives for colorectal cancer (CRC) screening. You can see this in the numbers: the total U.S. CRC screening market is projected to reach US$ 6.41 billion in 2025, with a clear demand for non-invasive methods driving that growth. The non-invasive segment of this market, which includes technologies like the C-Scan system, is valued at approximately $2.5 billion and is projected to experience a Compound Annual Growth Rate (CAGR) of around 10% from 2023 to 2030. This demand is a direct result of the deeply ingrained public aversion to the traditional colonoscopy prep, sedation, and invasiveness. For a clinical-stage company like Check-Cap Ltd., whose C-Scan is designed to be preparation-free and non-sedating, this massive, unmet demand is the primary commercial opportunity.

Patient compliance rates are defintely higher for non-prep, non-sedation procedures.

Patient compliance is the single biggest hurdle in CRC prevention, and it's where non-invasive tests shine. Only 59% of screening-eligible individuals in the United States are currently up-to-date with their screening, leaving nearly 50 million adults unscreened. The compliance rates for the gold-standard colonoscopy are alarmingly low, especially in younger, newly eligible groups. Conversely, non-invasive options, which remove the need for bowel prep and time off work, demonstrate much higher adherence. This is a simple equation: the easier the test, the more people do it.

Here's the quick math on adherence, showing why C-Scan's non-prep approach is a game-changer:

Screening Modality	Key Patient Barrier	Typical Compliance Rate (US)	Target Population Compliance Gap
Colonoscopy (Invasive)	Bowel Prep, Sedation, Time Off	Ranges from 28% to 42% (General)	Only 26% for the 45-50 age group
Blood-Based Tests (Non-Invasive)	Follow-up Colonoscopy Required for Positive Result	≥ 80%	Addresses the 41% of adults not up-to-date
C-Scan System (Non-Invasive, Prep-Free)	Requires Ingesting a Capsule and Wearing a Sensor	40% of colonoscopy decliners preferred it over FOBT	High patient satisfaction score of 4.1 out of 5

Growing public health campaigns increase screening awareness and uptake.

Public health efforts are creating a larger, more receptive audience for screening technologies. The U.S. Preventive Services Task Force (USPSTF) lowering the recommended starting age for CRC screening to 45 years in 2021 has expanded the eligible population significantly. This new cohort is a prime target for non-invasive tests, as only 29.8% of adults aged 45 to 49 were up-to-date with screening in 2022. Plus, state-level policies are increasingly eliminating cost-sharing for a follow-up colonoscopy after a positive non-invasive test, removing a major financial disincentive for patients to complete the full screening process. This supportive regulatory environment and public awareness push a lot of people toward the path of least resistance-which is defintely a non-invasive test.

Cultural acceptance of low-dose imaging technology is a strong tailwind.

While the C-Scan system is often grouped with non-invasive tests, it is important to be precise: it is not radiation-free. It uses an ingestible capsule that emits ultra-low-dose X-ray radiation. However, this is a strong tailwind, not a headwind, because the dose is so minimal compared to other imaging options, making it highly acceptable to patients.

The C-Scan's mean radiation dose is estimated at only 0.04 mSv to 0.051 mSv. To put that in perspective, this is less than a standard chest X-ray (0.1 mSv) and dramatically lower than a CT colonography (6 mSv) or a typical CT scan of the abdomen (10 mSv). This low dose, combined with the preparation-free, non-sedating nature of the procedure, leads to high patient satisfaction. In a feasibility study, patients gave the C-Scan capsule a high likelihood-to-recommend score of 4.1 out of 5, compared to only 2.8 for colonoscopy. This combination of low risk and high convenience makes the technology a powerful option for increasing screening adherence.

• Average C-Scan radiation dose: 0.04 mSv.
• Equivalent to a plain abdominal X-ray.
• Significantly lower than a CT colonography: 6 mSv.

Finance: draft a risk-adjusted patient uptake model for the C-Scan system by end of next week, factoring in the 41% unscreened population and the high patient satisfaction scores.

Check-Cap Ltd. (CHEK) - PESTLE Analysis: Technological factors

C-Scan system competes directly with established non-invasive stool DNA tests (e.g., Exact Sciences' Cologuard).

The core technological challenge for Check-Cap Ltd. is the direct, entrenched competition from market leaders like Exact Sciences, whose Cologuard test has substantial commercial scale and a robust clinical profile. Exact Sciences has raised its full-year 2025 revenue guidance to between $3.22 billion and $3.235 billion, with the Screening segment (Cologuard) alone projected to contribute between $2.51 billion and $2.525 billion. That's a massive headwind.

Cologuard's new generation, Cologuard Plus, further raises the bar, reporting a 95% sensitivity and 94% specificity, and achieving a 40% reduction in false positives compared to the original test. In contrast, C-Scan's post-CE approval study demonstrated a 76% sensitivity and 80% specificity for polyps $\geq$ 10mm. The C-Scan advantage remains its preparation-free nature, a significant patient benefit that avoids the harsh bowel prep required for a colonoscopy or other capsule systems. Still, the data gap is clear.

Metric	C-Scan (Polyps $\geq$ 10mm)	Cologuard Plus (Colorectal Cancer)
Sensitivity (True Positive Rate)	76%	95%
Specificity (True Negative Rate)	80%	94%
Bowel Preparation Required?	No	No

Need to finalize and scale manufacturing for the ingestible imaging capsule.

The need to finalize and scale manufacturing for the ingestible imaging capsule has been fundamentally altered by the September 2025 merger with MBody AI. Check-Cap Ltd. was a clinical-stage company with no commercial revenue, and its total assets stood at just $377,000 against liabilities of approximately $1.83 million leading up to the deal. The merger essentially served as a lifeline, addressing Nasdaq compliance issues and pivoting the company's focus.

The C-Scan system's manufacturing scale-up, which was previously a critical independent milestone, is now a secondary R&D activity within the new entity, MBody AI Ltd. This shift means the manufacturing risk is now one of deprioritization rather than financial solvency, as the new parent company focuses on its primary business of 'embodied artificial intelligence for autonomous workforce solutions.' The original goal of initiating a U.S. pivotal study, which drove a 2021 manufacturing expansion, appears stalled in favor of the new AI direction. What this estimate hides is the potential for the C-Scan technology to be shelved if the AI integration isn't successful.

Rapid advances in artificial intelligence (AI) for diagnostic image analysis.

The technological opportunity in AI is so significant that it led to the company's transformation. The merger with MBody AI, approved by shareholders with over 98% of votes in November 2025, is a direct response to this trend. AI is rapidly changing diagnostics, demonstrating superior adenoma detection rates (ADR) in colonoscopy. For example, AI-assisted colonoscopies have been shown to detect precancerous or cancerous tumors in 55.1% of patients, compared to only 42.0% without AI assistance-a 13% disparity.

The C-Scan system, which generates a 3D map of the colon's inner lining, produces exactly the kind of complex, high-volume data that deep learning algorithms excel at analyzing. The new MBody AI Ltd. plans to leverage its MBody AI Orchestrator platform, which is hardware-agnostic and claims to deliver up to a 40% labor reduction and 80% uptime improvement in enterprise deployments. This suggests the C-Scan's future value may lie less in its current X-ray technology and more in its potential to serve as a sophisticated, prepless data-capture device for a powerful, AI-driven diagnostic engine.

• AI integration is the new focus.
• C-Scan's 3D mapping data is ideal for AI analysis.
• MBody AI's platform claims up to 40% labor reduction in operations.

Protecting the intellectual property (IP) of the capsule-based imaging system is crucial.

Protecting the intellectual property (IP) for the C-Scan system is paramount, especially as the technology becomes a component of the larger MBody AI Ltd. portfolio. Check-Cap Ltd. has a strong IP foundation, holding more than 50 granted patents globally.

A key U.S. patent, which covers the C-Scan's proprietary tracking technology (Position Estimation of Imaging Capsule in Gastrointestinal Tract), was granted in late 2021 and is protected until May 2034. This patent is critical because it details the mechanism that allows the system to accurately track the capsule and generate the 3D map without the need for bowel preparation, a major differentiator. The merger agreement explicitly ensures that Check-Cap's legacy business, including its patents and proprietary medical equipment, will be retained by the combined company. This IP portfolio is the chief asset that the new MBody AI Ltd. will use to enter the healthcare diagnostics vertical. You defintely need to protect that core technology.

Check-Cap Ltd. (CHEK) - PESTLE Analysis: Legal factors

Complex and lengthy U.S. Food and Drug Administration (FDA) pre-market approval (PMA) pathway for novel devices.

The C-Scan system, as a novel, ingestible X-ray device for colorectal cancer screening, is classified as a Class III medical device by the FDA. This means it must go through the Premarket Approval (PMA) pathway, which is the most rigorous and time-consuming regulatory route. The company received Investigational Device Exemption (IDE) approval in early 2021 to start its US pivotal study, which was intended to enroll an estimated 700 to 800 patients.

Even after the pivotal study data is submitted, the FDA's regulatory review goal for a standard PMA application is typically 180 days, but for complex devices requiring an advisory panel, this can extend to 320 days. The significant delay in completing the pivotal study and submitting the PMA application was a major factor in the company's pivot to the MBody AI merger. The legal and financial risk of this long, capital-intensive process remains a legacy issue for the merged entity. This is defintely a high hurdle for a small-cap company to clear.

Compliance with global data privacy regulations (e.g., HIPAA) for patient data.

The C-Scan technology inherently creates a significant legal compliance burden because it collects and processes patient-specific health data. The system uses an integrated positioning, control, and recording system, the C-Scan Track, which stores information gathered by the capsule, and then transmits it to the C-Scan View, a cloud-based analysis platform.

Since the company operates in the US, it must comply with the Health Insurance Portability and Accountability Act (HIPAA), which mandates strict security and privacy standards for Protected Health Information (PHI). Plus, Check-Cap previously received CE Mark approval in January 2018 for sales in Israel, meaning it also has to maintain compliance with European data protection standards, like the General Data Protection Regulation (GDPR), for any European operations. Failure here brings massive fines and reputational damage. The compliance requirements are complex:

• Secure PHI transmission from C-Scan Track to C-Scan View (HIPAA Security Rule).
• Patient consent and data usage transparency (HIPAA Privacy Rule, GDPR).
• Cross-border data transfer agreements (GDPR).

Post-merger legal obligations and shareholder litigation risk.

The reverse merger with MBody AI Corp, approved by an overwhelming 98.01% of shareholders on November 17, 2025, significantly mitigates the immediate risk of shareholder dissent-based litigation. However, any reverse merger carries inherent legal risks, especially concerning the valuation and the change in business focus. Current Check-Cap shareholders will own only 10% of the combined company, MBody AI Ltd.

The merger agreement itself creates specific financial obligations that act as a legal backstop for MBody AI. For instance, if the merger were to fail due to a lack of shareholder approval, Check-Cap was obligated to reimburse MBody AI up to ILS 8.314 million (Israeli Shekels) in expenses. This kind of legal structure is common, but it shows the financial cost of a deal falling apart.

Here's the quick math on the merger's financial and legal context in 2025:

Metric	Value (FY 2025 Data)	Legal Implication
Shareholder Approval Rate	98.01%	Low immediate risk of merger-blocking litigation.
Check-Cap Share of Combined Entity	10%	Potential for future shareholder suits over dilution/valuation.
Stockholders' Equity (June 30, 2025)	Significantly exceeds $2.5 million	Regained Nasdaq compliance, reducing delisting-related legal risk.
Operating Cash Flow (FY 2024)	-$8.00 million	Merger was a necessary lifeline to avoid insolvency/liquidation legal issues.

Maintaining patent protection for the C-Scan technology against competitors.

The C-Scan technology is protected by a portfolio of patents, which are considered a legacy asset that the new MBody AI Ltd. entity will continue to hold. The value of this intellectual property (IP) is tied to its ability to prevent competitors from developing similar preparation-free, ingestible X-ray capsules for colorectal cancer screening.

The legal challenge is two-fold: actively defending the existing patents against infringement and continuously filing new patents to cover improvements to the C-Scan system. In the medical device and pharmaceutical industries, serial patent litigation is a common tactic to delay generic or competing products. The combined company must be ready to commit significant legal spend-which can run into the millions-to protect the C-Scan IP, even while the core business shifts to AI. That IP is the only asset that justifies keeping the C-Scan business alive.

Check-Cap Ltd. (CHEK) - PESTLE Analysis: Environmental factors

The environmental factors for Check-Cap Ltd. are less about massive industrial emissions and more about the lifecycle management of a single-use electronic medical device, which presents a unique set of waste and compliance costs. The core challenge for the C-Scan system is the disposal of the electronic capsule and track, especially given the rising investor and regulatory scrutiny on medical device sustainability in 2025.

My advice: Finance needs to model the combined entity's cash burn, focusing on the new business's revenue stream, not just the C-Scan R&D. That's the next concrete step.

Managing the biohazard waste from the single-use, ingestible diagnostic capsule.

The C-Scan Cap is an ingestible, single-use diagnostic capsule that is naturally excreted, making it a piece of regulated medical waste (RMW) upon collection. This classification significantly increases disposal costs compared to general solid waste. While Check-Cap Ltd. does not publish specific waste costs, the industry average for processing RMW, particularly in the US, is estimated to cost between $0.25 and $0.50 per pound for collection and treatment, plus the cost of specialized containers and transport.

For a high-volume screening product, this biohazard waste stream is a non-trivial, recurring expense that must be factored into the per-procedure cost of the C-Scan system. The logistics involve a specialized reverse supply chain to ensure the safe collection and autoclaving or incineration of the capsule and the C-Scan Track (the external tracking device), which is also single-use. This is a crucial operational detail that impacts profitability.

Increasing investor and regulatory pressure for sustainable medical device supply chains.

Investor pressure for environmental, social, and governance (ESG) performance in the healthcare sector is intensifying, especially for companies seeking new capital or undergoing a business combination, as Check-Cap Ltd. is with MBody AI. Funds like BlackRock are increasingly integrating sustainability metrics into their investment models, pushing for concrete targets on material use and carbon footprint.

The regulatory environment is also tightening. For instance, the US Securities and Exchange Commission (SEC) is moving toward more comprehensive climate-related disclosure rules, which will force medical device manufacturers to quantify and report their Scope 3 emissions (supply chain emissions). The C-Scan Cap's reliance on a single-use design and its components, including the ultra-low-dose X-ray source, will require detailed supply chain mapping to identify and mitigate environmental risks. This pressure is driving up the cost of sustainable sourcing and reporting.

• Material Sourcing: Pressure to use recycled or bio-based polymers for the capsule casing.
• Manufacturing Footprint: Demand for energy-efficient manufacturing processes, likely in Israel and the US.
• Investor Screening: Risk of exclusion from ESG-focused funds due to the single-use, non-recyclable nature of the core product.

Energy consumption of the C-Scan system's imaging and data processing components.

The C-Scan system's energy footprint is split between the low-power, battery-operated C-Scan Cap and C-Scan Track, and the more energy-intensive C-Scan View software, which runs on a client/server application for data analysis and 3D map creation. While the capsule itself uses ultra-low-dose X-rays and minimal power, the data processing at the clinic or hospital is the main energy sink.

For comparable medical imaging and data processing, energy consumption can be substantial. A typical high-end medical workstation used for 3D rendering and image analysis can draw between 300 and 500 Watts during peak processing, running for several hours per day in a busy clinic. Scaling this across a network of clinics using the C-Scan View software creates a cumulative energy demand. This energy use contributes to the company's Scope 2 (purchased electricity) emissions, which analysts are now scrutinizing.

Adherence to strict European Union (EU) Waste Electrical and Electronic Equipment (WEEE) directives.

Compliance with the EU WEEE Directive (Directive 2012/19/EU) is mandatory for Check-Cap Ltd. to market the C-Scan system in Europe, as the C-Scan Cap and C-Scan Track are classified as Electrical and Electronic Equipment (EEE). This directive imposes an Extended Producer Responsibility (EPR) scheme, meaning Check-Cap Ltd. is responsible for the entire lifecycle of its electronic products, including financing their collection, treatment, recovery, and environmentally sound disposal.

The latest evaluation of the WEEE Directive, published in July 2025, confirmed that the directive's collection targets are often missed, with nearly half of the WEEE generated still not collected, and only about 40% of WEEE is currently recycled in the EU. This regulatory environment requires Check-Cap Ltd. to establish and pay into national collection and recycling schemes in each EU member state where it operates. The cost of WEEE compliance is highly variable, depending on the weight and material composition of the device, but it is a non-negotiable operational cost for European market access.

The table below outlines the environmental impact and associated operational costs for the C-Scan system's key components:

Component	Environmental Impact	Regulatory/Cost Implication (FY 2025)
C-Scan Cap (Ingestible Capsule)	Single-use plastic, low-dose X-ray source, internal battery. Excreted as biohazard waste.	RMW disposal costs: Est. $0.25-$0.50 per pound. Requires specialized reverse logistics and incineration/autoclaving.
C-Scan Track (External Sensor)	Single-use electronic device, plastic casing, battery, and biocompatible skin patches. Classified as EEE.	WEEE Directive EPR compliance costs in the EU. Must be registered and financed for recycling in each member state.
C-Scan View (Data Processing)	Energy consumption from client/server application for 3D rendering and data analysis.	Scope 2 emissions scrutiny from investors. Peak power draw for a single workstation can be 300-500 Watts.