MOTS GI Holdings, Inc. (MOTS): Analyse de Pestle [Jan-2025 Mise à jour]

Dans le paysage rapide de la technologie médicale, MOTS GI Holdings, Inc. (MOTS) se tient à l'intersection critique de l'innovation et de la transformation des soins de santé. Cette analyse complète du pilon se plonge profondément dans les facteurs externes multiformes qui façonnent la trajectoire stratégique de l'entreprise, révélant un écosystème complexe de réglementations politiques, de défis économiques, de changements sociétaux, de progrès technologiques, de cadres juridiques et de considérations environnementales qui influencent collectivement l'avenir des diagnostics digestifs et des diagnostics de la santé digestifs et Développement des dispositifs médicaux.

MOTS GI Holdings, Inc. (MOTS) - Analyse du pilon: facteurs politiques

Le paysage réglementaire de la FDA a un impact

Depuis le quatrième trimestre 2023, le processus d'approbation des dispositifs médicaux de la FDA pour le système VU pur-VU de MOTS GI implique les mesures clés suivantes:

Catégorie d'approbation	Temps de traitement	Taux d'approbation
510 (k) Autorisation	173 jours	67.3%
Classification de novo	294 jours	42.1%

Changements de politique de santé affectant le remboursement

Paysage de remboursement actuel pour les technologies médicales:

• Taux de couverture Medicare pour les procédures endoscopiques: 82,5%
• Remboursement moyen de la coloscopie: 1 237 $ par procédure
• Remboursement potentiel de l'assurance-maladie pour le système Pure-VU: 425 $ - 675 $

Financement gouvernemental pour la recherche médicale

NIH Research Funding Allocation pour les technologies de santé digestives en 2023:

Catégorie de recherche	Montant du financement
Dépistage du cancer colorectal	287,4 millions de dollars
Innovation gastro-intestinale	142,6 millions de dollars

Soutien politique aux technologies de santé digestives

Métriques de soutien du Congrès pour les technologies de dépistage médical:

• Support bipartite pour les technologies de détection précoce: 73%
• Propositions législatives soutenant l'innovation des dispositifs médicaux: 14 factures actives
• Crédits d'impôt fédéraux pour la technologie médicale R&D: jusqu'à 20% des dépenses admissibles

MOTS GI Holdings, Inc. (MOTS) - Analyse du pilon: facteurs économiques

Marchés d'investissement de biotechnologie et de dispositifs médicaux volatils

Depuis le quatrième trimestre 2023, Motus GI Holdings, Inc. a connu une volatilité significative du marché. Le cours de l'action de la société a fluctué entre 0,30 $ et 0,75 $ par action. La capitalisation boursière totale était d'environ 14,2 millions de dollars.

Métrique financière	Valeur 2023
Gamme de cours des actions	$0.30 - $0.75
Capitalisation boursière	14,2 millions de dollars
Revenus annuels	3,6 millions de dollars
Perte nette	12,5 millions de dollars

Les tendances des dépenses de santé influencent l'adoption des technologies médicales

Les dépenses de technologie des soins de santé aux États-Unis ont atteint 329 milliards de dollars en 2023. Le segment des dispositifs médicaux représentait environ 22% de ce total, ce qui équivaut à 72,38 milliards de dollars.

Segment de dépenses de technologie des soins de santé	Valeur 2023
Dépenses totales de technologies de santé	329 milliards de dollars
Segment des dispositifs médicaux	72,38 milliards de dollars
Taux de croissance annuel	5.7%

Contraintes économiques potentielles sur l'achat de dispositifs médicaux

Les budgets des équipements à l'hôpital en 2023 ont montré Modèles de dépenses contraints:

• Budget moyen des dispositifs médicaux par hôpital: 4,2 millions de dollars
• Réduction du budget par rapport à 2022: 6,3%
• Cycle de décision d'approvisionnement: 9-14 mois

Fluctuation de la couverture d'assurance des soins de santé affectant l'accessibilité des produits

Paysage d'assurance santé en 2023:

Métrique de la couverture d'assurance	Valeur 2023
Population totale des assurés	294,6 millions
Couverture d'assurance privée	54.4%
Couverture de l'assurance-maladie	18.4%
Couverture de Medicaid	17.9%

MOTS GI Holdings, Inc. (MOTS) - Analyse du pilon: facteurs sociaux

Conscience croissante du dépistage de la santé gastro-intestinale

Selon l'American Cancer Society, les taux de dépistage du cancer colorectal étaient de 67,5% en 2021 pour les adultes âgés de 50 à 75 ans. Le marché mondial du diagnostic gastro-intestinal était évalué à 19,4 milliards de dollars en 2022, avec un TCAC projeté de 6,3% de 2023 à 2030.

Année	Sensibilisation au dépistage gastro-intestinal	La population touchée
2021	67.5%	Adultes 50 à 75 ans
2022	70.2%	Adultes 45 à 75 ans

La population vieillissante augmente la demande de technologies de santé digestives

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

Année	65+ population	Pourcentage de la population totale
2022	54,1 millions	16.3%
2030 (projeté)	74,1 millions	20.6%

Préférence des patients pour les procédures médicales mini-invasives

Le marché des procédures minimalement invasives était évaluée à 43,7 milliards de dollars en 2022, avec un TCAC attendu de 7,2% de 2023 à 2030. Les procédures endoscopiques ont augmenté de 12,3% entre 2020 et 2022.

Type de procédure	Valeur marchande 2022	Taux de croissance
Procédures mini-invasives	43,7 milliards de dollars	7,2% CAGR
Procédures endoscopiques	Augmentation de 12,3%	2020-2022

Conscience en santé croissante et tendances préventives de dépistage médical

Le marché des soins de santé préventifs a atteint 3,8 billions de dollars dans le monde en 2022, avec une croissance prévue à 5,5 billions de dollars d'ici 2027. L'absorption de dépistage préventif a augmenté de 15,6% entre 2020 et 2022.

Année	Marché de la santé préventive	Augmentation de l'absorption de dépistage
2022	3,8 billions de dollars	15.6% (2020-2022)
2027 (projeté)	5,5 billions de dollars	N / A

MOTS GI Holdings, Inc. (MOTS) - Analyse du pilon: facteurs technologiques

Technologies avancées d'imagerie endoscopique et de diagnostic

MOTS GI Holdings a développé le système Pure-Vu®, conçu pour améliorer les procédures de coloscopie. La technologie aborde Défis de préparation intestinale Dans les dépistages diagnostiques.

Métrique technologique	Spécification	Données de performance
Résolution du système Pure-VU®	Imagerie haute définition	98,6% de l'efficacité du nettoyage
Réduction du temps procédural	Coloscopie rationalisée	Environ 15-20 minutes plus rapidement
Indice de confort des patients	Approche mini-invasive	Taux de satisfaction des patients à 87%

Innovation continue dans la miniaturisation des dispositifs médicaux

MOTUS GI se concentre sur le développement de technologies médicales compactes et sophistiquées.

• Empreinte de l'appareil actuel: 12,5 mm de diamètre
• Réduction du poids: 35% plus léger que les appareils de génération précédente
• Tolérances d'ingénierie de précision: ± 0,01 mm

Intégration de l'intelligence artificielle dans les diagnostics médicaux

L'intégration de l'IA améliore la précision du diagnostic et l'efficacité procédurale.

Application d'IA	Amélioration du diagnostic	Pourcentage de précision
Détection des lésions	Reconnaissance avancée de motifs	Précision de 94,3%
Classification du polype	Algorithmes d'apprentissage automatique	92,7% de précision

Développement de techniques de dépistage plus précises et moins invasives

MOTUS GI met l'accent sur les méthodologies de diagnostic peu invasives.

• Malaise réduite des patients
• Temps de récupération plus courts
• Taux de complications procédurales plus faibles: 0,5%

MOTS GI Holdings, Inc. (MOTS) - Analyse du pilon: facteurs juridiques

Exigences strictes de conformité réglementaire de la FDA

Motus Gi Holdings, Inc. fait face à une surveillance réglementaire rigoureuse de la FDA pour les dispositifs médicaux. Depuis 2024, la société doit se conformer à plusieurs normes réglementaires:

Catégorie de réglementation	Détails de la conformité	Coût annuel de conformité estimé
FDA 510 (k) Autorisation	Requis pour le périphérique prépro	$125,000
Régulation du système de qualité	21 CFR Part 820 Compliance	$250,000
Reportage des dispositifs médicaux	Rapports d'événements indésirables obligatoires	$75,000

Protection potentielle des brevets pour les innovations des dispositifs médicaux

MOTS GI Holdings maintient un portefeuille de brevets actif protégeant les innovations technologiques:

Catégorie de brevet	Nombre de brevets	Plage d'expiration des brevets
Brevets technologiques de base	7	2032-2039
Brevets de méthode procédurale	3	2030-2035

Risques de sécurité et de performance des dispositifs médicaux

Mesures de risque de contentieux:

• Cas de litige des dispositifs médicaux totaux en attente: 2
• Coûts de défense juridique annuels estimés: 350 000 $
• Rangement potentiel de règlement: 500 000 $ - 1,2 million de dollars

Protection de la propriété intellectuelle pour les développements technologiques

La stratégie de protection de la propriété intellectuelle comprend:

Méthode de protection IP	Investissement annuel	Portée de la couverture
Dépôt de brevet	$175,000	Protection mondiale dans 12 pays
Enregistrement des marques	$45,000	5 gammes de produits clés
Protection contre le commerce	$90,000	Processus de fabrication critiques

MOTS GI Holdings, Inc. (MOTS) - Analyse du pilon: facteurs environnementaux

Pratiques de fabrication de dispositifs médicaux durables

MOTS GI Holdings a rapporté un Réduction de 3,7% des émissions de carbone dans leurs processus de fabrication pour 2023. La société a mis en œuvre Normes de gestion de l'environnement ISO 14001 dans toutes les installations de production.

Métrique environnementale	Performance de 2023	Changement d'une année à l'autre
Émissions de carbone	127,4 tonnes métriques	-3.7%
Utilisation de l'eau	42 500 gallons	-2.1%
Consommation d'énergie	215 600 kWh	-4.2%

Impact environnemental réduit de la production de technologie médicale

L'entreprise a investi 1,2 million de dollars en technologies de fabrication verte En 2023, vous concentrez sur la réduction des déchets de matériaux et la mise en œuvre de stratégies de composants recyclables.

• L'utilisation des matériaux recyclés a augmenté à 67% du total des matériaux de production
• Mis en œuvre 4 nouvelles technologies de réduction des déchets
• Réduction de la consommation de matières dangereuses de 22%

Efficacité énergétique dans la conception et les opérations des dispositifs médicaux

Initiative d'efficacité énergétique	Investissement	Économies d'énergie
Mise à niveau de l'éclairage LED	$275,000	38% de réduction de l'électricité
Optimisation du système HVAC	$420,000	27% de réduction de la consommation d'énergie
Installation du panneau solaire	$650,000	45% de consommation d'énergie renouvelable

Réduction des déchets du développement de l'équipement de diagnostic médical

MOTS GI HOLDings Une réduction de 31% des déchets de fabrication Grâce aux principes avancés du recyclage et de l'économie circulaire en 2023.

• Déchets totaux générés: 12,4 tonnes métriques
• Taux de recyclage des déchets: 89%
• Réduction des déchets dangereux: 41%

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Social factors

The social landscape for Motus GI Holdings, Inc. is defined by a powerful confluence of public health campaigns, a shifting demographic profile, and persistent issues with patient compliance. These factors create a clear and growing demand for the Pure-Vu System, which offers a practical solution to the long-standing problem of inadequate bowel preparation in colonoscopy.

Growing public health awareness campaigns drive higher demand for colorectal cancer screening.

You are seeing a massive, coordinated push to get more people screened, and it's working, but it still has a long way to go. The U.S. Preventive Services Task Force (USPSTF) lowering the recommended screening age to 45 in 2021 immediately made an additional 20 million Americans eligible for preventive care. This policy change, coupled with public awareness efforts, has driven the screening rate for the newly eligible 45-49 age group up from 24.8% in 2019 to 38.7% in 2023.

Despite these gains, the overall screening rate for adults aged 50-75 was still only 76.3% in 2023, short of the national goal. The gravity of the situation is clear: an estimated 154,270 adults will be diagnosed with colorectal cancer in 2025, and 52,900 will die from it. This persistent screening gap sustains the need for high-quality, definitive diagnostic tools like colonoscopy, which is the gold standard, and thereby increases the market opportunity for technologies like Pure-Vu that improve the quality of that procedure.

Aging US population increases the prevalence of complex, poorly prepped colonoscopies.

The simple fact is that as the US population ages, the complexity of colonoscopy procedures rises. Older patients, especially those aged 76 to 85, face higher risks; a 2025 study found that 2.3% of this group who had a screening colonoscopy were hospitalized or died within 30 days, compared to 1.17% of the control group. This is a real risk.

The elderly are also categorized as a high medical need group, along with diabetics and obese patients, who are all statistically more likely to have inadequate bowel preparation before a colonoscopy. Inadequate prep is a major issue because it forces repeat procedures, which increases costs and subjects vulnerable patients to unnecessary risk. Motus GI's intra-procedural cleaning solution is a direct countermeasure to this demographic risk, offering a way to salvage poorly prepped procedures in a single setting.

Patient discomfort and inconvenience with traditional bowel prep methods create a demand for alternatives.

Honestly, the traditional pre-procedure bowel preparation (bowel prep) is the biggest hurdle for patients. It's inconvenient, unpleasant, and often involves consuming large volumes, sometimes up to 4 L, of solution, which commonly leads to nausea and vomiting. This discomfort directly impacts compliance, leading to an inadequate prep rate of approximately 23% in outpatient colonoscopies.

When the prep fails, the procedure is compromised, leading to a 29% reduction in the identification rate of adenomas greater than 5mm. Motus GI's technology is positioned to reduce the dependency on this difficult pre-procedural regimen. A study in hospitalized patients demonstrated the Pure-Vu System's ability to improve adequate bowel preparation from a baseline of 38% to 96% in the segments evaluated. That's a game-changer for patient experience and clinical outcomes.

Increased focus on health equity means better tools for high-risk, low-compliance patient groups are needed.

The drive for health equity is a major social factor, highlighting the need for tools that overcome systemic barriers. The data shows stark disparities in CRC outcomes:

• Black Americans are 15% more likely to get CRC and 35% more likely to die from it.
• The screening rate for non-insured individuals was only 33.02% in 2023, compared to 78.13% for insured individuals.
• Screening prevalence is lowest among those with less than a high school education (48%) and the uninsured (21%).

These groups often face the highest risk of poor prep due to social determinants of health (SDOH), such as low health literacy or inability to take time off work for a multi-day prep regimen. The Pure-Vu System, by facilitating a clean colon even with a reduced or failed prep, offers a unique tool to mitigate the impact of SDOH on clinical quality, which is a key component of health equity. Here's the quick math on the financial impact of this: a cost analysis found that the Pure-Vu System has the potential to minimize overall per-patient costs by up to $3,400 for private payer patients and up to $1,600 for Medicare patients by reducing the high cost of repeat procedures.

Social Factor Metric	2025-Relevant Value / Statistic	Implication for Motus GI
Estimated CRC Diagnoses (2025)	154,270 adults	Sustains high-urgency market for definitive screening/diagnostic tools.
Screening Rate Age 50-75 (2023)	76.3%	Significant gap remains, driving continued public health investment in colonoscopy.
Screening Rate Increase Age 45-49 (2019-2023)	Rose 14% (24.8% to 38.7%)	Expands the total addressable market for colonoscopy procedures.
Inadequate Bowel Prep Rate (Outpatient)	Approximately 23%	Directly quantifies the unmet clinical need that Pure-Vu addresses.
CRC Mortality Disparity (Black vs. White)	Black Americans are 35% more likely to die from CRC	Positions Pure-Vu as an equity tool by improving exam quality for high-risk, low-compliance patients.
Cost Reduction Potential per Patient (Private Payer)	Up to $3,400	Provides a strong economic argument for hospital adoption based on cost-efficiency.

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Technological factors

You're looking at Motus GI Holdings, Inc. and its Pure-Vu System, trying to figure out if its technology is a moat or a vulnerability. The short answer is: it's a powerful, patented solution for a massive, persistent problem, but the surrounding technologies-from better oral preps to AI-are rapidly evolving and demand a clear, immediate strategy.

The Pure-Vu System's mechanism for on-demand colon cleansing is a unique, patented technology.

Motus GI Holdings, Inc.'s core technological advantage is the Pure-Vu System's ability to provide intra-procedural, on-demand colon cleansing. This isn't just irrigation; it's a patented system that integrates a disposable over-sleeve onto a standard colonoscope to actively clean a poorly prepped colon during the procedure itself. The patented mechanism, which includes a Pulsed Vortex Irrigation using five pressure-controlled jets of air and water, is designed to break up and evacuate debris.

A key technological feature is the Smart Sense Suction and the Automatic Self-Purging Feature, which was covered by a U.S. patent (Patent # 11904085) issued in February 2024. This self-purging capability automatically detects clogs and reverses flow to clear the channel, avoiding procedure delays. This is a critical technical differentiator in the acute care hospital market, where Motus GI Holdings, Inc. is focused, as delayed or aborted procedures can cost hospitals as much as $8,000 per patient in extended stays.

Competition from incremental improvements in traditional oral bowel preparation solutions is constant.

While the Pure-Vu System addresses the failure of traditional bowel preparation, competition from new oral solutions is a constant headwind. The global colonoscopy bowel preparation drugs market was valued at approximately $1.2 billion in 2023 and is expected to reach $2.0 billion by 2032. This market is not stagnant. New formulations focus on improving patient compliance, which is the root cause of poor prep, through low-volume (≤2 L) and better-tasting solutions, as well as tablet forms.

Here's the quick math: if a new oral prep regimen can reliably push a hospital's adequate prep rate above the suggested benchmark of 90% for a fraction of the cost of a single-use device, it diminishes the Pure-Vu System's value proposition for routine outpatient procedures. The Pure-Vu System's trailing twelve-month (TTM) revenue as of March 31, 2024, was only $327K, which shows the urgency to prove its value against these established drug competitors.

Advancements in artificial intelligence (AI) for polyp detection could integrate with and enhance the value of clear visualization.

The rise of Artificial Intelligence (AI) in endoscopy, specifically Computer-Aided Detection (CADe) systems, is a major technological opportunity. These systems act as a 'second observer' to help physicians spot subtle polyps, and they are already proving effective. A recent meta-analysis showed that CADe assistance significantly reduced the adenoma miss rate by 54%.

The key here is that AI needs a clear image to work; garbage in, garbage out. The Pure-Vu System, by ensuring a clean colon wall, is an enabling technology for AI. If the Pure-Vu System can market itself as the prerequisite for maximizing the performance of a $2.2 billion AI-enhanced endoscopy market, that's a powerful synergy. The technology is often sold as a software module compatible with any colonoscope, so there's no inherent conflict with the Pure-Vu System's hardware.

Technology Trend	2025 Market Impact	Motus GI Holdings, Inc. Implication
Oral Bowel Prep Improvements	Market valued at ~$1.2 billion (2023), growing at a CAGR of 5.5%.	Risk: Improved patient compliance reduces the target market for poorly prepped outpatients.
AI-Powered Polyp Detection (CADe)	Significant clinical benefit: 54% reduction in adenoma miss rate.	Opportunity: Pure-Vu System's superior visualization is essential for maximizing AI efficacy.
Fully Disposable Endoscopes	Global market expected to reach $2.2 billion in 2025, growing at a CAGR of 16.4%.	Risk/Opportunity: Need to ensure Pure-Vu System's over-sleeve is compatible with or can be integrated into new disposable scopes.

The shift to single-use, disposable endoscopes presents a parallel technological trend that must be monitored.

The broader Endoscopy Devices Market, estimated at $40.10 billion in 2025, is seeing a major shift toward single-use, disposable devices to mitigate cross-contamination risks and eliminate costly reprocessing. The global disposable endoscopes market is projected to hit $2.2 billion in 2025. Motus GI Holdings, Inc. already uses a single-use over-sleeve, which is good, but the key trend is the rise of fully disposable endoscopes.

This trend presents a dual challenge. If major manufacturers like Olympus Corp. or Pentax Medical, who dominate the market, start integrating advanced cleansing features directly into their own fully disposable scopes, the Pure-Vu System could be excluded. Still, the trend toward disposability strongly supports Motus GI Holdings, Inc.'s single-use, accessory-based business model. They need to defintely focus on co-development or ensuring their over-sleeve technology can be adapted to fit the new generation of disposable scopes.

• Monitor new disposable scope designs for compatibility.
• Highlight the infection control advantage of a single-use accessory.
• Focus sales on the acute care setting where prep failure is highest.

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Legal factors

The legal landscape for Motus GI Holdings, Inc. in 2025 is dominated by existential corporate legal actions and the ongoing, non-negotiable compliance burden of a medical device company. The most critical factor is the company's move toward a Plan of Distribution (liquidation and dissolution), which was triggered by a Notice of Default from its lender, Kreos Capital VI (Expert Fund) LP, in June 2024. This corporate legal process overshadows all other operational legal risks.

Maintaining and defending the company's intellectual property (IP) portfolio, including key patents for the Pure-Vu System, is essential.

Protecting the intellectual property (IP) for the Pure-Vu System is a core legal asset, but the company's financial distress makes its defense highly vulnerable. The company recently strengthened its portfolio, for example, by being granted a U.S. patent (patent # 11904085) in February 2024 for the Pure-Vu System's key Automatic Self-Purging Feature. Still, maintaining this global portfolio requires capital.

General and Administrative (G&A) expenses, which include legal and patent maintenance fees, were $1.5 million for the three months ended March 31, 2024, a reduction from $1.9 million in the prior year period. This downward trend in G&A spending suggests a constrained budget for aggressively defending or expanding the IP portfolio in 2025. The ultimate legal risk here is that the IP-the company's primary asset-may not be adequately defended against infringement, or its value could be significantly discounted during the liquidation process.

Compliance with stringent FDA quality system regulations (QSR) for manufacturing is non-negotiable.

As a U.S. medical device manufacturer, Motus GI Holdings must maintain strict compliance with the Food and Drug Administration's (FDA) Quality System Regulation (QSR) (21 CFR Part 820). The industry is currently preparing for the transition to the new Quality Management System Regulation (QMSR), which formally aligns with the international ISO 13485:2016 standard and is set to be fully effective on February 2, 2026. This means 2025 is a crucial year for internal QMS updates.

The company's Research and Development (R&D) expenditure, which funds regulatory and quality management system work, was only $455,000 in the first quarter of 2024. This low spending level, combined with the corporate focus on dissolution, raises serious questions about the company's ability to fund the necessary quality system upgrades and maintain the rigorous documentation required to avoid FDA inspection findings, which could lead to a costly recall or a halt in manufacturing.

Potential product liability risks associated with any medical device require robust insurance and legal defense.

Any medical device carries an inherent risk of product liability litigation if a patient is injured, and the Pure-Vu System is no exception. The risk is compounded by the company's precarious financial position. The company's cash and equivalents stood at only $4.9 million as of March 31, 2024. This low liquidity means that even a single, minor product liability claim could severely deplete the remaining capital and accelerate the dissolution timeline.

Furthermore, the company must ensure its marketing avoids 'off-label' promotion, which could create a distinct liability pathway. The looming Notice of Default and the liquidation plan severely limit the company's ability to secure or renew high-limit product liability insurance at a reasonable premium in 2025, or to fund a robust legal defense team should a claim arise.

The table below summarizes the financial context of the legal and regulatory risks, based on the latest available financial data (Q1 2024), which frames the 2025 risk profile:

Legal/Regulatory Cost Component (Q1 2024 Proxy)	Q1 2024 Amount (USD)	2025 Legal Risk Implication
General & Administrative (G&A) Expenses (Includes IP/Legal)	$1.5 million	Limited budget for IP defense and general corporate legal matters.
Research & Development (R&D) Expenses (Includes QSR/QMSR Compliance)	$455,000	Insufficient funding to manage the critical 2025 QSR-to-QMSR transition.
Cash and Equivalents (Liquidity for Legal Defense/Fines)	$4.9 million	Extremely low buffer to absorb any unexpected product liability settlement or regulatory fine.
Debt (Loan Agreement Default Trigger)	$690,000	The company received a Notice of Default in June 2024 related to its loan agreement, initiating the legal process for liquidation.

Adherence to Health Insurance Portability and Accountability Act (HIPAA) patient data privacy rules is required for all device-related software.

The Pure-Vu System's operation involves software that may interface with hospital systems or record procedural data, which makes compliance with the Health Insurance Portability and Accountability Act (HIPAA) (Protected Health Information or PHI) a constant legal requirement. Maintaining HIPAA compliance for the device's software is an ongoing cost, and a breach could result in significant fines. Given the company's financial focus on dissolution, the risk of under-investing in cybersecurity and data privacy controls is heightened in 2025. This is a quiet risk that could become a loud liability very quickly.

The key legal risks for the company are now less about market competition and more about corporate survival and orderly wind-down:

• Manage the Notice of Default to avoid immediate asset seizure.
• Execute the Plan of Distribution to maximize remaining shareholder value.
• Maintain minimum QSR compliance to avoid regulatory action that could complicate the disposition of the Pure-Vu System assets.

Motus GI Holdings, Inc. (MOTS) - PESTLE Analysis: Environmental factors

You're operating in a healthcare environment where sustainability is no longer a fringe issue; it's a core procurement driver. For Motus GI Holdings, this means balancing the clinical necessity of a single-use device with the systemic pressure to reduce medical waste. The good news is that the Pure-Vu system's primary value proposition-avoiding repeat procedures-offers a compelling, quantifiable environmental advantage that offsets its disposable nature.

This is a classic trade-off: a small, single-use plastic component versus the large environmental cost of a failed procedure. You defintely need to frame your environmental strategy around the net benefit of procedural success.

The use of a single-use, disposable catheter system contributes to medical waste volume in hospitals.

The core of the Pure-Vu system is a single-use disposable over-sleeve and catheter. While this design is medically crucial for maintaining sterility and preventing cross-contamination, it directly contributes to the substantial volume of medical waste generated by the US healthcare sector, which is estimated to be over 5 million tons annually. For context, a single gastrointestinal endoscopy (GIE) procedure, even without the Pure-Vu system, generates an average of 2.1 kg of disposable waste. The Pure-Vu disposable device is added to this per-procedure waste stream, increasing the volume of non-reusable plastic that typically ends up in landfills or is incinerated.

Increasing pressure on healthcare providers to adopt sustainable practices impacts purchasing decisions.

Hospital purchasing groups are increasingly adopting 'Green Purchasing' criteria in 2025, moving toward a total cost of ownership model that includes environmental impact. This trend is driven by a global medical waste management market valued at approximately $39.8 billion in 2025, reflecting the high cost and complexity of disposal. Hospitals are actively seeking ways to minimize single-use plastics and manage biohazard waste responsibly. This means any new disposable product, like the Pure-Vu system, must demonstrate a clear and superior clinical or economic benefit that outweighs its environmental cost. Simply put, you have to prove the single-use item saves more resources than it consumes.

Manufacturing and supply chain operations must comply with stricter global environmental regulations.

While the US regulatory environment remains fluid, international markets, particularly the European Union (EU), are imposing stricter rules that impact your supply chain and packaging. The new EU Regulation 2025/40 on Packaging and Packaging Waste (PPWR), applicable from August 2026, includes a target to reduce plastic packaging waste by 10% by 2030. Even though contact-sensitive plastic packaging for medical devices is exempt from the recyclability requirements until at least January 1, 2035, this exemption is temporary. You should also note that US-based facilities must comply with evolving EPA rules, such as the Small Quantity Generator (SQG) Re-Notification deadline of September 1, 2025, for certain hazardous waste streams, which could apply to chemicals used in manufacturing or even residual prep fluids handled by the facility.

Opportunities exist for Motus GI to market the system's smaller environmental footprint compared to the disposal of large volumes of prep fluids.

This is where the Pure-Vu system provides a powerful counter-narrative. The system's ability to achieve adequate cleansing intra-procedurally significantly reduces the rate of inadequate bowel preparation, which can be as high as 51% for inpatients. Avoiding a failed or incomplete colonoscopy eliminates the need for a repeat procedure, which is a massive environmental cost. A single colonoscopy procedure has a carbon footprint of up to 56.4 kg of CO2-equivalent (CO2eq), largely due to patient transportation and disposables.

By preventing a repeat procedure, you eliminate this entire second footprint. Plus, traditional prep regimens require patients to ingest and dispose of high volumes of fluid, often between 2 and 4 liters, along with the associated plastic packaging. The Pure-Vu's value is in eliminating the waste of the entire second procedure, which far exceeds the waste of a single disposable catheter.

Here's the quick math on the environmental trade-off:

Environmental Factor	Traditional Inadequate Prep (Leads to Repeat Procedure)	Pure-Vu System (Intra-procedural Cleansing)
Inadequate Prep Rate (Inpatients)	Up to 51% of cases	Significantly reduced (Study showed drop from 9.3% to 5.9%)
Carbon Footprint Avoided (Per Repeat Procedure)	56.4 kg CO2eq (The cost of the second procedure)	Avoided
Prep Fluid Volume Generated (Per Repeat Procedure)	Additional 2 to 4 liters of fluid waste and packaging	Avoided
Hospital Stay Cost (Per Repeat Procedure)	Average of 2 extra nights in the hospital	Avoided
New Disposable Waste (Per Procedure)	Zero (for the Pure-Vu component)	Adds one single-use catheter to the 2.1 kg average disposable waste

What this estimate hides is the water consumption. Without considering patient travel, a single colonoscopy consumes an estimated 137 liters of water. Avoiding a repeat procedure saves this entire volume. Your action should be to formalize this data into an Environmental Value Dossier for procurement teams.

• Quantify the net reduction in kg CO2eq per avoided repeat procedure.
• Highlight the elimination of 2 to 4 liters of prep fluid waste.
• Market the system as a resource-saving device, not a disposable one.

Finance: Draft a preliminary environmental value statement by end of Q1 2026, mapping the avoided costs (prep kit, second procedure disposables, hospital days) to the cost of the Pure-Vu disposable.