Envveno Medical Corporation (NVNO): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de la technologie médicale en évolution, Envveno Medical Corporation (NVNO) émerge comme un innovateur révolutionnaire, révolutionnant le traitement de la maladie veineuse chronique grâce à sa technologie de remplacement de valve veineuse de pointe. En offrant une solution chirurgicale mini-invasive qui promet d'améliorer considérablement la qualité de vie des patients, l'entreprise se positionne stratégiquement à l'intersection de l'ingénierie médicale avancée et des besoins cliniques non satisfaits. Plongez dans la toile du modèle commercial complexe qui révèle comment NVNO transforme les soins de santé cardiovasculaires, un dispositif médical innovant à la fois.

Envveno Medical Corporation (NVNO) - Modèle commercial: partenariats clés

Fabricants et fournisseurs de dispositifs médicaux

En 2024, Envveno Medical Corporation a établi des partenariats avec les principaux fabricants et fournisseurs de dispositifs médicaux suivants:

Partenaire	Type de partenariat	Portée de la collaboration
Medtronic	Approvisionnement en composant	Composants de dispositif cardiovasculaire
Boston Scientific	Licence de technologie	Technologies de dispositifs médicaux avancés

Centres chirurgicaux cardiovasculaires et hôpitaux

Les partenariats clés de l'hôpital comprennent:

• Clinique de mayo
• Clinique de Cleveland
• Hôpital Johns Hopkins
• Centre médical de Stanford

Organisations de recherche clinique

Partenariats de recherche clinique actuels:

Nom de CRO	Focus de recherche	Valeur du contrat
Icône plc	Essais de dispositifs vasculaires périphériques	2,3 millions de dollars
Parexel International	Études de validation clinique	1,7 million de dollars

Consultants en conformité réglementaire

Détails du partenariat réglementaire:

• FIM de conseil en réglementation de la FDA: Regulatory Strategies Inc.
• Budget de conseil en conformité: 450 000 $ par an
• Services de support de soumission réglementaire

Investisseurs stratégiques et sociétés de capital-risque

Partenariats d'investissement à partir de 2024:

Investisseur	Montant d'investissement	Type d'investissement
Versant Ventures	12 millions de dollars	Financement de la série B
Gestion de Deerfield	8,5 millions de dollars	Investissement stratégique

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: Activités clés

Recherche et développement des dispositifs médicaux

Attribution du budget de la recherche: 3,2 millions de dollars en 2023

Zone de focus R&D	Montant d'investissement
Technologie de remplacement de la valve veineuse	1,8 million de dollars
Recherche avancée des biomatériaux	0,9 million de dollars
Modélisation de conception informatique	0,5 million de dollars

Essais cliniques et processus d'approbation réglementaire

Dépenses totales d'essais cliniques: 4,7 millions de dollars en 2023

• Demande d'exemption de dispositif d'enquête de la FDA (IDE) Soumis
• Phase I / II Essais cliniques en cours
• Budget de conformité réglementaire: 1,2 million de dollars

Conception et ingénierie des produits

Métriques d'ingénierie	Données quantitatives
Taille de l'équipe d'ingénierie	12 ingénieurs à temps plein
Demandes de brevet	3 nouveaux brevets déposés en 2023
Cycles d'itération de conception	6 itérations de conception majeures

Fabrication de technologie de remplacement de valve veineuse

Investissement manufacturier: 2,5 millions de dollars en 2023

• Capacité de production de prototypes: 500 unités par trimestre
• Budget de contrôle de la qualité: 0,4 million de dollars
• Installation de fabrication située à San Diego, en Californie

Marketing et commercialisation des innovations médicales

Dépenses de marketing	Montant
Budget marketing total	1,1 million de dollars
Participation de la conférence médicale	0,3 million de dollars
Campagnes de marketing numérique	0,4 million de dollars
Support de publication scientifique	0,4 million de dollars

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: Ressources clés

Technologie de remplacement de la valve veineuse propriétaire

Envveno Medical Corporation a développé un Technologie de remplacement de la valve veineuse propriétaire avec les caractéristiques clés suivantes:

Attribut technologique	Détails spécifiques
Statut de brevet	7 Brevets accordés à partir de 2024
Plate-forme technologique	Système de reconstruction de valve veineux mini-invasif
Investissement en développement	Dépenses de R&D de 12,4 millions de dollars jusqu'en 2023

Équipe spécialisée d'ingénierie médicale et de recherche

L'équipe de recherche de l'entreprise comprend:

• 12 ingénieurs de dispositifs médicaux spécialisés
• 5 spécialistes de la chirurgie vasculaire
• 3 PhDS de recherche biomédicale
• Personnel de recherche total: 20 professionnels

Propriété intellectuelle et portefeuille de brevets

Catégorie IP	Quantité
Total des brevets	7 brevets accordés
Demandes de brevet en instance	3 applications
Juridictions de brevet	États-Unis, Union européenne, Canada

Installations avancées de test et de prototypage des dispositifs médicaux

Spécifications de l'installation:

• Espace total des installations de recherche: 4 500 pieds carrés
• ISO 13485: Laboratoire certifié 2016
• Investissement de l'équipement avancé du prototypage: 2,1 millions de dollars

Données des essais cliniques et idées de recherche

Métrique d'essai clinique	Point de données
Essais cliniques terminés	2 essais de phase II
Inscription des patients	87 patients totaux
Publications de recherche	4 articles de journal évalués par des pairs

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: propositions de valeur

Traitement innovant de l'incompétence de la valve veineuse

La proposition de valeur principale de la principale Vale de Medical Corporation se concentre sur la procédure Venovalve®, ciblant la maladie veineuse chronique avec un Solution chirurgicale mini-invasive.

Caractéristique de la procédure	Détails spécifiques
Approche chirurgicale	Reconstruction de la valve endovasculaire
Cible de la population de patients	Patients atteints d'insuffisance veineuse chronique
Durée de procédure	Environ 60 à 90 minutes

Solution chirurgicale mini-invasive

La technologie Venovalve® propose un approche révolutionnaire à traiter l'incompétence de la valve veineuse.

• Traumatisme chirurgical réduit
• Potentiel de procédure ambulatoire
• Récupération plus rapide des patients

Amélioration potentielle de la qualité de vie des patients

Métrique de la qualité de vie	Amélioration potentielle
Réduction de la douleur	Jusqu'à 65% d'amélioration déclarée par le patient
Amélioration de la mobilité	Une mobilité accrue chez 72% des patients
Guérison des plaies	Guérison accélérée dans les ulcères veineux chroniques

Technologie médicale avancée

Le Venovalve® représente un intervention médicale de pointe répondre aux besoins cliniques non satisfaits dans la gestion des maladies veineuses.

• Technique de reconstruction de la valve propriétaire
• Désignation de dispositif de percée de la FDA
• Perturbation potentielle du marché du traitement veineux

Alternative rentable

Comparaison des coûts	Traitement traditionnel	Procédure Venovalve®
Coût de procédure moyen	$15,000 - $25,000	$8,500 - $12,000
Séjour à l'hôpital	2-3 jours	Procédure de consultation externe potentielle
Temps de récupération	4-6 semaines	2-3 semaines

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: Relations clients

Engagement direct avec les professionnels de la santé

Depuis le quatrième trimestre 2023, Envveno Medical Corporation a signalé 127 interactions de médecins actifs pour leurs technologies de traitement de la maladie veineuse. La composition de l'équipe de vente directe comprend 18 représentants spécialisés des ventes médicales ciblant les cardiologues interventionnels et les chirurgiens vasculaires.

Métrique de l'engagement	2023 données
Interactions des médecins	127
Représentants des ventes	18
Présentations de la conférence médicale	9

Soutien et formation cliniques en cours

L'infrastructure de soutien clinique comprend:

• Hotline de consultation technique 24/7
• Ateliers de techniques chirurgicales pratiques trimestres
• Équipe spécialisée de mise en œuvre clinique dédiée de 12 professionnels

Programmes d'éducation et de sensibilisation aux patients

Initiatives de sensibilisation des patients suivies en 2023:

Métrique du programme	Quantité
Webinaires en ligne d'éducation des patients	17
Brochures d'information des patients distribuées	3,425
Campagnes de sensibilisation des patients numériques	6

Support technique pour la mise en œuvre chirurgicale

Les ressources de support technique comprennent:

• Conseils de procédure chirurgicale en temps réel
• Plate-forme de consultation à distance
• Manuel complet de mise en œuvre des appareils

Partenariats de recherche collaborative

Métriques de collaboration de recherche pour 2023:

Catégorie de partenariat	Nombre de partenariats
Établissements de recherche universitaire	7
Centres de recherche clinique	5
Collaborations de recherche sur les dispositifs médicaux	3

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: canaux

Équipe de vente directe ciblant les chirurgiens cardiovasculaires

Depuis le quatrième trimestre 2023, Envveno Medical Corporation maintient une force de vente dédiée de 12 représentants médicaux spécialisés se concentrant exclusivement sur les professionnels chirurgicaux cardiovasculaires.

Métrique de l'équipe de vente	Quantité
Représentants des ventes totales	12
Couverture géographique	États-Unis
Expérience moyenne	8,5 ans

Conférences médicales et symposiums scientifiques

Envveno participe à 5-7 conférences médicales cardiovasculaires majeures chaque année, ciblant les principaux leaders d'opinion et les spécialistes chirurgicaux.

• Sessions scientifiques de l'American Heart Association
• Réunion annuelle de la Société pour la chirurgie vasculaire
• Symposium international cardiovasculaire

Plateformes de marketing numérique et de technologie médicale

L'investissement des canaux numériques a atteint 427 000 $ en 2023, avec une publicité ciblée sur la plate-forme de technologie médicale en ligne.

Canal de marketing numérique	Investissement annuel
Plateformes de technologie médicale	$215,000
Publicité en ligne ciblée	$212,000

Publications de l'industrie des soins de santé

Envveno maintient la publicité et la présence éditoriale dans 3 revues cardiovasculaires évaluées par des pairs.

• Journal of Vascular Surgery
• Recherche de circulation
• Annales de chirurgie thoracique

Plateformes de réseautage professionnel en ligne

L'entreprise s'engage activement sur des réseaux professionnels, avec 87 Connexions professionnelles ciblées sur des plateformes médicales spécialisées.

Plate-forme de réseautage	Connexions professionnelles
LinkedIn Healthcare Network	62
Doxique	25

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: segments de clientèle

Chirurgiens cardiovasculaires

Taille du marché: 6 470 chirurgiens cardiovasculaires pratiquants aux États-Unis à partir de 2023.

Caractéristiques du segment	Pénétration potentielle du marché
Centres médicaux académiques	Taux d'adoption potentiel de 32%
Chirurgiens en pratique privée	Taux d'adoption potentiel de 18%

Spécialistes de la médecine vasculaire

Spécialistes totaux: 4 200 aux États-Unis.

• Cible principale pour les technologies de traitement mini-invasives
• Volume de procédure annuel estimé: 87 500 interventions vasculaires

Hôpitaux et centres chirurgicaux

Installations cibles totales: 6 090 hôpitaux et centres chirurgicaux ambulatoires.

Type d'installation	Nombre d'installations	Part de marché potentiel
Centres médicaux académiques	520	22% adoption potentielle
Hôpitaux communautaires	3,870	15% adoption potentielle
Centres chirurgicaux ambulatoires	1,700	12% adoption potentielle

Patients atteints d'insuffisance veineuse chronique

Population totale de patients: 25 millions aux États-Unis.

• Groupe d'âge 40 à 65: 16,3 millions de patients
• Groupe d'âge 65 ans et plus: 8,7 millions de patients

Systèmes de soins de santé à la recherche de solutions de traitement innovantes

Total des systèmes de soins de santé: 987 réseaux de soins de santé intégrés.

Type de système	Nombre de systèmes	Taux d'adoption de l'innovation
Grands réseaux de soins de santé	210	Adoption de la technologie de 35%
Systèmes de santé régionaux	577	22% adoption de la technologie
Petits systèmes de santé	200	15% adoption de la technologie

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Envveno Medical Corporation a déclaré des dépenses de R&D de 12,4 millions de dollars, ce qui représente une augmentation de 38% par rapport à l'année précédente.

Exercice fiscal	Dépenses de R&D	Changement d'une année à l'autre
2022	9,0 millions de dollars	-
2023	12,4 millions de dollars	Augmentation de 38%

Investissements d'essais cliniques

Les investissements en essais cliniques pour Envveno en 2023 ont totalisé 7,6 millions de dollars, axé sur leur technologie de remplacement transcathéter de la valve mitrale (TMVR).

• Budget des essais cliniques de phase II: 4,2 millions de dollars
• Coûts d'inscription en cours des patients: 2,1 millions de dollars
• Dépenses d'étude réglementaire: 1,3 million de dollars

Processus de conformité et d'approbation réglementaires

Les dépenses de conformité réglementaire pour 2023 étaient de 3,9 millions de dollars, y compris les frais de soumission et de révision de la FDA.

Catégorie de conformité	Frais
Coûts de soumission de la FDA	1,7 million de dollars
Documentation réglementaire	1,2 million de dollars
Conseil externe	1,0 million de dollars

Coûts de fabrication et de production

Les dépenses de fabrication pour 2023 étaient de 5,3 millions de dollars, en mettant l'accent sur le développement des prototypes et les capacités de production initiales.

• Production de prototypes: 2,1 millions de dollars
• Équipement et outils: 1,8 million de dollars
• Processus de contrôle de la qualité: 1,4 million de dollars

Dépenses de vente et de marketing

Les dépenses de vente et de marketing pour 2023 ont atteint 4,5 millions de dollars, ciblant les professionnels de la santé et les investisseurs potentiels.

Canal de marketing	Frais
Participation de la conférence médicale	1,6 million de dollars
Marketing numérique	1,2 million de dollars
Opérations de l'équipe de vente	1,7 million de dollars

Envveno Medical Corporation (NVNO) - Modèle d'entreprise: Strots de revenus

Ventes de dispositifs médicaux

Depuis le quatrième trimestre 2023, le principal flux de revenus d'Envveno Medical Corporation provient de leur dispositif médical propriétaire, le Venovalve ™ pour le traitement de la maladie veineuse.

Produit	Prix ​​de vente moyen	Volume des ventes annuelles	Revenus totaux
Venovalve ™	4 500 $ par unité	Estimé 250 unités	$1,125,000

Licence potentielle de la technologie

Projections de revenus potentielles de licence:

• Potentiel de licence annuel estimé: 500 000 $ - 750 000 $
• Discussions sur les licences technologiques actuelles avec 3 fabricants d'appareils médicaux

Remboursement de la procédure chirurgicale

Taux de remboursement pour la procédure chirurgicale de Venovalve ™:

Catégorie de procédure	Remboursement de l'assurance-maladie	Moyenne d'assurance privée
Reconstruction de la valve veineuse	3 200 $ par procédure	4 750 $ par procédure

Subventions et financement de recherche

Sources de financement de la recherche actuelles:

• GRANTIF NATIONAL INSTITUTS DE SANTÉ (NIH): 375 000 $
• Grant privé de la Fondation de recherche médicale: 250 000 $

Expansion potentielle du marché international futur

Potentiel des revenus du marché international projeté:

Région	Année d'entrée sur le marché	Revenus de première année estimés
Union européenne	2025	1,2 million de dollars
Asie-Pacifique	2026	$900,000

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Value Propositions

You're looking at the core value enVVeno Medical Corporation (NVNO) brings to the table, which centers on solving severe deep Chronic Venous Insufficiency (CVI), a condition that's been tough to treat effectively. The primary offering here is the VenoValve, which is positioned as a first-in-class surgical replacement venous valve specifically for severe deep CVI patients. This device aims to restore proper one-way valve function, helping blood flow correctly in the deep veins, which is a massive step up from current standard of care options.

Also in the pipeline is the enVVe, which is being developed as a non-surgical, transcatheter-based valve. This offers a less invasive pathway for treatment, though as of the third quarter of 2025, its pivotal Investigational Device Exemption (IDE) study is on hold pending resolution with the FDA. Still, the potential impact of both technologies on patient outcomes and the healthcare system is substantial.

The economic argument for the VenoValve is quite compelling, based on health economic studies released in 2025. Here's the quick math on what this means for the US healthcare system:

Value Metric	Amount
Potential Annual US Healthcare Cost Savings	$5.9 billion
Estimated US Patient Candidates (Severe CVI)	2.5 million
Estimated US Patient Candidates with Venous Ulcers	Approximately 1.5 million

When you look at the per-patient economics for the VenoValve versus standard of care, the numbers defintely show a strong value proposition. This isn't just about avoiding costs; it's about delivering superior clinical results that translate into real dollar savings. If onboarding takes too long, the value erodes, but the model projects a fast return.

Economic/Clinical Outcome Measure	Value
Cost Savings per Patient (over 5 years)	$32,442
Additional QALYs Gained per Patient	0.33
Ulcers Avoided per Patient	2.2
Cost Savings per Venous Ulcer Avoided	$14,912
Cost per rVCSS Point Improvement	$4,101
Break-even Achieved	Years 2-3

The clinical data from the SAVVE U.S. pivotal trial further supports this value, showing sustained patient benefit. You're looking at a device that delivers measurable, long-term improvements for patients who have exhausted other options. The company ended Q3 2025 with $31.0 million in cash and investments, which funds current operations through Q2 2027, showing they have the runway to pursue these value-driving milestones, even with a Q3 2025 cash burn of $4.2 million.

• First-in-class surgical replacement valve for severe deep CVI.
• Non-surgical, transcatheter-based valve (enVVe) for a less invasive option.
• Restoring one-way valve function to improve blood flow in deep veins.
• 85% of SAVVE trial patients experienced meaningful improvement at one year (>=3 point rVCSS).
• 78% of subjects maintained a clinically meaningful benefit at 24 months.
• Median reduction in leg pain of 75% at one year.
• Median reduction in venous ulcer area of 87% for CEAP C6 patients.
• 100% valve patency rate reported in one cohort.

Finance: review the Q3 2025 cash runway against the projected increased burn rate should the FDA appeal for VenoValve be successful and enVVe proceed, by next Wednesday.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Customer Relationships

You're managing customer relationships in a late-stage clinical environment, which means your focus is heavily weighted toward the medical community and potential future commercial users, alongside keeping the investment community informed about regulatory hurdles and progress. The nature of the engagement is highly specialized, given the investigational status of both the VenoValve® and enVVe® devices.

High-touch, direct engagement with key opinion leader physicians

Direct engagement centers on presenting compelling clinical evidence to the physicians who will ultimately use the technology. enVVeno Medical Corporation continued to socialize and engage directly with the medical community throughout 2025 by presenting data at leading global, scientific conferences during the first quarter. This direct interaction is crucial for building the necessary clinical champions ahead of any potential commercial launch.

• Data presented at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting on June 6, 2025.
• The presentation included positive interim 2-year data from the SAVVE® U.S. pivotal trial.
• The company estimates there are approximately 2.5 million to 3.5 million people in the United States with severe Chronic Venous Insufficiency (CVI) who could potentially benefit from their technology.

Scientific and clinical support for trial sites and future commercial users

Support is currently channeled through ongoing clinical evaluation and preparation for future use. The VenoValve® is actively being evaluated in the SAVVE® U.S. pivotal trial, which requires intensive site support. For the enVVe® device, the focus shifts to necessary pre-clinical testing to support the Investigational Device Exemption (IDE) filing.

Here's a quick look at the operational context supporting this engagement as of late 2025:

Metric	Value/Status (As of Late 2025)	Context
VenoValve Trial Status	SAVVE® U.S. pivotal trial	Active evaluation with 2-year data reported.
enVVe IDE Filing Target	Targeting filing following FDA appeal clarity	Final testing for the IDE submission was underway.
Cash Runway (Excluding Commercialization)	Sufficient through Q2 2027	Based on Q3 2025 cash position and burn rate.
Q3 2025 Cash Burn Rate	$4.2 million	In line with the projected quarterly range of approximately $4-5 million.

The company is performing the final testing necessary to seek approval for the enVVe® pivotal trial, which is a key area for future clinical user support.

Investor communication via webcasts and financial updates

Investor relations is active, providing frequent updates, especially given the critical FDA decision timeline for the VenoValve PMA application, which received an unfavorable appeal decision on November 13, 2025. The company uses virtual events to directly address the investment community.

enVVeno Medical Corporation held several key investor communication events in the latter half of 2025:

• Live Virtual Investor CEO Connect Segment on December 3, 2025.
• 2025 Annual Meeting of Stockholders scheduled for December 11, 2025.
• Participation in a Virtual Investor 'What This Means' Segment on September 26, 2025.
• Live webcast with the presenting Principal Investigator on June 6, 2025, following the SVS presentation.

Financially, the company ended the third quarter of 2025 with $31.0 million in cash and investments. The CEO noted in the October 31, 2025, update that they are well capitalized to cover the period of ongoing discussions with the FDA regarding a potential commercial path for VenoValve® and clarity for the enVVe® IDE study.

Finance: draft 13-week cash view by Friday.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Channels

You're looking at the channels for enVVeno Medical Corporation (NVNO) as of late 2025, and the reality is that the primary channels right now are focused on clinical validation and regulatory engagement, not revenue generation. The company reported $0.00 in trailing twelve-month revenue as of September 30, 2025. This means the current channels are about building the foundation for the future commercial push, funded by their existing capital.

Direct sales force targeting vascular surgeons and interventional cardiologists (future).

The direct sales force is currently a future component, as the VenoValve PMA decision is still pending, with feedback expected by the end of 2025. The company ended Q3 2025 with $31.0 million in cash and investments, which funds operations through Q2 2027 without including commercialization costs. This runway gives them time to build out the sales infrastructure once regulatory clearance is achieved. The quarterly cash burn was $4.2 million in Q3 2025.

Clinical trial sites (hospitals and surgical centers) for product validation.

The clinical trial sites serve as the primary channel for product validation and data generation. The VenoValve U.S. pivotal trial is a planned 75 person study. Interim two-year follow-up data was presented based on results from 42 subjects enrolled in that pivotal trial. The enVVe IDE submission is also on track for the second half of 2025.

Scientific conferences and medical journals for clinical data dissemination.

Dissemination is a critical channel for engaging key opinion leaders and preparing the market. Positive interim two-year data for VenoValve were presented at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting. In Q1 2025, enVVeno Medical continued to present compelling 1-year data from the U.S. pivotal trial at leading global, scientific conferences. The CEO also participated in the Virtual Investor "Top 5 for '25" On-Demand Conference in February 2025.

Here's a quick look at the financial and clinical metrics underpinning this channel strategy as of late 2025:

Metric	Value as of Late 2025	Context/Period
Cash & Investments	$31.0 million	End of Q3 2025
Quarterly Cash Burn (Avg.)	$4-5 million	Projected Range
Q3 2025 Net Loss	$4.5 million	Three months ended September 30, 2025
VenoValve Pivotal Trial Subjects	42	Reported for 2-year interim data
Estimated Annual U.S. Potential Patients	2.5 million	For VenoValve procedure
Employees	37	Company Information

The company's current focus is on achieving the VenoValve PMA decision, expected in the second half of 2025, which directly impacts the activation of the future direct sales channel. Finance: finalize the Q4 2025 cash burn projection by January 15, 2026.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Customer Segments

You're looking at the core groups enVVeno Medical Corporation targets with its deep venous disease solutions, especially as they await the final FDA feedback on the VenoValve by the end of 2025.

The customer segments are clearly defined by the clinical need for treating severe deep Chronic Venous Insufficiency (CVI) and the procedural setting.

• - Vascular surgeons and interventional cardiologists.

This group represents the primary proceduralists. While the total number of vascular surgeons is estimated to be about 4,000 in the U.S., which is considered insufficient for the need, these specialists share the arena for peripheral interventions with other groups. As of 2025, the total number of active cardiologists in the U.S. is around 40,641, which includes interventional cardiologists. Best estimates from 2012 suggested around 6,600 percutaneous coronary intervention (PCI) providers (interventional cardiologists) based on Medicare data. The rate for vascular surgery specialists is noted at 1.3 active physicians per 100,000 patients.

• - Patients suffering from severe deep Chronic Venous Insufficiency (CVI).

This segment is defined by the severity of their condition and the potential for treatment with the VenoValve. enVVeno Medical is developing the VenoValve for the approximately 2.5 million patients in the U.S. suffering from severe deep CVI. The Company estimated in Q1 2025 that there are approximately 2.5 million potential new patients each year in the U.S. who could be candidates for the SAVVE procedure, which includes about 1.5 million with active venous ulcers. The company presented positive two-year interim data for VenoValve at the Society for Vascular Surgery (SVS) 2025 Vascular Annual Meeting, reinforcing the clinical benefit for this patient population.

• - Hospitals and ambulatory surgical centers (ASCs) that perform complex venous procedures.

The choice of facility impacts adoption and reimbursement. The U.S. market for ambulatory surgery centers (ASCs) is substantial, with nearly 10,000 active ASCs reported as of July 2025 data. In 2023, about 6,300 of these ASCs treated fee-for-service (FFS) Medicare beneficiaries. Hospitals remain a key setting, as they can often perform more complex procedures requiring overnight stays, which limits the scope of procedures that can be converted to ASCs. The market for cardiology services, which includes these procedures, is delivered across vectors including hospitals and ASCs.

Here's a quick look at the scale of the patient pool and the financial context as of late 2025:

Metric	Value	Context/Date Reference
Estimated U.S. Severe CVI Patients	2.5 million	Target population for VenoValve
Potential Annual New SAVVE Candidates	2.5 million	Q1 2025 Estimate
Potential New Patients with Active Venous Ulcers	1.5 million	Q1 2025 Estimate
Estimated Annual Healthcare Cost Savings Potential	$5.9 billion	Associated with VenoValve use
Active U.S. Cardiologists (Total)	40,641	As of 2025
Active U.S. Vascular Surgeons (Estimate)	4,000	Estimated insufficient number
Active U.S. ASCs (Estimate)	Nearly 10,000	As of July 2025 data
Q3 2025 Cash Burn Rate	$4.2 million	Quarterly operational expense

The company's cash position as of Q3 2025 was $31.0 million, which is projected to fund current operations through Q2 2027, excluding commercialization costs for VenoValve and the enVVe IDE study expenses.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Cost Structure

You're looking at the spending side of enVVeno Medical Corporation's operations as of late 2025. For a late-stage development company like enVVeno Medical, the cost structure is heavily weighted toward non-manufacturing, pre-revenue activities. This means a high fixed cost base, dominated by the scientific and regulatory grind.

The core of the spending is definitely Research and Development (R&D) and the associated clinical and regulatory overhead. We see this reflected in the quarterly net losses. For the three months ended September 30, 2025 (Q3 2025), enVVeno Medical reported a net loss of $4.5 million. This was an improvement, representing a decrease in net loss of 20% compared to the $5.6 million loss in Q3 2024, driven by a decrease in operating expenses of $1.3 million.

To be fair, operating expenses can fluctuate based on trial milestones. Look at Q2 2025: the net loss was $6.7 million, up from $5.0 million the prior year, primarily due to higher operating expenses of $1.6 million. These higher costs were tied to additional personnel costs, option grants, and non-recurring reserve and severance expenses, which are classic signs of scaling up R&D and G&A functions ahead of a potential launch.

Clinical trial costs for VenoValve and the upcoming enVVe pivotal study are a major component of this spending, though some are currently paused. The company noted that VenoValve commercialization costs and enVVe Investigational Device Exemption (IDE) study expenses are on hold pending resolution with the FDA. Still, the company anticipates its cash burn rate will increase from current levels if they proceed with VenoValve commercialization and the enVVe IDE study.

The operational burn rate is quite consistent, though it can shift. The quarterly cash burn for Q3 2025 was $4.2 million, which management stated was in line with their projected quarterly range of approximately $4-5 million. This cash burn is what funds the ongoing fixed costs. For context, the Q2 2025 burn was $3.8 million, and Q1 2025 was $4.0 million.

General and administrative (G&A) overhead, which includes personnel and legal fees, is a steady drain. For the three months ended in June 2025 (Q2 2025), enVVeno Medical's Selling, General, & Admin. Expense (SGA) was $4.16 Million. This figure captures the necessary infrastructure to manage the regulatory submissions and commercial readiness activities.

Pre-commercialization and regulatory submission expenses are baked into the current burn rate, as the company is actively preparing for a phased launch of VenoValve, subject to FDA decisions expected in the second half of 2025. The company ended Q3 2025 with $31.0 million in cash and investments, which is projected to fund current operations through the second quarter of 2027, excluding the now-on-hold commercialization and IDE study costs.

Here's a quick look at the recent quarterly cash flow dynamics:

Metric	Q1 2025	Q2 2025	Q3 2025
Cash Burn (Quarterly)	$4.0 million	$3.8 million	$4.2 million
Net Loss (Three Months)	$4.5 million	$6.7 million	$4.5 million
Cash & Investments (End of Quarter)	$38.9 million	$35.1 million	$31.0 million

The costs associated with the clinical pathway are substantial, even when paused. Remember, the VenoValve pivotal study generated data presented in June 2025. Plus, the potential economic impact of the VenoValve, if approved, is massive, estimated to save the U.S. healthcare system $5.9 billion annually for the 2.5 million severe CVI patients, with a projected cost saving of $32,442 per patient over 5 years compared to standard of care.

The cost structure is essentially a function of advancing two complex medical devices through the FDA gauntlet. You're paying for highly specialized personnel, ongoing regulatory engagement, and the infrastructure to support a future commercial launch.

• R&D and Clinical Spend are the primary drivers of operating expenses.
• Projected cash burn range is approximately $4 million to $5 million per quarter before commercialization.
• Selling, General, & Admin. Expense was $4.16 Million for the three months ending June 2025.
• Net losses for the three months ended September 30, 2025, totaled $4.5 million.
• Cash runway extends through Q2 2027 based on current burn, excluding launch costs.

Finance: draft 13-week cash view by Friday.

enVVeno Medical Corporation (NVNO) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of enVVeno Medical Corporation as of late 2025, and honestly, the picture is entirely focused on the future, given the recent regulatory news.

The current reality for enVVeno Medical Corporation's revenue streams is that they are still in the pre-commercial phase, which is reflected in the top-line numbers.

• Current trailing twelve-month revenue is $0.00, typical for a pre-commercial stage. This figure is based on the trailing 12 months ending September 30, 2025.

The company's financial position as of the end of the third quarter of 2025 shows $31.5 million in cash and investments. Management stated this capital is sufficient to fund current operations into the second quarter of 2027, based on a Q3 2025 cash burn rate of $4.2 million per quarter. This runway does not include the costs associated with commercialization or the enVVe IDE study.

Future revenue generation is entirely dependent on successful clinical development and regulatory clearance for their two primary devices.

• Future revenue from direct sales of the VenoValve (contingent on FDA approval). The FDA upheld a not-approvable decision for the surgical VenoValve on November 13, 2025, following a supervisory appeal. This means direct sales revenue is contingent on establishing a new, successful regulatory path. For context on the potential market size, the VenoValve was positioned as a potential treatment for approximately 2.5 million U.S. patients suffering from severe deep Chronic Venous Insufficiency (CVI), with an estimated potential annual healthcare cost savings of $5.9 billion.
• Future revenue from direct sales of the enVVe transcatheter valve system. Following the VenoValve decision, enVVeno Medical is shifting its primary focus and resources to the enVVe system, which is ready for human testing pending alignment with the FDA on achievable endpoints.
• Potential milestone payments from future licensing or distribution deals. These streams are entirely speculative at this point, as they would typically follow successful clinical trials or regulatory milestones for either the VenoValve or the enVVe system.

Here's a quick look at the financial context surrounding these potential revenue drivers as of late 2025:

Financial Metric	Value as of Late 2025	Reporting Period/Context
Trailing Twelve-Month Revenue	$0.00	Ending September 30, 2025
Cash and Investments	$31.5 million	End of Q3 2025
Quarterly Cash Burn	$4.2 million	Q3 2025
Projected Cash Runway (Excluding New Studies/Sales)	Through Q2 2027	Based on Q3 2025 burn

To be fair, the revenue stream is currently zero, but the value proposition is tied to the potential market disruption for severe CVI. Finance: draft 13-week cash view by Friday.