enVVeno Medical Corporation (NVNO): Business Model Canvas

In der sich schnell entwickelnden Landschaft der Medizintechnik erweist sich die enVVeno Medical Corporation (NVNO) als bahnbrechender Innovator, der die Behandlung chronischer Venenerkrankungen durch seine hochmoderne Venenklappenersatztechnologie revolutioniert. Durch das Angebot einer minimalinvasiven chirurgischen Lösung, die eine deutliche Verbesserung der Lebensqualität der Patienten verspricht, positioniert sich das Unternehmen strategisch an der Schnittstelle zwischen fortschrittlicher Medizintechnik und ungedeckten klinischen Bedürfnissen. Tauchen Sie ein in das komplexe Business Model Canvas, das zeigt, wie NVNO die kardiovaskuläre Gesundheitsversorgung transformiert – ein innovatives medizinisches Gerät nach dem anderen.

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Wichtige Partnerschaften

Hersteller und Lieferanten medizinischer Geräte

Seit 2024 hat die enVVeno Medical Corporation Partnerschaften mit den folgenden wichtigen Herstellern und Lieferanten medizinischer Geräte aufgebaut:

Partner	Art der Partnerschaft	Umfang der Zusammenarbeit
Medtronic	Komponentenversorgung	Komponenten von Herz-Kreislauf-Geräten
Boston Scientific	Technologielizenzierung	Fortschrittliche medizinische Gerätetechnologien

Herz-Kreislauf-Chirurgiezentren und Krankenhäuser

Zu den wichtigsten Krankenhauspartnerschaften gehören:

• Mayo-Klinik
• Cleveland-Klinik
• Johns Hopkins Krankenhaus
• Stanford Medical Center

Klinische Forschungsorganisationen

Aktuelle klinische Forschungspartnerschaften:

CRO-Name	Forschungsschwerpunkt	Vertragswert
ICON plc	Versuche mit peripheren Gefäßgeräten	2,3 Millionen US-Dollar
Parexel International	Klinische Validierungsstudien	1,7 Millionen US-Dollar

Berater für die Einhaltung gesetzlicher Vorschriften

Einzelheiten zur Regulierungspartnerschaft:

• FDA-Beratungsunternehmen: Regulatory Strategies Inc.
• Budget für Compliance-Beratung: 450.000 US-Dollar pro Jahr
• Unterstützungsdienste für behördliche Einreichungen

Strategische Investoren und Risikokapitalfirmen

Investmentpartnerschaften ab 2024:

Investor	Investitionsbetrag	Anlagetyp
Versant Ventures	12 Millionen Dollar	Finanzierung der Serie B
Deerfield-Management	8,5 Millionen US-Dollar	Strategische Investition

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung medizinischer Geräte

Zuweisung des Forschungsbudgets: 3,2 Millionen US-Dollar im Jahr 2023

F&E-Schwerpunktbereich	Investitionsbetrag
Venenklappenersatztechnologie	1,8 Millionen US-Dollar
Fortgeschrittene Biomaterialforschung	0,9 Millionen US-Dollar
Computergestützte Designmodellierung	0,5 Millionen US-Dollar

Klinische Studien und behördliche Genehmigungsprozesse

Gesamtausgaben für klinische Studien: 4,7 Millionen US-Dollar im Jahr 2023

• Antrag auf Ausnahmegenehmigung für Untersuchungsgeräte (Investigational Device Exemption, IDE) bei der FDA eingereicht
• Klinische Studien der Phasen I/II laufen
• Budget für die Einhaltung gesetzlicher Vorschriften: 1,2 Millionen US-Dollar

Produktdesign und Engineering

Technische Kennzahlen	Quantitative Daten
Größe des Engineering-Teams	12 Vollzeit-Ingenieure
Patentanmeldungen	3 neue Patente im Jahr 2023 angemeldet
Design-Iterationszyklen	6 große Design-Iterationen

Herstellung von Venenklappenersatztechnologie

Fertigungsinvestitionen: 2,5 Millionen US-Dollar im Jahr 2023

• Produktionskapazität für Prototypen: 500 Einheiten pro Quartal
• Budget für Qualitätskontrolle: 0,4 Millionen US-Dollar
• Produktionsstätte in San Diego, Kalifornien

Vermarktung und Kommerzialisierung medizinischer Innovationen

Marketingausgaben	Betrag
Gesamtes Marketingbudget	1,1 Millionen US-Dollar
Teilnahme an der medizinischen Konferenz	0,3 Millionen US-Dollar
Digitale Marketingkampagnen	0,4 Millionen US-Dollar
Unterstützung wissenschaftlicher Veröffentlichungen	0,4 Millionen US-Dollar

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Schlüsselressourcen

Proprietäre Venenklappenersatztechnologie

enVVeno Medical Corporation hat ein entwickelt proprietäre Venenklappenersatztechnologie mit folgenden Hauptmerkmalen:

Technologieattribut	Spezifische Details
Patentstatus	7 erteilte Patente ab 2024
Technologieplattform	Minimalinvasives Venenklappenrekonstruktionssystem
Entwicklungsinvestitionen	12,4 Millionen US-Dollar F&E-Ausgaben bis 2023

Spezialisiertes Medizintechnik- und Forschungsteam

Das Forschungsteam des Unternehmens besteht aus:

• 12 spezialisierte Medizintechnik-Ingenieure
• 5 Spezialisten für Gefäßchirurgie
• 3 Doktoranden in biomedizinischer Forschung
• Gesamtes Forschungspersonal: 20 Fachkräfte

Geistiges Eigentum und Patentportfolio

IP-Kategorie	Menge
Gesamtzahl der Patente	7 erteilte Patente
Ausstehende Patentanmeldungen	3 Anwendungen
Patentgerichte	Vereinigte Staaten, Europäische Union, Kanada

Fortschrittliche Test- und Prototyping-Einrichtungen für medizinische Geräte

Spezifikationen der Einrichtung:

• Gesamtfläche der Forschungseinrichtung: 4.500 Quadratfuß
• Nach ISO 13485:2016 zertifiziertes Labor
• Investition in moderne Prototyping-Ausrüstung: 2,1 Millionen US-Dollar

Klinische Studiendaten und Forschungseinblicke

Klinische Studienmetrik	Datenpunkt
Abgeschlossene klinische Studien	2 Phase-II-Studien
Patientenregistrierung	Insgesamt 87 Patienten
Forschungspublikationen	4 peer-reviewte Zeitschriftenartikel

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Wertversprechen

Innovative Behandlung für Venenklappeninsuffizienz

Das primäre Wertversprechen der enVVeno Medical Corporation konzentriert sich auf das VenoValve®-Verfahren, das auf die Behandlung chronischer Venenerkrankungen abzielt minimalinvasive chirurgische Lösung.

Verfahrensmerkmal	Spezifische Details
Chirurgischer Ansatz	Endovaskuläre Klappenrekonstruktion
Zielgruppe der Patienten	Patienten mit chronischer Veneninsuffizienz
Verfahrensdauer	Ungefähr 60-90 Minuten

Minimalinvasive chirurgische Lösung

Die VenoValve®-Technologie bietet a bahnbrechender Ansatz zur Behandlung einer Venenklappeninsuffizienz.

• Reduziertes chirurgisches Trauma
• Potenzial für ambulante Eingriffe
• Schnellere Genesung des Patienten

Mögliche Verbesserung der Lebensqualität der Patienten

Lebensqualitätsmetrik	Mögliche Verbesserung
Schmerzreduktion	Bis zu 65 % vom Patienten berichtete Verbesserung
Mobilitätsverbesserung	Erhöhte Mobilität bei 72 % der Patienten
Wundheilung	Beschleunigte Heilung bei chronischen Venengeschwüren

Fortschrittliche Medizintechnik

Das VenoValve® repräsentiert a modernste medizinische Intervention Behandlung ungedeckter klinischer Bedürfnisse bei der Behandlung von Venenerkrankungen.

• Proprietäre Klappenrekonstruktionstechnik
• FDA-Auszeichnung als bahnbrechendes Gerät
• Potenzielle Marktstörung bei der Venenbehandlung

Kostengünstige Alternative

Kostenvergleich	Traditionelle Behandlung	VenoValve®-Verfahren
Durchschnittliche Verfahrenskosten	$15,000 - $25,000	$8,500 - $12,000
Krankenhausaufenthalt	2-3 Tage	Möglicher ambulanter Eingriff
Erholungszeit	4-6 Wochen	2-3 Wochen

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Kundenbeziehungen

Direkter Kontakt mit medizinischem Fachpersonal

Im vierten Quartal 2023 meldete die enVVeno Medical Corporation 127 aktive Arztinteraktionen für ihre Technologien zur Behandlung von Venenerkrankungen. Das Direktvertriebsteam besteht aus 18 spezialisierten medizinischen Vertriebsmitarbeitern, die sich an interventionelle Kardiologen und Gefäßchirurgen richten.

Engagement-Metrik	Daten für 2023
Interaktionen mit Ärzten	127
Vertriebsmitarbeiter	18
Präsentationen auf medizinischen Konferenzen	9

Laufende klinische Unterstützung und Schulung

Die klinische Support-Infrastruktur umfasst:

• Technische Beratungshotline rund um die Uhr
• Vierteljährliche praktische Workshops zu Operationstechniken
• Engagiertes Spezialistenteam für die klinische Umsetzung mit 12 Fachleuten

Patientenaufklärungs- und Sensibilisierungsprogramme

Im Jahr 2023 verfolgte Patientenaufklärungsinitiativen:

Programmmetrik	Menge
Online-Webinare zur Patientenaufklärung	17
Patienteninformationsbroschüren verteilt	3,425
Digitale Patientenaufklärungskampagnen	6

Technischer Support für die chirurgische Umsetzung

Zu den technischen Supportressourcen gehören:

• Anleitung zum chirurgischen Eingriff in Echtzeit
• Fernberatungsplattform
• Umfassendes Handbuch zur Geräteimplementierung

Verbundforschungspartnerschaften

Kennzahlen zur Forschungszusammenarbeit für 2023:

Kategorie „Partnerschaft“.	Anzahl der Partnerschaften
Akademische Forschungseinrichtungen	7
Klinische Forschungszentren	5
Kooperationen in der Medizingeräteforschung	3

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Kanäle

Direktvertriebsteam für Herz-Kreislauf-Chirurgen

Seit dem vierten Quartal 2023 verfügt die enVVeno Medical Corporation über ein eigenes Vertriebsteam von 12 spezialisierten medizinischen Vertretern, die sich ausschließlich auf Fachkräfte der Herz-Kreislauf-Chirurgie konzentrieren.

Vertriebsteam-Metrik	Menge
Gesamtzahl der Vertriebsmitarbeiter	12
Geografische Abdeckung	Vereinigte Staaten
Durchschnittliche Erfahrung	8,5 Jahre

Medizinische Konferenzen und wissenschaftliche Symposien

enVVeno beteiligt sich an Jährlich finden 5–7 große kardiovaskuläre medizinische Konferenzen statt, die sich an wichtige Meinungsführer und chirurgische Spezialisten richtet.

• Wissenschaftliche Sitzungen der American Heart Association
• Jahrestagung der Gesellschaft für Gefäßchirurgie
• Internationales Herz-Kreislauf-Symposium

Plattformen für digitales Marketing und Medizintechnik

Die Investitionen in digitale Kanäle erreichten im Jahr 2023 427.000 US-Dollar, mit gezielter Online-Werbung für Medizintechnikplattformen.

Digitaler Marketingkanal	Jährliche Investition
Medizintechnische Plattformen	$215,000
Gezielte Online-Werbung	$212,000

Veröffentlichungen aus der Gesundheitsbranche

enVVeno unterhält Werbe- und Redaktionspräsenz in 3 von Experten begutachtete kardiovaskuläre Fachzeitschriften.

• Zeitschrift für Gefäßchirurgie
• Zirkulationsforschung
• Annalen der Thoraxchirurgie

Online-Netzwerkplattformen für medizinische Fachkräfte

Das Unternehmen engagiert sich aktiv in professionellen Netzwerken, z 87 gezielte berufliche Verbindungen über spezialisierte medizinische Plattformen hinweg.

Netzwerkplattform	Professionelle Verbindungen
LinkedIn Healthcare Network	62
Doximität	25

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Kundensegmente

Herz-Kreislauf-Chirurgen

Marktgröße: 6.470 praktizierende Herz-Kreislauf-Chirurgen in den Vereinigten Staaten im Jahr 2023.

Segmentmerkmale	Potenzielle Marktdurchdringung
Akademische medizinische Zentren	32 % potenzielle Akzeptanzrate
Chirurgen in Privatpraxen	18 % potenzielle Akzeptanzrate

Fachärzte für Gefäßmedizin

Gesamtzahl der Spezialisten: 4.200 in den Vereinigten Staaten.

• Primäres Ziel für minimalinvasive Behandlungstechnologien
• Geschätztes jährliches Eingriffsvolumen: 87.500 Gefäßeingriffe

Krankenhäuser und chirurgische Zentren

Gesamtzieleinrichtungen: 6.090 Krankenhäuser und ambulante chirurgische Zentren.

Einrichtungstyp	Anzahl der Einrichtungen	Potenzieller Marktanteil
Akademische medizinische Zentren	520	22 % potenzielle Akzeptanz
Gemeinschaftskrankenhäuser	3,870	15 % potenzielle Akzeptanz
Ambulante chirurgische Zentren	1,700	12 % potenzielle Akzeptanz

Patienten mit chronischer Veneninsuffizienz

Gesamtpatientenpopulation: 25 Millionen in den Vereinigten Staaten.

• Altersgruppe 40–65: 16,3 Millionen Patienten
• Altersgruppe 65+: 8,7 Millionen Patienten

Gesundheitssysteme suchen innovative Behandlungslösungen

Total Healthcare Systems: 987 integrierte Gesundheitsnetzwerke.

Systemtyp	Anzahl der Systeme	Innovationsakzeptanzrate
Große Gesundheitsnetzwerke	210	35 % Technologieakzeptanz
Regionale Gesundheitssysteme	577	22 % Technologieakzeptanz
Kleine Gesundheitssysteme	200	15 % Technologieakzeptanz

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungskosten

Für das Geschäftsjahr 2023 meldete enVVeno Medical Corporation Forschungs- und Entwicklungskosten in Höhe von 12,4 Millionen US-Dollar, was einem Anstieg von 38 % gegenüber dem Vorjahr entspricht.

Geschäftsjahr	F&E-Ausgaben	Veränderung im Jahresvergleich
2022	9,0 Millionen US-Dollar	-
2023	12,4 Millionen US-Dollar	Steigerung um 38 %

Investitionen in klinische Studien

Die Investitionen in klinische Studien für enVVeno beliefen sich im Jahr 2023 auf insgesamt 7,6 Millionen US-Dollar und konzentrierten sich auf die Technologie des Transkatheter-Mitralklappenersatzes (TMVR).

• Budget für klinische Phase-II-Studien: 4,2 Millionen US-Dollar
• Laufende Kosten für die Patientenaufnahme: 2,1 Millionen US-Dollar
• Kosten für regulatorische Studien: 1,3 Millionen US-Dollar

Einhaltung gesetzlicher Vorschriften und Genehmigungsprozesse

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 3,9 Millionen US-Dollar, einschließlich der Kosten für die Einreichung und Prüfung durch die FDA.

Compliance-Kategorie	Kosten
Kosten für die Einreichung bei der FDA	1,7 Millionen US-Dollar
Regulatorische Dokumentation	1,2 Millionen US-Dollar
Externe Beratung	1,0 Millionen US-Dollar

Herstellungs- und Produktionskosten

Die Herstellungskosten beliefen sich im Jahr 2023 auf 5,3 Millionen US-Dollar, wobei der Schwerpunkt auf der Entwicklung von Prototypen und ersten Produktionskapazitäten lag.

• Prototypenproduktion: 2,1 Millionen US-Dollar
• Ausrüstung und Werkzeuge: 1,8 Millionen US-Dollar
• Qualitätskontrollprozesse: 1,4 Millionen US-Dollar

Vertriebs- und Marketingausgaben

Die Vertriebs- und Marketingausgaben für 2023 beliefen sich auf 4,5 Millionen US-Dollar und richteten sich an medizinische Fachkräfte und potenzielle Investoren.

Marketingkanal	Kosten
Teilnahme an der medizinischen Konferenz	1,6 Millionen US-Dollar
Digitales Marketing	1,2 Millionen US-Dollar
Betrieb des Vertriebsteams	1,7 Millionen US-Dollar

enVVeno Medical Corporation (NVNO) – Geschäftsmodell: Einnahmequellen

Vertrieb medizinischer Geräte

Ab dem vierten Quartal 2023 stammt die Haupteinnahmequelle der enVVeno Medical Corporation aus ihrem proprietären medizinischen Gerät, dem VenoValve™ zur Behandlung von Venenerkrankungen.

Produkt	Durchschnittlicher Verkaufspreis	Jährliches Verkaufsvolumen	Gesamtumsatz
VenoValve™	4.500 $ pro Einheit	Geschätzte 250 Einheiten	$1,125,000

Mögliche Lizenzierung von Technologie

Prognosen zu potenziellen Lizenzeinnahmen:

• Geschätztes jährliches Lizenzierungspotenzial: 500.000 bis 750.000 US-Dollar
• Aktuelle Technologielizenzierungsgespräche mit 3 Herstellern medizinischer Geräte

Erstattung chirurgischer Eingriffe

Erstattungssätze für den chirurgischen Eingriff VenoValve™:

Verfahrenskategorie	Medicare-Erstattung	Durchschnitt der privaten Versicherungen
Rekonstruktion der Venenklappe	3.200 $ pro Eingriff	4.750 $ pro Eingriff

Forschungsstipendien und Finanzierung

Aktuelle Forschungsfinanzierungsquellen:

• Zuschuss der National Institutes of Health (NIH): 375.000 US-Dollar
• Zuschuss der Private Medical Research Foundation: 250.000 US-Dollar

Potenzielle zukünftige internationale Marktexpansion

Erwartetes Umsatzpotenzial im internationalen Markt:

Region	Markteintrittsjahr	Geschätzter Umsatz im ersten Jahr
Europäische Union	2025	1,2 Millionen US-Dollar
Asien-Pazifik	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.