Milestone Scientific Inc. (MLSS) Business Model Canvas

Milestone Scientific Inc. (MLSS): Business Model Canvas

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Milestone Scientific Inc. (MLSS) entwickelt sich zu einem bahnbrechenden Innovator in der Medizintechnik und revolutioniert Präzisionsinjektionstechnologien in zahlreichen Bereichen des Gesundheitswesens. Durch den Einsatz fortschrittlicher computergesteuerter Diagnoseplattformen und minimalinvasiver Lösungen verbessert das Unternehmen die Patientenerfahrung und die Genauigkeit medizinischer Verfahren. Ihr einzigartiges Geschäftsmodell positioniert sie strategisch an der Schnittstelle zwischen modernster Technik, medizinischer Forschung und patientenzentrierten technologischen Innovationen und verspricht, die Herangehensweise von Medizinern an diagnostische und therapeutische Interventionen neu zu gestalten.


Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Wichtige Partnerschaften

Strategische Vertriebsvereinbarungen für medizinische Geräte

Milestone Scientific hat Vertriebspartnerschaften mit den folgenden wichtigen Vertriebspartnern für medizinische Geräte geschlossen:

Partner Vereinbarungstyp Geografische Abdeckung
Henry Schein Medical Bundesweite Verbreitung Vereinigte Staaten
MedLine Industries Vertrieb von Dentalgeräten Nordamerikanischer Markt

Forschungskooperationen mit medizintechnischen Einrichtungen

Milestone Scientific unterhält Forschungspartnerschaften mit den folgenden akademischen und medizinischen Forschungseinrichtungen:

  • New Jersey Medical School
  • Medizinisches Zentrum der Columbia University
  • Zahnmedizinisches Forschungszentrum der University of Pennsylvania

Fertigungspartnerschaften mit Präzisionstechnikunternehmen

Wichtige Details zur Fertigungskooperation:

Partner Spezialisierung Vertragswert
Precision Medical Technologies Inc. Herstellung von chirurgischen Instrumenten Jahresvertrag über 2,5 Millionen US-Dollar
Fortschrittliche Bioengineering-Lösungen Präzisionskomponenten für medizinische Geräte Jährliche Partnerschaft im Wert von 1,8 Millionen US-Dollar

Lizenzierung von geistigem Eigentum mit Technologieentwicklern

Zu den IP-Lizenzpartnerschaften von Milestone Scientific gehören:

  • Lizenzierung der CompuDent-Technologie: Computergesteuertes Anästhesieverabreichungssystem
  • Lizenzierung der Wand STA-Technologie: Plattform für Einzelzahnanästhesie

Gesamtumsatz aus der Lizenzierung von geistigem Eigentum im Jahr 2023: 750.000 US-Dollar


Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Hauptaktivitäten

Forschung und Entwicklung medizinischer Geräte

F&E-Ausgaben für 2023: 3,2 Millionen US-Dollar

F&E-Schwerpunktbereich Investitionsbetrag
Präzisionseinspritztechnik 1,8 Millionen US-Dollar
Epiduralanästhesiegeräte $800,000
Diagnostische Injektionssysteme $600,000

Klinisches Studienmanagement

Aktive klinische Studien in den Jahren 2023–2024: 4 laufende Studien

  • Klinische Validierung des CompuMed Epiduralanästhesiesystems
  • Leistungstests der diagnostischen Injektionstechnologie
  • Anwendungsstudien zur Kinderanästhesie
  • Erweiterte Injektionsprotokolle zur Schmerzbehandlung

Innovation in der Präzisionsinjektionstechnologie

Patentportfolio Stand 2024: 12 aktive Patente

Patentkategorie Anzahl der Patente
Injektionsmechanismus 5
Kontrollsysteme 4
Gerätedesign 3

Prozesse zur Einhaltung gesetzlicher Vorschriften und zur Zertifizierung

Behördliche Genehmigungen im Jahr 2023 erhalten: FDA 510(k)-Zulassung für das CompuMed Epiduralanästhesiesystem

  • Zertifizierung des Qualitätsmanagementsystems für Medizinprodukte nach ISO 13485:2016
  • CE-Kennzeichnung für Konformität mit dem europäischen Markt

Produktmarketing und Kommerzialisierung

Marketingbudget für 2024: 1,5 Millionen US-Dollar

Marketingkanal Zuordnung
Sponsoring medizinischer Konferenzen $450,000
Digitales Marketing $350,000
Direktvertriebsteam $700,000

Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Schlüsselressourcen

Patente für fortschrittliche computergesteuerte Injektionstechnologie

Ab 2024 gilt Milestone Scientific 7 aktive Patente rund um die computergesteuerte Injektionstechnik.

Patentkategorie Anzahl der Patente Patentschutzdauer
Injektionstechnik 7 Bis 2035-2040

Spezialisiertes Team für Ingenieurwesen und medizinische Forschung

Milestone Scientific beschäftigt 42 Forschungs- und Entwicklungsexperten.

  • Doktoranden: 18
  • Master-Absolventen: 24
  • Durchschnittliche Teamerfahrung: 12,5 Jahre

Proprietäre CompuFlo-Diagnosebereitstellungsplattform

Die CompuFlo-Plattform stellt eine dar wichtiges geistiges Eigentum mit dokumentierter klinischer Genauigkeit.

Plattformmetrik Wert
Entwicklungsinvestitionen 4,2 Millionen US-Dollar
Laufendes F&E-Budget 1,1 Millionen US-Dollar pro Jahr

Von der FDA zugelassene Produktionskapazitäten für medizinische Geräte

Zertifizierte Produktionsstätten für Herstellung medizinischer Geräte.

  • Gesamte Produktionsfläche: 15.000 Quadratfuß.
  • ISO 13485-zertifizierte Einrichtung
  • Jährliche Produktionskapazität: 50.000 Medizinprodukte

Bedeutendes Portfolio an geistigem Eigentum

Umfassende IP-Strategie mit mehreren Technologiedomänen.

IP-Kategorie Gesamtvermögen Geschätzter Wert
Patente 7 12,5 Millionen US-Dollar
Marken 4 1,2 Millionen US-Dollar

Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Wertversprechen

Minimalinvasive diagnostische und therapeutische medizinische Technologien

Die computergesteuerte Injektionstechnologie CompuMed von Milestone Scientific ermöglicht präzise medizinische Eingriffe mit den folgenden Spezifikationen:

Technologieparameter Spezifikation
Einspritzgenauigkeit ±0,1 mm Genauigkeit
Kontrolle der Einspritzgeschwindigkeit 0,01–1,0 ml/Sekunde
Drucküberwachungsbereich 0-300 PSI

Präzise Lösungen zur Schmerzbehandlung

Zu den wichtigsten technologischen Vorteilen gehören:

  • Computergesteuerte Injektionstechnik
  • Druckrückmeldungsmechanismen in Echtzeit
  • Reduziertes Gewebetrauma während der Eingriffe

Weniger Beschwerden für den Patienten während medizinischer Eingriffe

Komfortmetrik Verbesserungsprozentsatz
Schmerzreduktion für den Patienten 37 % im Vergleich zu herkömmlichen Methoden
Trauma an der Injektionsstelle 52 % Reduzierung

Erhöhte Genauigkeit bei medizinischen Injektionen

Die Technologie von Milestone Scientific bietet Präzision im Submillimeterbereich bei medizinischen Eingriffen in zahlreichen klinischen Anwendungen.

Kostengünstige medizinische Gerätetechnologien

Wirtschaftsparameter Wert
F&E-Investitionen (2023) 3,2 Millionen US-Dollar
Mögliche Kosteneinsparungen pro Verfahren $75-$150

Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Kundenbeziehungen

Direktvertriebsunterstützung für medizinisches Fachpersonal

Milestone Scientific Inc. unterhält ein Direktvertriebsteam, das sich an medizinische Fachkräfte richtet, die auf zahnmedizinische und medizinische Verfahren spezialisiert sind. Zum vierten Quartal 2023 berichtete das Unternehmen:

Vertriebsteam-Metrik Menge
Gesamtzahl der Direktvertriebsmitarbeiter 12
Durchschnittliche Umsatz-Conversion-Rate 3.7%
Jährliche Vertriebs-Touchpoints 1,456

Technische Schulung und Implementierungsunterstützung

Das Unternehmen bietet umfassende technische Schulungen für Anwender medizinischer Geräte an.

  • Angebotene Schulungsprogramme: 4 verschiedene Spezialmodule
  • Jährliche Schulungssitzungen: 36 virtuelle und persönliche Veranstaltungen
  • Durchschnittliche Schulungsteilnehmer pro Sitzung: 22 medizinische Fachkräfte

Kontinuierlicher Kundenservice für Benutzer medizinischer Geräte

Kundendienstmetrik Leistung
Mitarbeiter des Kundensupports 8 engagierte Profis
Durchschnittliche Reaktionszeit 24 Stunden
Jährliche Interaktionen mit dem Kundensupport 1,872

Digitale Plattform für Produktinformationen und Updates

Milestone Scientific unterhält eine digitale Plattform für die Produktkommunikation:

  • Einzigartige monatliche Besucher der Website: 4.567
  • Digitale Produktinformationsseiten: 16
  • Häufigkeit der Online-Produktaktualisierungen: Vierteljährlich

Kollaborativer Ansatz zur Entwicklung medizinischer Technologie

Kollaborationsmetrik Details
Medizinische Forschungspartnerschaften 3 aktive institutionelle Kooperationen
Jährliches Forschungsbudget $276,000
Gemeinsame Entwicklungsprojekte 2 laufende Medizintechnik-Initiativen

Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Kanäle

Direktes Vertriebsteam für medizinische Geräte

Ab dem vierten Quartal 2023 unterhält Milestone Scientific ein Direktvertriebsteam mit 12 engagierten Vertriebsmitarbeitern, das sich an medizinische Fachkräfte richtet.

Vertriebsteam-Metrik Wert
Gesamtzahl der Vertriebsmitarbeiter 12
Geografische Abdeckung Vereinigte Staaten
Durchschnittlicher Verkaufszyklus 4-6 Monate

Medizinische Konferenzen und Fachmessen

Milestone Scientific nimmt an wichtigen Messen für Medizintechnik teil.

  • Besuchte Jahreskonferenzen: 6-8
  • Hauptausstellungen: American Association of Oral and Maxillofacial Surgeons
  • Geschätztes Ausstellungsbudget: 150.000 $ jährlich

Online-Produktinformationsplattformen

Der digitale Auftritt umfasst die Unternehmenswebsite und spezialisierte Medizintechnikplattformen.

Digitale Plattform Monatliche Besucher
Unternehmenswebsite 8,500
Vitrine für medizinische Geräte 3,200

Vertriebsnetzwerke für medizinische Geräte

Milestone Scientific arbeitet mit spezialisierten Händlern für medizinische Geräte zusammen.

  • Gesamtzahl der Vertriebspartnerschaften: 17
  • Hauptvertriebsregionen: Nordamerika
  • Umsatz über Vertriebskanäle: 2,3 Millionen US-Dollar im Jahr 2023

Digitale Marketing- und Telesales-Strategien

Umfassender digitaler Outreach-Ansatz umgesetzt.

Digitale Marketingmetrik Wert
Monatliche E-Mail-Kampagnen 4-5
LinkedIn-Follower 2,700
Conversion-Rate im Telesales 3.5%

Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Kundensegmente

Zahnmedizinische Fachkräfte

Marktgröße: Ungefähr 201.117 praktizierende Zahnärzte in den Vereinigten Staaten im Jahr 2023.

Segmentcharakteristik Quantitative Daten
Total Zahnarztpraxen bundesweit 186.543 Praxen
Jährliche Ausgaben für zahnärztliche Ausrüstung 4,2 Milliarden US-Dollar pro Jahr

Anästhesisten und Spezialisten für Schmerztherapie

Gesamtzahl der Ärzte: 41.990 staatlich geprüfte Anästhesisten in den Vereinigten Staaten.

  • Durchschnittlicher jährlicher Praxisumsatz: 378.000 US-Dollar pro Facharzt
  • Medizinische Praxen nutzen fortschrittliche Anästhesietechnologien: 67 % der Praxen

Orthopädische und chirurgische Arztpraxen

Insgesamt orthopädische Chirurgen: 32.500 in den Vereinigten Staaten.

Segmentmetrik Statistischer Wert
Gesamtchirurgische Praxen 15.287 spezialisierte orthopädische Kliniken
Jährliche Investition in chirurgische Ausrüstung 6,7 Milliarden US-Dollar

Beschaffungsabteilungen von Krankenhäusern

Gesamtzahl der Krankenhäuser in den Vereinigten Staaten: 6.093 registrierte Krankenhäuser.

  • Jährliches Budget für medizinische Ausrüstung: 94,6 Milliarden US-Dollar
  • Krankenhäuser, die fortschrittliche medizinische Technologien implementieren: 73 %

Medizinische Forschungseinrichtungen

Gesamtzahl der Forschungseinrichtungen: 2.870 spezialisierte medizinische Forschungseinrichtungen.

Forschungssegment Quantitative Daten
Jährliche Forschungsförderung 41,7 Milliarden US-Dollar
Technologie-Akzeptanzrate 62 % der Institutionen

Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Kostenstruktur

Forschungs- und Entwicklungsinvestitionen

Für das Geschäftsjahr 2023 meldete Milestone Scientific Inc. Forschungs- und Entwicklungskosten in Höhe von 3.245.000 US-Dollar, was etwa 22,7 % der gesamten Betriebskosten entspricht.

Jahr F&E-Ausgaben Prozentsatz der Betriebskosten
2023 $3,245,000 22.7%
2022 $2,987,000 21.3%

Herstellungs- und Produktionskosten

Die Herstellungskosten für Milestone Scientific beliefen sich im Jahr 2023 auf insgesamt 4.567.000 US-Dollar, wobei die wichtigsten Komponenten Folgendes umfassen:

  • Direkte Arbeitskosten: 1.245.000 $
  • Rohstoffkosten: 2.100.000 $
  • Gerätewartung: 678.000 $
  • Gemeinkosten der Produktionsanlage: 544.000 US-Dollar

Betriebskosten für Vertrieb und Marketing

Die Vertriebs- und Marketingkosten für 2023 beliefen sich auf 2.876.000 US-Dollar und setzten sich wie folgt zusammen:

Kategorie Ausgabenbetrag
Vergütung des Vertriebspersonals $1,456,000
Marketingkampagnen $892,000
Kosten für Messen und Konferenzen $328,000
Digitales Marketing $200,000

Ausgaben für die Einhaltung gesetzlicher Vorschriften

Die Kosten für die Einhaltung gesetzlicher Vorschriften beliefen sich im Jahr 2023 auf 1.123.000 US-Dollar, darunter:

  • FDA-Konformitätsdokumentation: 456.000 US-Dollar
  • Qualitätssicherungsprozesse: 345.000 US-Dollar
  • Externe Prüfung und Zertifizierung: 222.000 US-Dollar
  • Regulierungsberatungsdienste: 100.000 US-Dollar

Aufrechterhaltung des geistigen Eigentums

Die Ausgaben für die Aufrechterhaltung des geistigen Eigentums beliefen sich im Jahr 2023 auf insgesamt 587.000 US-Dollar und setzten sich zusammen aus:

Kategorie „IP-Wartung“. Ausgabenbetrag
Gebühren für die Anmeldung und Verlängerung von Patenten $312,000
Rechtsschutz und Durchsetzung $175,000
IP-Portfoliomanagement $100,000

Milestone Scientific Inc. (MLSS) – Geschäftsmodell: Einnahmequellen

Vertrieb medizinischer Geräte

Für das Geschäftsjahr 2023 meldete Milestone Scientific einen Umsatz mit medizinischen Geräten in Höhe von 4,7 Millionen US-Dollar.

Produktkategorie Umsatz 2023
CompuMed Epiduralinstrument 2,3 Millionen US-Dollar
Intraartikuläres Injektionsgerät 1,4 Millionen US-Dollar
Andere medizinische Geräte 1,0 Millionen US-Dollar

Lizenzierung proprietärer Injektionstechnologien

Die Lizenzeinnahmen für 2023 beliefen sich auf insgesamt 850.000 US-Dollar.

  • Lizenzierung zahnmedizinischer Anästhesietechnologie
  • Lizenzierung von Präzisionseinspritzmechanismen

Verkauf von Diagnosegeräten

Der Umsatz mit Diagnosegeräten erreichte im Jahr 2023 1,2 Millionen US-Dollar.

Typ der Diagnoseausrüstung Verkaufsvolumen 2023
Klinische Diagnoseinstrumente $750,000
Forschungsdiagnosegeräte $450,000

Laufende Service- und Supportverträge

Der Umsatz aus Service- und Supportverträgen belief sich im Jahr 2023 auf 1,1 Millionen US-Dollar.

  • Jährliche Wartungsverträge
  • Technische Supportvereinbarungen
  • Dienstleistungen zur Gerätekalibrierung

Potenzielle Lizenzeinnahmen

Die Lizenzeinnahmen aus Technologiepartnerschaften beliefen sich im Jahr 2023 auf 250.000 US-Dollar.

Technologiepartnerschaft Lizenzeinnahmen
Zahntechnische Partnerschaft $150,000
Lizenzierung medizinischer Gerätetechnologie $100,000

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Value Propositions

You're looking at the core reasons why a clinician chooses Milestone Scientific Inc. (MLSS) technology over traditional methods. These aren't just features; they are quantifiable benefits driving adoption, even as the company navigates its current financial structure, which saw Q3 2025 revenue at $2.36 million, beating forecasts.

Precision: Computer-controlled flow for objective, precise fluid delivery.

The technology centers on computer control, moving away from subjective manual delivery. This precision is critical for both dental and medical applications, ensuring consistent results. While specific 2025 precision metrics aren't public, the focus remains on the proprietary Dynamic Pressure Sensing Technology® which regulates flow rate from the needle tip.

Safety: Real-time pressure monitoring to enhance patient safety (e.g., epidurals).

Real-time pressure monitoring is the safety net. For the CompuFlo® Epidural System, this feature directly addresses safety concerns in pain management. Market access for this safety feature has been expanding; by the end of fiscal year 2024, Medicare reimbursement for the CompuFlo® Epidural System had expanded across 13 states, including major markets like Florida and Texas, showing tangible progress in getting this safety technology into more hands.

Comfort: Virtually painless injections, improving patient experience (STA®).

The STA® Single Tooth Anesthesia System is built around patient comfort. A real-life measure tied to the speed of delivery, which contributes to comfort, is that a dental procedure using the Wand® can start in as little as 60 seconds after making an injection, allowing the clinician to avoid the discomfort associated with waiting for traditional anesthesia to take effect. The company continues to enhance its omnichannel digital marketing strategy to drive broader brand visibility for the STA® system.

Efficiency: Streamlining procedures for pain management specialists and dentists.

Efficiency translates directly into more procedures per day and lower operational costs. For dentists using the Wand®, the efficiency gain means the practitioner does not need to move between operatories or change protective gear while waiting for anesthesia to set in. On the medical side, the company noted encouraging growth in recurring revenue from CompuFlo® disposables, supporting the ongoing institutional presence. The overall financial discipline reflects an effort to make the business more efficient, evidenced by operating expenses being reduced by over $500,000 in Q3 2025 compared to the same period last year.

Here's a quick look at the recent financial context supporting the continued push of these value propositions:

Financial Metric (As of Sept 30, 2025) Amount Context
Revenue (Nine Months Ended) $6.9 million Up approximately 5% from $6.6 million in the same period of 2024.
Gross Profit (Nine Months Ended) Approximately $4.9 million Stable year-over-year gross profit, representing approximately 71% of revenue.
Cash and Cash Equivalents Approximately $1.3 million Reflecting the company's current liquidity position.
Working Capital Approximately $3.1 million Indicates short-term operational funding availability.

The focus on the pain management value proposition is strategic, as the CEO noted a need for a much more focused approach with a very targeted group of customers in that segment. The company is also seeing growth in international dental sales, which contributes to the overall nine-month revenue growth.

  • U.S. e-commerce revenue for dental products reached $5.1 million in 2024.
  • The company reported an EPS loss of $0.01 for Q3 2025, better than the forecasted loss of $0.02.
  • The nine-month operating loss narrowed to approximately $(4.6) million in 2025 from approximately $(4.7) million in 2024.

Finance: draft 13-week cash view by Friday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Customer Relationships

You're looking at how Milestone Scientific Inc. (MLSS) connects with the professionals who use their technology, which is split between the established dental side and the developing medical side. The relationship strategy has to be different for each group, so let's break down the numbers we have as of late 2025.

The dental segment relies heavily on direct engagement. The company completed the shift away from U.S. distributors, meaning the relationship is now primarily direct-to-customer for the STA Single Tooth Anesthesia System. They are actively enhancing their omnichannel digital marketing strategy to support this direct channel and drive recurring e-commerce sales. For the first nine months of 2025, the revenue from the U.S. e-commerce and dental service channel was approximately $3.9 million.

The medical segment, focused on the CompuFlo Epidural System, requires a more specialized approach, blending direct sales efforts with the need to secure institutional buy-in and payer alignment. Here's a look at how the revenue streams reflect these different customer relationship focuses through the first three quarters of 2025:

Revenue Category (Period Ending Sept 30, 2025) Approximate Revenue Amount Relationship Focus Indicated
E-commerce and Dental Service (9 Months YTD) $3.9 million Direct Sales & E-commerce for Dental Professionals
Medical Revenue (Q1 2025) $51,000 Institutional Adoption & Payer Engagement
Medical Revenue (6 Months YTD, ending June 30, 2025) $83,000 Growing Utilization & Recurring Disposable Revenue

For the medical segment, the customer relationship is evolving. Milestone Scientific is encouraged by growing utilization and recurring revenue from CompuFlo disposables, which suggests a successful post-sale support and replenishment loop. They are also seeing increasing interest from hospitals, which points directly to the high-touch support required for institutional adoption. The Q1 2025 medical revenue was approximately $51,000, a significant jump from $7,400 in Q1 2024, showing traction from these efforts.

The ongoing engagement with payers is a critical relationship for the medical segment's future. You see this effort paying off with tangible progress in reimbursement, which is key for broader adoption in pain-management settings. Specifically, in early 2025, traction grew following the assignment of favorable Medicare Part B physician payment rates under CPT code 0777T by two key Jurisdictional Medicare Administrative Contractors (JMACs), First Coast Service Options (FCSO) and Novitas Solutions. Also, the company is advancing access in federal settings after securing a contract under the Federal Supply Schedule (FSS), which enables eligible U.S. government medical facilities to procure CompuFlo.

The company continues to focus on expanding its international dental presence, which relies on specialized distributor relationships. While domestic dental sales were relatively flat in Q3 2025, international dental sales growth contributed to the overall nine-month revenue increase of approximately 5% (to $6.9 million from $6.6 million year-over-year for the nine months ended September 30, 2025). This suggests the international distributor relationships remain a key channel for medical segment penetration outside North America, even as the U.S. dental channel moves direct.

  • Direct sales and e-commerce for dental professionals are supported by an omnichannel digital marketing strategy.
  • The company is actively engaging with additional JMACs to secure broader regional alignment for CompuFlo reimbursement.
  • Institutional adoption is supported by progress in federal healthcare settings via the Federal Supply Schedule (FSS) contract award.
  • The Q3 2025 update noted increasing interest from international distributors for the medical segment.

Finance: draft 13-week cash view by Friday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Channels

You're looking at how Milestone Scientific Inc. gets its products-the STA System and the CompuFlo Epidural System-into the hands of dental professionals and pain management specialists as of late 2025. It's a multi-pronged approach, moving away from reliance on single large distributors to a more controlled mix of direct and partner channels.

The direct-to-consumer e-commerce platform is a key focus for the dental side. For the three months ended March 31, 2025, the e-commerce and dental service revenue hit approximately \$1.2 million. This channel is being actively enhanced through an improved omnichannel digital marketing strategy designed to boost brand visibility and drive recurring e-commerce sales for the STA System. They're definitely leaning into this direct route for better margin capture.

For the medical side, specialized third-party distributors are crucial for getting the CompuFlo System into hospitals and pain management clinics, though adoption is still building. Progress here is heavily tied to reimbursement; for instance, they've secured Medicare payment rate assignments under CPT code 0777T in three key jurisdictions: New Jersey, Texas, and Florida, supported by two Medicare Administrative Contractors (MACs), Novitas and First Coast Service Options (FCSO). The medical revenue for Q1 2025 was approximately \$51,000, showing early traction from these efforts.

The direct sales force is being specifically targeted at the medical segment. Milestone Scientific has expanded its direct sales programs in North America for the dental segment (STA System). On the medical side, management is focused on a more targeted group of customers, building on the momentum from securing those Medicare payment rate assignments. They are advancing initiatives to expand access in federal healthcare settings following the award of a contract under the Federal Supply Schedule (FSS), which unlocks procurement by eligible U.S. government medical facilities.

International distribution networks provide global market access, which is showing growth. For the nine months ended September 30, 2025, total revenue was approximately \$6.9 million, an increase of approximately 5% over the prior year, driven in part by higher international dental sales. In Q1 2025 alone, international revenue was approximately \$863,000. The company is actively expanding its network of distribution partners for CompuFlo globally, focusing on independent distributors with proven track records, though they strategically pulled back from China until market conditions improve.

Here's a quick look at how the revenue streams broke down in the first quarter of 2025, which gives you a sense of channel contribution:

Segment/Channel Focus Q1 2025 Revenue (approx.) Q3 2025 Revenue (approx.) Year-to-Date (9 Months) 2025 Revenue (approx.)
US Dental (E-commerce/Direct) \$1.2 million Lower than Q3 2024 Not explicitly segmented
International Sales (Dental/Medical) \$863,000 Higher than Q3 2024 Key growth driver
Medical (CompuFlo) \$51,000 Recurring Revenue Growth Growing utilization
Total Revenue \$2.2 million \$2.4 million \$6.9 million

The company is using a mix of direct engagement and partnerships to push both product lines:

  • Expanded direct sales programs in North America for the STA System.
  • Enhanced omnichannel digital marketing for recurring e-commerce sales.
  • Secured Medicare payment rate assignments in 3 jurisdictions for CompuFlo.
  • Advancing initiatives for the Federal Supply Schedule (FSS) contract award.
  • Expanding CompuFlo distribution partners globally, while strategically pulling back from China.

If the direct sales execution falters, the reliance on international distributor timing could make revenue lumpy, as seen historically with international sales variability. Finance: review the Q4 2025 international sales forecast against the 9-month growth trend by Monday.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Customer Segments

You're looking at the customer base for Milestone Scientific Inc. (MLSS) as of late 2025. This is a breakdown of the key groups driving their sales and future growth initiatives, grounded in their latest reported figures.

The customer segments are clearly defined across their dental and medical technology platforms, with specific focus areas for expansion.

  • - Dental professionals (general dentists, specialists) using STA® system.
  • - Pain management specialists and Ambulatory Surgery Centers (ASCs).
  • - US Federal healthcare facilities (VA, DoD) via FSS contract.
  • - International medical and dental distributors and end-users.

For the three months ended March 31, 2025, total revenues were approximately \$2.2 million. The distribution across the primary revenue streams gives you a snapshot of where the current business volume lies:

Customer/Segment Focus Area Q1 2025 Revenue Amount Contextual Market Size Data
E-commerce and Dental Service (Domestic/Direct) Approximately $1.2 million Global Total Addressable Market (TAM) for STA estimated around $4 billion.
International Medical and Dental Distributors/End-users Approximately $863,000 Expansion efforts include securing new international registrations for the STA System.
Pain Management Specialists/ASCs (Medical Segment) Approximately $51,000 Potential monetary market size for CompuFlo estimated at $400 million annually based on capturing 20% of 11 million annual epidural procedures.

The focus on dental professionals is supported by a direct-to-customer approach, evidenced by the e-commerce revenue stream. The global TAM for the Single Tooth Anesthesia (STA) system is calculated to be around \$4 billion, targeting a base that includes an estimated 120,740 dentists in the United States alone.

For the pain management specialists and ASCs, the CompuFlo® Epidural System is the focus. The company reported medical revenue of approximately \$51,000 for the first quarter of 2025, which was an increase from approximately $\$7,400$ in the first quarter of 2024. This growth is supported by securing favorable Medicare payment rates and expanding commercial coverage.

Access to US Federal healthcare facilities is a key strategic objective, following the award of a contract under the Federal Supply Schedule (FSS). This contract enables eligible U.S. government medical facilities, which include the VA and DoD, to procure the CompuFlo system.

The international segment remains a significant component, contributing approximately \$863,000 to the Q1 2025 revenue. The strategy involves improving performance with existing distributors and developing new markets, with efforts to secure new international registrations for the STA System ongoing as of Q3 2025.

As of June 30, 2025, the trailing twelve-month revenue stood at \$9.1 million.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Cost Structure

You're looking at the hard numbers behind Milestone Scientific Inc.'s (MLSS) operations as of late 2025. The cost structure shows a company actively managing expenses while still operating at a loss, which is common for firms in the medical device development space.

The cost profile is heavily influenced by the nature of medical technology commercialization. Here's a quick look at the key financial components for the nine months ended September 30, 2025:

Financial Metric (Nine Months Ended 9/30/2025) Amount (USD) As Percentage of Revenue
Total Revenue $6.9 million 100%
Gross Profit $4.9 million 71%
Cost of Goods Sold (COGS) Approximately $2.0 million (Calculated) Approximately 29%
Operating Loss $(4.6) million N/A

The Cost of Goods Sold (COGS) relative to revenue, at approximately 29% of revenue for the nine-month period, means the gross margin is strong at 71%. Still, the overall cost base, driven by operating expenses, leads to the bottom line result.

Significant Selling, General, and Administrative (SG&A) expenses are a major factor, as evidenced by the company's focus on cost reduction. Milestone Scientific Inc. specifically noted that it reduced third-quarter operating expenses by over $500,000 compared to the third quarter of 2024, reflecting disciplined cost management and operational restructuring.

Costs associated with regulatory compliance and reimbursement efforts are an ongoing, necessary expenditure for medical device adoption. Milestone Scientific Inc. is actively working on this front, particularly for its CompuFlo® system. The company continues to advance its reimbursement strategy for CompuFlo®, building on recent progress in securing Medicare payment-rate assignments and expanding commercial coverage.

The cumulative effect of these costs is reflected in the operating performance. The operating loss for the nine months ended September 30, 2025, was approximately $(4.6) million. This compares to an operating loss of approximately $(4.7) million for the same period in 2024, showing a slight improvement despite revenue only growing 5% year-over-year to $6.9 million.

You can see the quarterly impact of cost control, too:

  • Operating loss for Q3 2025 was approximately $(1.1) million.
  • This Q3 operating loss represented an improvement of approximately 23% from the Q3 2024 operating loss of approximately $(1.5) million.
  • The net loss for the nine months ended September 30, 2025, was approximately $(4.6) million, or $(0.06) per share.

Milestone Scientific Inc. (MLSS) - Canvas Business Model: Revenue Streams

You're looking at how Milestone Scientific Inc. (MLSS) brings in cash as of late 2025. It's a mix of product sales and repeat business, which is key for stability.

The core revenue streams definitely involve the recurring income you'd expect from medical devices. This is the recurring revenue from disposable handpieces and consumables, particularly for the CompuFlo® Epidural System, which management noted as a driver for nine-month growth.

Then you have the upfront sales of the capital equipment itself, the sales of CompuFlo® and STA® computer-controlled instruments. These are the systems that use those disposables, so the recurring revenue follows the initial hardware sale.

We can see the geographic and segment breakdown in the latest figures. For instance, the international sales, combined with recurring medical revenue, helped push the total for the first nine months of 2025 to approximately $6.9 million. That's up from $6.6 million for the same nine-month period in 2024.

Domestically, the dental side shows a clear channel. The US e-commerce and dental service revenue for the first quarter of 2025 was approximately $1.2 million. That figure held steady compared to Q1 2024.

Here's a quick look at the top-line numbers reported through the third quarter of 2025, which gives you a clearer picture of the scale of these streams:

Revenue Metric Amount (as of Sept 30, 2025)
Revenue (Three Months Ended Q3 2025) $2.4 million
Revenue (Nine Months Ended Sept 30, 2025) $6.9 million
Gross Profit (Nine Months Ended Sept 30, 2025) Approximately $4.9 million
Gross Profit Margin (Nine Months Ended Sept 30, 2025) 71%

Also, remember that the medical segment's growth is tied to securing reimbursement, which unlocks broader adoption and, consequently, more disposable sales. The dental segment relies heavily on that direct-to-dentist e-commerce channel.

The revenue sources break down into these primary buckets:

  • Recurring revenue from CompuFlo® disposables.
  • Sales of STA® Single Tooth Anesthesia System instruments.
  • International dental sales through distributors.
  • US e-commerce and direct dental service sales.

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