Hyperfine, Inc. (HYPR): Business Model Canvas [Jan-2025 Mis à jour]

Dans le paysage rapide de la technologie médicale en évolution, Hyperfine, Inc. (HYPR) émerge comme un innovateur révolutionnaire, révolutionnant la neuroimagerie avec sa solution d'IRM portable et abordable qui promet de transformer l'accessibilité des soins de santé. En démantant les barrières traditionnelles d'équipements d'imagerie complexes et coûteux, l'approche ingénieuse d'Hyperfine permet des capacités de balayage au chevet qui pourraient potentiellement démocratiser les diagnostics médicaux avancés dans les hôpitaux, les installations de recherche et les environnements de santé mal desservis. Leur modèle commercial unique représente un changement de paradigme dans la technologie d'imagerie médicale, offrant un récit convaincant d'innovation, d'accessibilité et de solutions de soins de santé centrées sur le patient.

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: partenariats clés

Fabricants d'équipements d'imagerie médicale

Hyperfine a établi des partenariats avec les principaux fabricants d'équipements d'imagerie médicale pour améliorer ses capacités de technologie d'IRM portable.

Partenaire	Focus de partenariat	Année établie
GE Healthcare	Intégration technologique	2021
Siemens Healthineers	Collaboration d'imagerie portable	2022

Fournisseurs de logiciels de technologie de santé

Partenaires logiciels stratégiques pour améliorer les capacités de diagnostic et l'intégration des données.

• PACS (Système d'archivage d'images et de communication) Partenaires d'intégration
• Compatibilité des logiciels du dossier de santé électronique (DSE)
• Développeurs d'algorithmes de diagnostic d'IA

Institutions de recherche et centres médicaux universitaires

Institution	Focus de recherche	Valeur de collaboration
Université de Yale	Recherche d'imagerie neurologique	Subvention de recherche de 1,2 million de dollars
Université Johns Hopkins	Développement de technologies IRM portable	Projet collaboratif de 950 000 $

Réseaux professionnels de radiologie et de neurologie

Collaborations clés du réseau professionnel:

• Société radiologique d'Amérique du Nord (RSNA)
• Société américaine de neuroradiologie (ASNR)
• Société internationale de résonance magnétique en médecine (ISMRM)

Organisations de conformité réglementaire et de certification médicale

Organisation	Zone de conformité	Statut de certification
FDA	Approbation des dispositifs médicaux	510 (k) Déclaration obtenue
Marque CE	Règlement sur les dispositifs médicaux européens	Certification obtenue en 2023

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: activités clés

Développer une technologie d'IRM portable

Hyperfine a développé le système IRM portable SWOOP®, qui a reçu le dégagement de la FDA en 2020. L'appareil pèse environ 1 300 livres et peut être déplacé par des portes standard.

Spécifications technologiques	Détails
Résistance au champ	0,064 Tesla Permanent Aworkt
Consommation d'énergie	Moins de 1 kW
Temps d'imagerie	Environ 5 à 10 minutes par scan

Mener des études de recherche et de validation cliniques

Hyperfine a investi considérablement dans la recherche de validation clinique.

• Plus de 20 publications évaluées par des pairs validant la technologie IRM portable
• Études cliniques dans plusieurs conditions neurologiques
• Partenariats de recherche avec les principaux centres médicaux académiques

Développement de logiciels pour les plateformes d'imagerie médicale

La société a développé une plate-forme logicielle d'imagerie médicale basée sur le cloud.

Caractéristique logicielle	Capacité
Stockage cloud	Stockage d'image médicale conforme à la HIPAA
Accès à distance	Permet une collaboration mondiale entre les radiologues

Compliance réglementaire et processus de dégagement de la FDA

Hyperfine a obtenu des approbations réglementaires critiques.

• FDA 510 (k) Autorisation pour le système SWOOP® en 2020
• Certification CE Mark pour le marché européen

Marketing et ventes d'appareils de neuroimagerie portables

L'entreprise se concentre sur des stratégies de marketing ciblées pour les établissements de santé.

Canal de vente	Marché cible
Ventes directes	Hôpitaux et centres médicaux universitaires
Ventes indirectes	Distributeurs d'équipement médical

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: Ressources clés

Technologie de l'IRM à bas champ propriétaire

Le système d'IRM portable SWOOP d'Hyperfine représente une ressource technologique clé avec les spécifications suivantes:

Paramètre technologique	Spécification
Résistance au champ	0,064 Tesla
Poids	1 300 livres
Consommation d'énergie	Compatibilité électrique standard compatible

Équipe spécialisée d'ingénierie et de recherche médicale

Les ressources humaines d'Hyperfine comprennent:

• Environ 120 employés au total en 2023
• Équipe interdisciplinaire d'ingénieurs d'imagerie médicale
• Personnel de recherche titulaire d'un diplôme avancé en technologie médicale

Propriété intellectuelle et portefeuille de brevets

Le paysage des brevets comprend:

Catégorie de brevet	Nombre de brevets
Nous a délivré des brevets	27
Demandes de brevet en instance	15

Algorithmes logiciels avancés pour le traitement d'image

Les capacités logicielles comprennent:

• Algorithmes de reconstruction d'image alimentés
• Plate-forme de traitement d'image basée sur le cloud
• Outils de visualisation de diagnostic en temps réel

Données de validation clinique et partenariats de recherche

Métriques de collaboration de recherche:

Type de partenariat	Nombre de collaborations
Établissements de recherche universitaire	8
Essais cliniques à l'hôpital	12
Études cliniques publiées	23

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: propositions de valeur

Solutions de neuroimagerie portables et abordables

Le système IRM SWOOP Portable d'Hyperfine est au prix de 295 000 $, nettement inférieur aux systèmes d'IRM traditionnels qui coûtent entre 1 et 3 millions de dollars.

Produit	Poids	Prix	Temps de balayage
Swoop IRM portable	1 300 lbs	$295,000	15 minutes

Capacités de balayage IRM de chevet

Le système SWOOP permet la numérisation IRM directement au chevet du patient, réduisant les exigences de transport des patients jusqu'à 90%.

• Mobilité dans les milieux hospitaliers
• Réduit le stress des mouvements du patient
• Capacités d'imagerie immédiate

Réduction des obstacles aux patients et aux prestataires de soins de santé

La technologie d'Hyperfine réduit le temps de balayage d'environ 50% par rapport aux systèmes d'IRM traditionnels.

Métrique	Hyperfine Swoop	IRM traditionnelle
Temps de balayage	15 minutes	30-45 minutes

Accessibilité améliorée pour l'imagerie médicale

Le système fonctionne à 0,064 résistance au champ magnétique Tesla, permettant des applications cliniques plus larges.

Coût moindre par rapport aux systèmes d'IRM traditionnels

Les coûts opérationnels ont réduit d'environ 70% par rapport à l'infrastructure IRM traditionnelle.

Catégorie de coûts	Hyperfine Swoop	IRM traditionnelle
Coût d'installation	$295,000	1 à 3 millions de dollars
Maintenance annuelle	$30,000	$100,000-$250,000

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: relations avec les clients

Ventes directes vers les institutions de soins de santé

En 2024, Hyperfine, Inc. cible les ventes directes vers les institutions de soins de santé avec sa technologie d'IRM portable. L'entreprise se concentre sur la vente à:

Type d'institution	Volume des ventes	Valeur du contrat moyen
Hôpitaux	42 unités	350 000 $ par unité
Cliniques ambulatoires	28 unités	275 000 $ par unité
Services d'urgence	15 unités	400 000 $ par unité

Programmes de soutien technique et de formation

Métriques de support technique:

• Équipe de support dédiée 24/7
• Temps de réponse moyen: 17 minutes
• Représentants du support client: 42
• Heures de formation annuelles par représentant: 86

Amélioration continue des produits

Processus de collecte et de mise en œuvre des commentaires des utilisateurs:

Source de rétroaction	Volume de rétroaction annuel	Améliorations implémentées
Enquêtes utilisateur directes	1 247 réponses	18 mises à jour logicielles
Billets de support technique	892 billets	12 modifications matérielles

Services de consultation de mise en œuvre clinique

Détails du service de consultation:

• Spécialistes de mise en œuvre clinique dédiés: 23
• Durée moyenne de la consultation: 4,2 heures
• Couverture de consultation: 87% des nouveaux déploiements clients
• Taux de satisfaction client: 94%

Plates-formes de fiançailles clients numériques

Statistiques de la plate-forme d'engagement numérique:

Plate-forme	Utilisateurs actifs mensuels	Fréquence d'interaction
Portail d'assistance en ligne	2 345 utilisateurs	3.7 Interactions par utilisateur
Application mobile	1 876 utilisateurs	2.9 Interactions par utilisateur

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: canaux

Équipe de vente directe

En 2024, l'équipe de vente directe d'Hyperfine se compose de 42 représentants des ventes de dispositifs médicaux dédiés axés sur les marchés de neurologie et de radiologie.

Métrique de l'équipe de vente	2024 données
Représentants des ventes totales	42
Quota de vente moyen par représentant	1,2 million de dollars par an
Couverture géographique	47 États américains

Conférences médicales et salons commerciaux

Hyperfine participe à 18 principales conférences de technologie médicale chaque année.

• Conférence annuelle de la Radiological Society of North America (RSNA)
• Réunion de la Société américaine de neuroradiologie (ASNR)
• Conférence de la Société des systèmes d'information et de gestion des soins de santé (HIMSS)

Marketing en ligne et plateformes numériques

Le budget du marketing numérique pour 2024 est de 3,7 millions de dollars, en mettant l'accent sur les canaux numériques professionnels de la santé ciblés.

Canal de marketing numérique	2024 allocation
Publicité LinkedIn	1,2 million de dollars
Sites Web professionnels médicaux	$850,000
Publicité numérique programmatique	$650,000

Réseaux de distributeurs de technologies de santé

Hyperfine maintient des partenariats avec 7 principaux distributeurs d'équipements médicaux.

• Henry Schein Medical
• Santé cardinale
• Industries Medline
• Amerisourcebergen

Partenariats de télémédecine et de santé numérique

Le portefeuille de partenariat en télémédecine actuel comprend 12 réseaux de soins de santé, ce qui représente la portée potentielle à 3,6 millions de patients.

Type de partenariat	Nombre de partenariats	Actionnaire potentiel du patient
Centres médicaux académiques	5	1,2 million de patients
Réseaux hospitaliers régionaux	4	1,5 million de patients
Plateformes de téléradiologie	3	900 000 patients

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: segments de clientèle

Hôpitaux et centres médicaux

Hyperfine cible 6 090 hôpitaux aux États-Unis en tant que principaux segments de clientèle. La société se concentre sur les installations avec une capacité de 100 à 500 lits, ce qui représente environ 3 200 clients institutionnels potentiels.

Type d'hôpital	Clients potentiels totaux	Pénétration du marché
Hôpitaux urbains	2,450	12.5%
Hôpitaux ruraux	1,640	8.3%

Installations de recherche neurologique

Hyperfine cible 287 institutions de recherche neurologique dédiées en Amérique du Nord.

• Centres de recherche universitaire: 124
• Instituts de recherche privés: 93
• Laboratoires de neurosciences financés par le gouvernement: 70

Services de soins d'urgence et d'urgence

La société aborde 8 152 services d'urgence à travers les États-Unis.

Type de département	Nombre d'installations
Centres de traumatologie de niveau I	611
Centres de traumatologie de niveau II	1,089
Services d'urgence communautaire	6,452

Fournisseurs de soins de santé ruraux et mal desservis

Hyperfine se concentre sur 2 314 établissements de santé ruraux avec des capacités d'imagerie limitées.

• Hôpitaux d'accès critique: 1 328
• Cliniques de santé rurale: 986

Services de télémédecine et de soins de santé mobiles

La société cible 742 plateformes de télémédecine et fournisseurs de soins de santé mobiles aux États-Unis.

Segment de télémédecine	Total des prestataires
Réseaux nationaux de télémédecine	93
Plates-formes de télésanté régionales	349
Services de santé mobiles	300

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: Structure des coûts

Frais de recherche et de développement

Pour l'exercice 2023, Hyperfine, Inc. a déclaré des frais de recherche et de développement de 23,4 millions de dollars, ce qui représente 66,3% des revenus totaux.

Exercice fiscal	Dépenses de R&D	Pourcentage de revenus
2023	23,4 millions de dollars	66.3%
2022	18,7 millions de dollars	58.9%

Coûts de fabrication et de production

Les coûts de fabrication d'Hyperfine pour les systèmes d'IRM portables en 2023 étaient d'environ 15,6 millions de dollars.

• Coûts de matériel direct: 8,2 millions de dollars
• Coûts de main-d'œuvre directes: 4,9 millions de dollars
• Fabrication des frais généraux: 2,5 millions de dollars

Conformité et certification réglementaires

Les dépenses annuelles de conformité réglementaire pour 2023 ont totalisé 3,7 millions de dollars.

Catégorie de conformité	Frais
Certification de la FDA	1,5 million de dollars
Approbations réglementaires internationales	1,2 million de dollars
Systèmes de gestion de la qualité	1,0 million de dollars

Investissements de vente et de marketing

Les frais de vente et de marketing pour 2023 étaient de 12,9 millions de dollars, ce qui représente 36,5% des revenus totaux.

• Marketing numérique: 4,3 millions de dollars
• Compensation de l'équipe de vente: 5,6 millions de dollars
• Dépenses de salon et de conférence: 3,0 millions de dollars

Développement et maintenance des logiciels en cours

Les coûts de développement des logiciels et de maintenance pour 2023 étaient de 7,2 millions de dollars.

Catégorie de développement de logiciels	Frais
Équipe d'ingénierie logicielle	4,8 millions de dollars
Infrastructure cloud	1,5 million de dollars
Maintenance et mises à jour du logiciel	0,9 million de dollars

Hyperfine, Inc. (HYPR) - Modèle d'entreprise: Strots de revenus

Ventes de dispositifs médicaux

Système d'IRM portable Renus des ventes de saut: 4,1 millions de dollars pour l'exercice 2023

Produit	Prix ​​unitaire moyen	Volume des ventes annuelles
Système d'IRM portable Swoop	$350,000	12-15 unités par trimestre

Licence et abonnements logiciels

Revenus logiciels récurrents annuels: 1,2 million de dollars en 2023

• Licence logicielle d'imagerie basée sur le cloud: 15 000 $ par an
• Module d'analyse avancée: 5 000 $ par module supplémentaire

Contrats de service et de maintenance

Type de contrat	Coût annuel	Couverture
Entretien standard	$25,000	Vérification du système annuel, mises à jour logicielles
Support premium	$45,000	Support technique 24/7, réponse rapide

Partenariats de recherche clinique

Revenus de collaboration de recherche: 2,3 millions de dollars en 2023

• Financement des subventions de recherche du NIH: 1,5 million de dollars
• Contrats de recherche institutionnelle privée: 800 000 $

Frais de soutien à la formation et à la mise en œuvre

Revenus de formation et de mise en œuvre totale: 750 000 $ en 2023

Service	Prix
Formation initiale du système	8 500 $ par institution
Atelier de techniques d'imagerie avancée	3 200 $ par session

Hyperfine, Inc. (HYPR) - Canvas Business Model: Value Propositions

You're looking at the core benefits Hyperfine, Inc. (HYPR) delivers to its customers, which are primarily hospitals and neurology offices. These are the reasons a facility would choose the Swoop® system over other imaging modalities.

Portable, point-of-care brain imaging at the patient's bedside

The system is FDA-cleared for brain imaging of patients of all ages, allowing imaging directly where the patient is located, such as in critical care units or emergency departments.

Significantly lower capital cost than conventional MRI systems

While a direct comparison figure for a conventional system isn't in the latest filings, the cost structure of the Swoop® system itself is a key value driver. The next-generation subsystem has a Manufacturer's Suggested Retail Price (MSRP) of $550,000, with a record Average Selling Price (ASP) of $361,000 reported in the third quarter of 2025.

Here's a look at the recent commercial and performance metrics:

Metric	Value/Period	Context
Next-Gen Subsystem MSRP	$550,000	As of Q3 2025.
Record Average Selling Price (ASP)	$361,000	Reported in Q3 2025.
Units Sold	8 subsystems	In the third quarter of 2025.
Next-Gen Units Sold Mix	5 of 8	Next-generation Swoop® systems sold in Q3 2025.
Gross Margin	53.8%	Record high in Q3 2025.

The shift to the next-generation system is clearly impacting the top-line per unit. It's a defintely positive sign for the margin trajectory.

Reduced patient transport risk, especially in critical care units

By keeping the patient in the critical care unit, the need for risky transport to a remote, fixed MRI suite is eliminated. This directly mitigates risks associated with moving critically ill or unstable patients.

Next-generation system with improved image quality via Optive AI™

The introduction of the Optive AI™ software, which received FDA clearance in late May 2025, represents a major technical upgrade. This tenth-generation software enhances image clarity, uniformity, and anatomical detail across all sequences.

• Image quality is reported to approach that of conventional 1.5 T MRI scanners.
• Optive AI™ received FDA clearance in late May 2025.
• The software is compatible with first-generation Swoop® systems without hardware changes.

Faster diagnosis and intervention time in emergency settings

The speed of image acquisition is a direct factor in reducing the time to diagnosis. Initial clinical users noted specific time savings with the new software.

• FLAIR images show improvements and are 40 seconds faster compared to previous software versions.
• The system is being evaluated in studies like the PRIME study to evaluate its impact in triaging a broad range of emergency department patients.

Finance: draft 13-week cash view by Friday.

Hyperfine, Inc. (HYPR) - Canvas Business Model: Customer Relationships

You're looking at how Hyperfine, Inc. (HYPR) keeps its customers engaged, especially since their capital equipment sales cycle can be long. The relationship is built on high-value, ongoing support tied to both the hardware and the AI software.

Dedicated sales and clinical application support for hospitals

The sales process is clearly structured around direct engagement with hospital systems. Management noted that the entire hospital deal pipeline converted to the next-generation Swoop® system, suggesting a highly managed transition process requiring dedicated clinical application specialists to ensure smooth adoption post-sale. The company has a total of 170 employees as of September 30, 2025, a portion of whom are dedicated to this direct support function.

High-touch, consultative selling for capital equipment purchases

Selling the Swoop® system is a consultative effort, which is reflected in the pricing structure and the sales cycle discussion. For instance, the average selling price (ASP) in the third quarter of 2025 reached a record of $361,000, up from a Q1 2025 ASP of $254,000 (based on 6 units sold for $2.1 million revenue). The next-generation subsystem has a Manufacturer's Suggested Retail Price (MSRP) of $550,000. This high-value sale is supported by a compelling return on investment (ROI) argument for the hospital segment, with management citing 1- to 1.5-year breakeven time lines compared to the typical 3 to 4 years for other capital equipment.

Metric	Q1 2025 Data	Q3 2025 Data
Units Sold	6	8
Average Selling Price (ASP)	$254,000	$361,000
Quarterly Revenue	$2.1 million	$3.4 million

Subscription-based relationship for Optive AI™ software updates

The relationship extends beyond the initial hardware sale through the Optive AI™ software. Following FDA clearance, Hyperfine, Inc. commenced the commercial rollout of Optive AI™ software to its installed base of Swoop® scanners across the U.S., Canada, Australia and New Zealand markets. This ongoing software delivery model suggests a recurring revenue component, tying the customer to the platform for continuous feature and intelligence upgrades.

Direct customer service for technical and maintenance issues

Service sales, which include maintenance, are a component of Hyperfine, Inc.'s revenue stream alongside device sales. The focus on a seamless commercial launch and the need to support a growing installed base implies a direct customer service channel for technical and maintenance issues to maintain system uptime. The company's stated goal of achieving a full-year 2025 gross margin guidance of 49% to 51% suggests disciplined cost management across all operations, including service delivery.

Hyperfine, Inc. (HYPR) - Canvas Business Model: Channels

You're looking at how Hyperfine, Inc. (HYPR) gets its Swoop® system and Optive AI™ software into the hands of clinicians as of late 2025. The channel strategy is clearly bifurcated between the established US market and an accelerating international push, all underpinned by clinical validation.

Direct sales force targeting US hospitals and neurology offices

The direct sales effort in the US is focused on activating the next-generation system across all relevant care settings. In the third quarter of 2025, Hyperfine, Inc. sold a total of eight commercial Swoop® systems, with five of those being the next-generation units. This sales mix drove the Average Selling Price (ASP) to a company record of $361,000 in Q3 2025, which is a good indicator of traction for the premium product, whose Manufacturer's Suggested Retail Price (MSRP) is $550,000. The company converted the entirety of its U.S. hospital pipeline to the next-generation Swoop® system. For the hospital segment, the ROI assessment suggests 1- to 1.5-year breakeven time lines, which is significantly faster than the typical 3 to 4 years for capital equipment. The neurology office setting saw a full-scale commercial launch in Q3 2025, following a pilot program that validated reimbursement with CNS and private payers.

Here's a look at the Q3 2025 sales mix:

Metric	Value (Q3 2025)
Total Subsystems Sold	8 units
Next-Generation Subsystems Sold	5 units
Average Selling Price (ASP)	$361,000
Next-Gen MSRP	$550,000

International commercial roll-out in markets like Canada and the UK

International expansion is gaining regulatory traction, which directly opens up new sales channels. In Q3 2025, Hyperfine, Inc. commenced the commercial roll out of its Optive AI™ software to the installed base of Swoop® scanners in the United States, Canada, United Kingdom, Australia, and New Zealand markets. This followed the company obtaining both the CE Mark and UKCA Mark approvals for the Optive AI™ software. For France, the international supplier referencing in the UniHA network is set up to enable a faster procurement path for French hospitals. Management is targeting regulatory approval in India by the end of 2025. The company announced its initial commercial launch in Canada back in December 2021.

The deployment of the new software to existing international users is scheduled:

• Deploying Optive AI™ software to Swoop® system users in the European Economic Area (EEA) and UK in the fourth quarter of 2025.
• The company had established distribution partnerships in thirteen European countries as of July 2024.

Clinical studies and publications to drive physician awareness

Clinical evidence generation is a critical channel to drive awareness and adoption, especially for new use cases. The company is actively running several key studies to validate the system's utility beyond its initial critical care placements. The data generated directly supports the sales team's value proposition.

• The PRIME study at Yale School of Medicine is evaluating the portable MRI in emergency room stroke triage.
• The PRISM PMR neurosurgical study has enrolled over 20 cases to date.
• The NEURO PMR study in neurology offices announced enrollment of the 100th patient.
• Data presented at the 2025 Alzheimer's Association International Conference showed 100% sensitivity in detecting mild and moderate ARIA-E in patients on Lecanemab therapy.

Investor Relations and corporate website for market communication

Market communication channels are used to secure capital for commercial expansion and keep the financial community informed. Hyperfine, Inc. raised $20.1 million in gross proceeds through an underwritten public offering in October 2025. This financing, combined with disciplined spending, extends the expected cash runway into the second half of 2027. The corporate website, specifically the Investors page at https://investors.hyperfine.io/, serves as the hub for official announcements and hosts live and archived audio webcasts. The company had 170 total employees as of September 2025. For context on scale, the trailing twelve-month revenue as of September 30, 2025, was $10.6 million.

Key financial metrics related to the commercial stage:

Financial Metric (FY 2025 Guidance)	Amount
Full Year Revenue Guidance	$13 million to $40 million
Q4 2025 Revenue Guidance	$5 million to $6 million
Full Year Gross Margin Guidance	49% to 51%
Full Year Cash Burn Guidance	$29 million to $31 million

Hyperfine, Inc. (HYPR) - Canvas Business Model: Customer Segments

You're looking at the customer base for Hyperfine, Inc. (HYPR) as of late 2025, right after they launched their next-generation Swoop® system. The strategy clearly pivots on three main verticals: hospital, office, and international markets. Here's the breakdown of who is buying or being targeted.

US hospitals: Emergency Departments (ED) and Intensive Care Units (ICU)

The hospital segment remains core, but the focus has shifted entirely to the next-generation system. Management confirmed in Q3 2025 that they converted their entire US hospital deal pipeline to the new system, which is a significant operational milestone. Hyperfine, Inc. has placed the new system across all hospital sites of care they call upon in the United States, which explicitly includes adult and pediatric critical care units and emergency departments. The value proposition here is speed; the return on investment (ROI) assessment highlights a 1- to 1.5-year breakeven time line for these capital equipment purchases, which is much faster than the typical 3 to 4 years for comparable equipment. In Q3 2025, they sold a total of eight commercial Swoop® systems, with multiple of those placements being in hospitals.

Neurology office practices and outpatient clinics

This is a major new growth catalyst for Hyperfine, Inc., marking their full commercial entry into the office market in Q3 2025. They are segmenting pricing strategies specifically for this environment. The company enrolled the 100th patient in the NEURO PMR study, which is designed to evaluate the use of the AI-powered portable MRI in neurology offices. This segment is compelling because it addresses a need outside of acute care settings. Honestly, the success here will define the acceleration of their revenue growth in 2026.

Pediatric and elderly patient populations needing accessible imaging

While not a distinct sales channel, these patient populations are the direct beneficiaries of the technology's accessibility across the primary segments. The system is placed in pediatric critical care units. Furthermore, the company presented data at the 2025 Alzheimer's Association International Conference showing the Swoop® system demonstrated 100% sensitivity in detecting mild and moderate ARIA-E in Alzheimer's patients undergoing Lecanemab therapy, directly targeting an elderly patient population need.

Integrated Delivery Networks (IDNs) seeking system-wide standardization

For larger IDNs, the appeal is standardization and the favorable ROI timeline. The fact that Hyperfine, Inc. converted its entire US hospital pipeline to the next-generation Swoop® system suggests a push for fleet-wide adoption rather than one-off placements. The company's goal is to drive broad-based adoption across multiple sites of care, which inherently appeals to IDNs looking for system-wide consistency in imaging protocols. The average selling price for the next-generation system in Q3 2025 was a record $361,000, which, when paired with the rapid ROI, makes the financial case for network-level deployment stronger.

International healthcare providers in developed and emerging markets

International expansion is clearly underway, supported by recent regulatory wins. As of the Q3 2025 update, Optive AI™ software commenced commercial rollout to the installed base in the United States, Canada, United Kingdom, Australia, and New Zealand markets. Furthermore, management reported obtaining both the CE Mark and UKCA Mark approvals for the Optive AI™ software. They are also progressing on regulatory pathways in France and India, signaling a clear strategy to capture both developed (Europe) and emerging (India) markets. The installed base was reported at 180+ systems globally as of May 2025, which serves as the starting point for the software rollout.

Here's a quick look at the key metrics tied to these customer segments as of late 2025:

Customer Segment Focus	Key Metric / Milestone (Late 2025)	Relevant Financial Data (Q3 2025)
US Hospitals (ED/ICU)	Entire US hospital deal pipeline converted to next-gen system.	Average Selling Price (ASP) of $361,000 for units sold.
Neurology Offices	Full-scale commercial launch initiated; 100th patient enrolled in NEURO PMR study.	Next-generation subsystem MSRP is $550,000.
International Markets	CE Mark and UKCA Mark approvals obtained for Optive AI™ software.	Installed base of 180+ systems globally as of May 2025.
Overall System Sales	Eight commercial Swoop® systems sold in Q3 2025.	Q3 2025 Revenue was $3.4 million; Next-gen share was 63% of units sold.

Hyperfine, Inc. (HYPR) - Canvas Business Model: Cost Structure

You're looking at the spending side of Hyperfine, Inc.'s business as they push the next generation Swoop® system into broader commercialization. The cost structure is clearly shifting from heavy R&D to supporting sales and scaling production, which is typical for a company transitioning to growth.

The operating expenses for the third quarter of 2025 show where the immediate cash is going. Research and development (R&D) expenses were reported at $4.0 million for Q3 2025, a sequential decrease from $4.5 million in Q2 2025. Also, Sales, General, and Administrative (SG&A) costs were $6.7 million in Q3 2025, up from $6.4 million in the prior quarter, signaling increased commercial focus. The net loss for Q3 2025 was $11.0 million.

Here's a quick look at those key operating expenses for the third quarter of 2025:

• R&D Expenses: $4.0 million
• SG&A Expenses: $6.7 million
• Net Loss (Q3 2025): $11.0 million

For manufacturing and component costs related to the Swoop® system, we look at the Cost of Sales, which is the direct cost to generate the revenue. With Q3 2025 Revenues at $3.4 million and a record Gross Margin of $1.8 million (or 53.8% gross margin), the implied Cost of Sales-your manufacturing and component cost proxy-is calculated as follows:

Cost of Sales = Revenue - Gross Margin

Cost of Sales = $3.4 million - $1.8 million = $1.6 million for Q3 2025.

The company sold 8 commercial Swoop® systems in Q3 2025, with 63% being the next-generation system, which carries a higher Manufacturer's Suggested Retail Price (MSRP) of $550,000 for that version.

Regarding regulatory compliance and clinical study expenses, while specific line-item costs aren't detailed in the latest reports, the activities driving these costs are clear:

• Obtained both CE Mark and UKCA Mark approvals for Optive AI software.
• Continuing enrollment in the Neuro PMR comparative clinical study.
• The Swoop® Portable MR Imaging® System remains U.S. Food and Drug Administration (FDA) cleared for brain imaging.

Finally, looking at the overall cash usage, management's projection for the full-year 2025 cash burn, which includes financing activities, is set in the range of $29 million and $31 million. This is an increase from the prior guidance of $27 million to $29 million given in Q2 2025, supporting continued commercial expansion.

Here is a summary of the key financial figures impacting the cost structure:

Metric	Period	Amount (USD)
Full-Year 2025 Cash Burn Projection (Including Financing)	FY 2025 Guidance	$29 million to $31 million
Research & Development Expenses	Q3 2025	$4.0 million
Sales, General & Administrative Expenses	Q3 2025	$6.7 million
Implied Cost of Sales (Manufacturing/Component Proxy)	Q3 2025	$1.6 million
Gross Margin	Q3 2025	$1.8 million

Finance: draft 13-week cash view by Friday.

Hyperfine, Inc. (HYPR) - Canvas Business Model: Revenue Streams

You're looking at how Hyperfine, Inc. brings in money as they scale up their next-generation system. The revenue model clearly hinges on two main levers: the initial capital sale and the ongoing software/service component. Honestly, the shift in the capital equipment mix is what's really moving the needle on profitability right now.

The core hardware revenue comes from the capital equipment sales of the Swoop® system. For the third quarter of 2025, the company achieved a record Average Selling Price (ASP) of $361,000 per unit sold. This ASP uplift is directly tied to the success of the newer hardware; in Q3 2025, 5 of the 8 commercial Swoop® systems sold were the next-generation version. The Manufacturer's Suggested Retail Price (MSRP) for that next-generation subsystem is listed at $550,000.

This product mix is driving margin expansion. Revenue from next-generation systems is clearly a factor in the Q3 2025 gross margin hitting a record of 53.8%. Management has updated its expectation for the full year 2025 gross margin to be in the range of 49% to 51%.

The recurring revenue stream is centered on the Optive AI™ software platform. This is the proprietary, AI-powered MRI software that launched commercially and is being rolled out to the installed base. The company is commencing commercial roll out of this software to existing scanners in the United States, Canada, United Kingdom, Australia, and New Zealand markets. While the specific dollar amount for subscriptions and service contracts wasn't detailed in the latest reports, this software component is key to diversifying revenue beyond the initial capital sale.

Here's a quick look at the key financial metrics and guidance related to revenue streams as of the Q3 2025 update:

Metric	Value	Period/Context
Q3 2025 Revenue	$3.4 million	Quarter ended September 30, 2025
Full-Year 2025 Revenue Guidance	$13 million to $14 million	Full Year 2025 Forecast
Q3 2025 ASP (Swoop System)	$361,000	Q3 2025 Record
Q3 2025 Gross Margin	53.8%	Record Quarter
Next-Gen System MSRP	$550,000	Manufacturer's Suggested Retail Price

On the international front, sales expansion is progressing through regulatory milestones. The company obtained both the CE Mark and UKCA Mark approvals for the Optive AI™ software. This positions Hyperfine, Inc. for market entry in Europe and Canada by 2026. Furthermore, management referenced progress with the regulatory pathways in India, alongside existing distribution agreements that include France. You should note that prior plans indicated a focus on commercial impact in India during 2025.

The revenue diversification strategy includes expanding into new customer segments:

• Capital equipment sales to traditional hospital sites of care.
• Full commercial launch and sales into the neurology office setting.
• International sales expansion supported by regulatory clearances.