Hyperfine, Inc. (HYPR): Business Model Canvas [Dec-2025 Updated]

You're digging into Hyperfine, Inc.'s strategy, and what we see in 2025 is a defintely calculated shift from pure hardware sales to a hybrid model that marries the portable Swoop® system with recurring AI software revenue. This transition is key: while they are burning cash-projected between $29 million and $31 million for the full year-the Q3 gross margin hit 53.8%, supported by an average selling price of $361,000 per unit. This structure is what underpins their $13 million to $14 million revenue guidance for 2025, so you need to see the full nine-block breakdown to understand the partnerships and resources fueling this next phase.

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

You're looking at the ecosystem that allows Hyperfine, Inc. to scale its Swoop® system beyond the initial hospital base. Partnerships are critical here, especially as the company pivots toward broader commercialization in late 2025.

Clinical Research Institutions for Validation Studies

Validation is everything in medical devices, and Hyperfine, Inc. relies on academic heavyweights to prove the clinical utility of its portable MRI. The UNITY project, for instance, is a massive global effort.

• The UNITY project is led by King's College London.
• The UNITY research consortium includes over 40 academic and clinical centers.
• These centers span countries including Malawi, Ghana, Zambia, Kenya, India, and Pakistan.
• For the neurology office segment, the NEURO PMR study involves sites like DENT Neurologic Institute and Texas Neurology.
• The development of the next-generation Swoop® system was accelerated by collaboration with programs like Jefferson Abington.

Neuro Net for Commercial Expansion in the Neurology Office Segment

Moving into outpatient neurology offices is a major growth vector for Hyperfine, Inc., and the partnership with NeuroNet Pro is central to that push. This segment represents a significant untapped market, considering that neurologists typically order between 500 and 600 brain MRIs each year, yet only 5% of private neurology offices have in-house imaging as of mid-2025. The NEURO PMR study, designed to support this commercial launch, hit a milestone of 100 patient enrollments just 16 weeks after starting on April 15, 2025.

Gates Foundation for Funding Neonatal Scanning Initiatives

The support from the Bill & Melinda Gates Foundation provides crucial, non-dilutive capital for global health initiatives. Hyperfine, Inc. announced a $3.7 million grant in November 2025 to advance neonatal scanning, with funding supporting activities through 2028. This funding directly supports the UNITY project, aiming to use the Swoop® system for objective evaluation of neurodevelopment in resource-constrained settings. To date, Hyperfine, Inc. has already scanned more than 6,000 babies and infants across five continents, performing over 10,000 examinations.

Component Suppliers for the Swoop® System Hardware

While specific supplier names and contract values aren't always public, the successful launch of the next-generation Swoop® system in mid-2025, following FDA clearance in June 2025, implies a successful ramp-up with key hardware partners. The company converted its entire U.S. hospital pipeline to the next-generation system by the third quarter of 2025, which requires a reliable supply chain capable of delivering the hardware featuring innovations engineered for the highest signal-to-noise ratio.

International Distributors for Market Penetration Outside the US

International expansion is clearly a focus, building on earlier 2024 agreements. By late 2025, Hyperfine, Inc.'s distribution network covers North America, Europe, Asia, Oceania, and the Middle East. A significant recent win involves the distribution partner in France, UpCare Europe SAS, which secured a national referencing agreement with UniHA, France's leading public healthcare purchasing cooperative. This agreement, effective November 2, 2025, covers over 1,500 French public hospitals and allows for Swoop® system purchases over the next three years.

Here's a quick view of the scope of these key relationships:

Finance: draft 13-week cash view by Friday.

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

You're looking at the core engine driving Hyperfine, Inc.'s value creation as of late 2025. These activities are where the company puts its time and money to generate revenue from the Swoop® system.

Research and development of AI-powered imaging software (Optive AI™)

The R&D focus is clearly on advancing the proprietary software, which is central to the system's value proposition. The Optive AI™ software is now the tenth-generation release since the initial Swoop® system clearance, showing a consistent cadence of improvement.

Here's the quick math on the investment in this area:

This spending supports the development that led to the May 2025 FDA clearance for Optive AI™, which early users reported brought image quality close to conventional 1.5 tesla MRI scanners.

Manufacturing and scaling production of the Swoop® system

Scaling production is a major activity, especially with the launch of the next-generation Swoop® system. The company converted its entire U.S. hospital pipeline to the new hardware in Q3 2025, indicating a significant manufacturing ramp-up.

System sales volume shows the scaling effort:

• Q2 2025 commercial systems sold: 8 units (up from 6 in Q1 2025).
• Q3 2025 commercial systems sold: 8 units.
• Of the 8 units sold in Q3 2025, 5 were the next-generation Swoop® systems.

The average selling price reflects the premium nature of the new hardware and software combination. The preliminary effective average device selling price for Q3 2025 was approximately $360,000, which was a sequential growth of approximately 36% compared to Q2 2025.

Securing global regulatory clearances (FDA, CE Mark, UKCA Mark)

Regulatory work is a non-negotiable gate for commercial expansion. Hyperfine, Inc. achieved several critical clearances in 2025:

• FDA clearance for Optive AI™ software: May 2025.
• FDA clearance for the next-generation Swoop® system: Around June 2025.
• CE Mark and UKCA Mark approvals for Optive AI™ software: Obtained in Q3 2025.

The original Swoop® system had its CE certification in February 2023 and UKCA certification in November 2022, but the 2025 clearances were essential for the new platform.

Direct sales and commercial execution across three verticals

Commercial execution is focused on driving adoption across specific care environments. The company is targeting hospital sites of care and the neurology office market.

The three primary hospital sites of care mentioned are:

• Adult Critical Care.
• Pediatric Critical Care.
• Emergency Department.

The company initiated a full-scale commercial launch in the neurology office setting in Q3 2025 to unlock a new revenue stream.

Financial results tied to sales execution for 2025:

Management projects full year 2025 revenue to be approximately $13 to $14 million.

Post-sale installation, training, and technical support

Supporting the installed base is key to recurring value and margin. The company commenced the commercial rollout of the Optive AI™ software to its existing installed base in the United States, Canada, United Kingdom, Australia, and New Zealand markets during Q3 2025.

This activity directly impacts the gross margin, which shows improvement as the company scales and rolls out new software:

The Q3 2025 gross margin of 53.8% was a record quarter, up 450 basis points compared to Q2 2025.

Finance: draft 13-week cash view by Friday.

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

You're looking at the core assets Hyperfine, Inc. (HYPR) relies on to execute its business strategy as of late 2025. These aren't just things they own; they are the capabilities that drive their value proposition.

Proprietary ultra-low-field MRI and deep learning AI technology is central. The company's offering is built on its unique hardware platform combined with sophisticated software. The latest iteration of their deep learning AI is the Optive AI™ software, which is their tenth-generation release since initial FDA clearance. This technology received a major validation with the FDA clearance of the entirely new portable MRI scanner, powered by this software, on June 2, 2025. Early clinical users even reported that the image quality from this system is approaching that of conventional 1.5 tesla MRI scanners.

The physical manifestation of this technology is the FDA-cleared Swoop® Portable MR Imaging System. This system is specifically cleared by the FDA for brain imaging of patients of all ages. The company is actively deploying the next-generation hardware, having successfully initiated its commercial launch in the United States. In the third quarter of 2025, Hyperfine, Inc. sold 8 commercial Swoop® systems, with 5 of those being the next-generation units.

Protection for this core technology comes via Intellectual property protecting the portable MR and AI algorithms. While I don't have a patent count, the proprietary nature is evident in the continuous, numbered software releases like the Optive AI™ platform. Furthermore, the company secured international regulatory approvals, obtaining both the CE Mark and UKCA Mark approvals for the Optive AI™ software, which supports international commercial rollout.

Financial stability is a key resource, especially for scaling a hardware-enabled service. Hyperfine, Inc. significantly bolstered its balance sheet by raising $20.1 million in gross proceeds through an underwritten public offering in October 2025. As of September 30, 2025, the company reported $21.6 million in cash and cash equivalents, which was before accounting for the October financing proceeds. The management is guiding for a full-year 2025 cash burn in the range of $29 million to $31 million.

The human capital, specifically Specialized R&D and regulatory personnel, is critical for maintaining the technology lead. You can see the investment in this area through the R&D spending. For the third quarter of 2025, Research and development expenses were $4.0 million. This investment supports the ongoing evolution of the technology, which is key to capturing the total market opportunity estimated in excess of $6 billion.

Here's a quick look at the key operational and financial figures underpinning these resources as of late 2025:

The deployment of the technology is accelerating, as shown by the sales figures:

• 5 of the 8 units sold in Q3 2025 were the next-generation Swoop® systems.
• The company converted its entirety of its U.S. hospital pipeline to the next-generation Swoop® system.
• The next-generation system is being rolled out across multiple sites of care, including adult and pediatric critical care units, emergency departments, and neurology offices.

The financial resource base is being managed with discipline. For instance, the net cash burn, excluding financing activities, for Q3 2025 was $5.9 million. This reflects a sequential decrease, showing operational leverage as the company scales its commercial efforts. Finance: draft 13-week cash view by Friday.

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:

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.

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:

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:

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:

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:

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:

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.