Hyperfine (NASDAQ:HYPR) reported fourth-quarter results that management said reflected accelerating adoption of its next-generation Swoop portable brain MRI system, driven by improved image quality from its Optive AI software and expanding demand across hospitals, neurology offices, and international markets.
Commercial momentum driven by next-generation Swoop and Optive AI
President and CEO Maria Sainz said fourth-quarter revenue of more than $5 million marked “very strong performance” for the second straight quarter following the mid-2025 introduction of Hyperfine’s second-generation Swoop scanner and Optive AI software. She described the combination of hardware and AI as a “market turning point” for portable brain MRI and ultra-low field MRI, emphasizing Hyperfine’s ability to generate diagnostic-quality images with an ultra-low field magnet and deploy the system across preventative, acute, and chronic brain health settings.
Regulatory, clinical evidence, and software updates
Hyperfine said the FDA cleared an update in December 2025 following the release of Optive AI software, which management described as the eleventh generation of Swoop software. The latest software includes diffusion-weighted imaging features intended to refine the system’s value in stroke workflows, with Sainz stating that the company expects to continue delivering one to two software releases per year.
The company also pointed to external validation efforts and data releases, including:
- Recently published “Vein Stroke” publication and the NEURO PMR presentation, which management said support clinical diagnostic utility for stroke triage and neurology office use, respectively.
- A published health economic impact analysis using real-world data from Jefferson Abington Hospital across 143 scans, which management said documented savings from reduced supplies, faster clinical decision-making, accelerated discharges, and freed capacity on conventional scanners for elective procedures.
- The PRIME study led by Yale School of Medicine evaluating AI-powered portable MRI for broader emergency department triage; management said Yale completed enrollment ahead of schedule and expects to provide an update later in 2026.
On product expansion, Sainz discussed the company’s Contrast PMR study, a prospective multicenter clinical trial evaluating contrast-enhanced ultra-low field portable MRI. She said enrollment is approximately 20% toward the goal, and the study is intended to support a potential FDA submission in late 2026 to expand Swoop’s intended use to include gadolinium-based contrast agents. Sainz added that contrast-enabled scans could broaden office and hospital use, and noted that outpatient contrast scans are reimbursed under CPT code 70553.
Hospitals, neurology offices, and international markets highlighted as growth vectors
Management described three near-term business opportunities: hospital placements, neurology office adoption, and international expansion. In hospitals, Sainz said interest is rising as stakeholders model return on investment timelines of roughly 1 to 1.5 years, compared with typical 3-to-4-year capital equipment ROI, using the published health economic analysis as a reference point. She also cautioned that larger, strategic deals with IDNs can involve longer administrative processes and budget cycles, potentially creating quarterly variability.
In neurology offices, Sainz said the company’s full commercial launch began in the third quarter of 2025 and progressed rapidly in the fourth quarter. She said only about 10% of private neurology practices have on-site MRI, presenting a large market opportunity with minimal incumbent competition. Hyperfine is using a segmentation-based pricing strategy with different configurations, including both first- and next-generation systems, to fit differing practice sizes. The company is also leveraging a partnership referred to as its “Neural Network” to promote adoption across neurology practices.
Internationally, management said Optive AI software is now available in 10 European languages and that Hyperfine is going through the European regulatory process to introduce the next-generation Swoop scanner to the U.K. and CE markets before the end of 2026. Sainz also highlighted late-2025 regulatory approval for the first-generation Swoop system in India, with plans to launch through a local partner and engage key opinion leaders; placements are expected to scale at a measured pace during the year.
Financial results: revenue growth, margin expansion, and lower cash burn
Chief Administrative Officer and CFO Brett Hale reported fourth-quarter 2025 revenue of $5.3 million, up 128% from $2.3 million in the year-ago quarter. Hyperfine sold 16 units net in the quarter, compared with 9 units in the fourth quarter of 2024, with demand across hospitals, neurology offices, and international markets. Hale said some hospital systems pursued “core technology upgrades” that included multiple unit placements.
For full-year 2025, revenue was $13.6 million, up 5% from $12.9 million in 2024. Hale characterized 2025 as “a tale of two halves,” with $8.7 million of revenue in the second half versus $4.8 million in the first half, driven by mid-year product launches.
Gross profit in the fourth quarter was $2.7 million, up 226% year over year, and gross margin was 50.9%, the second consecutive quarter above 50%. For the full year, gross profit was $6.8 million and gross margin was 49.8%, representing 410 basis points of expansion versus 2024.
Operating expenses declined year over year in R&D and were essentially flat in SG&A. R&D expense was $3.8 million in the quarter (down from $5.1 million), and $17.5 million for the year (down from $22.5 million), which Hale attributed to benefits from a reorganization completed in early 2025. SG&A was $6.5 million in the quarter (flat year over year) and $26.4 million for the year (slightly down from $26.6 million).
Net loss narrowed to $5.9 million, or $0.06 per share, in the fourth quarter, compared with a net loss of $10.4 million, or $0.14 per share, a year earlier. Full-year net loss was $35.6 million, or $0.43 per share, compared with $40.7 million, or $0.56 per share, in 2024. Results included a non-cash gain related to changes in the fair value of warrant liabilities ($1.5 million in Q4 and $0.8 million for the year).
Hyperfine’s net cash burn excluding financing was $5.7 million in the fourth quarter, down 30% year over year, and $29.9 million for 2025, down 22% from 2024. The company ended 2025 with $35.1 million in cash and cash equivalents, which included net proceeds from an October equity financing but excluded the initial $15 million tranche from a new debt facility.
2026 outlook and capital position
Hale said Hyperfine strengthened its capital position with more than $20 million in equity raised in October and a $15 million initial tranche under an up to $40 million long-term debt facility. He said the initial tranche extends the cash runway into 2028, with additional tranches of up to $25 million available through the end of 2027 upon achieving prescribed commercial targets. For modeling purposes, Hyperfine expects quarterly interest payments of about $400,000, which are included in cash burn guidance.
For 2026, Hyperfine guided to:
- Revenue: $20 million to $22 million (55% growth at the midpoint)
- Gross margin: 50% to 55%, with stronger margins expected in the second half
- Total cash burn: $26 million to $28 million, including debt servicing (10% decline at the midpoint)
Management said the company expects a “typical step down” from fourth-quarter capital revenue levels and anticipates revenue to strengthen progressively through 2026 as multi-unit hospital and IDN deals advance and as the next-generation scanner begins launching internationally in the second half of the year.
During Q&A, management also discussed pricing. Sainz said the next-generation system’s MSRP is $590,000, up from $550,000 at the Model 2 launch, primarily affecting the U.S. hospital business. She added that office pricing is segmented, including use of Model 1 for smaller practices, while international sales are conducted through distributors at distributor pricing.
In closing comments, Sainz shared that a customer site that purchased two next-generation units in the third quarter of 2025 has completed more than 200 scans to date and reported high satisfaction along with clinical and economic workflow impact.
About Hyperfine (NASDAQ:HYPR)
Hyperfine, Inc (NASDAQ: HYPR) is a medical technology company focused on expanding access to advanced neuroimaging through its portable magnetic resonance imaging (MRI) system. The company’s flagship product, Swoop®, is designed to enable bedside MRI scanning in a wide range of clinical environments, including emergency departments, intensive care units and outpatient clinics. By leveraging a compact, high-performance permanent magnet and a custom-designed gradient system, Hyperfine aims to reduce the logistical and financial barriers associated with traditional, large-scale MRI installations.
The Swoop system features a lightweight, wheeled design that can be maneuvered directly to a patient’s bedside, allowing clinicians to conduct diagnostic imaging without the need to transport critically ill or immobile patients.
