# Hyperfine, Inc.: Form 10-Q for the period ended Mar 31, 2025

- Company: [Hyperfine, Inc.](/companies/hypr.md) (CIK 1833769)
- Form: 10-Q
- Filed: 2025-05-13
- Accepted by EDGAR: May 13, 2025, 20:20 ET
- Period: 2025-03-31
- Accession: 0000950170-25-070402
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1833769/000095017025070402/hypr-20250331.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1833769/000095017025070402/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2025-03-31.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2025-01-01 to 2025-03-31 | $2.1m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Cost of revenue | 3 months, 2025-01-01 to 2025-03-31 | $1.3m | us-gaap:CostOfGoodsAndServicesSold |
| Gross profit | 3 months, 2025-01-01 to 2025-03-31 | $883.0k | us-gaap:GrossProfit |
| Research and development | 3 months, 2025-01-01 to 2025-03-31 | $5.0m | us-gaap:ResearchAndDevelopmentExpense |
| Operating income | 3 months, 2025-01-01 to 2025-03-31 | −$10.9m | us-gaap:OperatingIncomeLoss |
| Income tax | 3 months, 2025-01-01 to 2025-03-31 | $0 | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2025-01-01 to 2025-03-31 | −$9.4m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2025-01-01 to 2025-03-31 | −$0.12 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2025-01-01 to 2025-03-31 | −$0.12 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2025-01-01 to 2025-03-31 | 75,697,199 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 3 months, 2025-01-01 to 2025-03-31 | −$9.2m | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 3 months, 2025-01-01 to 2025-03-31 | $472.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Cash and equivalents | at 2025-03-31 | $33.1m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2025-03-31 | $48.4m | us-gaap:AssetsCurrent |
| Total assets | at 2025-03-31 | $53.4m | us-gaap:Assets |
| Current liabilities | at 2025-03-31 | $8.0m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2025-03-31 | $10.3m | us-gaap:Liabilities |
| Shareholders' equity | at 2025-03-31 | $43.1m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 32,230 characters.

*The following discussion and analysis provides information which management believes is relevant to an assessment and understanding of our condensed consolidated results of operations and financial condition. The discussion should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto contained in this Quarterly Report on Form 10-Q and the consolidated financial statements and notes thereto for the year ended December 31, 2024 contained in our 2024 Annual Report on Form 10-K. This discussion contains forward-looking statements and involves numerous risks and uncertainties, including, but not limited to, those described in the “Risk Factors” sections of our 2024 Annual Report on Form 10-K and of this Quarterly Report on Form 10-Q, as updated and/or supplemented in subsequent filings with the SEC. Actual results may differ materially from those contained in any forward-looking statements. Unless the context otherwise requires, references to “we,” “us,” “our,” and “the Company” are intended to mean the business and operations of Hyperfine, Inc. and its consolidated subsidiaries. The unaudited condensed consolidated financial statements for the three months ended March 31, 2025 and 2024, respectively, present the financial position and results of operations of Hyperfine, Inc. and its wholly owned subsidiaries.*

### Overview

We are an innovative health technology business with a mission to revolutionize patient care globally through accessible, affordable, clinically relevant artificial intelligence (“AI”)-powered portable ultra-low-field (“ULF”) magnetic resonance (“MR”) brain imaging. Our Swoop® Portable MR Imaging® System (“Swoop® system”) produces high-quality images at a lower magnetic field strength than conventional magnetic resonance imaging (“MRI”) scanners. Our Swoop® system is designed to transform brain MR for the patient, the clinician and the provider, enabling a highly differentiated experience for patients, timely imaging for clinicians, and favorable economics for hospital administrators. The Swoop® system is a portable, ULF MRI device for producing images that display the internal structures of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. Healthcare professionals can use the Swoop® system to make effective clinical diagnoses and decisions in various care settings where conventional MRI devices are inaccessible or when they are not readily available. The easy-to-use interface and portable design of our Swoop® system make it easily and readily accessible anywhere in a hospital, clinic, physician office, or patient care site and it does not require any special facilities accommodations nor specialized personnel to operate safely. ULF MR does not expose patients to harmful ionizing radiation and compares favorably in this regard to X-ray, computed tomography or positron emission tomography.

The demand for MR imaging has been increasing due to the aging population and the rising prevalence of neurological, neurodegenerative, and cardiovascular conditions, recent approval of new Alzheimer’s medications, as well as the trends towards decentralized healthcare in mature, as well as low- and middle-income countries. Healthcare professionals and insurers recognize imaging as an effective, non-invasive diagnostic tool for evaluation and ongoing monitoring. The Swoop® system is the next generation brain imaging device designed to increase access to MRI in a cost-effective manner. We believe our market opportunity is significant across the multiple sites of care where the Swoop® system brings clinical and economic value. We estimate in the United States alone that our total addressable market for Swoop® system device placements is more than $16 billion.

Despite their advantages, many healthcare institutions worldwide lack the facilities, specialized operators, and capital necessary to acquire, maintain, and staff expensive conventional MRI devices. The Swoop® system is the first FDA-cleared, portable, ULF, MR brain imaging system that is capable of providing imaging at multiple sites of care, such as intensive care units, clinics, emergency departments or physicians’ offices, and can inform the timely detection, diagnosis, monitoring, and treatment of acute and chronic neurological conditions inside and outside the hospital. We designed the Swoop® system to address the limitations of conventional imaging technologies and make brain MR imaging accessible nearly anytime and anywhere across professional healthcare settings. We believe the adoption of the Swoop® system by healthcare professionals has clinical and economic benefits throughout healthcare communities in both high and low resource settings.

The Swoop® system is AI-powered and integrates deep learning, a form of AI in the reconstruction pipeline of T1, T2, diffusion-weighted Imaging, and fluid-attenuated inversion recovery sequences. The integration of deep learning does not require any additional steps from the user. As a result, deep learning can enhance the image quality and, consequently, the diagnostic value of images generated at ULF. The algorithms are designed to improve ULF image quality, while reducing the impact of scan artifacts. The images created with these algorithms were validated by expert radiologists. The Swoop® system is used clinically every day as the first mover in the field of AI-powered portable MRI, and the install base continues to expand. The learnings from this market experience have served to improve our software, AI, and denoising algorithms resulting in the image quality and performance improvements of our product over the nine generations of software since our initial clearance. As we move forward, we are continuously investing in improving our AI-powered image quality and leveraging each imaging-focused software release to further improve the Swoop® system performance.

Our Swoop® system received initial 510(k) clearance for brain imaging from the U.S. Food and Drug Administration (the “FDA”) in 2020. In July 2024, we received 510(k) clearance from FDA of the ninth-generation AI-powered Swoop® system software. This latest software update released to date significantly reduces scan times across multiple MR sequences without sacrificing image quality. Outside of the United States, the Swoop® system has received marketing authorization for brain imaging in several countries, including the European Union (“CE Mark”), the United Kingdom (UK Conformity Assessment (“UKCA Mark”)), Canada, Australia and New Zealand. In October 2024 and February 2025, we received CE Mark and UKCA Mark approval for the latest generation of software, respectively.

### Key Performance Metrics

Management reviews and analyzes several key performance metrics including Total revenues and Total Swoop® system units sold. These metrics are reviewed and analyzed to evaluate our business performance, identify trends affecting our business, allocate capital, and make strategic decisions.

Total revenues were $2.1 million for the three months ended March 31, 2025, as compared to revenues of $3.3 million for the three months ended March 31, 2024, primarily driven by decreases in Swoop® system units sold offset by an increase in average selling price. See "Results of Operations - Sales" below for further information. Total Swoop® system units sold were 6 units for the three months ended March 31, 2025, as compared to 13 units sold for the three months ended March 31, 2024.

### Factors Affecting Results of Operations

The following factors have been important to our business and we expect them to impact our results of operations and financial condition in future periods:

### Technical innovation

We have developed our Swoop® system through extensive research and development activities. Moreover, our team is dedicated to clinical support programs designed to integrate the Swoop® system into an array of diverse healthcare environments, workflow, and applications. We believe that, from our commercial and clinical experience, we are gaining invaluable insights into the Swoop® system’s clinical utility. We believe these learnings will enable us to further improve our product and develop new services and tools in the future. We are continuously improving our image quality and imaging capabilities. Building upon this foundation and our expertise in ULF brain imaging, we plan to develop new imaging applications, broadening the range of clinical uses for our proprietary technology. Additionally, we are leveraging our strengths in AI and cloud technology to explore the Swoop® system’s role as a brain imaging clinical decision support platform. While these technical innovations may increase our research and development expenses, we expect them to have a positive impact on our results of operations and profitability in the future.

### Commercialization efforts of the Swoop® system

Our results have included revenue from the United States and outside the United States. Our Swoop® system received initial 510(k) clearance from the FDA in 2020. Initially, we have been focused on executing contracts with U.S. hospitals and hospital systems. We have built a direct sales and field support organization in the United States who are working in strong collaboration to increase adoption, support successful implementations and support routine use at customer sites. We are planning to expand our commercial focus beyond our initial call point of critical care in the hospital into hospital emergency departments, hospital-based neurology clinics and outside the hospital in neurology offices.

### Expand sales in international markets

The countries in which we have begun commercializing our Swoop® system include Canada, certain European markets, Australia, and New Zealand. We obtained a Medical Device License issued by Health Canada, UKCA Mark in the United Kingdom, CE Mark in the EU, and regulatory authorization in Australia and New Zealand. The Swoop® system CE mark and UKCA mark approval of the latest AI-powered Swoop® system software in October 2024 and February 2025, enables a broader European commercial expansion of the Swoop® system, bringing cutting-edge brain imaging technology to new global markets. Further we are executing on a global expansion strategy, broadening access to MR brain imaging in regions with large populations, low penetration of MRI, and significant unmet healthcare needs.

Our commitment to the vision of providing affordable and accessible imaging that enables earlier detection and timely management of health conditions worldwide is furthermore advanced by grant funding from the Bill and Melinda Gates Foundation (“BMGF”). Through our engagement with the BMGF, we have deployed the Swoop® system in low-middle income settings without readily-accessible MRI technology. During 2020 and 2021, we were awarded multiple grants totaling $4.9 million from the BMGF for the provision and equipping of sites with our portable MR brain imaging system to enable the performance of a multi-site study focused on optimizing diagnostic image quality. These grants were designed to provide data to validate the use of the Swoop® system in measuring the impact of maternal anemia, malnutrition, infection and birth related injury. These grants were designed to support the deployment of a total of 25 Swoop® system devices and other services to investigators, which commenced in the spring of 2021 and was completed by February 2024. In May 2023, we were awarded an additional $3.4 million grant from the BMGF to continue to develop a scalable approach to measuring neurodevelopment via low-field MRI in neonates, infants, and young children in low-to-middle income countries through February 2026. During the three months ended March 31, 2025, we completed and fulfilled grant deliverables and milestones amounting to $0.2 million and we received cash grant funding of $0.6 million.

### Results of Operations

The following is a discussion of our results of operations for the three months ended March 31, 2025 and 2024. Our accounting policies are described under *"Summary of Significant Accounting Policies"* in Note 2 to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q.

|  | Three Months Ended March 31, | Change |
| --- | ---: | ---: |
| **($ Amounts in thousands)** | **2025** | **2024%** |
| Sales |  |  |
| Device | $1,522 | $2,704 (43.7)% |
| Service | 615 | 591 4.1% |
| Total sales | 2,137 | 3,295 (35.1)% |
| Cost of Sales |  |  |
| Device | 985 | 1,499 (34.3)% |
| Service | 269 | 442 (39.1)% |
| Cost of sales | 1,254 | 1,941 (35.4)% |
| **Gross margin** | **883** | **1,354** (34.8)% |
| Operating expenses: |  |  |
| Research and development | 5,037 | 5,570 (9.6)% |
| General and administrative | 4,208 | 4,430 (5.0)% |
| Sales and marketing | 2,540 | 2,004 26.7% |
| **Total operating expenses** | **11,785** | **12,004** (1.8)% |
| **Loss from operations** | **(10,902)** | **(10,650)** 2.4% |
| Interest income | 317 | 796 (60.2)% |
| Change in fair value of warrant liabilities | 1,618 | — NM |
| Other income, net | (451) | 6 NM |
| **Loss before provision for income taxes** | **(9,418)** | **(9,848)** (4.4)% |
| Provision for income taxes | — | — |
| **Net loss and comprehensive loss** | **$(9,418)** | **$(9,848)** (4.4)% |

### Comparison of the Three Months Ended March 31, 2025 and 2024 ($ Amounts shown in tables in thousands)

### Sales

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | ---: |
| Device | $1,522 | $2,704 | $(1,182) | (43.7)% |
| Service | 615 | 591 | 24 | 4.1% |
| Total sales | $2,137 | $3,295 | $(1,158) | (35.1)% |

Device sales decreased by $1.2 million, or 43.7%, for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease is mainly driven by a decrease in units sold offset by an increase in average selling price.

Service sales increased for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The increase is driven by an increase in device install base.

### Cost of sales

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | ---: |
| Device | $985 | $1,499 | $(514) | (34.3)% |
| Service | 269 | 442 | (173) | (39.1)% |
| Total cost of sales | $1,254 | $1,941 | $(687) | (35.4)% |
| Percentage of revenue | 58.7% | 58.9% |  |  |

Cost of device sales decreased by $0.5 million, or 34.3%, for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This decrease was driven primarily by a decrease in units sold.

Cost of service sales decreased by $0.2 million, or 39.1%, for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This decrease is driven primarily by a decrease in infrastructure costs.

### Research and development

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | ---: |
| Research and development | $5,037 | $5,570 | $(533) | (9.6)% |

Research and development expenses decreased by $0.5 million, or 9.6%, for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This decrease was driven primarily by a decrease in salary and benefits of $0.9 million, and a decrease in consulting expenses of $0.3 million, partially offset by a decrease in grant fulfillment credits of $0.7 million.

### General and administrative

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | ---: |
| General and administrative | $4,208 | $4,430 | $(222) | (5.0)% |

General and administrative expenses decreased by $0.2 million, or 5.0%, for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This decrease was driven primarily by a decrease in auditing and accounting fees of $0.2 million, a decrease in insurance, legal, and intellectual property expenses of $0.1 million, and a decrease in stock-based compensation of $0.1 million, partially offset by an increase in allowance for credit losses of $0.2 million.

### Sales and marketing

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | ---: |
| Sales and marketing | $2,540 | $2,004 | $536 | 26.7% |

Sales and marketing expenses increased by $0.5 million, or 26.7% for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This increase was driven primarily by an increase in salary and benefits of $0.3 million and an increase in marketing expenses of $0.2 million.

### Interest income

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | ---: |
| Interest income | $317 | $796 | $(479) | (60.2)% |

Interest income decreased by $0.5 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The decrease was driven primarily by lower cash balances in money market funds and demand deposit accounts.

### Change in fair value of warrant liabilities

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | --- |
| Change in fair value of warrant liabilities | $1,618 | $— | $1,618 | NM |

Change in fair value of warrant liabilities for the three months ended March 31, 2025 represented a gain of $1.6 million caused by a decrease in the fair value of the warrant liabilities from the initial fair value evaluation on February 12, 2025, the closing date of the Offering (as defined below) to the subsequent fair value evaluation on March 31, 2025, primarily related to changes in the price per share of our Class A common stock. There was no similar change in fair value during the three months ended March 31, 2024 as the warrants were not outstanding during that period.

### Other (expense) income, net

|  | Three Months Ended March 31, 2025 | 2024 | Change Amount% |  |
| --- | ---: | ---: | ---: | --- |
| Other (expense) income, net | $(451) | $6 | $(457) | NM |

Other (expense) income, net increased by $0.5 million for the three months ended March 31, 2025 compared to the three months ended March 31, 2024. This increase is mainly driven by financing cost allocated to warrant liabilities.

### Liquidity and Capital Resources

We have funded our operations primarily with proceeds from the issuance of common stock, preferred stock and warrants. We have incurred significant cash burn and recurring net losses, which includes a net loss of $9.4 million for the three months ended March 31, 2025, and an accumulated deficit of $303.9 million as of March 31, 2025. As of March 31, 2025, we had cash and cash equivalents of $33.1 million. As we continue to invest in research and development of our products and sales and marketing, we expect to continue to incur a significant cash burn and recurring net losses for the foreseeable future until such time that our product and services sales generate enough gross profit to cover our operating expenses. However, we can provide no assurance that our product and service sales will generate a net profit in the future or that our cash resources will be sufficient to continue our commercialization and development activities.

In November 2023, we filed a shelf registration statement on Form S-3 (the “Shelf Registration Statement”) with the SEC pursuant to which we registered for sale up to $150 million of any combination of our Class A common stock, preferred stock, debt securities, warrants, rights and/or units from time to time and at prices and on terms that we may determine. The Shelf Registration Statement also includes a prospectus covering up to an aggregate of $50.0 million in shares of Class A common stock that we may issue and sell from time to time, through B. Riley Securities, Inc. (“B. Riley”) acting as our sales agent, pursuant to the sales agreement that we entered into with B. Riley (the “Sales Agreement”) for our “at-the-market” equity program (“ATM”). We are not obligated to make any sales of Class A common stock under the Sales Agreement. As of March 31, 2025, an aggregate total of 898,119 shares of our Class A common stock, for total gross proceeds of $1,013 thousand and net proceeds of $947 thousand, after deducting commissions and other offering expenses related to the ATM, have been issued and sold under the Sales Agreement.

On February 12, 2025, we closed the transactions pursuant to a securities purchase agreement with certain institutional investors (the “Investors”), in which we issued and sold, in a registered direct offering directly to the Investors (the “Offering”): (i) 4,511,278 shares (the “Shares”) of our Class A common stock and (ii) warrants to purchase up to 4,511,278 shares of our Class A common stock (the “Warrants”). Each Share and accompanying Warrant were sold together at a combined offering price of $1.33. The aggregate gross proceeds to from the Offering were $6.0 million before deducting the placement agent’s fees and offering expenses.

Our ability to access capital when needed is not assured and, if capital is not available when, and in the amounts needed, we could be required to delay, scale back or abandon some or all of our development programs, commercialization of our products, and other operations which could materially harm our operations, financial condition and operating results. We expect that our existing cash and cash equivalents, together with proceeds from the sales of our products and services, will enable us to conduct our planned operations for at least the next 12 months. Factors that could accelerate cash needs include: (i) delays in achieving scientific and technical milestones; (ii) unforeseen capital expenditures and fabrication costs related to manufacturing; (iii) changes we may make in our business or commercialization and hiring strategy; (iv) costs of running a public company; (v) higher inflation and increases in product transportation and labor costs; (vi) the effects of the tariffs; and (vii) other items affecting our forecasted level of expenditures and use of cash resources including potential acquisitions.

We expect to use our cash to further invest in the development of our products and services, commercial expansion, and for working capital and general corporate purposes.

Our future cash requirements will depend on many factors, including market adoption of our products; the cost and timing of establishing additional sales, marketing and distribution capabilities; the cost of our research and development activities; our ability to enter into and maintain collaborations; the cost and timing of potential future regulatory clearances or approvals for our products; and the effect of competing technological and market developments. We cannot assure you that we will be able to obtain additional funds on acceptable terms, or at all. If we raise additional funds by issuing equity or equity-linked securities, our stockholders may experience dilution. Future debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt. Any debt or equity financing that we raise may contain terms that are not favorable to us or our stockholders. If we raise additional funds through collaboration and licensing arrangements with third parties, it may be necessary to relinquish some rights to our technologies or our products, or grant licenses on terms that are not favorable to us. If we do not have or are not able to obtain sufficient funds, we may have to delay development or commercialization of our products. We also may have to reduce marketing, customer support or other resources devoted to our products and services or cease operations.

### Cash

As of March 31, 2025, we had cash and cash equivalents of $33.1 million. Our future capital requirements may vary from those currently planned and will depend on various factors including further development costs, commercialization strategy, international expansion, and regulatory costs. If we need additional funds and are unable to obtain funding on a timely basis, we may need to curtail significantly our product development and commercialization efforts to provide sufficient funds to continue our operations, which could adversely affect our business prospects.

### Cash flows

The following table summarizes our cash flows for the periods indicated:

*(In thousands)*

|  | Three Months Ended March 31, 2025 | 2024 |
| --- | ---: | ---: |
| Net cash used in operating activities | $(9,249) | $(12,510) |
| Net cash used in investing activities | (472) | (145) |
| Net cash provided by financing activities | 5,582 | 55 |
| **Net decrease in cash, cash equivalents, and restricted cash** | **$(4,139)** | **$(12,600)** |

#### Net cash used in operating activities

For the three months ended March 31, 2025, net cash used in operating activities of $9.2 million was due primarily to a net loss of $9.4 million and non-cash items of $0.4 million, partially offset changes in operating assets and liabilities of $0.6 million. Non-cash items were primarily gain on change in fair value of warrant liabilities of $1.6 million, partially offset by stock-based compensation expense of $0.9 million and depreciation expense of $0.2 million. Changes in operating assets and liabilities were driven primarily by a decrease in inventory of $1.2 million, a decrease in accounts receivable and unbilled receivables of $1.0 million, an increase in accounts payable of $0.6 million, and an increase in deferred funding of $0.4 million, partially offset a decrease in accrued expense and other current liabilities of $1.4 million primarily due to annual bonus payout and an increase in prepaid expenses and other current assets of $1.2 million, primarily due to the timing of payment of the directors and officers liability insurance.

For the three months ended March 31, 2024, net cash used in operating activities of $12.5 million was due primarily to a net loss of $9.8 million and changes in operating assets and liabilities of $4.0 million, partially offset by non-cash items of $1.3 million. Non-cash items were primarily stock-based compensation expense of $1.0 million and depreciation expense of $0.3 million. Changes in operating assets and liabilities were driven primarily by an increase in accounts receivable of $2.1 million due to timing of billing and collection, a decrease in accrued expenses and other current liabilities of $1.4 million primarily due to annual bonus payout, an increase in prepaid expenses and other current assets of $1.3 million primarily due to the timing of payment of the directors and officers liability insurance and the recording of a grant receivable, an increase in inventory of $0.8 million, a decrease in deferred grant funding of $0.6 million due to fulfillment and delivery of a BMGF grant milestone related to a delivery of an enhanced version of our software, partially offset by an increase in accounts payable of $1.2 million, a decrease in prepaid inventory of $0.7 million, a decrease in other long term assets of $0.2 million, and an increase in deferred revenue of $0.1 million.

#### Net cash used in investing activities

For the three months ended March 31, 2025, net cash used in investing activities of $472 thousand was from fixed assets purchased.

For the three months ended March 31, 2024, net cash used in investing activities of $142 thousand was from fixed assets purchased.

#### Net cash provided by financing activities

For the three months ended March 31, 2025, net cash provided by financing activities of $5.6 million which consisted primarily of proceeds from issuance and sale of the Shares and Warrants in the Offering, net of offering discounts and other costs of $5.4 million, proceeds from issuance of the Shares under the Sales Agreement of $0.1 million and proceeds from stock option exercises of $33 thousand.

For the three months ended March 31, 2024, net cash provided by financing activities of $55 thousand was proceeds from option exercises.

### Contractual obligations

We sponsor a 401(k) defined contribution plan covering all eligible U.S. employees. Contributions to the 401(k) plan are discretionary. We did not make any matching contributions to the 401(k) plan for the three months ended March 31, 2025 and 2024.

Through our engagement with the BMGF, we have deployed and continue to deploy the Swoop® system in low-middle income settings without readily-accessible MRI technology. The multiple grants provided by our research partnership with the BMGF, which commenced funding in the spring of 2020, support the deployment of 25 Swoop® system and accessories to investigators. The ongoing investigation is designed to provide data to validate the potential use of the Swoop® system in measuring the impact of maternal anemia, malnutrition, infection, and birth-related injury. In May 2023, we were awarded an additional three-year grant from the BMGF to continue to develop a scalable approach to measuring neurodevelopment via ULF brain imaging in neonates, infants, and young children in low-to-middle income countries.

Our purchase commitments and obligations include all open purchase orders and contractual obligations in the ordinary course of business, including commitments with contract manufacturers and suppliers, for which we have not received the goods or services. A majority of these purchase obligations are due within a year. Although open purchase orders are considered enforceable and legally binding, the terms generally allow us the option to cancel, reschedule, and adjust our requirements based on our business needs prior to the delivery of goods or performance of services.

We had no other significant contractual obligations as of March 31, 2025.

For information on contingencies, refer to Note 13 in the notes to our unaudited condensed consolidated financial statements for the three months ended March 31, 2025 and 2024 included elsewhere in this Quarterly Report on Form 10-Q.

### Critical Accounting Policies and Significant Judgments and Estimates

Our management's discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, as well as the reported revenue generated and expenses incurred during the reporting periods. Our estimates are based on our historical experience and various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about items that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Except as described in Note 2 “Summary of Significant Accounting Policies – Recently Issued Accounting Pronouncements Not Yet Adopted”, to our unaudited condensed consolidated financial statements included in this Quarterly Report on Form 10-Q, there have been no material changes to our critical accounting policies and estimates as compared to the critical accounting policies and estimates disclosed in our 2024 Annual Report on Form 10-K.

### Recently Issued Accounting Pronouncements

A description of recently issued accounting pronouncements that may potentially impact our financial position and results of operations is disclosed in Note 2 to our unaudited condensed consolidated financial statements and notes thereto for the three months ended March 31, 2025 and 2024 included elsewhere in this Quarterly Report on Form 10-Q.

## Market risk

As filed, 2,065 characters.

We are exposed to market risk in the ordinary course of business. Market risk represents the risk of loss that may impact our results of operations or financial position due to adverse changes in financial market prices and rates. Our market risk exposure is primarily a result of fluctuations in interest rates, inflation risk, and foreign exchange risk. We do not hold, issue or enter into any financial instruments for speculative or trading purposes. We do not have significant exposure to foreign currencies.

### Interest Rate Risk

Our cash, cash equivalents and restricted cash as of March 31, 2025 consisted of $33.5 million in money market funds, demand deposit and savings accounts. Such interest-earning instruments carry a degree of interest rate risk. The goals of our investment policy are liquidity and capital preservation. We believe that we do not have any material exposure to changes in the fair value of these assets as a result of changes in interest rates due to the short-term nature of our cash equivalents. Based on our balance sheet position at March 31, 2025, the annualized effect of a 0.5 percentage point decrease in interest rates would be to decrease earnings before income taxes by $0.2 million.

### Inflation Risk

We do not believe that inflation has had a material effect on our business, financial condition, or results of operations, other than its impact on the general economy. Nonetheless, if our costs were to become subject to inflationary pressures, we might not be able to fully offset such higher costs through price increases. Our inability or failure to do so could harm our business, financial condition, and results of operations.

### Foreign Exchange Risk

We operate our business primarily within the United States and currently execute the majority of our transactions in U.S. dollars. We have not utilized hedging strategies with respect to such foreign exchange exposure. This limited foreign currency translation risk is not expected to have a material impact on our condensed consolidated financial statements.

## Controls and procedures

As filed, 1,516 characters.

### Evaluation of Disclosure Controls and Procedures

Our principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) as of March 31, 2025. Based upon that evaluation, our principal executive officer and principal financial officer have concluded that, as of March 31, 2025, the end of the period covered by this report, our disclosure controls and procedures were effective at a reasonable assurance level to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and is accumulated and communicated to our management, including our principal executive officer and principal financial officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding required disclosure.

### Changes in Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting, identified in connection with the evaluation of such internal control that occurred during the three months ended March 31, 2025, that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

### PART II — OTHER INFORMATION

### Item1. Legal Proceedings

We are not currently a party to any material legal proceedings.

## Risk factors

As filed, 2,452 characters.

Our business, results of operations and financial condition are subject to various risks and uncertainties including the risk factors described under the caption “Risk Factors” in our 2024 Annual Report on Form 10-K. There have been no material changes in our risk factors from those described in our 2024 Annual Report on Form 10-K, other than the updates to the risk factor set forth below. We may disclose changes to risk factors or additional risk factors from time to time in our future filings with the SEC.

***We could fail to maintain the listing of our Class A common stock on Nasdaq, which could seriously harm the liquidity of our shares and our ability to raise capital or complete a strategic transaction.***

The Nasdaq Stock Market has established continued listing requirements, including a requirement to maintain a minimum closing bid price of at least $1.00 per share. On April 30, 2025, we received a written notice from Nasdaq notifying us that, because the closing bid price for our Class A common stock had fallen below $1.00 per share for 30 consecutive business days, we no longer met the minimum bid price requirement for continued inclusion on The Nasdaq Global Market. Under Nasdaq Listing Rule 5810(c)(3)(A), we have a 180-calendar day period, or until October 27, 2025 (the “Compliance Date”), to regain compliance with the minimum bid price requirement. The minimum bid price requirement will be met if our Class A common stock has a minimum closing bid price of at least $1.00 per share for a minimum of 10 consecutive business days during the 180-calendar day period, unless Nasdaq exercises its discretion to extend such 10‑day period. If we do not regain compliance by the Compliance Date, we may be eligible for an additional 180-calendar day period, subject to satisfying the conditions in the applicable Nasdaq Listing Rules. There can be no assurance that we will be able to regain compliance with the bid price requirement within the 180-calendar day compliance period provided by Nasdaq rules or maintain compliance with other Nasdaq requirements in the future. If we are not able to maintain compliance with Nasdaq requirements, our Class A common stock may be delisted from Nasdaq, which could have a material adverse effect on us and our stockholders, including by reducing the liquidity of our shares and having a material adverse effect on our ability to raise capital or complete a strategic transaction.

Filed May 13, 2025.
Source: SEC EDGAR, the filing index for accession 0000950170-25-070402. Last ingested by Listed: Oct 24, 2026, 15:15 ET. No prices; not investment advice.