Form 8-K

8-K — Hyperfine, Inc.

Accession: 0001193125-26-219380

Filed: 2026-05-12

Period: 2026-05-12

CIK: 0001833769

SIC: 3845 (ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS)

Item: Results of Operations and Financial Condition

Item: Financial Statements and Exhibits

Documents

8-K — hypr-20260512.htm (Primary)

EX-99.1 (hypr-ex99_1.htm)

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8-K

8-K (Primary)

Filename: hypr-20260512.htm · Sequence: 1

8-K

0001833769false00018337692026-05-122026-05-12

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 12, 2026

Hyperfine, Inc.

(Exact name of Registrant as Specified in Its Charter)

Delaware

001-39949

98-1569027

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

351 New Whitfield Street

Guilford, Connecticut

06437

(Address of Principal Executive Offices)

(Zip Code)

Registrant’s Telephone Number, Including Area Code: (866) 796-6767

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

Trading

Symbol(s)

Name of each exchange on which registered

Class A common stock, $0.0001 par value per share

HYPR

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

On May 12, 2026, Hyperfine, Inc. issued a press release announcing its results for the first quarter ended March 31, 2026 and providing a business update. A copy of the press release is furnished as Exhibit 99.1 hereto.

The information in this Current Report on Form 8-K (including Exhibit 99.1) shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Number

Description

99.1

Press Release dated May 12, 2026

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

The press release may contain hypertext links to information on our website. The information on our website is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

HYPERFINE, INC.

Date:

May 12, 2026

By:

/s/ Brett Hale

Brett Hale

Chief Administrative Officer, Chief Financial Officer, Treasurer and Corporate Secretary

EX-99.1

Filename: hypr-ex99_1.htm · Sequence: 2

EX-99.1

Exhibit 99.1

Hyperfine, Inc. Reports First Quarter 2026 Financial Results

GUILFORD, Connecticut, May 12, 2026 (GLOBE NEWSWIRE) – Hyperfine, Inc. (Nasdaq: HYPR), the groundbreaking health technology company that has redefined brain imaging with the first FDA-cleared AI-powered portable magnetic resonance (MR) brain imaging system—the Swoop® system—today announced first quarter 2026 financial results and provided a business update.

“Our execution in Q1 was strong. We delivered our second-highest revenue quarter to date with over 80% year-over-year revenue growth, driven by our accelerating commercial engine. We believe the international regulatory clearances we secured, the clinical data we released to the neurology and stroke communities, and the continued momentum in our office and hospital businesses all indicate portable brain MRI is becoming mainstream, and we are leading the charge,” said Maria Sainz, Chief Executive Officer and President of Hyperfine, Inc.

Recent Achievements and Business Highlights

•

Obtained CE Marking and UK Conformity Assessment (UKCA) approval for both the next-generation Swoop® system and the latest Optive AI™ software in Europe.

•

Enrolled first patient in Contrast PMR, a study designed to support a future FDA 510(k) submission to expand the Swoop® system’s intended use to include gadolinium-based contrast agents; enrollment currently is over 50% of target.

•

Presented NEURO-PMR results at the 2026 American Society of Neuroimaging showing high diagnostic value and superior patient experience in neurology clinics.

•

Published paper in Stroke: Vascular and Interventional Neurology (SVIN) demonstrating the Swoop® system’s enhanced stroke detection capabilities.

•

Published paper in Clinical Neuroimaging demonstrating the significant health economic benefit of using the Swoop® system.

•

Began launch activities in India market with first Swoop® system live in clinical use at All India Institute of Medical Sciences (AIIMS), New Delhi.

•

Bolstered balance sheet through $15.0 million debt financing, extending the expected cash runway into 2028, and providing capital for commercial growth.

First Quarter 2026 Financial Results

•

Revenues for the first quarter of 2026 were $3.90 million, increasing 83% compared to $2.14 million in the first quarter of 2025.

•

Sold 10 commercial Swoop® systems in the first quarter of 2026, compared to six in the first quarter of 2025.

•

Gross profit for the first quarter of 2026 was $1.98 million, compared to $0.88 million in the first quarter of 2025, representing 51% gross margin in the first quarter of 2026, compared to 41% gross margin in the first quarter of 2025.

•

Research and development expenses for the first quarter of 2026 were $3.85 million, decreasing 24% compared to $5.04 million in the first quarter of 2025.

•

Sales, marketing, general, and administrative expenses for the first quarter of 2026 were $6.69 million, compared to $6.75 million in the first quarter of 2025.

•

Net loss for the first quarter of 2026 was $8.62 million, equating to a net loss of $0.09 per share, as compared to a net loss of $9.42 million, or a net loss of $0.12 per share, for the first quarter of 2025. The first quarter of 2026 net loss includes a $0.24 million loss from a change in the fair value of warrant liabilities, compared to a $1.62 million gain in the first quarter of 2025.

2026 Financial Guidance

•

Management continues to expect revenue for the full year 2026 to be approximately $20 to $22 million, representing 55% growth at the midpoint as compared to full year 2025.

•

Management continues to expect cash burn1 for the full year 2026 to be approximately $26 to $28 million, representing a 10% decline at the midpoint as compared to full year 2025.

1Cash burn is calculated as change in cash and cash equivalents less net financing proceeds.

Conference Call

Hyperfine, Inc. will host a conference call at 1:30 p.m. PT/ 4:30 p.m. ET on Tuesday, May 12, 2026 to discuss its first quarter 2026 financial results and provide a business update. Those interested in listening should register online by visiting https://investors.hyperfine.io/ and clicking on News & Events. Participants are encouraged to register more than 15 minutes before the start of the call. A live and archived audio webcast will be available through the Investors page of Hyperfine, Inc.’s corporate website at https://investors.hyperfine.io/.

About Hyperfine, Inc. and the Swoop® Portable MR Imaging® Systems

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first U.S. Food and Drug Administration (FDA)-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of professional care. The mission of Hyperfine, Inc. is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Founded by Dr. Jonathan Rothberg in a technology-based incubator called 4Catalyzer, Hyperfine, Inc. scientists, engineers, and physicists developed the Swoop® system out of a passion for redefining brain imaging methodology and how clinicians can apply accessible diagnostic imaging to patient care. For more information, visit hyperfine.io.

The Swoop® Portable MR Imaging® systems are FDA cleared for brain imaging of patients of all ages. They are portable, ultra-low-field magnetic resonance imaging devices for producing images that display the internal structure 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. The Swoop® system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop® system is commercially available in a select number of international markets.

Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Actual results of Hyperfine, Inc. (the “Company”) may differ from its expectations, estimates and projections and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as “expect,” “estimate,” “project,” “budget,” “forecast,” “anticipate,” “intend,” “plan,” “may,” “will,” “could,” “should,” “believes,” “predicts,” “potential,” “continue,” and similar expressions (or the negative versions of such words or expressions) are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations about the Company’s financial and operating results, including, the Company’s expected revenue and cash burn for the full year 2026, the Company's cash runway, the Company’s goals and commercial plans, including the Company’s commercial rollout of the Company’s Optive AITM software and next generation Swoop® system, the acceleration of the adoption of the Swoop® system across multiple sites of care in the hospital, neurology office and international markets, the benefits of the Company’s products and services, progress on improvements and advancements in the Company’s products and services, and the Company’s future performance, including its financial performance, and its ability to implement its strategy. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the Company’s control and are difficult to predict. Factors that may cause such differences include, but are not limited to: the success, cost and timing of the Company’s product development and commercialization activities, including the degree that the Swoop® system is accepted and used by healthcare professionals; the Company’s ability to grow and manage growth profitably and retain its key employees; changes in applicable laws or regulations; the ability of the Company to raise financing in the future; the ability of the Company to obtain and maintain regulatory clearance or approval for its products, and any related restrictions and limitations of any cleared or approved product; the ability of the Company to identify, in-license or acquire additional technology; the ability of the Company to maintain its existing or future license, manufacturing, supply and distribution agreements and to obtain adequate supply of its products; existing and potential future National Institutes of Health funding pressures; existing and potential future effects from U.S. export controls and tariffs; the ability of the Company to compete with other companies currently marketing or engaged in the development of products and services that the Company is currently marketing or developing; the size and growth potential of the markets for the Company’s products and services, and its ability to serve those markets, either alone or in partnership with others; the pricing of the Company’s products and services and reimbursement for medical procedures conducted using the Company’s products and services; the Company’s ability to successfully complete and generate positive data from the PRIME study, ACTION PMR study, Contrast PMR study, CARE PMR study and NEURO PMR study; the Company’s ability to generate clinical evidence of the benefits of the Company’s products and services and to progress on product advancements and improvements; the Company’s estimates regarding expenses, revenue, capital requirements and needs for additional financing; the Company’s financial performance; and other risks and uncertainties indicated from time to time in the Company’s filings with the Securities and Exchange Commission, including those under “Risk Factors” therein. The Company cautions readers that the foregoing list of factors is not exclusive and that readers should not place undue reliance upon any forward-looking statements which speak only as of the date made. The Company does not undertake or accept any obligation or undertaking to release

publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions or circumstances on which any such statement is based.

Investor Contact

Webb Campbell

Gilmartin Group LLC

webb@gilmartinir.com

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share amounts)

(Unaudited)

March 31,

2026

December 31,

2025

ASSETS

CURRENT ASSETS:

Cash and cash equivalents

40,778

35,085

Restricted cash

500

957

Accounts receivable, less allowance of $534 and $1,372 as of March 31, 2026 and December 31, 2025, respectively

3,791

5,254

Unbilled receivables

2,006

1,268

Inventories

6,327

7,090

Prepaid expenses and other current assets

2,631

1,255

Property and equipment, net

56,033

50,909

Other long term assets

2,503

2,549

Total assets

1,803

1,804

LIABILITIES AND STOCKHOLDERS’ EQUITY

60,339

55,262

CURRENT LIABILITIES:

Accounts payable

4,552

4,051

Deferred grant funding

500

957

Deferred revenue

1,578

1,544

Due to related parties

Accrued expenses and other current liabilities

3,468

5,130

Total current liabilities

10,154

11,732

Long-term debt, net

13,123

—

Warrant liabilities

1,971

1,730

Long term deferred revenue

713

729

Other noncurrent liabilities

Total liabilities

25,978

14,257

STOCKHOLDERS' EQUITY

Class A Common stock, $0.0001 par value per share; 600,000,000 shares authorized; 83,464,909 and 82,166,458 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

Class B Common stock, $0.0001 par value per share; 27,000,000 shares authorized; 15,055,288 shares issued and outstanding at March 31, 2026 and December 31, 2025, respectively

Additional paid-in capital

372,990

371,011

Accumulated deficit

(338,639

)

(330,016

)

Total stockholders' equity

34,361

41,005

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

60,339

55,262

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share amounts)

(Unaudited)

Three Months Ended

March 31,

2026

2025

Sales

Device

3,257

1,522

Service

646

615

Total sales

3,903

2,137

Cost of sales

Device

1,646

985

Service

278

269

Total cost of sales

1,924

1,254

Gross profit

1,979

883

Operating Expenses:

Research and development

3,845

5,037

General and administrative

4,130

4,208

Sales and marketing

2,562

2,540

Total operating expenses

10,537

11,785

Loss from operations

(8,558

)

(10,902

)

Interest income

254

317

Interest expense

(83

)

—

Change in fair value of warrant liabilities

(241

)

1,618

Other income (expense), net

(451

)

Loss before provision for income taxes

(8,623

)

(9,418

)

Provision for income taxes

—

Net loss and comprehensive loss

(8,623

)

(9,418

)

Net loss per common share attributable to common stockholders, basic and diluted

(0.09

)

(0.12

)

Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted

97,695,133

75,697,199

HYPERFINE, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

(in thousands)

(Unaudited)

Three Months Ended March 31,

2026

2025

Cash flows from operating activities:

Net loss

(8,623

)

(9,418

)

Adjustments to reconcile net loss to net cash used in operating activities:

Depreciation

274

229

Stock-based compensation expense

647

945

Loss on disposal of property and equipment, net

—

Change in fair value of warrant liabilities

241

(1,618

)

Amortization of debt discount and issuance costs

—

Other

Changes in assets and liabilities:

Accounts receivable, net

1,463

626

Unbilled receivables

(738

)

412

Inventory

763

1,193

Prepaid expenses and other current assets

(1,401

)

(1,241

)

Other long term assets

(69

)

128

Accounts payable

504

600

Deferred grant funding

(457

)

413

Deferred revenue

(80

)

Due to related parties

)

Accrued expenses and other current liabilities

(1,667

)

(1,435

)

Operating lease liabilities, net

)

Net cash used in operating activities

(9,008

)

(9,249

)

Cash flows from investing activities:

Purchases of property and equipment

(242

)

(472

)

Net cash used in investing activities

(242

)

(472

)

Cash flows from financing activities:

Proceeds from issuance of debt, net

13,641

—

Proceeds from exercise of stock options

Proceeds from issuance of Class A common stock under “at-the-market” offering program, net

803

129

Proceeds from issuance of Class A common stock with warrants under February 2025 Offering, net

—

5,420

Net cash provided by financing activities

14,486

5,582

Net increase (decrease) in cash and cash equivalents and restricted cash

5,236

(4,139

)

Cash, cash equivalents and restricted cash, beginning of period

36,042

37,673

Cash, cash equivalents and restricted cash, end of period

41,278

33,534

Reconciliation of cash, cash equivalents, and restricted cash reported in the balance sheets

Cash and cash equivalents

40,778

33,093

Restricted cash

500

441

Total cash, cash equivalents and restricted cash

41,278

33,534

Supplemental disclosure of noncash information:

Issuance of warrants in connection with Loan Agreement, net

495

—

Initial measurement of warrant liabilities

—

2,858

Unpaid purchase of property and equipment

509

Unpaid debt issuance and financing costs

238

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May 12, 2026

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- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

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- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

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- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

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