GUILFORD, Conn.--(BUSINESS WIRE)--May 12, 2026--
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$(R)$ 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(R) system and the latest Optive AI$(TM)$
software in Europe.
-- Enrolled first patient in Contrast PMR, a study designed to support a
future FDA 510(k) submission to expand the Swoop(R) 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(R) system's enhanced stroke detection
capabilities.
-- Published paper in Clinical Neuroimaging demonstrating the significant
health economic benefit of using the Swoop(R) system.
-- Began launch activities in India market with first Swoop(R) 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(R) 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.
(1) Cash 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(R) Portable MR Imaging(R) Systems
Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop(R) 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(R) 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(R) Portable MR Imaging(R) 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(R) system also has CE Mark in the European Union and UKCA Mark in the United Kingdom. The Swoop(R) 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 AI(TM) software and next generation Swoop(R) system, the acceleration of the adoption of the Swoop(R) 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(R) 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.
HYPERFINE, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share amounts)
(Unaudited)
March 31, December 31,
2026 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 56 50
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 17 66
-------- ----------
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 8 8
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 2 2
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 5 (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 5 --
Change in fair value of
warrant liabilities 241 (1,618)
Amortization of debt
discount and issuance
costs 17 --
Other 6 11
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 18 (80)
Due to related parties 6 (7)
Accrued expenses and
other current
liabilities (1,667) (1,435)
Operating lease
liabilities, net 3 (7)
------------ -----------
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 42 33
Proceeds from issuance of
Class A common stock under
"at-the-market" offering
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