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HYPR on Nasdaq

Hyperfine, Inc.

American electromedical and electrotherapeutic apparatus company1

In its 2026 annual report the company says: “We are an innovative health technology business with a mission to revolutionize patient care globally through accessible, affordable, clinically relevant artificial intelligence-powered portable ultra-low-field magnetic resonance brain imaging. Our Swoop® Portable MR Imaging® System produces high-quality images at a significantly lower magnetic field strength than conventional magnetic resonance imaging scanners.”4 It is headquartered in Guilford, Connecticut.1 Its shares trade on Nasdaq under the symbol HYPR.1

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Last updated Oct 21, 2026.

Overview

$13.6MRevenue, fiscal 20252
-$35.6MNet income, fiscal 20252

Compare with CapsoVision, Inc, ESCALON MEDICAL CORP or QT IMAGING HOLDINGS, INC., or pick any stock.

  • TickerHYPR on Nasdaq1
  • IndustryElectromedical & Electrotherapeutic Apparatus1
  • HeadquartersGuilford, Connecticut1
  • Incorporated inDE3
  • Business address351 New Whitfield Street, Guilford, Ct 064373
  • Filer category, Emerging growth company3

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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 significantly 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 patient-friendly experience, 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 in…4 From its latest annual report

Financials

From the company’s reports to the SEC. Every number links to the filing it came from.

Key numbers, fiscal 2025

49.8%Gross margin2
-273.4%Operating margin2
-262.3%Net margin2
5.2%Revenue growth, 20252
-86.8%Return on equity2
-$29.1MFree cash flow2

What sells

Revenue by product, business segment and region, as the company reports it to the SEC.

Products and services

Product brought in 84% of the revenue Hyperfine, Inc. broke down this way in fiscal 2025.

  1. Product$11.4M284%up 9% from 2024
  2. Service$2.2M216%down 11% from 2024
Products and services by year
Products and services20242025
Product$10.4M$11.4M
Service$2.4M$2.2M

Where the money goes

Where each dollar of revenue went, fiscal 2025

  • Cost of revenue28¢$6.8M
  • Research and development72¢$17.5M

Out of $13.6M in revenue.2 The company lost money this year.

Financial statements

Revenue56782$13.6M in 2025+4513% since 2020
0$5.0M$10.0M$15.0M2020: $294.0K$294.0K20202021: $1.5M$1.5M2021+409%2022: $6.8M$6.8M2022+355%2023: $11.0M$11.0M2023+62%2024: $12.9M$12.9M2024+17%2025: $13.6M$13.6M2025+5%
Gross profit56782$6.8M in 2025
-$2.0M0$2.0M$4.0M$6.0M$8.0M2020: -$477.0K-$477.0K20202021: -$1.2M-$1.2M2021+145%2022: $907.0K$907.0K20222023: $4.8M$4.8M2023+424%2024: $5.9M$5.9M2024+24%2025: $6.8M$6.8M2025+15%
Operating income56782-$37.1M in 2025+58% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$23.5M-$23.5M20202021: -$64.9M-$64.9M2021+176%2022: -$73.9M-$73.9M2022+14%2023: -$48.1M-$48.1M2023−35%2024: -$43.2M-$43.2M2024−10%2025: -$37.1M-$37.1M2025−14%
Net income5682-$35.6M in 2025+52% since 2020
-$80.0M-$60.0M-$40.0M-$20.0M02020: -$23.4M-$23.4M20202021: -$64.9M-$64.9M2021+177%2022: -$44.2M-$44.2M2022−32%2023: -$44.2M-$44.2M2023+0%2024: -$40.7M-$40.7M2024−8%2025: -$35.6M-$35.6M2025−13%

Every line of the income statement as filed: the last 2 fiscal years, latest first.2

Period ending2025-12-312024-12-31
Total sales$13.6M$12.9M
Total cost of sales$6.8M$7.0M
Gross profit$6.8M$5.9M
Research and development$17.5M$22.5M
General and administrative$16.3M$17.5M
Sales and marketing$10.1M$9.1M
Total operating expenses$43.8M$49.1M
Loss from operations-$37.1M-$43.2M
Interest income$1.0M$2.5M
Change in fair value of warrant liabilities$825.0K$0
Other income (expense), net-$337.0K$12.0K
Loss before provision for income taxes-$35.6M-$40.7M
Provision for income taxes$0$0
Net loss and comprehensive loss-$35.6M-$40.7M
Net loss per common share attributable to common stockholders, basic-$0.43-$0.56
Net loss per common share attributable to common stockholders, diluted-$0.43-$0.56
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic81.8M shares72.4M shares
Weighted-average shares used to compute net loss per share attributable to common stockholders, diluted81.8M shares72.4M shares

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Corporate structure

Hyperfine, Inc. sits at the top of its group. 1 entity, 1 country on record. Switch between the flow chart and the network, and select any entity to see its details.

Major holders of Hyperfine, Inc.

  • BlackRock Filed SCHEDULE 13G on Hyperfine, Inc., latest Jul 28, 2026
  • VANGUARD GROUP INC Filed SCHEDULE 13G/A on Hyperfine, Inc., latest Jan 30, 2026 (2 filings since Feb 13, 2024)
  • HC Sponsor LLC Filed SC 13G/A on Hyperfine, Inc., latest Feb 14, 2023 (3 filings since Feb 14, 2022)
  • Jonathan M. Rothberg Filed SC 13D/A on Hyperfine, Inc., latest Dec 7, 2022 (2 filings since Dec 30, 2021)
  • Empyrean Capital Partners, LP Filed SC 13G/A on Hyperfine, Inc., latest Feb 10, 2022
  • Hyperfine, Inc. Guilford, Connecticut

Built from major holders from Schedules 13D and 13G. Each entity in the chart links to its source.

What it owns

What Hyperfine, Inc. reports owning in its annual reports to the SEC: buildings, land and equipment, real estate and locations, investments, intangible assets and inventory, at the end of its latest fiscal year and a year before.

Property and equipment

ItemLatestA year beforeChange
Property and equipment, before depreciation$7.0M2 Dec 31, 2025$6.7M2 Dec 31, 2024+4.7%
Accumulated depreciation$4.4M2 Dec 31, 2025$3.6M2 Dec 31, 2024+24.9%
Property and equipment, net$2.5M2 Dec 31, 2025$3.1M2 Dec 31, 2024−18.4%
Operating-lease assets (leased space)$316.0K2 Dec 31, 2025$341.0K2 Dec 31, 2024−7.3%

Investments

ItemLatestA year beforeChange
Cash and cash equivalents$35.1M2 Dec 31, 2025$37.6M2 Dec 31, 2024−6.8%

Inventory

ItemLatestA year beforeChange
Inventory, total$7.1M2 Dec 31, 2025$5.8M2 Dec 31, 2024+21.6%
Raw materials$2.9M2 Dec 31, 2025$3.1M2 Dec 31, 2024−4.4%
Finished goods$4.2M2 Dec 31, 2025$2.8M2 Dec 31, 2024+50.4%

Properties, in its own words

We currently maintain our principal executive offices and a warehouse at 351 New Whitfield Street, Guilford, Connecticut 06437. We also occupy office space in Palo Alto, California. We lease office space under operating leases. We consider our current office space adequate for our current operations.

Item 2 of the 10-K filed Mar 18, 2026.4

Leadership

Who has led Hyperfine, Inc., and when. Pick a name to see everywhere that person has worked.

Chief executive

  1. Christopher Jon Gaulin2021

President

  1. George C. Petrocheilos2021

Chief financial officer

  1. Christine Clarke2021
  2. Alok Gupta2021–2023
  3. Brett Hale2025–now

Chief operating officer

  1. Thomas Teisseyre2023–now
2025
Board members and other officers (15)

Former names

  • HealthCor Catalio Acquisition Corp.Dec 9, 2020 to Dec 22, 20213

Timeline

  1. Oct 8, 20268-K Results of operations; Regulation FD disclosure33
  2. Sep 18, 20268-K Listing notice or transfer34
  3. Aug 6, 20268-K Results of operations35
  4. May 21, 20268-K Shareholder vote36
  5. May 12, 20268-K Results of operations37
  6. Mar 18, 20268-K Results of operations38
  7. Mar 18, 20268-K Entered a material agreement; New debt or obligation; Unregistered sale of shares39
  8. Jan 12, 20268-K Results of operations; Regulation FD disclosure40
  9. Dec 29, 20258-K Entered a material agreement; Other events41
  10. Nov 13, 20258-K Results of operations42
  11. Oct 16, 20258-K Entered a material agreement; Other events43
  12. Oct 15, 20258-K Results of operations; Regulation FD disclosure; Other events44
  13. Jan 26, 2021New chief executive Christopher Jon Gaulin becomes CEO13

Calendar

Coming up

  1. Nov 9, 2026 · After the closeReports results for the quarter ending Sep/2026 A year earlier it reported ($0.11) a share, on Nov 13, 2025.45

When it reported results

  1. Oct 8, 2026Reported quarterly or annual results33
  2. Aug 6, 2026Reported quarterly or annual results35
  3. May 12, 2026Reported quarterly or annual results37
  4. Mar 18, 2026Reported quarterly or annual results38
  5. Jan 12, 2026Reported quarterly or annual results40
  6. Nov 13, 2025Reported quarterly or annual results42
  7. Oct 15, 2025Reported quarterly or annual results44
  8. Aug 13, 2025Reported quarterly or annual results46

Upcoming dates from Nasdaq's calendar; past results from the company's 8-K filings (Item 2.02). The full markets calendar

Filings

320 filings to the SEC since October 2021: 5 annual reports, 15 quarterly reports, 65 major events, 134 insider forms, 9 large holders, 92 other. The latest 20:

  1. Oct 8, 20268-K EDGAR
  2. Sep 18, 20268-K EDGAR
  3. Aug 25, 20264 EDGAR
  4. Aug 25, 20264 EDGAR
  5. Aug 6, 202610-Q EDGAR
  6. Aug 6, 20268-K EDGAR
  7. Jul 28, 2026SCHEDULE 13G EDGAR
  8. Jun 4, 20264 EDGAR
  9. May 27, 20264 EDGAR
  10. May 27, 20264 EDGAR
  11. May 22, 20264 EDGAR
  12. May 22, 20264 EDGAR
  13. May 22, 20264 EDGAR
  14. May 22, 20264 EDGAR
  15. May 21, 2026EFFECT EDGAR
  16. May 21, 20268-K EDGAR
  17. May 19, 2026CORRESP EDGAR
  18. May 18, 2026UPLOAD EDGAR
  19. May 12, 2026S-3 EDGAR
  20. May 12, 202610-Q EDGAR

The 320 filings since October 2021 can be filtered by form type and year here when JavaScript is on.

Every filing from the last five years, summarized. The full record is on SEC EDGAR.

Insider trades

47 open-market trades by officers, directors and large owners since October 2021: 17 buys and 30 sales. Grants, option exercises and gifts are left out.

DateWhoTradeSharesPriceValueFiling
Aug 24, 2026TEISSEYRE THOMASChief Operating OfficerSale7,345$0.85$6.2KForm 4
Aug 24, 2026HALE BRETTCFO and CAOSale7,345$0.85$6.2KForm 4
May 26, 2026HALE BRETTCFO and CAOSale6,047$1.65$10.0KForm 4
May 26, 2026TEISSEYRE THOMASChief Operating OfficerSale6,047$1.65$10.0KForm 4
Mar 23, 2026TEISSEYRE THOMASChief Operating OfficerSale24,188$1.21$29.3KForm 4
Mar 23, 2026HALE BRETTCFO and CAOSale24,188$1.21$29.3KForm 4
Feb 13, 2026TEISSEYRE THOMASChief Operating OfficerSale821$1.11$911Form 4
Nov 19, 2025TEISSEYRE THOMASChief Operating OfficerSale1,405$1.08$1.5KForm 4
Aug 18, 2025TEISSEYRE THOMASChief Operating OfficerSale1,151$1.33$1.5KForm 4
May 16, 2025TEISSEYRE THOMASChief Operating OfficerSale2,776$0.58$1.6KForm 4
Feb 20, 2025TEISSEYRE THOMASChief Operating OfficerSale3,238$1.08$3.5KForm 4
Feb 18, 2025TEISSEYRE THOMASChief Operating OfficerSale3,237$1.20$3.9KForm 4
Nov 18, 2024TEISSEYRE THOMASChief Operating OfficerSale2,800$0.85$2.4KForm 4
Aug 16, 2024TEISSEYRE THOMASChief Operating OfficerSale2,746$1.05$2.9KForm 4
May 16, 2024TEISSEYRE THOMASChief Operating OfficerSale2,753$0.88$2.4KForm 4
Feb 16, 2024TEISSEYRE THOMASChief Operating OfficerSale3,230$1.11$3.6KForm 4
Nov 16, 2023TEISSEYRE THOMASChief Operating OfficerSale2,655$1.26$3.3KForm 4
Aug 16, 2023TEISSEYRE THOMASChief Operating OfficerSale2,785$2.26$6.3KForm 4
Aug 16, 2023Siddiqui KhanCMO and Chief Strategy OfficerSale1,729$2.26$3.9KForm 4
May 16, 2023Siddiqui KhanCMO and Chief Strategy OfficerSale1,735$1.25$2.2KForm 4

All 47 trades can be filtered by person here when JavaScript is on.

From Forms 4 filed with the SEC.

Major holders

Investors who own more than 5% of the shares must tell the SEC: a 13D if they may seek to influence the company, a 13G if they hold passively.

Executive pay

What the company paid its top executives, from the summary compensation table in its proxy statement. Total pay includes salary, bonus, stock and option awards and other pay, as the company valued them.

YearExecutiveAgeSalaryTotal pay
2025Maria SainzPresident and Chief Executive Officer60$582.2K$896.8K52
2025Brett HaleChief Administrative Officer and Chief Financial Officer52$449.8K$799.6K52
2025Thomas Teisseyre, Ph.D.Chief Operating Officer42$449.8K$799.6K52
2024Maria SainzPresident and Chief Executive Officer60$567.7K$2.3M52
2024Brett HaleChief Administrative Officer and Chief Financial Officer52$438.8K$1.1M52
2024Thomas Teisseyre, Ph.D.Chief Operating Officer42$438.8K$1.1M52

Held by these funds

The largest holders among investment managers' 13F reports for the quarter ending Jun 30, 2026, the top 25 of 81. Change is in shares since the quarter before.

FundSharesValueShare of the fundChange
BlackRock, Inc.4,673,087$6.3M0.0%+4,098,184
Vanguard Capital Management LLC3,380,087$4.6M0.0%−73,076
Geode Capital Management, LLC1,960,811$2.6M0.0%+1,005,551
Fosun International Ltd1,742,020$2.4M0.5%No change
Catalio Capital Management, LP1,320,041$1.8M0.3%No change
State Street Corp1,016,970$1.4M0.0%+692,900
Renaissance Technologies LLC945,836$1.3M0.0%+215,603
Alphabet Inc.898,720$1.2M0.0%No change
Northern Trust Corp633,054$854.6K0.0%+455,686
Vanguard Fiduciary Trust Co567,109$765.6K0.0%+40,403
Vanguard Portfolio Management LLC547,200$738.7K0.0%New
Marshall Wace, Llp342,116$461.9K0.0%New
Two Sigma Investments, LP325,999$440.1K0.0%New
Isthmus Partners, LLC313,350$423.0K0.0%No change
Bank of New York Mellon Corp310,405$419.0K0.0%+171,442
Gwn Securities Inc.274,677$370.8K0.1%New
Charles Schwab Investment Management Inc190,235$256.8K0.0%New
HighTower Advisors, LLC186,737$252.1K0.0%No change
Bridgeway Capital Management, LLC128,400$173.3K0.0%+8,700
Nuveen, LLC102,831$138.8K0.0%New
Cerity Partners LLC85,000$114.8K0.0%+5,000
Deutsche Bank Ag\78,220$105.6K0.0%New
Wells Fargo & Company/mn73,992$99.9K0.0%+71,411
Tortoise Investment Management, LLC72,000$97.2K0.0%No change
Centiva Capital, LP63,035$85.1K0.0%+38,087

13F reports cover disclosed long positions in U.S. stocks only.

SEC filer profile

How Hyperfine, Inc. is registered with the Securities and Exchange Commission, from its EDGAR record and the cover page of its latest annual report.

  • Name on EDGARHyperfine, Inc.1
  • CIK0001833769
  • Employer ID (EIN)98-15690274
  • Filer statusNon-accelerated filer an emerging growth company; a smaller reporting company; not a shell company4
  • Incorporated inDelaware4
  • Fiscal year endsDecember 311
  • Industry code (SIC)3845 Electromedical & Electrotherapeutic Apparatus1
  • SEC reviewing officeOffice of Industrial Applications and Services, Division of Corporation Finance1
  • Business address351 New Whitfield Street, Guilford, CT 064371
  • Phone866-796-67671
  • Shares outstanding82,902,422 Common Class A shares; 15,055,288 Common Class B shares as of Mar 13, 20264
  • Public float$44.2M as of Jun 30, 20254
  • AuditorGRANT THORNTON LLP, San Jose, California PCAOB ID 248; no auditor attestation of internal control over financial reporting4
  • On EDGAR sinceDec 9, 20201
  • Filings367 in all: 4 (107), 8-K (68), 3 (24), 425 (23), 424B3 (20), 10-Q (17), 4/A (11), CORRESP (9)1
    All 41 form types

    UPLOAD (8), EFFECT (7), 10-K (6), 424B5 (6), DEF 14A (5), DEFA14A (5), S-8 (5), ARS (4), S-4/A (4), SC 13G (3), SC 13G/A (3), 3/A (2), 8-K/A (2), DRS (2), NT 10-Q (2), POS AM (2), PRE 14A (2), S-1 (2), S-1/A (2), S-3 (2), SEC STAFF LETTER (2), 424B4 (1), 8-A12B (1), CERT (1), DEF 14C (1), PRE 14C (1), S-1MEF (1), S-4 (1), S-4MEF (1), SC 13D (1), SC 13D/A (1), SCHEDULE 13G (1), SCHEDULE 13G/A (1)

  • Latest filingsAnnual report (10-K) Mar 18, 2026
    Quarterly report (10-Q) Aug 6, 2026
    Proxy statement (DEF 14A) Apr 8, 2026
    Latest 8-K (8-K) Oct 8, 2026

Securities registered for trading

ClassSymbolExchange
Class A common stock, $0.0001 par value per shareHYPRNasdaq

From the cover page of the 10-K filed Mar 18, 2026 (Section 12(b) of the Exchange Act).4

Risk factors and legal proceedings

The risks Hyperfine, Inc. names in Item 1A of its 10-K filed Mar 18, 2026: 74 risks under these headings, as written.4

  • You should consider carefully the following risk factors, together with all of the other information included in this report. If any of the following risks, either alone or taken together, or other risks not presently known to us or that we currently believe to not be significant, develop into actual events, then our business, financial condition, results of operations or prospects could be materially adversely affected. If that happens, the market price of our Class A common stock could decline, and stockholders may lose all or part of their investment.
  • Unless the context otherwise requires, references in this section to “we,” “us,” “our” and the “Company” refer to Hyperfine, Inc. and its subsidiaries following the Business Combination, or to Legacy Hyperfine, Liminal, or HealthCor prior to the Business Combination, as the case may be.
  • Risks Related to Our Financial Condition and Capital Requirements
  • We are an early-stage health technology company with a history of net losses, which we expect to continue, and we may not be able to generate meaningful revenues or achieve and sustain profitability in the future.
  • We have a limited operating history, which may make it difficult to evaluate the prospects for our future viability and predict our future performance. As such, you cannot rely upon our historical operating performance to make an investment decision regarding us.
  • We may need to raise additional capital to fund commercialization plans for our products, including manufacturing, sales and marketing activities, expand our investments in research and development, develop clinical evidence, and commercialize new products and applications.
  • Our operating results may fluctuate significantly in the future, which makes our future operating results difficult to predict and could cause our operating results to fall below expectations or any guidance we may provide.
  • We maintain our cash at financial institutions, often in balances that exceed federally insured limits.
  • Risks Related to Our Businesses
  • Our success depends upon market acceptance of our products and services, our ability to develop and commercialize existing and new products and services and generate revenues, and our ability to identify new markets for our technology.
  • Health technology development is costly and involves continual technological change, which may render our current or future products obsolete.
  • We will be dependent upon the success of our sales and customer acquisition and retention strategies.
The other 64 risks
  • We expect to generate a substantial portion of our revenue internationally in the future and may become subject to various additional risks relating to our international activities, which could adversely affect our business, operating results and financial condition.
  • We are subject to export and import control laws and regulations that could impair our ability to compete in international markets or subject us to liability if we violate such laws and regulations.
  • If we experience decreasing prices for our products and are unable to reduce our expenses, including the per unit cost of producing our products, there may be a material adverse effect on our business, results of operations, financial condition and cash flows.
  • We have undertaken internal restructuring activities in the past that could result in disruptions to our business or otherwise materially harm our results of operations or financial condition.
  • If we are unable to attract, recruit, train, retain, motivate and integrate key personnel and expand our organization, our operations may be disrupted and we may not achieve our goals.
  • We have limited experience in marketing and selling our products and related services, and if we are unable to successfully commercialize our products and related services, our business and operating results will be adversely affected.
  • We rely on a single contract manufacturer, Benchmark, to test, assemble and supply our finished products. If Benchmark fails to fulfill its obligations under its existing contractual arrangements with us or does not perform satisfactorily, our ability to source our devices could be negatively and adversely affected.
  • We rely on a limited number of suppliers for our products. A loss of any of these suppliers could negatively affect our business.
  • We have experienced and may continue to experience pricing pressures from contract suppliers or manufacturers on which we rely.
  • If we do not successfully optimize and operate our sales and potential future distribution channels or we do not effectively expand and update our infrastructure, our operating results and customer experience may be negatively impacted.
  • The market for our products and services is new, rapidly evolving, and increasingly competitive, as the healthcare industry in the United States is undergoing significant structural change, which makes it difficult to forecast demand for our products and services.
  • Quality problems could lead to recalls or safety alerts and/or reputational harm and could have a material adverse effect on our business, results of operations, financial condition and cash flows.
  • If we are not able to develop and release new products and services, or successful enhancements, new features and modifications to our existing products and services, to successfully implement our software solutions or to achieve adequate clinical feasibility, our business, financial condition and results of operations could be adversely affected.
  • We are party to Technology and Services Exchange Agreements with certain affiliated companies, pursuant to which the parties agreed to share personnel and certain non-core technologies. The sharing arrangements under the agreements may prevent us from fully utilizing our personnel and/or the technologies shared under the agreements. Furthermore, if these agreements were to terminate, or if we were to lose access to these technologies and services, our business could be adversely affected.
  • We may acquire other companies or technologies, which could fail to result in a commercial product or net sales, divert our management’s attention, result in additional dilution to our stockholders and otherwise disrupt our operations and harm our operating results.
  • As international expansion of our business occurs, it will expose us to market, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations.
  • International trade disputes, including United States trade tariffs and retaliatory tariffs, could adversely impact our business.
  • The enactment of legislation implementing changes in the U.S. taxation of international business activities, the adoption of other tax reform policies or changes in tax legislation or policies in jurisdictions outside of the United States could materially impact our results of operations and financial condition.
  • U.S. taxation of international business activities or the adoption of tax reform policies could materially impact our future financial position and results of operations.
  • We may face exposure to foreign currency exchange rate fluctuations.
  • We may fail to recover our accounts receivable in a timely manner, which may affect our financial condition and results of operations.
  • Our ability to use net operating losses to offset future taxable income may be subject to certain limitations.
  • Risks Related to Healthcare Industry Shifts and Changing Regulations
  • We are subject to extensive government regulation, which could restrict the development, marketing, sale and distribution of our products and could cause us to incur significant costs.
  • Our employees, independent contractors, consultants, manufacturers and suppliers may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
  • There is no guarantee that the FDA will grant 510(k) clearance or premarket approval of our future products, and failure to obtain necessary clearances or approvals for our future products would adversely affect our ability to grow our business.
  • Recent initiatives by the FDA to enhance and modernize various regulatory pathways for device products and its overall approach to safety and innovation in the medical technology industry creates the possibility of changing product development costs, requirements, and other factors and additional uncertainty for our future products and business.
  • Disruptions at the FDA, the SEC and other government agencies caused by funding shortages, mass layoffs, or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent our products from being developed or commercialized in a timely manner or otherwise prevent those agencies from performing normal business functions on which the operation of our business relies, which could negatively impact our business.
  • If we fail to obtain regulatory authorizations in other countries for existing products or products under development, we will not be able to commercialize these products in those countries.
  • If we, our current or future contract manufacturers, or our current or future component suppliers are unable to manufacture our products in sufficient quantities, on a timely basis, at acceptable costs and in compliance with regulatory and quality requirements, the manufacturing and distribution of our devices could be interrupted, and our product sales and operating results could suffer.
  • Our current or future products may be subject to product recalls even after receiving FDA clearance or approval. A recall of our products, either voluntarily or at the direction of the FDA, or the discovery of serious safety issues with our products, could have a significant adverse impact on us.
  • We may be subject to enforcement action if we engage in improper or off-label marketing or promotion of our commercial medical device products, including fines, penalties and injunctions.
  • Digital marketing and social media efforts may expose us to additional regulatory scrutiny, including from the Federal Trade Commission (the “FTC”) and other consumer protection agencies and regulators.
  • Because we do not require extensive training for users of our current products, although they are limited under the FDA’s marketing clearances to use by, and that images generated from the scanner be interpreted by, trained healthcare practitioners, there exists a potential for misuse of these products, misinterpretation of images by untrained professionals or misuse of these products by untrained professionals, which could ultimately harm our reputation and business.
  • We are subject to federal, state and foreign laws prohibiting “kickbacks” and false or fraudulent claims, and other fraud and abuse laws, transparency laws, and other healthcare laws and regulations, which, if violated, could subject us to substantial penalties. Additionally, any challenge to or investigation into our practices under these laws could cause adverse publicity and be costly to respond to, and thus could harm our business.
  • If we are found to have violated laws protecting the confidentiality of health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business.
  • We are subject to complex and evolving U.S. and foreign laws and regulations regarding privacy, data protection, artificial intelligence, and other matters. Many of these laws and regulations are subject to change and uncertain interpretation, and could result in claims or monetary penalties, changes to our business practices, increased cost of operations, or declines in customer growth or engagement, or otherwise harm our business.
  • Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • Broad-based domestic and international government initiatives to reduce spending, particularly those related to healthcare costs, may reduce reimbursement rates for medical procedures, or make it more difficult for customers to purchase our products and services, all of which could adversely affect our business.
  • Risks Related to our Intellectual Property
  • If we are unable to obtain and maintain and enforce sufficient intellectual property protection for our products and technology, or if the scope of the intellectual property protection obtained is not sufficiently broad, our competitors could develop and commercialize products similar or identical to ours, and our ability to successfully commercialize our products may be impaired.
  • The U.S. law relating to the patentability of certain inventions in the life sciences and medical technology industry is uncertain and rapidly changing, which may adversely impact our existing patents or our ability to obtain patents in the future.
  • We may not be able to protect our intellectual property rights throughout the world.
  • Issued patents covering our products could be found invalid or unenforceable if challenged.
  • If we are unable to protect the confidentiality of our trade secrets, the value of our technology could be materially adversely affected and our business could be harmed.
  • We may be subject to claims challenging the inventorship and ownership of our patents and other intellectual property.
  • We may not be able to protect and enforce our trademarks and trade names or build name recognition in our markets of interest thereby harming our competitive position.
  • Patent terms may be inadequate to protect our competitive position on our products for an adequate amount of time.
  • We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed to us alleged trade secrets of their other clients or former employers, which could subject us to costly litigation.
  • We may become involved in lawsuits to defend against third-party claims of infringement, misappropriation or other violations of intellectual property rights or to protect or enforce our intellectual property, any of which could be expensive, time consuming and unsuccessful, and may prevent or delay our development and commercialization efforts.
  • Obtaining and maintaining our patent protection depends on compliance with various required procedures, document submissions, fee payments and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • In the future, we may rely on licenses from third parties, and if we lose such licenses, then we may be subjected to future litigation.
  • If we cannot license rights to use technologies on reasonable terms, we may not be able to commercialize new products in the future.
  • Certain of our future owned and in-licensed patents may be, subject to a reservation of rights by one or more third parties, including government march-in rights, that may limit our ability to exclude third parties from commercializing products similar or identical to ours.
  • Our products contain third-party open source software components and failure to comply with the terms of the underlying open source software licenses could restrict our ability to sell our products and provide third parties access to our proprietary software.
  • Intellectual property rights do not necessarily address all potential threats.
  • Litigation Risks
  • We face the risk of product liability claims and may be subject to damages, fines, penalties and injunctions, among other things.
  • Risks Related to Our Securities and to Being a Public Company
  • Future sales of substantial amounts of our Class A common stock, or the possibility that such sales could occur, could adversely affect the market price of our Class A common stock.
  • 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.
  • Because we are a “controlled company” within the meaning of the Nasdaq listing rules, our stockholders may not have certain corporate governance protections that are available to stockholders of companies that are not controlled companies.
  • The dual class structure of our common stock has the effect of concentrating voting power with Jonathan M. Rothberg, Ph.D., the Founder of Legacy Hyperfine and Liminal and a member of our board of directors, which limits an investor’s ability to influence the outcome of important transactions, including a change in control.
  • Potential conflicts of interest may arise among the holders of our Class B common stock and the holders of our Class A common stock.
  • Delaware law and provisions in our Charter and bylaws could make a takeover proposal more difficult.
  • Our Charter designates the Court of Chancery of the State of Delaware as the sole and exclusive forum for certain types of actions and proceedings and the federal district courts as the sole and exclusive forum for other types of actions and proceedings, in each case, that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain what such stockholders believe to be a favorable judicial forum for disputes with our company or our directors, officers or other employees.
  • Changes in laws or regulations, or a failure to comply with any laws and regulations, or any litigation that we may be subject to or involved in may adversely affect our business, investments and results of operations.

Legal proceedings

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

The opening of Item 3, Legal Proceedings.4

Sources

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