UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39949 _________________ Hyperfine, Inc. (Exact name of registrant as specified in its chart ...

Market Opportunity - The Swoop® system targets a $28 billion imaging market, expected to grow at a 4.9% CAGR from 2022 to 2030[29] - The global imaging market is estimated to exceed $20 billion, with over 100,000 potential installation sites for the Swoop® system[40] - The aging population and rising prevalence of neurological conditions are driving increased demand for MRI technology[40] - The Swoop® system aims to improve access to MRI for 90% of the world's population who have limited or no access to conventional MRI[59] Product Features and Benefits - The Swoop® system reduces the average conventional MRI process time from 11.7 hours to between 0.5 to 5.3 hours, achieving a workflow time reduction of 55% or greater[35] - The Swoop® system can potentially improve access to MRI for approximately 15 million new stroke sufferers annually, avoiding the risks associated with ionizing radiation from CT scans[34] - The use of the Swoop® system has resulted in a 20% increase in the utilization of existing MRI suites for additional outpatient procedures[35] - The Swoop® system is designed to be user-friendly, requiring minimal training and allowing operation via a tablet or smartphone[35] - The Swoop® system provides diagnostic-quality images with higher contrast resolution than conventional portable medical neuroimaging systems, achieving image resolution of 1.5 x 1.5 x 5 mm compared to 1.0 x 1.0 x 5 mm for traditional MRI[59] - The Swoop® system operates with an ultra-low-field magnet of 0.064T, allowing for portable MRI without the need for specialized facilities[52] - Approximately 30% of conventional MRI scans suffer from moderate to severe image quality issues due to patient motion, which the Swoop® system addresses with motion compensation technology[55] - The Swoop® system's design allows for easy mobility within hospitals, featuring a powered drive system and a zero-turn radius for positioning in tight spaces[65] Regulatory Approvals and Compliance - The company has received multiple regulatory approvals, including Medical Device License from Health Canada and CE marking in the EU, to expand its international market presence[38] - The company must develop a diversity action plan for clinical trials as mandated by the Consolidated Appropriations Act for 2023[131] - The medical devices developed by the company are subject to extensive regulation by the FDA and other international regulatory agencies, requiring compliance with various laws governing development and marketing[110][111] - The company is subject to the Physician Payments Sunshine Act, requiring annual reporting of payments to U.S.-licensed physicians, with significant penalties for violations[149] Financial Performance and Funding - The company has raised over $160 million in equity investments and partnership milestones from institutional investors and grants, including a $1.6 million grant from the Bill & Melinda Gates Foundation[28] - The company incurred net losses of $73.2 million and $64.9 million for the years ended December 31, 2022 and 2021, respectively, with an accumulated deficit of $209.5 million as of December 31, 2022[175] - The company has generated limited revenue from product sales to date and has not achieved wide market acceptance for its products, making future performance predictions uncertain[176] - The company may need to raise additional capital to fund commercialization plans, including manufacturing and sales activities, as well as research and development[178] Competition and Market Position - The company views competition in the medical imaging market as significant, with major players like General Electric and Siemens, but sees its technology as complementary to existing high-field MRI systems[99] - The company faces significant competition from established players in the medical imaging market, including General Electric, Siemens, and Philips, which may affect its market position[190] - The company’s future success depends on the acceptance of its products in the healthcare market, which may not be receptive compared to conventional MRI systems[184] Supply Chain and Manufacturing Risks - The company relies on a limited number of suppliers, increasing risks associated with potential interruptions in supply[211] - The company relies on a single contract manufacturer, Benchmark Electronics, which poses risks if they fail to meet obligations[210] - The company has incurred increased costs for the magnet, a key component in the Swoop® system, due to reliance on a single source supplier in Europe[196] - The company is working to add an additional magnet supplier to mitigate risks associated with reliance on a single supplier[93] Research and Development - The company plans to continue developing its technology to expand into new imaging applications and enhance its MRI system for broader diagnostic capabilities[37] - The market is characterized by rapid technological changes and evolving customer demands, necessitating substantial investment in research and development[222] - The introduction of new technologies may render existing products obsolete, impacting marketability and revenue[222] Compliance and Legal Risks - Non-compliance with various state and federal fraud and abuse laws can lead to substantial fines and criminal sanctions, increasing the risk of litigation[146] - The federal Anti-Kickback Statute prohibits remuneration to induce referrals for services payable under government healthcare programs, with penalties including imprisonment and fines up to $100,000 per violation[141] - The company must maintain a robust compliance program to meet diverse regulatory requirements, which increases the risk of potential violations and associated penalties[150] Workforce and Organizational Changes - As of February 15, 2023, the company employed 136 full-time employees, with 92 in research, development, manufacturing, and operations, and 133 located in the United States[72] - Approximately 13% of the global workforce was terminated as part of an organizational restructuring aimed at decreasing costs and streamlining operations[203] - Attracting and retaining key personnel is critical for the company's future success, given the intense competition in the medical device industry[204]

Hyperfine, Inc. (NASDAQ:HYPR) Q4 2022 Earnings Conference Call March 21, 2023 4:30 PM ET Company Participants Maria Sainz - President, Chief Executive Officer Brett Hale - Chief Administrative Officer, Incoming Chief Financial Officer Marissa Bych - Investor Relations, The Gilmartin Group Conference Call Participants Larry Biegelsen - Wells Fargo Kevin Joaquin - Evercore ISI Neil Chatterji - B. Riley Operator Thank you for standing by and welcome to Hyperfine’s Fourth Quarter and Full Year 2022 Conference C ...

Hyperfine, Inc. (NASDAQ:HYPR) Q3 2022 Earnings Conference Call November 10, 2022 4:30 PM ET Company Participants Marissa Bych – Investor Relations Maria Sainz – President and Chief Executive Officer Alok Gupta – Chief Financial Officer Scott Huennekens – Executive Chairman Conference Call Participants Larry Biegelsen – Wells Fargo Neil Chatterji – B. Riley Larry Biegelsen – Wells Fargo Operator Good afternoon, and welcome to Hyperfine’s Third Quarter 2022 Earnings Conference Call. At this time, all particip ...

HYPERFINE Defining the Future of Diagnostics at the Point of Care Corporate Presentation | November 2022 © 2022 Hyperfine, Inc. Forward Looking Statements This presentation includes forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-lookin ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39949 _________________ Hyperfine, Inc. (Exact name of registrant as specified in its c ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39949 _________________ Hyperfine, Inc. (Exact name of registrant as specified in its charte ...

Hyperfine, Inc. (NASDAQ:HYPR) Q2 2022 Earnings Conference Call August 10, 2022 4:30 PM ET Company Participants Marissa Bych - Gilmartin Group LLC Scott Huennekens - Interim President and Chief Executive Officer Alok Gupta - Chief Financial Officer Conference Call Participants Lawrence Biegelsen - Wells Fargo Vijay Kumar - Evercore ISI Operator Ladies and gentlemen, thank you for standing by and welcome to the Hyperfine Q2 2022 Earnings Conference Call. At this time all participants are in a listen-only mode ...

HYPERFINE Defining the Future of Life-Saving Diagnostics at the Point of Care Corporate Presentation | May 11, 2022 © 2022 Hyperfine, Inc. Forward Looking Statements This presentation includes forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are for ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _________________ FORM 10-Q _________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (Registrant's telephone number, including area code) Securities registered pursuant to Section 12(b) of the Act: | | Trading | Name of each exchange | | ...