Core Insights - Hyperfine (HYPR) has received FDA 510(k) clearance for its next-generation Swoop Portable MR Imaging system, which utilizes proprietary OptiVu AI software to enhance image quality and usability [1][4][8] Company Developments - The FDA clearance enhances Hyperfine's commitment to bedside imaging, allowing for rapid, low-field MRI capabilities without the logistical challenges of traditional systems [2] - The Swoop system is designed to improve clinical utility and operational efficiency in hospitals and care teams, making it more competitive against conventional MRI systems [4][10] - The upgraded Swoop system features a new hardware platform and OptiVu AI software, providing the highest signal-to-noise ratio to date, resulting in exceptional image quality and faster acquisition times [9][10] - The system is tailored for a broad patient population, including pediatric and elderly patients, and is particularly beneficial in emergency departments and under-resourced locations [10][11] Market Position and Financials - Following the FDA announcement, HYPR's shares increased by 41%, closing at $0.85, although the company has seen a 3.4% decline year-to-date compared to a 9.7% decline in the industry [3] - Hyperfine currently has a market capitalization of $46.89 billion and has delivered an average earnings surprise of 3.1% over the trailing four quarters [5] Industry Outlook - The global portable MRI market is projected to grow from $4.34 billion in 2025 to around $7 billion by 2034, with a CAGR of 5.44% from 2024 to 2034, indicating a favorable market environment for Hyperfine's Swoop system [12]

Company Performance - Hyperfine, Inc. reported a quarterly loss of $0.12 per share, which aligns with the Zacks Consensus Estimate, and is an improvement from a loss of $0.14 per share a year ago [1] - The company posted revenues of $2.14 million for the quarter ended March 2025, missing the Zacks Consensus Estimate by 27.07%, compared to revenues of $3.3 million in the same quarter last year [2] - Over the last four quarters, Hyperfine has surpassed consensus EPS estimates only once and has topped consensus revenue estimates two times [2][3] Stock Outlook - Hyperfine shares have declined approximately 17.1% since the beginning of the year, contrasting with the S&P 500's decline of 0.6% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the upcoming quarter is -$0.11 on revenues of $3.09 million, and for the current fiscal year, it is -$0.45 on revenues of $15.59 million [7] Industry Context - The Medical - Instruments industry, to which Hyperfine belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5][6]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $2.1 million, with six systems sold and a strong average selling price [6][16] - Gross profit for Q1 2025 was $900,000, resulting in a gross margin of 41.3%, a 20 basis point improvement year-over-year [18] - Net loss for Q1 2025 was $9.4 million, or $0.12 per share, compared to a net loss of $9.8 million, or $0.14 per share, in the same period last year [19] - Cash burn for Q1 2025 was $4.6 million, with a total cash balance of $33.1 million as of March 31, 2025 [19][23] - Full year 2025 revenue growth is expected to be in the range of 10% to 20% over 2024, with gross margin outlook updated to 47% to 50% [21][22] Business Line Data and Key Metrics Changes - The company sold six units in Q1 2025, with a strong average selling price, but faced longer deal cycles and lost several deals due to grant funding cancellations [16][19] - The focus is shifting towards diversified revenue across hospitals, office settings, and international markets, with plans to launch the office business in mid-2025 [7][12] Market Data and Key Metrics Changes - The company is experiencing headwinds in revenue due to a new political environment affecting large academic institutions funded by grants [6][19] - There is strong interest and demand in international markets, particularly in Europe, the Middle East, and Asia, with anticipated regulatory approval in India in the second half of 2025 [14][15] Company Strategy and Development Direction - The strategy focuses on site of care expansion, building an office business, and driving adoption in international markets [11][12] - The company aims to enhance its financial profile by reducing cash burn and transitioning from a development stage to a commercial stage company [23] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the future growth trajectory, particularly with the launch of new AI-powered technology and expansion into office settings [8][15] - The management acknowledged the challenges posed by longer sales cycles in the hospital sector and the impact of grant funding on revenue [19][43] Other Important Information - The company completed a reorganization to reduce cash burn and strengthen its balance sheet, raising $6 million through a registered direct offering [6][23] - Management is closely monitoring the impact of tariffs but currently does not anticipate any material effects on business operations [24][56] Q&A Session Summary Question: Initial feedback on pilot activity in the office setting - Management reported positive feedback from pilot accounts, with successful accreditation and enthusiasm from participating neurologists [30] Question: Recovery of lost business due to grant funding - Management does not expect grant funding to return and is focusing on deals that do not rely on such funding [33] Question: Update on international distributor receptivity - There is strong interest from international distributors, with ongoing efforts to establish centers of excellence and networks of users [35] Question: Changes in second half guidance - Adjustments to guidance were made due to lost revenue from grant funding, but growth catalysts remain in place for the second half [41][42] Question: Economics of selling in the office versus hospital settings - The implementation process differs significantly between office and hospital settings, with flexible payment models being explored for office sales [48][50] Question: Current visibility for the first half of 2025 - The pipeline is robust, with expectations for a significant ramp in business between the first and second halves of 2025 [61]

Financial Data and Key Metrics Changes - Revenue for Q1 2025 was $2.1 million, with a sale of six systems and a strong average selling price [5][15] - Gross profit for Q1 2025 was $900,000, resulting in a gross margin of 41.3%, a 20 basis point improvement year-over-year [17] - Net loss for Q1 2025 was $9.4 million, or $0.12 per share, compared to a net loss of $9.8 million, or $0.14 per share, in the same period last year [18] - Cash burn for Q1 2025 was $4.6 million, with total cash and cash equivalents at $33.1 million as of March 31, 2025 [18][21] - Full year 2025 revenue growth is expected to be in the range of 10% to 20% over 2024, with gross margin outlook updated to 47% to 50% [20] Business Line Data and Key Metrics Changes - The company is transitioning from a reliance on U.S. hospital deals to a diversified revenue model across hospitals, office settings, and international markets [6][14] - The office clinical study, NeuroPMR, is progressing well, with strong enthusiasm from participating sites and expected completion ahead of schedule [8][10] Market Data and Key Metrics Changes - The company is seeing strong interest and demand in international markets, particularly in Europe, the Middle East, and Asia, with anticipated regulatory approval in India in the second half of 2025 [13][14] - The sales cycle for hospital deals has lengthened, now averaging one to one and a half years [43] Company Strategy and Development Direction - The strategy focuses on site of care expansion, building an office business, and driving adoption in international markets [10][14] - The company aims to launch its office business in mid-2025, with pilot accounts already accredited and scanning [11][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the future growth trajectory, particularly with the launch of new AI-powered technology and expansion into office and international markets [14][24] - The company is cautious about the impact of grant funding on future deals, indicating a shift away from reliance on such funding sources [32] Other Important Information - The company completed a reorganization to reduce cash burn and strengthen its balance sheet, extending its cash runway to the end of 2026 [21] - Management is closely monitoring the impact of tariffs but currently reports no direct effects on international transactions [22][58] Q&A Session Summary Question: Feedback on pilot activity in the office setting - Management reported positive feedback from pilot accounts, with enthusiasm for the technology and its potential to transform practices [29] Question: Impact of grant funding headwinds in Q1 - Management does not expect grant funding to return and is focusing on deals that do not rely on such funding [32] Question: Changes in second half guidance - Adjustments to guidance were made primarily due to lost revenue from grant funding, but no major changes in growth expectations for the second half [41] Question: Office expansion and economic models - Management indicated that a handful of accounts are in the pilot phase, with flexible payment models being discussed to accommodate different office sizes [45][49] Question: Current visibility for the first half of 2025 - The pipeline is robust, with expectations for a significant ramp in business in the second half of the year as new opportunities arise [61]

[PART I FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20FINANCIAL%20INFORMATION) The company's first quarter financial results for 2025 show decreased sales and a net loss, with liquidity supported by recent financing activities [Item 1. Financial Statements](index=5&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements for Q1 2025 show decreased sales to $2.1 million, a net loss of $9.4 million, and reduced cash to $33.1 million [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of March 31, 2025, total assets decreased to $53.4 million, primarily due to reduced cash, while liabilities slightly increased and equity declined Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $33,093 | $37,645 | | Total current assets | $48,403 | $53,710 | | Total assets | $53,377 | $58,901 | | **Liabilities & Equity** | | | | Total current liabilities | $7,979 | $8,729 | | Total liabilities | $10,263 | $9,861 | | Total stockholders' equity | $43,114 | $49,040 | | **Total Liabilities & Equity** | **$53,377** | **$58,901** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Total sales for Q1 2025 decreased by 35.1% to $2.1 million, resulting in a net loss of $9.4 million, a slight improvement from Q1 2024 Q1 2025 vs Q1 2024 Statement of Operations (in thousands, except per share data) | Metric | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total sales | $2,137 | $3,295 | | Gross margin | $883 | $1,354 | | Total operating expenses | $11,785 | $12,004 | | Loss from operations | ($10,902) | ($10,650) | | Net loss | ($9,418) | ($9,848) | | Net loss per share | ($0.12) | ($0.14) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities improved to $9.2 million in Q1 2025, while financing activities provided $5.6 million, leading to a $4.1 million decrease in total cash Q1 2025 vs Q1 2024 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 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** | **($4,139)** | **($12,600)** | [Notes to Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) The notes detail accounting policies, a going concern assessment, a $6.0 million stock offering, and a $400 thousand restructuring charge from workforce reduction - The company's existing capital resources are expected to be sufficient to fund operations for at least twelve months from the financial statement issuance date, though failure to generate sufficient revenue or obtain additional financing in the longer term could raise substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk)[29](index=29&type=chunk) - In February 2025, the company raised aggregate gross proceeds of **$6.0 million** through a registered direct offering of 4,511,278 shares of Class A common stock and accompanying warrants at a combined price of $1.33 per share and warrant[69](index=69&type=chunk) - In January 2025, the company implemented a restructuring plan, terminating approximately **14% of its global workforce** and incurring approximately **$400,000 in costs**, primarily for severance[92](index=92&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=21&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management attributes the 35.1% revenue decline to fewer device sales, notes a slight decrease in operating expenses, and confirms sufficient liquidity for the next 12 months after a $6.0 million offering [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Total sales for Q1 2025 decreased by 35.1% to $2.1 million due to fewer device units sold, while gross margin fell and operating expenses saw mixed changes Comparison of Results for the Three Months Ended March 31 (in thousands) | Line Item | 2025 | 2024 | Change % | | :--- | :--- | :--- | :--- | | **Total sales** | **$2,137** | **$3,295** | **(35.1)%** | | Device Sales | $1,522 | $2,704 | (43.7)% | | Service Sales | $615 | $591 | 4.1% | | **Gross margin** | **$883** | **$1,354** | **(34.8)%** | | **Total operating expenses** | **$11,785** | **$12,004** | **(1.8)%** | | 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% | | **Loss from operations** | **($10,902)** | **($10,650)** | **2.4%** | - The decrease in device sales was mainly driven by a decrease in units sold, which was **6 units for Q1 2025** compared to **13 units for Q1 2024**[102](index=102&type=chunk)[110](index=110&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) The company ended Q1 2025 with $33.1 million in cash, supported by a $6.0 million offering and an ATM program, with management expecting sufficient funds for the next 12 months - As of March 31, 2025, the company had cash and cash equivalents of **$33.1 million** and an accumulated deficit of **$303.9 million**[120](index=120&type=chunk) - The company raised **$6.0 million** in gross proceeds from a registered direct offering in February 2025 and has an active ATM program which has raised net proceeds of **$947 thousand** as of March 31, 2025[121](index=121&type=chunk)[123](index=123&type=chunk) - Management expects that existing cash and cash equivalents, along with proceeds from sales, will be sufficient to fund planned operations for at least the next 12 months[124](index=124&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=30&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company identifies interest rate, inflation, and foreign exchange as primary market risks but considers their material effect on its business to be minimal - The company's market risk exposure is primarily from interest rates, inflation, and foreign exchange risk, but it does not consider any of these to be significant[144](index=144&type=chunk) - A hypothetical **0.5 percentage point decrease in interest rates** would decrease annualized earnings before income taxes by approximately **$0.2 million**[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=30&type=section&id=Item%204.%20Controls%20and%20Procedures) As of March 31, 2025, the company's disclosure controls and procedures were deemed effective, with no material changes in internal control over financial reporting during the quarter - Management concluded that as of March 31, 2025, the company's disclosure controls and procedures were effective[148](index=148&type=chunk) - No changes in internal control over financial reporting occurred during Q1 2025 that have materially affected, or are reasonably likely to materially affect, internal controls[149](index=149&type=chunk) [PART II OTHER INFORMATION](index=31&type=section&id=PART%20II%20OTHER%20INFORMATION) This section covers legal proceedings, significant risk factors related to Nasdaq listing compliance, and other standard disclosures [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) The company reports that it is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[152](index=152&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) The company faces a significant risk of delisting from Nasdaq due to its stock price falling below the $1.00 minimum bid requirement - On April 30, 2025, Hyperfine received a notice from Nasdaq for failing to meet the minimum bid price requirement of **$1.00 per share**[154](index=154&type=chunk) - The company has a **180-calendar day period**, until October 27, 2025, to regain compliance by maintaining a closing bid price of at least **$1.00 for a minimum of 10 consecutive business days**[154](index=154&type=chunk) - Failure to regain compliance could lead to the delisting of the company's Class A common stock from Nasdaq, which would adversely affect share liquidity and capital-raising abilities[154](index=154&type=chunk) [Other Items (Items 2, 3, 4, 5, 6)](index=31&type=section&id=Other%20Items) This section confirms no unregistered equity sales, no defaults, no mine safety disclosures, and no Rule 10b5-1 trading arrangement changes by officers or directors - Items 2, 3, and 4, concerning Unregistered Sales of Equity Securities, Defaults Upon Senior Securities, and Mine Safety Disclosures, are all marked as 'Not applicable'[155](index=155&type=chunk)[156](index=156&type=chunk) - During the three months ended March 31, 2025, none of the company's officers or directors entered into, modified, or terminated any Rule 10b5-1 trading arrangements[157](index=157&type=chunk)

AI-Powered, Portable Brain MRI The Swoop® Portable MR Imaging® system is driving the future of brain health. Corporate Investor Deck – May 2025 Hyperfine, Swoop, and Portable MR Imaging are registered trademarks of Hyperfine, Inc. PROPERTY OF HYPERFINE, INC. ©2025. All rights reserved. PROPERTY OF HYPERFINE, INC. ©2025. All rights reserved. Forward-looking Statements This presentation includes "forward-looking statements" within the meaning of the "safe harbor" provisions of the Private Securities Litigatio ...

[Hyperfine, Inc. First Quarter 2025 Results](index=1&type=section&id=Hyperfine,%20Inc.%20First%20Quarter%202025%20Results) The company reports Q1 2025 performance, highlighting strategic shifts, financial results, and updated guidance for the year [Business Overview and Management Commentary](index=1&type=section&id=Business%20Overview%20and%20Management%20Commentary) Hyperfine faces hospital sales delays but expands into neurology offices, expecting growth in H2 2025 - Commercial efforts in the hospital sector continue to face **longer and more variable sales cycles**[3](index=3&type=chunk) - The company is expanding its pipeline with new opportunities in the **neurology office setting** to diversify revenue[3](index=3&type=chunk) - Management expects **accelerated growth to begin in the second half of 2025**, driven by new market expansion and technology advancements[3](index=3&type=chunk) - Upcoming FDA clearances are expected to introduce a **new standard in image quality** for portable brain MRI[3](index=3&type=chunk) [Recent Achievements and Business Highlights](index=1&type=section&id=Recent%20Achievements%20and%20Business%20Highlights) The company extended its cash runway, submitted its next-gen system to the FDA, and initiated a key clinical study - Completed a reorganization to lower operating costs and raised $6 million, **extending the cash runway to the end of 2026**[7](index=7&type=chunk) - Submitted the **next-generation Swoop® system technology** to the U.S. FDA for review[7](index=7&type=chunk) - Began patient enrollment in the **NEURO PMR study** to evaluate its portable MRI in neurology offices, with completion expected by the end of Q3 2025[7](index=7&type=chunk) - Presented at major industry conferences, including the 2025 International Stroke Conference, to increase exposure[7](index=7&type=chunk) [First Quarter 2025 Financial Results](index=1&type=section&id=First%20Quarter%202025%20Financial%20Results) Q1 2025 revenue declined to $2.1 million, though gross margin remained stable and net loss slightly improved Q1 2025 Financial Performance vs. Q1 2024 | Financial Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | **Total Revenues** | **$2.1 million** | **$3.3 million** | **-36.4%** | | Swoop® Systems Sold | 6 | N/A | N/A | | **Gross Margin** | **$0.9 million** | **$1.3 million** | **-30.8%** | | Gross Margin % | 41.3% | 41.1% | +0.2 p.p. | | R&D Expenses | $5.0 million | $5.6 million | -10.7% | | SG&A Expenses | $6.7 million | $6.4 million | +4.7% | | **Net Loss** | **($9.4 million)** | **($9.8 million)** | **+4.1%** | | Net Loss Per Share | ($0.12) | ($0.14) | +14.3% | [2025 Financial Guidance](index=1&type=section&id=2025%20Financial%20Guidance) The company updated its 2025 outlook, projecting 10-20% revenue growth and a significant reduction in cash burn Full Year 2025 Financial Outlook | Guidance Metric | 2025 Expectation | | :--- | :--- | | **H1 2025 Revenue** | **$5 to $6 million** | | **Full Year 2025 Revenue Growth** | **10% to 20% over 2024** | | **Full Year 2025 Cash Burn** | **$25 to $28 million** (31% decline YoY at midpoint) | [Financial Statements](index=5&type=section&id=Financial%20Statements) This section presents the detailed consolidated balance sheets, statements of operations, and cash flows for the period [Consolidated Balance Sheets](index=5&type=section&id=Consolidated%20Balance%20Sheets) The balance sheet shows total assets of $53.4 million and stockholders' equity of $43.1 million as of March 31, 2025 Consolidated Balance Sheet Highlights (in thousands) | Account | March 31, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $33,093 | $37,645 | | Total current assets | $48,403 | $53,710 | | **Total assets** | **$53,377** | **$58,901** | | Total current liabilities | $7,979 | $8,729 | | **Total liabilities** | **$10,263** | **$9,861** | | **Total stockholders' equity** | **$43,114** | **$49,040** | [Consolidated Statement of Operations and Comprehensive Loss](index=7&type=section&id=Consolidated%20Statement%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a net loss of $9.4 million on $2.1 million in sales for the first quarter of 2025 Q1 Statement of Operations (in thousands) | Line Item | Q1 2025 | Q1 2024 | | :--- | :--- | :--- | | Total sales | $2,137 | $3,295 | | Gross margin | $883 | $1,354 | | Total operating expenses | $11,785 | $12,004 | | Loss from operations | ($10,902) | ($10,650) | | **Net loss** | **($9,418)** | **($9,848)** | | **Net loss per share** | **($0.12)** | **($0.14)** | [Consolidated Statement of Cash Flows](index=8&type=section&id=Consolidated%20Statement%20of%20Cash%20Flows) Cash used in operations was $9.2 million, with financing activities contributing $5.6 million in Q1 2025 Q1 Cash Flow Summary (in thousands) | Cash Flow Activity | Q1 2025 | Q1 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** | **($4,139)** | **($12,600)** | | **Cash, cash equivalents and restricted cash, end of period** | **$33,534** | **$63,204** |

Core Insights - Hyperfine, Inc. reported its first quarter 2025 financial results and highlighted progress in expanding its business pipeline, particularly in the neurology office setting, while facing longer sales cycles in hospitals [2][4] Business Highlights - The company has made significant advancements in its commercial efforts, focusing on both hospitals and neurology offices, which is expected to diversify its revenue profile starting in the second half of 2025 [2] - Hyperfine completed a reorganization to reduce operating costs and raised $6 million through a registered direct offering, extending its cash runway until the end of 2026 [7] - The company initiated patient enrollment in the NEURO PMR study to evaluate the use of AI-powered portable MRI in neurology offices, with completion expected by the end of Q3 2025 [7] Financial Results - Revenues for Q1 2025 were $2.1 million, down from $3.3 million in Q1 2024 [7] - Gross margin for Q1 2025 was $0.9 million, representing a gross margin of 41.3%, slightly up from 41.1% in Q1 2024 [7] - The net loss for Q1 2025 was $9.4 million, or $0.12 per share, compared to a net loss of $9.8 million, or $0.14 per share, in Q1 2024 [7][16] Financial Guidance - Management expects revenue for the first half of 2025 to be approximately $5 to $6 million and anticipates annual revenue growth of 10% to 20% over 2024 [7] - The projected cash burn for the full year 2025 is approximately $25 to $28 million, indicating a 31% decline at the midpoint compared to 2024 [7]

Core Insights - Hyperfine, Inc. (HYPR) has announced a strategic collaboration with NVIDIA to integrate advanced AI technologies into its Swoop Portable MRI system, aiming to enhance neuroimaging solutions and improve accessibility for brain scans [1][2] Company Developments - The partnership with NVIDIA emphasizes Hyperfine's commitment to revolutionizing neuroimaging by combining portable MRI technology with advanced computational platforms, positioning the company to improve patient outcomes and expand its leadership in point-of-care imaging [2] - Following the announcement, HYPR shares surged 39.3%, closing at $1.28, with a 33.3% gain over the past six months, outperforming the industry which declined by 9.2% [3] - The collaboration is expected to enhance the speed, intelligence, and accessibility of Hyperfine's MRI systems, potentially attracting more healthcare providers and improving revenue growth and market share [4] Financial Performance - Hyperfine currently has a market capitalization of $93.4 million and reported a 12.5% earnings surprise in the last quarter [5] - In 2024, Hyperfine reported revenues of $12.89 million, a 17% increase, and sold 48 Swoop MRI systems, improving its gross margin to 46%, while narrowing its net loss to $40.72 million [10] Market Context - Over three billion people globally suffer from brain diseases, with many lacking timely MRI access due to high costs and infrastructure needs; Hyperfine's AI-powered portable MRI aims to address this issue by providing affordable, point-of-care imaging [6] - The Swoop Portable MRI system is the first FDA-cleared portable MRI designed for bedside use, allowing rapid neuroimaging results without the need to transport critically ill patients [8] - The collaboration with NVIDIA will focus on advancing AI-powered image reconstruction and real-time clinical decision support, enhancing image quality and reducing scan times [9]

Financial Data and Key Metrics Changes - For the full year 2024, revenue was $12.9 million, representing a 17% year-over-year growth compared to $11.0 million in 2023 [9][13] - Gross profit for the fourth quarter of 2024 was $0.8 million, down from $1.0 million in the fourth quarter of 2023, while full year gross profit was $5.9 million, up 24% from 2023 [14][16] - Net loss for the fourth quarter of 2024 was $10.4 million, or $0.14 per share, compared to a net loss of $10.7 million, or $0.15 per share, in the same period of the prior year [16] - Cash burn for the fourth quarter of 2024 was $8.2 million, with total cash and cash equivalents at $37.6 million as of December 31, 2024 [16][17] Business Line Data and Key Metrics Changes - The company sold nine units in the fourth quarter of 2024, with revenue impacted by longer deal cycles and a lower average selling price due to a higher mix of international deals [11][12] - Organic year-over-year revenue growth was 70%, excluding a one-time purchase order from King's College London in 2023 [13][14] Market Data and Key Metrics Changes - The total addressable market for the company's subsystem in the U.S. is estimated to exceed $6 billion, covering placements in hospital and office settings [23] - The company exited 2024 with 13 distributors in international markets, including Europe, the Middle East, and Asia [34] Company Strategy and Development Direction - The company aims to transform into a commercial-stage company in 2025, focusing on diversification and expansion strategies [19] - Plans include launching two new subsystem software releases in 2025, which are expected to significantly improve image quality [20][36] - The company is expanding its market presence into neurology offices and emergency departments within hospitals [24][28] Management's Comments on Operating Environment and Future Outlook - Management noted that the sales cycles for U.S. hospitals are becoming longer and more complex, impacting revenue expectations [12][52] - The company is optimistic about growth opportunities in both domestic and international markets, with a focus on economic and clinical benefits in their sales strategy [54][61] Other Important Information - The company completed a reorganization to lower operating costs and raised $6 million through a direct offering to extend its cash runway to the end of 2026 [10][42] - Management is closely monitoring potential impacts from tariffs but does not expect material effects on the business [43] Q&A Session Summary Question: Details on the partnership with NVIDIA - Management stated that the collaboration relates to future technology, with no further details provided at this stage [48][64] Question: Capital trends and potential recessionary headwinds - Management indicated that hospital capital allocation processes are becoming more complex, while the office setting presents a different dynamic with fewer decision-makers [51][54] Question: Contributions from U.S. versus international markets and ASP durability - Management noted that ASPs have been increasing in the U.S., while international sales are through third-party distributors, leading to variability in ASPs [57][61] Question: Insights on the expansion into neurology offices - Management confirmed that pilot programs are underway, with positive feedback from initial sites regarding the accreditation process and use cases [68][70] Question: Confidence in new sales representatives - Management expressed confidence in the new sales team, highlighting their rigorous training and readiness to support upcoming product launches [92][94]