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Algernon Pharmaceuticals Announces Name Change to Algernon Health
Globenewswire· 2025-09-04 11:00
VANCOUVER, British Columbia, Sept. 04, 2025 (GLOBE NEWSWIRE) -- Algernon Pharmaceuticals Inc. (the “Company” or “Algernon”) (CSE: AGN) (FRANKFURT: AGW0) (OTCQB: AGNPF), a Canadian healthcare company announces that it is changing its name to Algernon Health. The planned name change reflects the Company’s recent announcement that it will be focusing on the Alzheimer’s Disease (AD) diagnostic market with plans to establish specialized neuroimaging clinics across North America as its lead program. The clinics w ...
4DMedical's CT:VQ™ receives FDA 510(k) clearance; First-and-only CT-based VQ technology
Prnewswire· 2025-09-04 10:00
Core Insights - 4DMedical has received FDA 510(k) clearance for CT:VQ™, the first non-contrast ventilation–perfusion imaging solution, and Medicare has confirmed reimbursement for this technology under Category III CPT codes, enhancing access to this imaging method nationwide [1][4]. Company Overview - 4DMedical is a global medical technology company focused on transforming respiratory care through advanced imaging and artificial intelligence, with patented technologies that enable quantitative ventilation and perfusion analysis from non-contrast chest CT scans [6]. Technology and Implementation - CT:VQ converts standard non-contrast chest CTs into quantitative lobar ventilation and perfusion maps, integrating seamlessly with existing radiology workflows and utilizing the installed base of approximately 14,500 CT scanners in the U.S. [3][4]. - The technology allows hospitals to perform high-resolution ventilation–perfusion studies without the need for new hardware or complex workflows, making it accessible to facilities without nuclear medicine capabilities [4]. Clinical Validation and Partnerships - More than one million nuclear V/Q scans are performed annually in the U.S., and 4DMedical's CT:VQ has undergone clinical validation through quantitative performance testing against SPECT and real-world studies across various lung conditions [5]. - Early clinical partners include Stanford University and Brooke Army Medical Center, which have presented initial findings at the 2025 American Thoracic Society meeting [5].
Perimeter Medical Imaging AI Announces Second Quarter 2025 Financial Results
Prnewswire· 2025-08-26 20:15
Conference Call/Webcast Today at 5 pm ETTORONTO and DALLAS, Aug. 26, 2025 /PRNewswire/ - Perimeter Medical Imaging AI, Inc. (TSXV: PINK) (OTCQX: PYNKF) ("Perimeter" or the "Company"), a commercial-stage medical technology company, today reported financial results for its second quarter ended June 30, 2025 and provided a corporate update. Unless specified otherwise, all amounts in this press release are expressed in U.S. dollars and are presented in accordance with International Financial Reporting Standards ...
Positron Corporation Announces New Corporate Headquarters and Strategic Redomiciling to Delaware
GlobeNewswire News Room· 2025-08-22 13:15
Company Overview - Positron Corporation is a leader in molecular imaging technology and services, specializing in cardiac Positron Emission Tomography (PET) imaging, which is considered the gold standard in cardiac diagnostics [4][5]. - The company co-develops, manufactures, and sells advanced PET and PET-CT imaging systems and clinical services to nuclear medicine healthcare providers across North America [4]. Recent Developments - Positron has established a new corporate headquarters in the Buffalo-Niagara Falls region under a long-term lease, which will house corporate operations and serve as a product showroom and testing center [2]. - The new headquarters is expected to support Positron's accelerated growth initiatives, enhance customer engagement, and provide new operational capabilities for faster scaling of the Company's PET-CT imaging solutions nationwide [2]. Corporate Strategy - The Board of Directors has approved the redomiciling of the Company from Texas to Delaware, aimed at enhancing corporate governance and legal framework [3]. - This move is part of Positron's preparation to file a Form 10 registration statement with the U.S. Securities and Exchange Commission to become a fully reporting public company [3]. Product and Market Position - Positron's Attrius® PET and NeuSight PET-CT imaging systems provide substantial advantages that facilitate the adoption of cardiac PET and the growth of the nuclear imaging market [6]. - The company plans to introduce a state-of-the-art PET-CT 4D molecular imaging device, the Affinity PET-CT 4D 64-Slice, which will enhance the capabilities of nuclear cardiologists and meet the demands of the oncology imaging segment [6]. Commitment to Innovation - Positron is dedicated to expanding the cardiac and oncology PET modality by delivering advanced technology and value to imaging specialists [7]. - The company continues to advance its technology through collaboration with Shenyang Intelligent Neuclear Technology Co., a subsidiary of Neusoft Medical Systems [7].
Hyperfine, Inc. Reports Second Quarter 2025 Financial Results
Globenewswire· 2025-08-13 20:05
Core Insights - Hyperfine, Inc. announced its second quarter 2025 financial results and significant business updates, highlighting key advancements in its AI-powered portable MRI technology and strong financial performance [1][2]. Business Highlights - The company received FDA clearances for its Optive AI software and the next-generation Swoop® system, marking a pivotal moment in its technology development [6]. - A commercial rollout of the next-gen Swoop® system began shortly after FDA clearance, with initial shipments to U.S. hospitals [6]. - The completion of a pilot neurology office program was announced, paving the way for a full-scale commercial launch [6]. - Enrollment of the 100th patient in the NEURO PMR study was achieved, which evaluates the use of AI-powered portable MRI in neurology offices [6]. - The PRIME study was initiated at Yale School of Medicine to assess the impact of AI-driven portable MRI in emergency departments [6]. - New data presented at the 2025 Alzheimer's Association International Conference indicated that the Swoop® system showed 100% sensitivity in detecting mild and moderate ARIA-E in Alzheimer's patients undergoing Lecanemab therapy [6]. Financial Results - Revenues for Q2 2025 reached $2.7 million, a 26% increase compared to Q1 2025 [6]. - The company sold 8 commercial Swoop® systems in Q2 2025, up from 6 in Q1 2025 [6]. - Gross margin for Q2 2025 was $1.3 million, representing a gross margin of 49.3%, an increase of 800 basis points from Q1 2025 [6]. - Research and development expenses decreased to $4.5 million in Q2 2025 from $5.0 million in Q1 2025 [6]. - Sales, marketing, general, and administrative expenses also decreased to $6.4 million in Q2 2025 from $6.7 million in Q1 2025 [6]. - The net loss for Q2 2025 was $9.2 million, consistent with the net loss of $9.4 million in Q1 2025, equating to a net loss of $0.12 per share [6]. Financial Guidance - Management expects full-year 2025 revenue to be 10% to 20% higher than in 2024 [6]. - Cash burn for the full year 2025 is projected to be approximately $27 to $29 million, reflecting a 27% decline at the midpoint compared to 2024 [6].
Positron Corporation Secures Multi-Unit Sale of PET-CT Scanners to Leading Cardiology Group
Globenewswire· 2025-08-13 13:21
Core Insights - Positron Corporation has announced the sale of four PET-CT 64-slice scanners to a recognized nuclear cardiology group, highlighting the increasing demand for its advanced imaging solutions [1][2] - The company's PET-CT scanners are designed to enhance clinical outcomes and operational efficiency, featuring high-resolution imaging capabilities for both cardiac and oncology applications [3][4] Company Overview - Positron Corporation specializes in developing, manufacturing, and selling state-of-the-art PET and PET-CT imaging systems and clinical services to nuclear medicine healthcare providers across North America [6][7] - The company focuses on cardiac Positron Emission Tomography (PET) imaging, which is considered the gold standard in cardiac diagnostics, enabling accurate diagnosis of coronary artery disease [7] Product Features - Positron's PET-CT scanners include a 72 cm wide-bore gantry for patient comfort, high-sensitivity detectors to reduce radiation exposure, and a compact design, making them suitable for various clinical environments [3] - The advanced data acquisition capabilities of Positron's systems allow for fast, high-precision imaging, which enhances diagnostic confidence and expands the range of studies that can be performed [4] Market Position and Future Developments - Positron's unique market position and innovative technologies, such as the upcoming Affinity PET-CT 4D 64-Slice device, are expected to facilitate the adoption of cardiac PET and support growth in the nuclear imaging market [8] - The company is committed to expanding its offerings in cardiac and oncology PET modalities, aiming to deliver superior technology and value to imaging specialists [9]
Nanox Announces Second Quarter of 2025 Financial Results and Provides Business Update
Globenewswire· 2025-08-12 12:00
Core Insights - Nanox Imaging Ltd. reported a net loss of $14.7 million for Q2 2025, an increase from a net loss of $13.6 million in Q2 2024, primarily due to higher gross loss and finance expenses [4][15] - The company generated revenue of $3.0 million in Q2 2025, up from $2.7 million in Q2 2024, driven by teleradiology services, imaging systems sales, and AI solutions [5][8] - Nanox is on track to meet its year-end deployment target for the Nanox.ARC system, with a growing commercial pipeline and a breakthrough in the European market [3][18] Financial Performance - The gross loss for Q2 2025 was $3.2 million, with a gross loss margin of 107%, compared to a gross loss of $2.9 million and a margin of 106% in Q2 2024 [6][8] - Non-GAAP gross loss for Q2 2025 was $0.6 million, compared to $0.2 million in Q2 2024, indicating a worsening trend in operational efficiency [16][47] - Research and development expenses remained stable at $4.8 million for both Q2 2025 and Q2 2024, while sales and marketing expenses increased to $1.2 million from $0.8 million [12][13] Business Developments - The company has expanded its customer base, including major medical imaging center chains in the U.S., and is preparing for the first system shipment to Romania [8][3] - Nanox has notified the FDA of its intent to submit the TAP2D software module for a 2D view image output, enhancing the functionality of the Nanox.ARC systems [8] - A multi-year Volume Supply Agreement was established with Fabrinet to support scalable production of Nanox.ARC X [8] Liquidity and Capital Resources - As of June 30, 2025, the company had total cash and equivalents of $62.6 million, down from $83.5 million at the end of 2024, with a negative cash flow from operations of $19.6 million during the reported period [19][20] - The total assets decreased to $184.2 million from $210.0 million at the end of 2024, reflecting a decline in cash and marketable securities [30][20] Shareholder Information - The company had approximately 63.9 million shares outstanding as of June 30, 2025, a slight increase from 63.8 million shares at the end of 2024 [21][20] - The accumulated deficit increased to $401.7 million as of June 30, 2025, compared to $373.7 million at the end of 2024 [30][20]
Perimeter Announces Preliminary Unaudited Revenues for the 2025 Second Quarter; Reduces Operating Costs by ~30% as Company Focuses on Commercial Sales Pipeline and Growth Opportunities
Prnewswire· 2025-08-11 20:15
Core Viewpoint - Perimeter Medical Imaging AI, Inc. reported preliminary unaudited revenues for Q2-2025, indicating significant growth and management changes, alongside the establishment of an Industry Advisory Board to support future growth strategies [1][3][5]. Financial Performance - Total revenue for Q2-2025 is anticipated to be approximately $500,000, reflecting a year-over-year growth of about 100% [3]. - The company expects over 35% growth in procedures, leading to more than 50% growth in recurring revenue compared to Q1-2025, driven by increased utilization of the Perimeter S-Series system [3]. - For the six-month period ending June 30, 2025, total revenue is projected to be around $1.0 million, compared to $345,000 for the same period in 2024 [4]. - Gross margin is expected to be approximately 69% for Q2-2025 and 61% for the six-month period ending June 30, 2025 [4]. Management Changes - Abbey Goodman has been appointed as Vice President of Sales, bringing over 20 years of medical device sales experience [7]. - Paolo DiPasquale has been appointed as Vice President of Corporate Development, with over 17 years of experience in capital markets [8]. - Tom Boon has retired as Chief Operating Officer but will continue to contribute to the company’s strategy through the newly formed Industry Advisory Board [9]. Industry Advisory Board - The newly created Industry Advisory Board will be chaired by Diana Chan, who has over 20 years of experience in the medical device industry [10]. - The board aims to support the company's growth strategies across various products and markets [10][11]. Future Outlook - The company anticipates initial savings from cost control efforts, projecting a 30% reduction in total operating costs starting in Q3-2025 [5]. - The sales pipeline is expected to continue building, with the Premarket Approval application for the next-generation Perimeter B-Series under review with the FDA [5].
Varex Imaging(VREX) - 2025 Q3 - Earnings Call Transcript
2025-08-07 22:00
Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $203 million, a decrease of 3% year over year, with the Medical segment down 4% and the Industrial segment up 1% [8][22] - Non-GAAP gross margin was 34%, which is 100 basis points higher than the same quarter last year [8][25] - Non-GAAP earnings per share increased to $0.18, up from $0.14 in the previous year [8][27] - Operating expenses were unusually high at $148 million, primarily due to a non-cash goodwill impairment charge of $94 million [25][28] Business Line Data and Key Metrics Changes - Medical revenues were $142 million, accounting for 70% of total revenues, while Industrial revenues were $61 million, making up 30% [22] - Sales in oncology and mammography modalities were above their respective sales trends, while sales in fluoroscopy were below trend [10][11] - Demand in the Industrial segment remained strong, particularly in cargo inspection systems and security screening components [11][20] Market Data and Key Metrics Changes - Americas saw a 1% increase in revenues year over year, while EMEA revenues were down 2% and APAC decreased by 8% [23] - Sales volume to China contributed 15% of total revenues, with a 4% increase year over year [23][24] - The company was able to accommodate shipment needs in China after tariffs dropped from 145% to 55% [6][7] Company Strategy and Development Direction - The company is expanding its manufacturing capabilities in India to establish low-cost production for radiographic components [12][13] - The focus on photon counting technology is expected to contribute significantly to revenue, with anticipated contributions of $150 million from medical and $50 million from industrial applications [54][58] - The company is ramping up system production in the UK and investing in its Las Vegas facility to support the growing demand in the cargo systems business [19][20] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the stability and health of demand in China, expecting it to remain normal barring external events [33][34] - The overall demand environment for capital spending in the medical sector appears healthy, with expectations for growth entering fiscal year 2026 [48][49] - Management indicated that the company is in a comfortable cash position and plans to target gross debt in the range of $300 million to $350 million [36][37] Other Important Information - The company paid off $200 million in convertible notes, reducing its overall debt burden [8][28] - The company expects fourth-quarter revenues to be between $210 million and $230 million, with non-GAAP earnings per diluted share expected between $0.10 and $0.30 [29][30] Q&A Session Summary Question: Did fulfilling orders to China result in higher than expected expenses? - Management confirmed that there were no higher than normal expenses related to fulfilling orders to China [32] Question: What are the expectations for China sales in Q4? - Management stated that demand in China is stable and healthy, expecting it to remain normal [33] Question: Are there any medical OEMs testing the photon counting technology? - Management confirmed ongoing activity with medical OEMs focusing on photon counting technology [34] Question: What is the plan for using operating cash to pay down debt? - Management indicated a comfortable cash situation and plans to continue building cash reserves before refinancing in the next 12-18 months [36] Question: Can you characterize the capital spending environment? - Management noted that the demand pattern is good, and the overall investment perspective in imaging seems decent [48] Question: What is the outlook for gross margin in Q4? - Management explained that the expected decrease in gross margin is due to tariff impacts and a shift in product mix [80][83] Question: What is the status of the tariff mitigation strategy? - Management reported good progress in redirecting supply chains and increasing local manufacturing to mitigate tariff impacts [96][100]
Guerbet : H1 2025 revenue
Globenewswire· 2025-07-24 15:45
Core Insights - Guerbet reported a total revenue of €387.8 million for the first half of 2025, reflecting a decrease of 7.5% compared to the same period in 2024, with a negative foreign exchange impact of €8.0 million [4][9][15] - The company confirmed its full-year revenue growth target of 3-5% at constant exchange rates and on a like-for-like basis, anticipating a recovery in the second half of the year driven by normalization in France and growth in specific products [15][16][17] Financial Performance - Group sales for H1 2025 were €387.8 million, down 7.5% from H1 2024, with a 5.6% decline at constant exchange rates (CER) [4][9] - Revenue breakdown by region showed EMEA sales at €169.6 million (-7.4%), Americas at €124.6 million (-5.5%), and Asia at €98.6 million (-9.1%) [5][8] - Diagnostic Imaging revenue decreased by 8.8% to €334.0 million, while Interventional Imaging saw a growth of 3.5% to €51.9 million [11][13][14] Geographical Insights - In EMEA, revenue fell by 7.7% at CER, primarily due to a decline in France, which was affected by distribution channel reforms; excluding France, EMEA grew by 6.9% [7] - The Americas maintained stable sales at CER, attributed to solid volume growth despite price pressures [8] - Asia experienced a decline of 7.3% at CER, although the second quarter showed a positive trend with a 1.2% increase [8] Future Outlook - The company expects double-digit growth in H2 2025, driven by a favorable comparison base and the normalization of activity in France [9][16] - Continued proactive cost management and a positive product mix are anticipated to support profitability, with a restated EBITDA margin expected to exceed 15% [17]